worldwide survey highlights current cataract surgery ...€¦ · cataract and refractive surgery...

57
Sean Henahan in Paris CLINICAL practice patterns of European and US cataract surgeons are becoming more similar, although some interesting and important differences continue to distin- guish the two groups, according to David Leaming MD. Dr Leaming will present a comparison study of practice styles of European and American surgeons at the XXII Congress of the ESCRS in Paris. He will compare the responses of 964 US surgeons surveyed by mail with those of 500 European surgeons who responded to an on site survey con- ducted at last year’s ESCRS Congress in Munich. The surveys showed similar practice pat- terns in terms of the use of anaesthesia. Topical anaesthesia was the favourite among 58% of the US respon- dents and 47% of the EU respondents, with retrobulbar second in US (24%) and peribul- bar second in EU (24%). US surgeons appeared more likely to use intracameral lidocaine than their European colleagues. Surgeons from both regions are more likely to use temporal, clear corneal, and sutureless incisions. A majority of both groups said they used Alcon phaco machines. Both groups also expressed a preference for acrylic as an optic material. Following the US trend where virtually all cataract surgeries are performed on an out- patient basis, 76% of cataract procedures in Europe now reportedly take place in the outpatient setting. “While there is much more variety in practice styles in Europe between individual countries, both societies as a whole seem to following a similar path,” he said. Regional differences among European respondents were particularly notable regarding extracapsular cataract extraction (ECCE).While 80% of US respondents said they perform no ECCE, only 37% of the Europeans said they did not perform the procedure at all.While respondents from Finland, Belgium, the UK and Switzerland rarely if ever perform ECCE; the procedure is still used in countries as diverse as Greece, Hungary, Italy, and Spain. Dr Leaming began surveying US eye sur- geons in 1984, and has done so annually ever since. He presented the results of a 2003 survey of nearly 1000 ASCRS mem- bers at the annual meeting of the ASCRS earlier this year.The results subsequently appeared in the April 2004 issue of the Journal of Cataract and Refractive Surgery. The survey respondents came from all regions in the US and ranged in age from 25 to more than 60 years old.The majority of respondents, 59%, were members of group practices. Some 32% of respondents were in solo practice with the remainder reporting that they were part of multispe- ciality practices. An analysis of monthly surgical volume responses indicated that overall cataract surgery volume continued to increase from the year before. Dr. Leaming estimated that US cataract surgery volume in 2003 exceeded 2.7 million procedures, well above the 2002 estimate of 2.4 million proce- dures. A look back at previous survey years shows that cataract surgery volume decreased slightly in 1997 and 1998, but rebounded in 2000.This apparently coin- cides with the rapid growth of interest in LASIK and subsequent flattening of that market during the same period, he noted. Ninety-seven percent of ASCRS respon- dents performed phacoemulsification in their cataract patients, a number that was echoed by European respondents. Phaco volume varied widely with 27% of US sur- geons and 19% of Europeans performing 16-25 phaco procedures per month, 32% of both groups performing up to 50 proce- dures per month and 17% and 22% of US and European surgeons, respectively, per- forming more than 50 procedures. Bimanual phaco appears to be catching on in the US, with 16.5% reporting they were now using the technique.Another 20% said they planned to switch to bimanu- al phaco within 12 months.The European survey also revealed a high level of interest in bimanual small incision surgery. The US respondents expressed enthusi- asm for new machines, with 44% saying the AMO Sovereign Whitestar held the greatest promise for bimanual small incision surgery. Another 28% expressed support for the Alcon Legacy, and 18% for the Alcon Infiniti Aqualase system. European respondents similarly showed strong interest in the Alcon Infiniti and the AMO Sovereign machines. In patients with bilateral cataract, almost half of US respondents said they perform cataract surgery in the second eye within three weeks. Most said they perform the second surgery within a month of the first. Less than one percent of surgeons said they performed bilateral same-day surgery. In contrast, 12% of the European surgeons reported that they did perform bilateral, same-day surgery on occasion. The surveys also yielded interesting clues regarding IOL choice. Some 70% of those surveyed in the US felt that acrylic is the best optic material.A majority, 87%, said the Alcon Acrysof was their preferred acrylic lens, followed by the AMO Sensar, preferred by 12%. Among Europeans, the Acrysof and Sensar IOLs were the most popular. The AMO SI-40 was the silicone lens most US surgeons used, followed by the Solfles/L161U,AMO Clariflex, and the recently approved AMO Tecnis lens. Europeans favoured the AMO SI-40, the Ceeon,Clariflex and Tecnis lenses. Staar’s Collamer lens was the hydrogel most mentioned by US respondents, accounting for 70% of the total, with 15% citing the B&L Hydroview and another 15% choosing the Ciba/Novartis Memory Lens. The Hydroview and MemoryLens were most cited by the Europeans surveyed. There was little agreement among the respondents when they were asked which IOL material appeared most promising for small incision surgery.There were advocates for foldable acrylics, silicone foldables, hydrogels and even injectable lens materials. Most US surgeons (93%) are not implant- ing the as yet unapproved phakic IOLs.A few pioneers are implanting a few phakic IOLs each month.However, the survey did show a high degree of interest in phakic IOLs among respondents and the number of implants is likely to jump after approval. Both the AMO Verisyse and the Staar ICL are close to approval in the US. Perhaps waiting for more clinical study results, the US surgeons reported only moderate interest in multifocal IOLs, toric IOLs, and thin optic diffractive IOLs.They showed considerably more enthusiasm for aspheric IOLs and accommodating IOLs. Interestingly, the European respondents expressed a higher degree of interest in multifocal IOLs than their US colleagues. Contact applanation continues to be the primary method chosen for A-scans, pre- ferred by 60% in the US survey.Another 29% use partial coherence interferometry and the remainder use the non-contact immersion method. However, partial coher- ence interferometry gained a few percent- age points from the year before, while con- tact applanation appears to have declined slightly in recent years, he noted. Prednisolone was by far the most pre- ferred anti-inflammatory used in the US postoperatively, while Europeans opted for dexamethasone. Preferred prophylactic antibiotics included:tobramycin (Tobrex, Alcon), gatifloxacin (Zymar Allergan); moxi- floxacin (Vigamox,Alcon); Ofloxacin (Ocuflox,Allergan); and Levofloxacin (Quixin, Santen). The survey also provides some clues to the current level of job satisfaction among US eye surgeons.While half of the respon- dents reported being as satisfied with work as they had been one year previously, another 27% said they were ‘somewhat less satisfied” or ‘much less satisfied’ with the job. Money worries could be a factor in job satisfaction.The survey saw many reporting that their offices had significant suffered fraud or embezzlement in the past three years. Some 28% of surgeons reported los- ing between $5,000 and $25,000, with another 17% reporting losing more than $25,000. Dr Leaming’s surveys provide some of the only national and international data on cataract and refractive surgery practice pat- terns. However, he cautions that the sur- veys have a number of weaknesses. For example, the US survey was presented in multiple-choice format, increasing the chances for bias to enter in. Other caveats are the limited sample sizes and the fact that the surveys query ASCRS members and ESCRS conference attendees, rather than all ophthalmologists who perform cataract and refractive surgery in the respective regions. David Leaming [email protected] Worldwide survey highlights current cataract surgery practice trends David Leaming MD

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Page 1: Worldwide survey highlights current cataract surgery ...€¦ · cataract and refractive surgery practice pat- ... and ESCRS conference attendees,rather ... Worldwide survey highlights

Sean Henahanin Paris

CLINICAL practice patterns of Europeanand US cataract surgeons are becomingmore similar, although some interesting andimportant differences continue to distin-guish the two groups, according to DavidLeaming MD.

Dr Leaming will present a comparisonstudy of practice styles of European andAmerican surgeons at the XXII Congress ofthe ESCRS in Paris. He will compare theresponses of 964 US surgeons surveyed bymail with those of 500 European surgeonswho responded to an on site survey con-ducted at last year’s ESCRS Congress inMunich.

The surveys showed similar practice pat-terns in terms of the use of anaesthesia.Topical anaesthesia was the favourite among

58% of the US respon-dents and 47% of theEU respondents, withretrobulbar second inUS (24%) and peribul-bar second in EU(24%). US surgeonsappeared more likelyto use intracamerallidocaine than theirEuropean colleagues.

Surgeons from bothregions are more likely

to use temporal, clearcorneal, and sutureless incisions.A majorityof both groups said they used Alcon phacomachines. Both groups also expressed apreference for acrylic as an optic material.

Following the US trend where virtually allcataract surgeries are performed on an out-patient basis, 76% of cataract procedures inEurope now reportedly take place in theoutpatient setting.

“While there is much more variety inpractice styles in Europe between individualcountries, both societies as a whole seemto following a similar path,” he said.

Regional differences among Europeanrespondents were particularly notableregarding extracapsular cataract extraction(ECCE).While 80% of US respondents saidthey perform no ECCE, only 37% of theEuropeans said they did not perform theprocedure at all.While respondents fromFinland, Belgium, the UK and Switzerlandrarely if ever perform ECCE; the procedureis still used in countries as diverse asGreece, Hungary, Italy, and Spain.

Dr Leaming began surveying US eye sur-geons in 1984, and has done so annuallyever since. He presented the results of a2003 survey of nearly 1000 ASCRS mem-bers at the annual meeting of the ASCRSearlier this year.The results subsequently

appeared in the April 2004 issue of theJournal of Cataract and Refractive Surgery.

The survey respondents came from allregions in the US and ranged in age from25 to more than 60 years old.The majorityof respondents, 59%, were members ofgroup practices. Some 32% of respondentswere in solo practice with the remainderreporting that they were part of multispe-ciality practices.

An analysis of monthly surgical volumeresponses indicated that overall cataractsurgery volume continued to increase fromthe year before. Dr. Leaming estimated thatUS cataract surgery volume in 2003exceeded 2.7 million procedures, well abovethe 2002 estimate of 2.4 million proce-dures.

A look back at previous survey yearsshows that cataract surgery volumedecreased slightly in 1997 and 1998, butrebounded in 2000.This apparently coin-cides with the rapid growth of interest inLASIK and subsequent flattening of thatmarket during the same period, he noted.

Ninety-seven percent of ASCRS respon-dents performed phacoemulsification intheir cataract patients, a number that wasechoed by European respondents. Phacovolume varied widely with 27% of US sur-geons and 19% of Europeans performing16-25 phaco procedures per month, 32% ofboth groups performing up to 50 proce-dures per month and 17% and 22% of USand European surgeons, respectively, per-forming more than 50 procedures.

Bimanual phaco appears to be catchingon in the US, with 16.5% reporting theywere now using the technique.Another20% said they planned to switch to bimanu-al phaco within 12 months.The Europeansurvey also revealed a high level of interestin bimanual small incision surgery.

The US respondents expressed enthusi-asm for new machines, with 44% saying theAMO Sovereign Whitestar held the greatestpromise for bimanual small incision surgery.Another 28% expressed support for theAlcon Legacy, and 18% for the Alcon InfinitiAqualase system. European respondentssimilarly showed strong interest in theAlcon Infiniti and the AMO Sovereignmachines.

In patients with bilateral cataract, almosthalf of US respondents said they performcataract surgery in the second eye withinthree weeks. Most said they perform thesecond surgery within a month of the first.Less than one percent of surgeons said theyperformed bilateral same-day surgery. Incontrast, 12% of the European surgeonsreported that they did perform bilateral,same-day surgery on occasion.

The surveys also yielded interesting cluesregarding IOL choice. Some 70% of those

surveyed in the US felt that acrylic is thebest optic material.A majority, 87%, said theAlcon Acrysof was their preferred acryliclens, followed by the AMO Sensar, preferredby 12%.Among Europeans, the Acrysof andSensar IOLs were the most popular.

The AMO SI-40 was the silicone lensmost US surgeons used, followed by theSolfles/L161U,AMO Clariflex, and therecently approved AMO Tecnis lens.Europeans favoured the AMO SI-40, theCeeon, Clariflex and Tecnis lenses.

Staar’s Collamer lens was the hydrogelmost mentioned by US respondents,accounting for 70% of the total, with 15%citing the B&L Hydroview and another 15%choosing the Ciba/Novartis Memory Lens.The Hydroview and MemoryLens weremost cited by the Europeans surveyed.

There was little agreement among therespondents when they were asked whichIOL material appeared most promising forsmall incision surgery.There were advocatesfor foldable acrylics, silicone foldables,hydrogels and even injectable lens materials.

Most US surgeons (93%) are not implant-ing the as yet unapproved phakic IOLs.Afew pioneers are implanting a few phakicIOLs each month. However, the survey didshow a high degree of interest in phakicIOLs among respondents and the numberof implants is likely to jump after approval.Both the AMO Verisyse and the Staar ICLare close to approval in the US.

Perhaps waiting for more clinical studyresults, the US surgeons reported onlymoderate interest in multifocal IOLs, toricIOLs, and thin optic diffractive IOLs.Theyshowed considerably more enthusiasm foraspheric IOLs and accommodating IOLs.Interestingly, the European respondentsexpressed a higher degree of interest inmultifocal IOLs than their US colleagues.

Contact applanation continues to be theprimary method chosen for A-scans, pre-ferred by 60% in the US survey.Another29% use partial coherence interferometryand the remainder use the non-contactimmersion method. However, partial coher-ence interferometry gained a few percent-age points from the year before, while con-tact applanation appears to have declinedslightly in recent years, he noted.

Prednisolone was by far the most pre-ferred anti-inflammatory used in the USpostoperatively, while Europeans opted fordexamethasone. Preferred prophylacticantibiotics included: tobramycin (Tobrex,Alcon), gatifloxacin (Zymar Allergan); moxi-floxacin (Vigamox,Alcon); Ofloxacin(Ocuflox,Allergan); and Levofloxacin(Quixin, Santen).

The survey also provides some clues tothe current level of job satisfaction amongUS eye surgeons.While half of the respon-

dents reported being as satisfied with workas they had been one year previously,another 27% said they were ‘somewhat lesssatisfied” or ‘much less satisfied’ with thejob.

Money worries could be a factor in jobsatisfaction.The survey saw many reportingthat their offices had significant sufferedfraud or embezzlement in the past threeyears. Some 28% of surgeons reported los-ing between $5,000 and $25,000, withanother 17% reporting losing more than$25,000.

Dr Leaming’s surveys provide some ofthe only national and international data oncataract and refractive surgery practice pat-terns. However, he cautions that the sur-veys have a number of weaknesses. Forexample, the US survey was presented inmultiple-choice format, increasing thechances for bias to enter in. Other caveatsare the limited sample sizes and the factthat the surveys query ASCRS membersand ESCRS conference attendees, ratherthan all ophthalmologists who performcataract and refractive surgery in therespective regions.

David Leaming

[email protected]

Worldwide survey highlights currentcataract surgery practice trends

David Leaming MD

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Daithí Ó hAnluainin Paris

PHOTOREFRACTIVE keratecto-my (PRK) may produce betterlong-term refractive stability thanLASIK in hyperopic patients, datafrom two new British studies sug-gest.

David O'Brart MD conductedtwo studies of refractive stabilityin hyperopic patients, one involv-ing LASIK, the other PRK. He willpresent the results at the XXIIannual ESCRS Congress in Paris.Both studies were conducted inthe Department ofOphthalmology, St.Thomas'Hospital, London, UK.

In the LASIK study, 26 patients(40 eyes) with hyperopia under-went LASIK, using a Moria LSKOne microkeratome to cut a flapwith a nasal hinge and a SummitSVS Apex Plus Excimer laser withan optical zone of 6.5 mm and ablend zone of 1.5 mm. Only sim-ple hyperopia was treated withno astigmatic correction.All eyeshad a follow-up of five years.

The mean age at time of sur-gery was 51 years, ranging from32 to 64 years.The preoperativemean spherical equivalent was+3.8 D.The mean attemptedLASIK correction was +3.4 D.Atfive years post-op, the meanspherical equivalent (SE) was+0.84D (range -0.375 to+3.375D) with 62.5% of eyes

within one dioptre of the intend-ed correction.

For corrections up to +3.0D,76% of eyes were within onedioptre of the intended correc-tion, compared to only 40% ofeyes for corrections between+4.0 D to +6.0 D.A statisticallysignificant reduction of refractivecorrection was found between sixmonths and five years postopera-tively, with 60% of eyes 24 eyesexperiencing an increase in hyper-opia of +0.5 D or more and 33%of eyes showing an increase of+1.0D or more.

Uncorrected visual acuity wasimproved in 95% of eyes at fiveyears and was better than 20/40in 85% of eyes and 20/25 or bet-ter in 70%. Best spectacle cor-rected visual acuity wasunchanged or improved in 85%.

Best-corrected acuity wasreduced by one line in 15% ofeyes at five year’s follow-up. Noeyes lost more than one line ofBSCVA. Clinically insignificantinterface debris was present intwo eyes. One eye had persistentmicrostriae. No eyes developedcorneal ectasia.

Dr. O'Brart concluded thatLASIK appears to be a safe andmoderately effective procedurefor the correction of low degreesof hyperopia, cautioning,

"There is, however, an increasein hyperopia over five years offollow-up, which is more than

would be expected with the phys-iological increase with age andlong-term stability of hyperopicLASIK refractive corrections aretherefore uncertain."

In the second study, Dr. O'Brartcarried out a long-term (mean 7.5years), prospective follow-upstudy to evaluate refractive stabil-ity and safety of excimer laserhyperopic PRK (H-PRK).

Twenty-one patients of an orig-inal cohort of 43 who participat-ed in one of the first clinical trialsto investigate the efficacy of H-PRK, underwent detailed clinicalassessment at a mean follow-upof 91 months (7.5 years). Patientsunderwent H-PRK with a SummitTechnology Apex Plus Excimerlaser (6.50 mm optical zone,1.5mm blend zone).The meanpre-operative SE was +4.7 diop-tres, ranging from +2D to+7.50D.

Patients were allocated to oneof four treatment groups basedon their preoperative refraction:+1.5, +3.0, +4.5 or +6.0D. Patientsin each group received an identi-cal treatment and thereforeemmetropia was not the primaryaim, Dr. O'Brart noted.

With long-term follow-up, therefractive correction remainedstable with a mean difference inspherical equivalent refractionbetween one year and 7.5 yearsof +0.28D.At 7.5 years, the meanSE was +0.83D. Sixty-seven per-

cent of eyes undergoing correc-tions of mild-to-moderate hyper-opia of +1.5 and +3.0D werewithin one dioptre of the predict-ed correction. Predictability waspoorer with +4.5 and +6.0D cor-rections with only 40% of eyeswithin one dioptre of the expect-ed refraction.

A majority of eyes, 87.5%,achieved an improvement inunaided near and distance acuity.Best spectacle corrected visualacuity was unchanged orimproved from pre-operative val-ues in 62.5% of eyes.Two eyeslost two lines of best-correctedacuity, which in one case wasattributable to cataract formationover the follow-up period.

No eyes showed any distur-bance of central corneal trans-parency.A peripheral ring of haze,6.5 mm in diameter, appeared inmost eyes at one month post-operatively. Its intensity was maxi-mal at six months and thendiminished with time. In 25% ofeyes, remnants of the haze ringwere still evident at 7.5 years.Sub-epithelial iron rings measur-ing 6.5 mm in diameter were evi-dent in 70% of eyes.

Dr. O'Brart concluded that inH-PRK refractive stabilityachieved at one year was main-tained up to 7.5 years with noevidence of hyperopic shift, diur-nal fluctuation or late regression.

Peripheral corneal hazedecreased with time but was stillevident in a number of eyes atthe last follow-up visit.

Dr. O'Brart’s study reflects thelongest follow-up data availablefor hyperopic LASIK and forhyperopic PRK in the UK, andpossibly Europe.

"I also have a very large data-base of LASEK for hyperopia,which is showing excellentresults, especially with large opti-cal zone treatments using flyingspot lasers," Dr. O'Brart toldEuroTimes.

Dr O'Brart told EuroTimesthat he was strongly opposed tothe use of phakic IOLs for hyper-opic patients, because of theirshallow anterior chambers. Heallowed that there was some rolein the presbyopic patient formulti-focal, or even some of theaccommodative IOLs.

[email protected]

PRK trumps LASIK in long-term outcomes for hyperopia

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EuroTimes September 2004

ESCRS PARIS CONGRESS

1 Survey suggests convergence of cataract surgerypractice styles in US and Europe

Two new studies suggest longterm results betterfor PRK than LASIK in treatment of hyperopia

6 French survey points to decreasing cataract surgeryincision size and increase in presbyopic surgery

8 Microincision cataract surgery increases safety indifficult cases

10 Improved outcomes achieved with enhanced cus-tom ablation platform

11 Delegation of tasks envisaged to reduce burden onFrench ophthalmologists

12 Survey suggests that most IOL explantations resultfrom preventable mistakes

13 Surveys shows differences between European andUS refractive surgery practice styles

14 Hormone treatment may increase post-LASIKregression

CATARACT AND REFRACTIVE

16 Wavefront designed aberration-neutral lensimmune to decentration

18 Tips for IOL calculation using laser interferometry

19 Autorefractors useful in predicting cataractpatients’ outcome

21 Sonic phaco may be easier on the eyes

31 LASIK enhancement corrects residual refractiveerror in phakic IOL patients

35 Toric phakic IOL effective over long term formyopic astigmatism

54 European refractive surgery volume expected toremain sluggish

65 OCT provides insight into capsule behaviourfollowing cataract surgery

OCULAR UPDATE

20 Uveitis incidence grossly underestimated

26 Glaucoma management entering new evi-dence-based era

30 Electronic approach makes it easier to keeptrack of patients

32 Caution required with systemic use of steroidsand immunosuppressants

34 Intravitreal steroid effective in treatment of macu-lar oedema

36 Aberrations influenced by neural adaptation andpulse rate

38 Research into AMD pathogenesis suggests newtreatment and prevention strategies

40 Refractive errors and ophthalmic disease and theirinfluence on the history of Art

46 Custom ablation puts the focus on quality of vision

48 Fine tuning the indications for photocoagulation inpatients with diabetic macular oedema

55 Caution urged in steroid treatment for laser retinalinjuries

56 New tamponades necessary for treating macularholes

57 Microkeratomes useful in anterior lamellar kerato-plasty procedures

58 New customisable prosthetic Iris system

60 Dacron mesh can prevent rejection of gold eyelidweights

62 New approach needed to tackle severe ocularinflammation

64 A new computer-based system provides objectivemeasurement of contrast sensitivity

FEATURES

22 EU Matters

28 Regulatory Matters

42 Out and About

44 An Eye on Travel

53 Bio-Ophthalmology

54 Journal Watch

Dan, P40-41

Wong, P56

De Angelis, P60

Busin, P57

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EuroTimes September 2004

Editorial

While writingthis editorial, dur-ing the last fewdays of August,the sun is desper-ately trying toshine throughafter one of theworst Augusts wehave had in thislittle island inNorthern

Europe. Many of you who are reading thiswill be doing so in Paris during the AnnualCongress of the ESCRS.This promises tobe our largest Congress ever as over threethousand delegates from eighty-sevencountries have pre-registered at the timeof writing this editorial.

Over a thousand abstracts were submit-ted and I am pleased to say that we haveaccepted four hundred free papers and five

hundred posters for presentation duringthe meeting.The Board of the ESCRS andthe members of the ProgrammeCommittee worked diligently to ensurethat the Scientific Programme for thismeeting would be interesting and challeng-ing for all the attendees.

The Residents Programme has been re-organised and re-named as the YoungOphthalmologists Programme as we foundthat many of the attendees were not resi-dents! This programme will include presen-tations on patient preparation, pre-opera-tive complications and refractive tech-niques.There will be a guest lecture byRobert Stegmann on “Trying to WidenLatitudes- Thirty Years On”.

On Saturday we have our ClinicalResearch Symposium discussing such var-ied topics as night vision after refractivesurgery, non-penetrating corneal transplan-tation and accommodating IOL’s.The first

ESCRS Workshop in Visual Optics has beenorganised by Marie-Jose Tassignon andIoannis Pallikaris and takes place onSunday, September 19th with presentationson Aberrations in the Living Human Eye,the Quest for Super-normal Vision andAdvances in Imaging Equipment andSoftware.In addition to the Symposia andFree Paper sessions we have eighty-sixinstructional courses and over forty surgi-cal skills training courses that are almostfully booked.

This year we have one hundred andsixty seven companies exhibiting duringthe Congress and I am sure you will alltake time between lectures to visit thebooths and support our colleagues in thetrade, all of whom we would like to thankfor their continued support and sponsor-ship for this meeting.

EuroTimes has been working togetherwith the industry to organise ten Satellite

Educational Programmes outside the timeof the main scientific programme.Thisgives Industry the independence theyrequire while making sure there are nomajor educational clashes with our coreprogramme.

.I hope that by the time you open yourcopy of EuroTimes the summer has man-aged to resurrect itself and that those whohave managed to “get away” will be havingan enjoyable warm and stimulating meetingin Paris. If you cannot be with us this yearmark your calendar for Lisbon 2005.

WELCOME TO PARIS 2004 Clive Peckar

The Clinical Cornea Committee of the ESCRS is conducting an epidemiological survey oncorneal ectasia following corneal excimer laser surgery.The survey’s aims are to discoverthe true incidence of the complication and the risk factors associ-ated with it.

“In the past years we have had reports of ectasia in the UnitedStates but we don’t have any idea of the epidemiology in Europe.So the goal is to ask the maximum number of European surgeons

to participate and to try to have a more accu-rate evaluation of this very severe complica-tion,” explained Joseph Colin MD, who will becoordinating the survey.

The Committee is inviting surgeons whohave seen cases of ectasia to visit the surveywebsite where they will be asked to anony-mously provide details about the patient and the surgery they under-went.

The information requested will include the age and sex of the patientand their preoperative refraction together with other preoperative details such as corneal

thickness and topography. Participants will also be asked to provide surgical details such asthe optical zone, the depth of ablation, model of laser, model of laser and microkeratome

used and the intended flap thickness. In addition they will beasked to provide postoperative findings such as corneal topogra-phy, keratometry, corneal thickness, refraction, and visual acuity.

Dr Colin said that the study may help identify the risk factorsfor ectasia and thereby enable surgeons to avoid the complicationin the future.The results of the survey will appear in the Journalof Cataract and Refractive Surgery and EuroTimes.

Ectasia Study Websitewww.escrs.org/Corneal_Ectasia.asp

ESCRS announces online European survey of kerate-ctasia following refractive surgery

So the goal is to ask the maximum number of European

surgeons to participate and to tryto have a more accurate evaluation

of this very severecomplication,”

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REFLECTIONS ONREFRACTIVE SURGERY

By Olivia Serdarevic

There have been ongoing advances on customised corneal laser recontour-ing, resulting in less induced optical aberration.The main sources for thecontinuing improvement in refractive and functional results are the sameones I wrote about in this column in November 2002 – “refined nomo-grams, better contour profiles, enlarged optical and blend zones, corneal tis-sue sparing and more accurate tracking and centration – and not wave-front”.

Wavefront technology has been the most useful for diagnostic purposes-not treatment. Improvements in the application of wavefront technologyhave increased our diagnostic capabilities and have allowed us to betterunderstand and evaluate the optical effects of our laser treatments.Aberrometers are evolving with higher dynamic ranges and higher spatialresolution.Aberrometry measurements need to differentiate contributionsfrom various parts of the eye. Simultaneous measurement of corneal curva-tures and optical aberrations is advantageous.

Diagnostic instrumentation to analyse how optical aberrations areprocessed centrally in each patient is not yet available.This type of analysis

will be necessary to gauge neural summationand neuroplasticity – which varies from patientto patient but is known to be markedlyreduced after childhood.

Paul-Rolf Preussner M.D. of Mainz, Germanyrecently quantified the limits of the wavefront approach for correction ofoptical errors of the human eye. He compared optical path length differ-ence (wavefronts) and refractive errors (angular deviation of rays). Hedemonstrated that “wavefront errors determined preoperatively cannot beused for optimisation of the optical quality if the surgical procedure coversa range of many (5-10) dioptres in defocusing power.Approximation of thewavefront error by a Zernicke polynomial series induces additional errors”.Dr Preussner concluded that “the poorer the visual function of a patient’seye, the less it can benefit from corrections calculated using the wavefrontapproach.”

Wavefront technology was developed for devices of much higher accura-cy than the human eye.This technology has been very useful for adjust-ments of the optical surface by telescopes by adaptive circuits.

Wavefront technology can be used to analyse the optics of the eye butcannot be “used to maintain the physiology of the cornea” and should notbe the only guide for laser ablation.

Customised AblationShould it be called Wavefront Guided?

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6

Dermot McGrathin Paris

A MARKED decrease in thesize of the incision for cataractsurgery and a significant rise inthe number of refractive proce-dures for presbyopia were amongsome of the more notable findingsof the latest survey of Frenchophthalmologists which RichardGold MD will be presenting atthis year’s annual congress of theESCRS.

In the seventh of his annual sur-veys of French practices in oph-thalmic surgery, Dr. Gold collected1,303 responses to an anonymousquestionnaire sent to over 5,700French ophthalmologists.Theresponse rate of 22.5% was amarked improvement on lastyear’s return of 19%, which wasthe lowest recorded since 1999.

“It was encouraging to see theresponse rate rise again after lastyear’s disappointing figure,”remarked Dr Gold, who said thatthis year’s survey provided someinteresting findings.

“For cataract surgery, I wouldparticularly highlight the decreaseof the incision size and theincreasing use of injectors as sig-nificant, while on the refractiveside, we are seeing a sharp

increase in presbyopia surgeryand an increasing use of refractiveIOLs,” he said.

As well as providing valuableinsights into trends and develop-ments in clinical practice, DrGold’s questionnaire serves as auseful barometer of the currentwell being of French ophthalmolo-gy in general.

The proportion of French oph-thalmologists with a low volumeof cataract surgery continued todecline, with 13% performingfewer than 100 cataract surgeriesper year, down from 22% in 1998.

The proportion performingbetween 100 and 199 proceduresannually increased slightly from27% to 28%, while the proportionperforming 200 to 300 per yearremained stable at 23%.At thehigh volume end of the spectrum,those treating 300 to 500 casesper year increased to 22% com-pared to 15% for 1998, while theproportion treating 500 or morerose from 10% to almost 12%.

Phacoemulsification is nowalmost universally established asstandard in cataract surgery inFrance, according to Dr Gold, for-mer Head of the Department ofOphthalmology at the Cognacq-Jay Hospital, Paris, and now in pri-vate practice at Le Raincy, France.In 1998, 95% of surgeons usedphacoemulsification for most oftheir cataract extractions, com-pared to over 98% in 2003.

Most respondents (92%) usedclear corneal incisions.The size of

the incisions used by French oph-thalmic surgeons for cataract sur-gery has continued to decreaseover the past few years.

In 1998, 28% of respondentssaid they used incisions greaterthan 4.0 mm compared to only3% in 2003, while those using inci-sions 3.2 mm or smaller took amajor leap to 49% from 34% in2002.Almost 4% of surgeons nowroutinely use incisions of less than2.8 mm compared to less than 1%when the survey started.

The use of injectors forcataract surgery has shown a dra-matic increase in recent years,noted Dr Gold, with 78% ofrespondents using injectors in2003 compared to 61% in 2002and just 21% in 1998.

Duovisc continues to be themost popular viscoelastic inFrance, used by 58.5% of respon-dents, followed by Viscoat (15%)and the remainder evenly dividedbetween Ophtalin,Amvisc,Healon, and Healon GV.OUTPATIENT SURGERY YET TODOMINATE

Ambulatory cataract surgery waspracticed by just over half ofrespondents (53%). Some 18% ofrespondents kept patients in hos-pital overnight. Just over onequarter of surgeons kept patientsin for two nights, with just 3%keeping them in for more thantwo nights. In terms of anaesthe-sia, Dr Gold found a slight trend

towards greater use of topicalanaesthesia, up to 17% for 2003compared to 6% for 1999.However, the French preferencefor peribulbar remains strong(56%) even though its use hasdeclined from its peak of 77% in2000. More than 13% of respon-dents used topical plus intracam-eral lidocaine, another 10% saidthey used sub-Tenons anaesthesia,while five percent preferredretrobulbar. Only one percentused general anaesthesia.For implants, foldable acrylics con-tinue to gain in popularity, with aslight preference for hydrophobicacrylic IOLs (66%) compared to

hydrophilic (60%, up from 49%in 2002).

The years of Dr Gold’s surveycharts the steady decline in use ofPMMA IOLs, down from 57% in1998 to only 13% in 2003. Siliconeimplants are also on the wane,from 31% in 1998 to just ninepercent in 2003.

As with cataract surgery, only asmall proportion of respondentsperformed refractive surgery at ahigh volume. Only 3% of respon-dents performed more than 300refractive procedures per year,12% performed 100 to 199 peryear, and the vast majority (78%)performed less than 100 proce-dures per year.Among therespondents who practicedrefractive surgery, all treated

myopia, 90% treated astigmatism,and 76% treated hyperopia.

The biggest leap, however, wasfor presbyopia procedures, up to19% compared to eight percent in2002 and just three percent in1998 when the survey first started.

The French preference for usingPRK to treat myopia was againconfirmed, with 82% of respon-dents expressing a preference forthat technique. LASIK however isslowly but surely making inroadsinto French practices, with 71%now using it for that indication,compared to just 31% back in1998.

The use of LASIK for the treat-ment of astigmatism alsoremained steady.The procedurewas used by two-thirds (66%) ofrespondents for that indication in2003, compared to 62% in 2002.

PRK use continues to declinefor treating astigmatism, downfrom 60% in 2002 to 56% lastyear, and considerably less than its75% high in 1998.

Clear lensectomy is the thirdmost widely practiced procedurefor myopia, its use remaining sta-ble between 1998 and 2003 at33%.The Artisan anterior cham-ber IOL continues to grow inpopularity with French ophthal-mologists, with 14% implanting thedevices in 2003 compared to lessthan one percent in 1998.

In contrast with its use inmyopia, LASIK continues to out-strip PRK in the treatment of

Incision size decreases, presbyopic surgery upsurge in French survey

Richard Gold MD

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7

hyperopia in France. More thanhalf (57%) of the respondentsused LASIK for treating hyperopia,while only 36% used PRK.

Phakic IOLs also gained in pop-ularity as a treatment for hyper-opia, with 12% of respondentsimplanting them in 2003, com-pared to only 4.4% in 1998 andnine percent in 2001.

For the treatment of presby-opia, nine percent of respondentsexpressed a preference for usingIOLTECH’s Newlife implant, thefirst time it has ever featured inthe survey. LASIK (6.5%) andPRELEX (6.2%) were the nextpreferred techniques for treatingpresbyopia,

While the use of topographicsystems has become almost uni-versally accepted in France, withover 95% of respondents nowusing topography in their refrac-tive procedures, the figure hasdeclined slightly from last year’s99% figure. Dr Gold surmised thatthis was probably due to theincreasing popularity of implantsin refractive surgery, requiring lesssystematic use of topography.

Orbscan remains the most pop-ular system for corneal mapping,used by almost one third (30%) ofrespondents ahead of EyeSys(21%) and TMS ((22%).

In microkeratome use, theHansatome (57%) is still the mostpopular followed by the MoriaCarriazo-Barraquer (35%).In terms of laser choice, twobrand names,Technolas (47%) andNidek (30%), continue to domi-nate the French market.

JOB

SATISFACTION

Some of the more intriguing

findings of Dr Gold’s survey con-

cerned the demographic profileand job satisfaction rating ofFrench ophthalmologists. Henoted that the number of women

responding to the survey had

grown steadily over the years(26% in 1998 compared to 41% in2003), reflecting the fact that oph-thalmology was less and less thepreserve of male physicians.

In terms of job satisfactionamong ophthalmologists, whenasked whether they would havebecome physicians if they hadknown what it would be like, 27%said they would not, a figure thathas remained steady over the pastseven years. One in twentyrespondents (5%) said that theywould choose another professionother than ophthalmology if theyhad the opportunity to go backand change their career path, upjust slightly from 3.9% in 1998.

A new question this year con-cerned the amount of holidaystaken by French ophthalmologists.The majority (61%) took between30-60 days annual leave everyyear, one quarter (26%) tookbetween 15-30 days, and only3.5% took less than 15 days.

[email protected]

The proportion of French ophthalmologists with lower volumes of cataract surgery has continued todecline over the years surveyed, while the proportion with higher volumes has steadily increased.

Most respondents (92%) used clear corneal incisions. The size of the incisions used by French ophthalmic surgeons for cataract surgery has continued to decrease over the past few years.

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EuroTimes September 2004

Cheryl Guttmanin Paris

BIMANUAL microincision pha-coemulsification instrumentationand techniques are proving valu-able in the management of a vari-ety of challenging situations,according to I. Howard Fine MD.

Dr. Fine will demonstrate how abimanual microincision approachenabled completion of cases com-plicated by zonular weakness ordialysis and recurrent microhy-phaema in a presentation at theXXII Congress of the ESCRS

He will also discuss usingbimanual microincision phaco as atool for optimising the safety oflens removal in eyes undergoingrefractive lens exchange.

“Bimanual microincision surgeryoffers improved fluidics along withenhanced chamber stability, and itgreatly minimises incisional out-flow so that it approaches theideal scenario of operating in acompletely closed system.Because of those reasons, sur-geons can use it to their advan-tage in a variety of difficult scenar-ios,” said Dr. Fine, clinical associateprofessor of ophthalmology, CaseyEye Institute, Oregon HealthSciences University, Eugene.

In any eye where there is zonu-lar damage, capsulorhexis creationcan be performed more easily,safely, and accurately using themicroincision capsulorhexis for-ceps designed for placementthrough a 1.2-mm incision.

Since no viscoelastic leaves theeye, there are no fluctuations inthe anterior chamber.Consequently, the capsular open-ing can be made very preciselywithout trampolining the lens andcausing stress on the remainingzonular fibres.

“There is a learning curve forthis technique because the sur-geon has to use the fingersinstead of the wrist. However, thefact is the fingers are much moreskilled, and I have been amazed athow precise and round the capsu-lorhexis is when made using thisapproach,” Dr. Fine said.

Two microincision capsulorhex-is forceps are available on themarket – the Fine-Hoffman for-ceps (Microsurgical Technology)

and the Fine-Ikeda forceps(ASICO).

Cataract removal has also beenfacilitated in eyes with zonulardialysis using bimanual microinci-sion techniques and technology,Dr. Fine said.

He illustrated that point withtwo cases, the first featuring asubluxated, posteriorly prolapsedlens associated with torn zonulesin all but the inferior quadrant. Inthat eye, Dr. Fine first used vis-coelastic to elevate thelens and capsule into theanterior chamber byplacing the Viscoat can-nula through onemicroincision and an irri-gating handpiece throughthe other. He then slight-ly constricted the pupiland performed bimanualphacoemulsification toremove the cataract.

Next, he performedvitrectomy using amicroincision high-speedvitrector, and introduceda foldable IOL through a2.5 mm incision createdbetween the two biman-ual microincisions.Toimplant the lens, heplaced the hapticsthrough the pupil andsutured them to the iriswhile leaving the optic inthe anterior chamber. Hethen gently nudged theoptic behind the pupil.

In another case of apatient who had sufferedtraumatic zonular dialysissuperiorly, the versatilityand control afforded bybimanual microincisionphaco enabled Dr Fineto pull the anteriorchamber contentstoward, versus awayfrom, the area of dialysisin order to minimisestress on the residual zonularfibres. In that case, the zonulardialysis was located to the left andwould become stressed whenworking temporally with his righthand holding the phaco tip andthe aspirator held in his left.Toresolve that situation, Dr. Finesimply switched instrumentsbetween his two hands.

“As in all cases of zonularweakness, I began by performing acapsulorhexis using a microinci-sion technique, and then in thiscase I placed a capsular tensionring and hydro-expressed the lensout of the bag. However, as Ibegan phaco and as soon as the

aspiration came on, all of theintraocular contents would bepulled toward the phaco tip in myright hand. Faced with the poten-tial for unzipping the attachedzonules that were located towardthe left, I instead used the phacotip in my left hand and aspiratorin my right so the intraocular con-tents would move in the directionof the zonular dialysis and allowthem to remain relaxed,” heexplained

In a case where bleeding devel-oped around the iris peripheryfollowing pupillary stretching, Dr.Fine used bimanual microincisioninstrumentation to effectivelytreat the microhyphaema intraop-eratively.

After making two side port inci-sions, he placed the irrigatorthrough one and a microcauterydevice through the other and letthe infusion from the irrigatorflow in until the IOP rose highenough to stop the bleeding.Next, he pinched the infusion tub-ing, allowing the eye to soften andcausing the bleeding to restart so

he could identify its sites of originand use wet field cautery toachieve haemostasis.

Dr. Fine also cited the efficiencyand safety of bimanual microinci-sion surgery for refractive lensexchange in eyes with a very softnucleus. In that situation, his tech-nique involves creation of twomicroincisions that are almost at aright angle to each other – theleft microincision is made almosthorizontally and the microincision

on the right is made to be almostvertical.

After creating the capsulorhexisand performing cortical cleavinghydrodissection to bring thenucleus out of the bag into theplane of the capsulorhexis, heplaces the phaco needle on theequator of the nucleus to theright and uses it in concert withthe irrigator to carousel the lens.

With that approach, lensremoval is achieved withoutphaco power in most cases and ata site that is remote from theposterior capsule and cornealendothelium. In addition, keepingthe irrigator in the eye

throughout the entire procedurefurther enhances safety since itminimises the risk of trampoliningthe vitreous face and causing cys-toid macular oedema.

“While it may seem counterin-tuitive, it is actually more difficultto perform coaxial phacoemulsifi-cation on a soft nucleus comparedwith a 2 or 3+ nuclear scleroticcataract because the soft nucleuscannot be chopped and does notbehave predictably.

Using a bimanual technique afterperforming cortical cleavinghydrodissection, it is possible tosimply tilt the needle back intothe capsule and remove the entirecortical envelope in the plane ofthe capsulorhexis in a single gulpusing fluidics alone,” Dr. Fine said.

[email protected]

Bimanual microincisional surgeryaffords benefits in diverse situations

8

I.Howard Fine

Cautery of a bleeding point at the margin of the iris after identifying it by pinching theinfusion tubing on the irrigator.

Bimanual micro-incision phacoemulsification of a lens prolapsed into the anterior chamber from its subluxed position within the vitreous cavity.

Movement of all of the anterior chamber toward the phaco tip when aspiration and vac-uum are on widening the dialysis to the left.

Use of the phaco tip in the left hand which closes the dialysis during phacoemulsificationof the cataract.

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DermotMcGrathin Paris

WAVE-FRONT-GUIDED cus-tom ablationusing the newenhanced

algorithmfor the

LADARVision® CustomCornea® platform(Alcon Laboratories) offers better refrac-tive outcomes and more effective treatmentof higher-order aberrations compared toconventional LASIK treatments, according to FrancescoCarones MD, Milan, Italy.

Dr Carones expressed satisfaction at theclinical performance of CustomCornea andsaid that the system scored highly in termsof safety, predictability and efficacy.

“The results thus far have been highlysatisfactory, both in terms of the quantityand quality of vision.The advanced algo-rithm results in enhanced contrast sensitivi-ty and a reduction of both residual andinduced higher order aberrations,” said DrCarones, who will present his study resultsat the XXII Congress of the ESCRS

His study involved 72 consecutive virgineyes of 43 patients who underwent LASIK(Hansatome and BD 4000 microkeratomes)and wavefront-guided custom ablation atthe Carones Ophthalmology Centre, Milan,Italy.The patients had a mean sphericalequivalent (SE) refractive error of -4.26 D(range: +0.30 D to -8.13 D) and a meanastigmatism of 0.97 D (range: 0 and -3.75D), using the commercial LADARVisionplatform. Follow-up was three months.

Uncorrected and best spectacle-correct-ed visual acuity, manifest refractive spherical

equivalent error, wavefront measurement ofhigh order aberrations and subjective visualsymptoms report were the parametersused to assess the treatment.

In terms of predictability, Dr Caronessaid that the mean MRSE was -0.18 D.Furthermore, MRSE was within ± 0.50 Dand ± 1.00 D of attempted correction in78% and96% ofeyes,respective-ly. In addi-tion, amajority(78%)achieved20/20 orbetteruncorrect-ed visualacuity.

Moreover, 89% of eyes recorded 20/16BSCVA postoperatively and 36% were20/12.5, compared to a preoperative figureof 54% and 7% respectively. Mean higher-order aberrations root mean square was0.34 ± 0.10 microns before and 0.35 ± 0.09microns after surgery.

Higher-order aber-rationswere eitherreduced orunchangedfrom preop-erative sta-tus in 60%of eyes.Subjectively,the patientsreported no visual symptoms or visionquality complaints.

“Looking at the overall data, it is clearthat patients treated with CustomCorneahave better quality of vision than might beexpected from eyes treated with conven-tional LASIK.Treating optical aberrations,which affect low-contrast visual acuitiessuch as night driving, has been shown toimprove a patient’s quality of vision,” said

Dr Carones.The CustomCornea platform, the first

customised ablation system to be grantedFDA approval in the United States, is com-prised of two principal components: theLADARVision 4000 excimer laser and theLADARWave® wavefront-measuring device.

The LADARWave offers registrationcapabilities that ensure accurate wavefront

ablation placement on the patient’s "line ofsight," and a wavefront measurement mapprecisely matched to the patient’s eye. Italso includes an automatic "fogging" systemthat eliminates patient accommodation toensure an accurate reading.

The LADARVision system uses a closed-loop eyetracker to allow the system to lockon to the eye and remain locked for theduration of the surgery.The laser thendelivers a Gaussian flying small spot, 0.8 mmbeam and sophisticated ablation algorithmsto produce smooth corneal surfaces.

Dr Carones said that the softwareenhancement has been optimised for high-er-order aberrations correction and offeredpatients a better quality and quantity ofvision. It provides for an extended range ofcorrection with defocus from +1.00 to -8.00 D, cylinder up to -6.00 D and monovi-sion and offset from +0.75 to -2.50 D.

The improved accuracy of theCustomCornea Planning Software results in20% less tissue removal during ablation andalso allows for customisation of personalnomograms for defocus and astigmatism.

“Although the clinical results showed aslight SE under-correction, the new opti-mised algorithm proved itself to be veryeffective in consistently reducing and notinducing higher-order aberrations. Clinically,this feature translates into significantBSCVA gain and an extremely satisfactorysubjective quality of vision,” noted DrCarones.

The U.S. Food & Drug Administration(FDA) recently approved an expansion ofthe treatment range for CustomCornea fortreatment of myopia up to -8.0 D (up from-7.0 D) and astigmatism up to -4.0 D (upfrom -0.5 D).

[email protected]

Improved outcomes achieved with enhancedcustom ablation platform

9

Francesco Carones“Looking at the overall data, it is clear

that patients treated withCustomCornea have better quality ofvision than might be expected from

eyes treated with conventional LASIK.”

“The new optimised algorithmproved itself to be very effective in

consistently reducing and not inducing higher-order aberrations.”

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Dermot McGrathin Paris

THE taxing question of theplace of optometry in the Frenchhealth system, the evolving roleand responsibilities of ophthalmol-ogists in the face of recent legisla-tive changes and the need forurgent measures to tackle theuneven geographical distributionof medical specialists throughoutthe country are among some ofthe more pressing issues facingFrench ophthalmologists.

While optometrists are anaccepted feature of the oph-thalmic landscape in England, theUnited States, Canada and someother European countries, the pic-ture in France is more complicat-ed,Thierry Bour MD.

He noted that recent changesto the nomenclature of France’ssocial security system means thatorthoptists have been singled outto play an enlarged role in oph-thalmic practices.The idea is toallow orthoptists carry out rou-tine technical tasks such as refrac-tion, IOP, visual field and othernon-contact measurements, underthe supervision of the ophthal-mologist, who remains medicallyand legally responsible for suchprocedures.

The decision has been wel-comed by the French Union ofOphthalmologists (SNOF), whosay that this new designation onlyconfirms and gives legal expres-sion to what was already the real-ity on the ground.

With an estimated 2,000orthoptists working in privatepractice or employed by the pub-lic health service, France has oneof the highest concentrations oforthoptists in the world. SNOFhas long railed against the practiceof optometry in France on thegrounds that it needlessly compli-cates the already well-definedrelationship between opticians,orthoptists and ophthalmologists,which they deem adequate tomeet the challenge of attending tothe nation’s ocular health.

They also believe that optome-try as practised along Anglo-Saxon/American lines blurs thedistinction between medical and

commercial services and wouldultimately lead to a diminution inthe standard of ocular care forthe French population.

SNOF estimates that the facilityto delegate certain tasks toorthoptists will ultimately result ina 30% gain of working time forophthalmologists, help to reducewaiting lists for ocular examina-tions in certain areas while main-taining high standards of care forpatients in a legally validated and

fully insured framework.“Orthoptists will collaborate

under the direct control of theophthalmologist, whether in apublic hospital or in private prac-tice.The visual and ocular care ofthe patient will thus be integratedwith a proper guarantee of qualityand medical responsibility,” saidJean-Luc Seegmuller MD,President of SNOF.

Needless to say, optometristsare up-in-arms at the way theyhave been effectively frozen out ofthe new arrangements. From theirperspective, the delegation oftasks to orthoptists is more aquestion of maintaining the privi-leged status quo than ensuring abetter and more efficient standardof eye care for the population.

In an open letter to the FrenchMinister of Health, the Associationof French Optometrists (AOF),which represents 1,100optometrists in France, called thegovernment plan “unrealistic” andclaimed that only their professionhad the skills, training and meansto help tackle the national deficitof proper eye care.

Their protests, however, havefallen on deaf ears, ensuring thatthe qualifications obtained by anestimated 2,000 optometrists inFrance currently remain unrecog-nised by the authorities.

In terms of the future needs ofthe population, Dr Bour, whoserves on the SNOF commissionfor rules and regulations, said that

some government reports hadpainted an overly pessimistic viewof the demographic situationregarding ophthalmology inFrance.

He noted that official figurespredicted a decrease of 4.5% inthe overall number of physiciansby 2010, rising to 20% in 2020.The same figures also predicted adrop of up to 30% in the numberof ophthalmologists by 2020.

According to SNOF’s own

demographic projections, howev-er, the decrease will be more ofthe order of about 5% for allphysicians in 2020, with a corre-sponding stabilisation in the num-ber of specialists.At the sametime, the number of interns willincrease to help make up anyshortfall from ophthalmologistsretiring.

“Looking at the overall data, 80ophthalmologists are being trainedevery year, and in the next fiveyears there will be less ophthal-mologists retiring than the officialfigures allowed for.We believethat the numbers of ophthalmolo-gists will rise slightly until 2007and remain stable until about2012 or 2013.The consequencesof a drop in the numbers afterthat date can be avoided if thecorrect decisions are taken in themeantime.We ultimately hope tomaintain the figures close to whatwe actually have at the moment,that is about 5,400 ophthalmolo-gists,” he said.

He added that the really criticalissue to be faced in the future willbe the increasing demands placedon the entire spectrum of eyecare professions by an ageing pop-ulation.About 17% of the Frenchpopulation was over 65 years-of-age in 2003, a figure expected torise to 29% by 2030.

“While stabilisation of the num-ber of ophthalmologists is perfect-ly possible, the need for ocularcare is also going to rise by 2020

by between 30% to 50% accordingto some estimates,” said Dr Bour.

While the transfer of certaincompetencies to orthoptists willgo some way towards meeting theanticipated upsurge in demand foreye care, SNOF has also proposeddoubling the number of interns inophthalmology over the next fiveyears and increasing recruitmentof accredited foreign ophthalmol-ogists to help plug any eventualgaps in the system.

Dr Seegmuller said that Frenchophthalmologists were ready toplay their part in spreading theword and enticing qualified oph-thalmologists from abroad.

“We are ready to welcomethem and to assist them in inte-grating in France in the regionswhere the need for doctors spe-cialised in ophthalmology aremost critical.”

The issue of the uneven geo-graphical distribution of ophthal-mologists throughout France alsoneeds urgent remedial action,according to SNOF.

A statistical breakdown of oph-thalmologists in France under-scores the true extent of theproblem: at one end of the scale,Ile-de-France incorporating Parisand surrounding regions has anaverage of 13.3 ophthalmologistsper 100,000 inhabitants com-pared, at the other end of thescale, to areas such as Nord-Pas-de-Calais, with just 5.7 ophthal-mologists per 100,000.

The upshot is that many peoplein northern France have to waitthree months or more to see anophthalmologist and the scene oflong queues forming outside oph-thalmology practices have becomecommonplace in certain areas.

While offering financial incen-tives in the form of reducedcharges and preferential rates forophthalmologists to set up prac-tices in underserved areas hasbeen proposed as one solution,SNOF believes that establishingfully-equipped ophthalmic centreswhich can function for limitedperiods to meet demand, especial-ly for cataract surgery, offers amore realistic way to reduce theimpact of the imbalance of med-ical specialists in certain regions.

Dr Bour concluded that therewas every reason to be optimisticthat ophthalmology could rise tothe challenge of ensuring the bestpossible ocular care for theFrench population in the years tocome.

“There is a broad consensusamong the relevant governmentministries, the Academy ofMedicine and ophthalmologists onthe direction the professionshould take in the future.We needmore and better-equipped centresof ophthalmology, multidisciplinaryin nature, comprised of medicaland paramedical personnel, includ-ing ophthalmologists, orthoptistsand administrative staff.We alsorecognise the need to make thebest use of ophthalmologists’work-time, by stabilising the num-ber of ophthalmologists in France,increasing the number of orthop-tists and improving coordinationwith opticians,” he said.

[email protected]

Delegation of tasks envisaged to reduce burden on French ophthalmologists

“The need for ocular care is also goingto rise by 2020 by between 30% to50%” Thierry Bour MD

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Sean Henahanin Paris

MOST IOL explants could beavoided with improved surgicaltechniques, better biometry andmore careful patient selection,according to a survey of ASCRSand ESCRS members conductedby Nick Mamalis MD, Moran EyeCentre, Salt Lake City, Utah, US.

Dr Mamalis will report theresults of his sixth annual surveyof explanted foldable IOLs at theXXII ESCRS Congress.

“Small incision cataract surgerywith foldable IOLs continues toincrease in popularity worldwide,with a consequent increase incomplications requiring explanta-tions of these lenses,” he notes.

He asked members of the twoorganisations to provide data oneach foldable lens that requiredremoval or secondary surgicalintervention. Nearly 300 respon-dents provided information on theIOL material and design, signs andsymptoms, pre- and post-op visualacuity and other relevant clinicalinformation.

Overall, 27% of problem casesinvolved three-piece silicone IOLs;16% involved one-piece plate sili-cone lenses; another 16% involved

three-piece acrylic lenses; and 14%involving one-piece acrylic lenseswith haptics. Surgeons also report-ed cases involving hydrogel lenses,collamer lenses and multifocalIOLS.

Complications varied dependingon the type of foldable IOL.Theoverall pattern indicated thatincorrect lens power and lens dis-location and decentrationaccounted for a majority of cases.

Respondents reported incorrectlens power, glare/visual aberrationsand lens dislocation/ decentrationas the leading reasons for removalof the three most commonlyexplanted IOLs reported in thesurvey- three-piece silicone IOLs,three-piece acrylic IOLs, and one-piece acrylic IOLs. Glare and opti-cal aberrations were also cited asreasons for explanting those typesof lenses, as were lenses damagedduring insertion, retinal problems,and endophthalmitis.

The situation was a bit differentfor hydrophilic acrylic, or hydro-gel, IOLs. Postoperative lens calci-fication and opacification account-ed for 80% of one-piece hydrogelexplants and 72% of three-piecehydrogel explants. Glare and opti-cal aberrations accounted forslightly more than 10% of three-piece hydrogel explants.

Lens dislocation and decentra-tion were also the most commoncomplication associated with one-piece silicone IOLs. Multifocal sili-cone IOLs presented a differentpicture.The leading reason forexplantation of those lenses wasproblems with glare and opticalaberrations, accounting for 40% ofcases. Incorrect lens power wascited in 30% of cases, and disloca-tion and decentration in another15% of cases.

A look back at six years worthof survey data suggests a pattern

in reasons for foldable IOLexplantations. For example, whilethe percentage of three-piece sili-cone removed because of incor-rect lens power dropped from50% to 30% between 1998 and2003, the percentage of casesassociated with dislocation anddecentration increased from 20%to 34%. Complications associatedwith glare and optical aberrationsremained the same, at about 12%.

Dislocation and decentrationcases also increased with three-piece acrylic IOLs, up from 15% to27%.The number of cases associ-ated with glare decreased from42% to 22% in the same period,while the number of cases associ-ated with incorrect lens powerdropped.

Lens dislocation and decentra-tion still accounts for a majority ofplate silicone one piece IOLexplants, having increased from50% in 1998 to 61% in 2003.Thenumber of lenses removedbecause of damage during inser-tion had dropped to below fivepercent. However, incorrect lenspower still accounts for 20% ofcases.

Incorrect lens power alsoaccounts for 30% of multifocal sili-cone IOL explants. However, thenumber of cases associated withglare and optical aberrations hasdeclined from a high of 70% to40% in 2003.

The data from this surveystrongly suggest that the majorityof complications involving foldableIOLs are avoidable, Dr Mamalisemphasised.

Good surgical technique, includ-ing a continuous curvilinear capsu-lorhexis with capsular bag fixationof the IOL is essential. Carefulfolding and insertion of the IOLcan also go a long way to prevent-ing problems later on, he said.

The high per-centage of IOLsexplanted sim-ply because thewrong power oflens was usedhighlights theimportance ofaccurate biome-try.There is aneed for newtechnologies foraxial lengthmeasurementsand IOL calcu-lations.

“New, highlyaccurate meth-ods of measur-ing axial lengthinclude partialcoherenceinterferometry.In addition,non-contact A-scan measure-ments of axiallength in thehands of a high-ly skilled techni-cian will also provide more accu-rate measurements of the axiallength. Highly accurate axiallength measurements coupledwith modern IOL formulas willhelp improve the accuracy of IOLpower calculations,” he toldEuroTimes.

Careful patient selection is alsovital.This is especially important inpatients in whom multifocal IOLplacement is being contemplated,he stressed.

There are other issues that arebeyond the surgeons’ control thatwould also make a difference,notably improved quality in manu-facturing. Surgeons need to beparticularly vigilant when implanti-ng IOLs made of new materials.

The ASCRS/ESCRS explant sur-vey is ongoing. Surgeons whowould like to submit cases ofexplanted foldable IOLs candownload the forms at the ASCRSwebsite, www.ascrs.org.

[email protected]

Most IOL explants preventable

Nick Mamalis

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Sean Henahanin Paris

EUROPEAN refractive surgeons differfrom their US colleagues both in terms ofthe equipment they own and the way theyuse it, recent surveys indicate.

In one survey, David Leaming MD evalu-ated the refractive preferences of 964members of the American Society ofCataract and Refractive Surgeons. He com-pared the results of that survey with a sub-sequent survey of 500 European surgeons.He will discuss the results at this year’sESCRS Congress in Paris.

The comparison showed some similari-ties between the US and European sur-geons. For example, 50% of the member-ship of both organisations reported thatthey do perform LASIK, and 40% from eachgroup report that they also perform refrac-tive lens exchange. However, LASEK ismuch more common in Europe, performedby 31% of surgeons in that region, com-pared with only 13% percent of those inthe US.

European surgeons were also far morelikely to implant phakic IOLs. Some 31% ofEuropean surgeons said they are alreadydoing this procedure, while only seven per-cent of US surgeons have implanted thosetypes of lenses.This is not particularly sur-prising, since the lenses have been availablefor some years in Europe but are not yetapproved in the US.The ASCRS survey didshow a high level of interest among mem-bers in phakic IOLs.

These findings were underscored byresponses to hypothetical clinical cases. Fora patient with –3.0 D of myopia, 86% of USrespondents said they would recommendLASIK, compared with only 14% ofEuropean doctors.There was closer agree-ment on a patient with –7.0 D, with 87% ofUS doctors and 67% of European advisingLASIK. However, for a patient with –12.0 D,52% of the European surgeons would rec-ommend implanting phakic IOLs, comparedwith 33% of their US colleagues.

Differences were also apparent on thehyperopic side.While 60% of US surgeonswere comfortable suggesting LASIK for a+1.0 D hyperope, 60% of their Europeancounterparts would advise the patient not

to have surgery. An even higher percent-age, 69%, of US respondents said theywould advise a +3.0 D hyperope to haveLASIK, as would 41% of European sur-geons. For a patient with +5.0 D hyperopia,44% of the US surgeons would opt forrefractive lens exchange, compared with34% of European surgeons. However, 34%of surgeons from both groups would advisethe same patient not to have any surgery.

The choice of equipment appeared toreflect market conditions.While 70% of USsurgeons say they mostly use the Visx plat-form, the Bausch and Lomb Technolas is theleader in Europe, cited by 41% of thosesurveyed.The Alcon Ladarvision platformwas the second preference in both regions.

The Bausch and Lomb Hansatome wasthe microkeratome most used, cited by52% of both groups. Moria microkeratomeswere the second most used in bothregions.The Amadeus microkeratomeappeared to gain support among Europeansurgeons.

The Intralase femtosecond laser ker-atome is catching on in America, with 52%of respondents saying they would like touse that instrument. Interest in theIntralase is beginning to appear in Europe,with 18% of respondents reporting theywould like to use it.

Some 45% of US respondents and 76% ofEuropean respondents reported that theyuse wavefront analysers in their practices.The Visx Waveprint system was the report-ed favorite among US surgeons, while theEuropean surgeons cited the Bausch andLomb Zyoptix system as their first choice.The Alcon Ladar system was the secondmost cited in both regions.

“I'm not sure what to say about thewavefront.There was a significant rise inthe numbers using it both in Europe andUS, but I can't tell if this is just marketpressure vs. real enthusiasm since I know anumber of centers that recommend it onlyto those with significant higher-order aber-rations,”he told EuroTimes.

Dr Leaming’s findings correlate withthose of another survey conducted in 2003by Kerry Solomon MD. He evaluated therefractive surgery preferences of ophthal-mologists around the world in a survey of1174 eye surgeons from North and South

America, Europe Oceania,Asia, andAfrica. He reported those findings inthe July 2004 issue of the Journal ofCataract and Refractive Surgeons.

The survey respondents expectedto see increases in volume of con-ventional LASIK, PRK and LASEK.Aminority, 12%, said they expected tosee an increase in custom ablationvolume.Another 26% said theywere not performing custom abla-tion but were planning to do so inthe future. Some 21% said theywould consider performing customablation once it was approved intheir areas.

Dr Solomon’s study revealed anintriguing link between refractivepractice patterns and surgeons whothemselves underwent refractivesurgery. Nearly four percent ofthose surveyed had undergonerefractive surgery, including LASIK,LASEK, clear lens extraction andphakic IOL implantation.A majorityof those who underwent refractivesurgery also performed refractivesurgery in their practices. However,surgeons who had not undergonesurgery were significantly less likelyto perform refractive surgery in their prac-tices. .

Dr Solomon’s survey showed similarfindings to Dr Leaming’s in terms ofexcimer laser and microkeratome choicesin the US and Europe. On a global scale,the Visx lasers were the most commonlyused, accounting for 56% of the total.TheBausch & Lomb Technolas® 217 was theleading laser among Asian respondents andthe Nidek was most cited by surgeons inLatin America.

The global survey showed a wide varietyin pricing for LASIK procedures. US prac-tices charged the most, with the majoritycharging at least $1500 per eye. LatinAmerican prices were the lowest, at $500per eye. Europe was in the middle pricerange, with most surgeons saying theycharged between $1000 and $1500 pereye.A majority of respondents worldwidesaid they expected prices to remain aboutthe same in the near future.

More than 90% of the respondent said

they routinely performed preoperativecorneal topography.A similar percentagesaid they measured scotopic pupil size, withan increasing number reporting that theywere utilising infrared pupillometry.Thenumber of surgeons saying they employedpreoperative wavefront measurementsmore than double from the year before, to23%.

Dr Solomon’s study indicated that bilat-eral surgery has become the norm aroundthe world. In particular, European and LatinAmerican surgeons are more inclined toperform bilateral procedures than in thepast.While most respondents, 78%, report-ed that they changed microkeratome bladeswith each new patient, half of Europeansurgeons reported that changed the micro-keratome blade for each operated eye.

David Leaming [email protected]

Kerry [email protected]

Surveys reveal global refractive surgery preferences

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Daithí Ó hAnluainin Paris

A NEW study from Ireland sug-gests a link between refractiveregression following LASIK sur-gery and hormone replacementtherapy.

Ms Maeve O'Doherty, leadresearcher on the Irish study, con-ducted a retrospective chartreview of all myopic females whounderwent LASIK at the MaterMisericordiae private hospital inDublin who were receiving eitherhormone replacement treatment(HRT) or using the oral contra-ceptive pill (OCP). She will pres-ent the study at the XXII AnnualCongress of the ESCRS in Paris.

There were 176 eyes in theOCP group and 44 eyes in theHRT group, with 81 eyes servingas a control group.Theresearchers recorded postopera-tive refraction and visual acuity atone week, three months, sixmonths and one year.They com-pared the change in refraction andchange in visual acuity over a six-month period for patients in theOCP, HRT and control groups.

Nearly all eyes (96%) of womentaking HRT at the time of LASIKhad postoperative visual acuitiesof 6/12 or better at one-weekpost surgery. However, only 81%of the HRT group maintained avisual acuity of 6/12 or better atsix months. In contrast, 97% of

eyes of patients in the oral con-traceptive group achieved 6/12 orbetter one-week post-op, main-tained by 96% at six months.

She told EuroTimes that sinceHRT may be a factor in determin-ing the risk of regression postLASIK, ophthalmologists neededto determine a prospectivepatient's hormone state. In addi-tion to HRT, doctors must checkif the patient is pregnant, has hada hysterectomy or oophorectomy,and whether she is peri- or post-menopausal.All these conditionseither lower the success rate ofrefractive procedures like LASIKand PRK, or could potentially doso.

"From our survey, and manyothers, there are indications thatall these conditions can have anegative impact on the outcomeof refractive procedures likeLASIK and PRK.We know hor-mones play a role in the structuralintegrity of the cornea, and sincethere is no current study on theimpact of HRT or OCP wewanted to examine whether a linkexisted," she said.

She believes there was no sig-nificant risk associated withwomen taking an oral contracep-tive because the hormone doseinvolved is so small.

A similar study on the impactof hormone and menopausal sta-tus following excimer laser pho-torefractive keratectomy (PRK) in

women (Aust. NZ J Ophthalm.1996;24;215-222) found that postmenopausal women suffered ahigher rate of regression postop-eratively and women on HRTfared even worse.

Meanwhile, another recentstudy (JCRS: 30; 3 (March 2004);675-684) examined the linkbetween dry-eye and LASIKregression in a retrospective chartreview.The study looked at 565eyes that were examined twoweeks before LASIK with follow-up at one, three, six, and 12months.

Regression after LASIK wasrelated to chronic dry eye. Itoccurred in 27% of 45 patientswith chronic dry eye and in sevenpercent of 520 patients who didnot have dry eye (P<.0001).Patients with chronic dry eye hadsignificantly worse myopic out-comes than those without chronicdry eye.

The risk for chronic dry eyewas significantly associated withfemale sex, higher attemptedrefractive correction, greater abla-tion depth, and the following pre-LASIK variables: increased ocularsurface staining; lower tear vol-ume, tear stability, and cornealsensation; and dry-eye symptomsbefore LASIK.The risk for regres-sion was significantly associatedwith higher attempted refractivecorrection, greater ablation depth,and dry-eye symptoms after

LASIK.That study added to the con-

sensus that the risk of refractiveregression after LASIK wasincreased in patients with chronicdry eye.An increasing body of evi-dence indicates that hormone sta-tus plays an important role inrefractive outcomes. But whetherthis is caused by a higher inci-dence of dry-eye among womenwith a disrupted hormone system,or whether it is as a direct resultof changes in the structure of thecornea, is not yet known.

It is known, however, that hor-monal status has an impact on theincidence of dry eye.A recentstudy by the National EyeInstitute found that women withpremature ovarian failure (POF)had a greater incidence of dry-eyethan age-matched controls (ArchOphthalmol. 2004;122:151-156).

In an editorial accompanyingthe POF study, Stephen C.Plugfelder, MD, Professor ofOphthalmology in the BaylorMedical School, wrote:“Theincreased prevalence of kerato-conjunctivitis sicca in patientswith POF supports the conceptthat hormones modulate ocularsurface homeostasis.”

But no study has yet demon-strated whether hormone disrup-tion alone is responsible for poor-er outcomes through damage tothe ocular surface, or whether itis mediated through a higher inci-

dence of dry-eye, though the twoappear to be linked.

It is known that hormone dis-ruption affects dry-eye, ocularstructure and PRK regression, butHRT is meant to reduce hormonedisruption in women post-menopause. One would thereforeexpect it to minimise ocular sur-face damage and, logically, refrac-tive regression after LASIK andPRK, she noted.At the same time,some studies have actuallydemonstrated that post-menopausal women on HRTreport higher rates of dry eyethan post menopausal women noton HRT, she pointed out, adding:

"The body's hormones are in aconstant state of change.Also, ofcourse, some HRT formulationshave no oestrogen content buthave higher progesterone levels toprevent uterine cancer, so I guessHRT can never truly representpre-menopausal status. It wouldbe interesting to perform a studythat examined dry-eye and LASIKoutcomes in post-menopausalwomen taking HRT vs. those thatare not,"

Maeve O'[email protected]

HRT linked with regression post-LASIK

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Roibeard O hÉineacháinin San Diego

A NEW aberration-neutral IOL(LI61AO, Bausch & Lomb) mayprovide cataract patients withbetter quality of vision than theywould achieve with a conventionallens and the effect would not belost or diminished through decen-tration, Louis D Nichamin MDtold the annual meeting of theAmerican Society of Cataract andRefractive Surgeons.

“The criteria used to designthis IOL were developed with therecognition that optical perform-ance of conventional IOL opticsand current aspheric IOL opticscan be adversely affected by

numerous factors including decen-tration and tilt as well as varia-tions in corneal aberrations orpupil diameters that exist within atypical pseudophakic population,”Dr Nichamin explained.

The investigational IOL has pro-late posterior and anterior sur-faces and no inherent sphericalaberration.The lens therefore nei-ther adds to nor subtracts fromthe natural spherical aberration ofthe cornea. Conventional spheri-cal IOLs impart positive sphericalaberration, adding to that alreadypresent in the cornea and degrad-ing image quality.

One currently available asphericIOL, the Tecnis (AMO), is designedto compensate for the positivespherical aberration of the corneaby mimicking the negative spheri-cal aberration of the natural lensin the young eye. However, thedesign of that lens is based on anaverage amount of corneal aberra-tion found in a sample populationof 71 eyes, whereas in fact thedegree of corneal aberrationvaries considerably throughoutthe population. Moreover, success-ful visual results with the Tecnisdepend on good centration andpupil size.

On the other hand, as the newaspheric LI61AO IOL is aberra-tion-neutral it should optimise theimage quality regardless of a

patient’s degree of corneal aberra-tion and the quality of vision willbe unaffected by decentration, tilt,or variation in pupil size.

“Pseudophakic eyes with theLI61AO will have less sphericalaberration than they would withconventional spherical IOLs.Furthermore, a lens withoutspherical aberration does notinduce higher-order asymmetricalaberrations, like coma and astig-matism, when it is decentred.When you consider that the aver-age lens decentration followingcataract surgery is 0.4 mm anddecentrations greater than 1.0mm do occur occasionally, this isan important advantage of thedesign.”

The new lens has a three-piecedesign with a 6.0 mm siliconeoptic body and blue PMMA, modi-fied C loop haptics with an overalllength of 13.0 mm blue PMMAhaptics. The anterior and poste-rior edges are square for theentire 360-degrees of the optic.The blue PMMA haptics have anangulation of six degrees to bringit into close contact with the pos-terior capsule and enhance capsu-lar bending in order to help miti-gate PCO.

The IOL will be available inpowers from 0 D through 30 D in1.0 D steps for powers less than5.0 D and in 0.5 D steps for pow-ers greater than or equal to 5.0D.The lens will be implantablewith the MportSI planar deliveryinjector that allows insertion of alens through an unenlarged phacoincision of 2.8 mm or less.

As a demonstration of the visu-al outcomes that might be expect-ed from the new lens, Jay PeposeMD presented an initial analysis ofthe optical performance of thelens performed with sophisticatedray-tracing software and a theo-retical model eye.

The study compared the newlens with a conventional IOL(LI61U, Bausch & Lomb), theTecnis IOL and the L161AO IOLin simulated range of intraocularconditions, said Dr Pepose,

Chesterfield, Missouri, US.The analysis showed that the

new lens performed better thanthe conventional IOL under allconditions regardless of centra-tion or pupil size. Furthermore,while the optical performance ofthe Tecnis IOL was diffraction-lim-ited when perfectly centred, withonly modest decentration, it per-formed less well than the newlens at all spatial frequencies.Thisdifference became more pro-nounced as pupil size increased.

At 0.5 mm to 1.0 mm decentra-tion, the aberration-free IOL hada much higher modulation trans-fer function at all spatial frequen-cies in comparison to both of theother lenses. In fact, even whendecentred by 1.0 mm it outper-formed a perfectly centred con-ventional IOL.

With perfect centration but aspupil size increased from 3.0 mmto 4.0 mm, the Tecnis lensremained diffraction limited whilethe performance of the aberra-tion- free IOL degraded some-what and that of the conventionalIOL degraded considerably more.However, when the lens wasdecentred by 0.5 mm to 1.0 mmthe modulation transfer functionof the new lens remainedunchanged as pupil size increasedwhile that of the conventional lensand the Tecnis both performedpoorly in comparison to the newlens and showed features suggest-ing increasing amounts of coma.

“There is some splaying of thecurve between a tangential andsagittal view and that’s becausewe’re inducing non-symmetricaberrations like coma when wehave a lens decentred that haseither positive or negative inher-ent spherical aberrations.Youdon’t see the splaying of the MTFcurve with an aberration-free IOLbecause it is basically immune tothe optical effects of decentra-tion.”

Dr Pepose told EuroTimes thatthe new lens has several featuresthat may further enhance visualoutcomes. For example, because

the anterior surface is steeperthan the posterior surface, itshould have less potential forunwanted surface reflections.Furthermore, since the refractiveindex of B&L's second-generationsilicone is only 1.43 and is sub-stantially lower than other lensmaterials, the potential for dys-

pho-topsia is further reduced.

Further studies carried out withlens involving bench testing of thelens with physical measurementshave supported the findings of hisinitial analysis, Dr Pepose noted.The results of these studies willbe presented at this year’s meet-ing of the ESCRS in Paris.The firstimplantation of the lens will mostlikely take place later this year, DrPepose noted, adding:

“Given the extensive and rigorouslaboratory testing of the technol-ogy and what we know about theclinical performance of otheraspheric technologies, we are con-fident that the L161AO will per-form as anticipated.”

[email protected]

[email protected]

Aberration-free IOL could provide improved quality ofvision regardless of decentration

14

Louis D Nichamin

When the pupil is small spherical aberration caused by the cornea and the IOL are not significant, so thecentered performance of each lens is quite good.

Jay Pepose

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EuroTimes September 2004

15

Even with 1.0 mm decentration, tangential (T) and sagittal (S) MTFcurves for aberration-free lens do not sink or separate, indicating

decentration does not affect optical performance

Decentration does not degrade the optical performance of the aberration-free lens, because it does not have inherent spherical

aberration.

Spherical aberration from the cornea and IOL is more detrimental whenthe pupil is enlarged. Tecnis clearly outperforms the other IOLs when

the lenses are well centered.

Decentration of 0.5 mm is typical post-operatively. In such conditionsthe aberration-free lens outperforms Tecnis and LI61U for all spatial

frequencies.

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Sean Henahanin Barcelona

WHILE the IOLMaster hasbecome an indispensable tool forpre-operative assessment ofcataract patients, it is important tounderstand its limitations, reportedBritish researchers at the 8thESCRS Winter Refractive Surgerymeeting.

“Accurate and precise biometryis one of the key factors in obtain-ing a good refractive outcomeafter cataract surgery.An error ofonly 1.0 mm in axial length willresults in a post-operative refrac-tive error of three dioptres,”noted consultant ophthalmologistAndrea Kerr MD.

She commented that the adventof the IOLMaster (HumphreyZeiss), which uses partial coher-ence interferometry technology,has mostly eliminated operatorerror, and proven to be a boon forbiometric assessment. But shecautioned that the IOLMaster isnot accurate in certain eyes, suchas those with very dense cataracts.Ultrasound biometry still has animportant role to play in thisregard.

Dr Kerr and colleagues atNorthampton General Hospital inEngland compared the accuracy ofmeasurements obtained with theStorz Compuscan A/B ultrasoundbiometry instrument and thoseobtained with the IOL Master.They compared axial length meas-urements and predicted intraocu-lar lens implant power in 93 eyes

of 93 patients undergoing preoper-ative assessment for cataract sur-gery.

Dr Kerr performed suturelessphacoemulsification, scleral tunnelincision, and in-the-bag IOL place-ment in all eyes. Patients receivedthe Akreos fit foldable lens (Bauschand Lomb). Emmetropia was thetarget postoperative refraction inall eyes.

The researchers used the HofferQ and SRKT formulae to calculateemmetropia according to guide-lines established by the RoyalCollege of Ophthalmology.A singleexaminer performed subjectiverefractions on all eyes two weeksafter surgery.

The axial length measurementsobtained with the IOLMaster weresignificantly longer than with theCompuscan technique. Indeed, theIOLMaster axial length measure-ments were longer than theCompuscan measurements in 98%of cases.The mean deviation inaxial lengths obtained by the twosystems was 0.637 mm, with arange of deviation between –02.2mm and +2.14 mm.The differenceswere highly statistically significant.

“The correlation value betweenthe A scan and IOL Master was0.17.This indicates that there is nolinear relationship between thetwo machines.The mean error inaxial length measurements was0.55 mm. IOL implant powerdetermined by the IOL Mastercompared to that suggested by theA scan showed a mean differenceof +2.4D,” Dr Kerr reported.

She noted that there was also alarge discrepancy between themachines in terms of the power ofthe predicted intraocular lens.Thedifference ranged from –0.5 D to+6.0 D.

Subjective refractive measure-ments obtained post-operativelyshowed that 55% of the eyes werewithin 0.5 D of the sphericalequivalent predicted by theIOLMaster and 80% were withinone dioptre.

The current prospective clinicalstudy confirms that the IOLMasterprovides longer axial length meas-urements than the A scanCompuscan machine. Otherresearch groups have reported thispreviously. In this study, the meandifference between the two axiallengths was 0.637 mm, a largermean difference in axial lengththan quoted in previous studies.This might be attributable torefractive instability during thetwo-week post-operative period inwhich the measurements weretaken.

Unlike the IOLMaster,A scanultrasound biometry is a contactmethod and is operator depend-ent. Experience has shown thatexcessive corneal indentation com-presses the eye, in the anterior-to-posterior direction.This producesan artificially short eye, producingthe kind of myopic refractiveresults seen in this and earlierstudies.

“Our study showed that thismyopic error could have been aslarge as 3.68D in some cases,

which would have resulted in anentirely unsatisfactory refractiveoutcome," Dr Kerr said.

She stressed that the inability tostandardise corneal indentation is amajor failing with applanationultrasound biometry.The errorassociated with corneal indenta-tion in applanation biometry is notpredictable, as it depends in largepart on the experience of theoperator.

“Despite these failings, the con-tact method still has a place in cur-rent ophthalmic practice.TheIOLMaster is unable to determineaxial length in up to ten percent ofcataract patients.This couldinclude patients with densecataracts or corneal opacification.In addition, patients with age-relat-ed macular degeneration or mentalhandicap might be unable to fixate,making them candidates for the Ascan method.”

The IOLMaster can measureaxial length, corneal radii and ante-rior-chamber depth. The onboardsoftware incorporates all operatingprocesses from the measurementof the parameters to the computa-tion of the IOL through the inte-grated biometric formulas and lensdatabase. Because it is a non-con-tact technique local anaesthesia isnot required and there and no riskof infection.

Dr Kerr told EuroTimes that inher clinic the A-scan still had animportant place, noting that severalof her senior nursing staff hadgained considerable expertise withthe ultrasound technique.

She noted that it was useful as acomparative tool for measuringthe accuracy and consistency ofthe IOL master. It is also useful indifficult cases where theIOLMaster does not give a resultand in difficult and uncooperativepatients.

Dr Kerr emphasised the value ofusing computer database pro-grammes for storing all pre-opera-tive and post-operative biometrydata.This greatly assists statisticalanalysis.

Over time, and with regularaudit of post-operative refractionresults, a nomogram can beobtained for each nurse/techni-cian’s A-scan results, which allowthe correct lens to be chosen ifthe IOL Master cannot be used.

[email protected]

Mastering the IOLMaster16

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Sean Henahanin Barcelona

WHILE modern autorefractorscannot replace subjective refrac-tion, the consistent readings theyproduce are very useful for pre-dicting post-operative cataractsurgery outcomes in a busy oph-thalmic clinic, reported Britishresearchers at the 8th ESCRSWinter Refractive SurgeryMeeting here.

How well do results obtainedwith autorefraction measure upagainst those obtained with themore labour intensive measure-ment of subjective refraction?Consultant ophthalmologistAndrea Kerr MD and colleaguesat Northampton General Hospitalin England conducted a studycomparing results obtained withthe Humphrey® Acuitus™ 5015autorefractor and standard sub-jective refraction.

The prospective study enrolled138 consecutive patients sched-uled for routine uncomplicatedsutureless phacoemulsificationcataract surgery with in-the-bagIOL implantation.The researchersobtained autorefractions in 79cases, subjective refractions in 59cases, while 48 patients were eval-uated with both technques.

The investigators obtainedmeasurements of post-operative

sphere, cylinder, axis and sphericalequivalent in all eyes.They com-pared the spherical equivalentsfrom both the autorefraction andsubjective refractions to thespherical equivalents predicted bythe IOL Master.

Measurements obtained by theautorefractor showed a meansphere of -0.266 D and a meancylinder of -0.377 D.The meanaxis measurements obtained withthe objective refraction was 97and the mean spherical equivalentwas -0.430 D.The numbers indi-cate that the autorefractor tendedto err consistently on the myopicside.

In contrast, the mean sphereobtained with subjective refrac-tion was -0.03 D and the meancylinder was –0.21 D.The subjec-tive mean axis was 91 and spheri-cal equivalent was –0.14 D.

The mean difference betweenthe predicted spherical equiva-lents and subjective sphericalequivalents was 0.60D, rangingfrom 0.03 to 1.9 units. In slightlymore than half of cases, 57%, thepatient’s subjective refraction waswithin half a dioptre of the pre-dicted spherical equivalent.

The systems were within 0.5 Dof agreement for sphere in 55.7%of eyes.The systems agreed in82.7% of cases for cylinder meas-urements. Cylinder axis measure-

ments were within ten degrees ofagreement in 75% of cases.

Among the 48 patients whowere measured by both tech-niques, autorefraction indicated amean sphere of 0.45 comparedwith a mean sphere of 0.00 indi-cated by subjective refraction.There was better agreement forcylinder, with autorefractionshowing a mean of -0.18 and sub-jective refraction showing a meancylinder of –0.17.

“The Humphrey Zeiss Acuitusautorefractor provided consistentreadings.The spherical equivalentobtained is more myopic com-pared to subjective refraction.Thismay be explained by failure of thefogging mechanism to completelyrelax the accommodation. Largernumbers are needed to formulatea nomogram to allow a closerapproximation to the subjectiverefraction,” noted Dr Kerr.

Given these results, Dr Kerrexpressed confidence in usingautorefraction for routine post-operative cases. suggest specificcircumstances where you woulduse both methods.

She would employ subjectiverefraction in specific situationincluding: cases of unexplainedpoor visual acuity; followingphaco-refractive procedures; inpost-keratoplasty patients and inpatients with keratoconus follow-

ing phaco procedures.She added that the current lit-

erature supports the view thatautorefractors provide goodobjective refraction and a basis tocommence subjective refraction.The advantage of autorefractors isthat they allow measurement ofrefraction with relative ease andaccuracy. Moreover, these instru-ments require only a minimal levelof expertise to use.

Dr Kerr commented that in factother studies in the literaturereport greater accuracy forautorefractors than her studyfound. She noted that this lowerdegree of accuracy could beexplained by the fact that thesepatients were seen within twoweeks of their surgery and quite

possibly the post-operative refrac-tion had not yet stabilised.

However, she noted thatautorefractors are less accurate atmeasuring eyes with high degreeof accommodation, which, in a

population of pseudophakes, maynot be relevant.

“While subjective refractionremains the gold standard, autore-fractors allow a rapid means ofassessing refractive error.Whilenot intended to do so, this willreduce time spent on retinoscopy,and provide a starting point forsubjective refraction,” she added.

The Humphrey® Acuitus™5015 automatic refractor/ker-atometer includes features thatallow refraction of a complete agerange of patients from young chil-dren to the elderly.With AutoAcquisition and Auto Z modes,the measurement is easilyacquired upon instrument align-ment.The instrument also fea-tures central and peripheral ker-

atometry measurements.

[email protected]

How do subjective and objective refraction compare?17

“While subjective refraction remainsthe gold standard, autorefractorsallow a rapid means of assessingrefractive error”

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EuroTimes September 2004

Daithí Ó hAnluain

THE incidence of uveitis in theUnited States may be three timesgreater than previously thought, anew large-scale population studysuggests.

The authors believe that morethan 280,000 people every yeardevelop some form of the disease.It is responsible for 30,000 newcases, or 10%, of blindness a year,in the US.

This cross-sectional, retrospec-tive study reviewed databases andmedical records to determine theincidence and prevalence of

uveitis in a large, well-defined pop-ulation in Northern California.

The authors drew the popula-tion from the membership ofKaiser Permanente NorthernCalifornia health care system.They searched the entire database(2,805,443 people) for patientswho had the potential diagnosesof uveitis during a 12-month peri-od.

This study population was fur-ther divided into six communities(731,898 people), represented bysix medical centres and chosen toprovide a variety of patient demo-graphics with varying medical cen-tre and population sizes.The sam-ple conformed to the epidemio-logical definition of a community.

Two uveitis specialists reviewedthe medical records of potentialcandidates to confirm diagnosesand establish time of diseaseonset.This yielded a sample of2070 people who had potentialdiagnoses of uveitis.

The review uncovered 382 newcases of uveitis during the targetperiod, while 462 cases of uveitiswere diagnosed before the targetperiod.These data yielded an inci-dence of 52.4/100,000 person-years and with a period preva-lence of 115.3/100,000 people.

In the current study, the inci-dence and prevalence of diseasewere lowest in paediatric agegroups 6.9/100,000 person yearsand were very high in patients 65years or older, 102.7/100,000,234.6/100,000.

Comparison between the group

of patients who had onset ofuveitis before the target period(ongoing uveitis) and the entirecohort of uveitis patients showedthat women had a higher preva-lence of ongoing uveitis than menand that this difference waslargest in the older age groups.

Idiopathic uveitis was the mostcommon type encountered by theauthors in complete medicalrecords, both in onset (48% ofnew cases) and prevalence(33.9%). It was also the mostcommon among incomplete med-ical records, which lacked a fundusexamination.

The authors concluded that theincidence of uveitis was approxi-mately three times that of previ-ous US estimates and increasedwith the increasing age ofpatients.Women had a higherprevalence of uveitis than men,and the largest differences were inolder age groups.

“I was surprised by the results. Iwas expecting similar results tothose reported previously byDarrell, (Darrell et al.,Arch.Ophthalmol. 1962:68:502-14), per-haps tending to be higher becausethe ethnic diversity is muchgreater in our study,” said leadauthor David Gritz MD,AssociateClinical Professor, University ofCalifornia San Francisco.

He said he believed the newlydiscovered prevalence wentunsuspected in part because mostcases were relatively simple iritis.

“So you don’t realise how com-mon it actually is. It’s not as ifthere’s an epidemic of cornealulcers,” he said.

In their discussion, the authorscite several possible reasons forthe disparity of their results withearlier studies.There may beselection bias given the samplewas drawn from the membershipof the Kaiser Permanent healthcare system, though this encom-passes a large cross section ofNorthern California’s population.

People from the sample mayreport symptoms more readily,because they have easy access tohealth care, whereas uninsuredcases that resolve without treat-ment may not be reported.This

would affect the reported inci-dence, but not prevalence.Moreover, different types ofuveitis affect various racial groupsin different ways.

In a discussion accompanyingthe paper William G. Hodge MD,Associate Professor ofOphthalmology at the Ottawa EyeInstitute, noted that the high inci-dence of uveitis uncovered by thestudy gives cause for concern.However, he noted that the find-ings require careful scrutiny.

“In this study, the overallincrease in rates relative to otherstudies is likely true. However, thehighest rate among the elderly isperplexing, as it defies publishedreports and the common experi-ence of uveitis specialists,” DrHodge comments.

He believes the denominator(the population) for the elderlygroup may have been artificiallyreduced, making the numerator(the cases) artificially high. He alsocautions that the overall resultsprobably apply to California only,possibly the US and almost cer-tainly not to other countries.

According to Dr. Gritz, thesestatements reflect Dr. Hodge’smisunderstanding of the Kaisersystem and the methodology ofthe study.The denominator isvery accurate and if anything, therates of disease may be even high-er than found in this study, forinstance if some Kaiser patientssought care outside of the Kaisersystem.

Dr. Gritz said he believed thesurge in cases among elderly peo-ple might be a result of a changein the epidemiology of the dis-ease.

“It certainly has a very worri-some implication because of theageing of our population. I would-n’t call it an epidemic, but I thinkit is of concern how many peoplemay likely be affected.”

Dr. Gritz added that ophthal-mologists may need to be verymeticulous in follow-up afterpatients finish medication toensure that apparently resolvedcases have in fact resolved.Also,it’s important to impress onuveitis patients that they must

report any recurrence.“My impression is that the

longer a patient has problems, thefewer symptoms they experience.I have seen patients who weretold to taper their steroids anddidn’t have a follow-up.When they were finally examined,they were having on-going inflam-mation all that time.That’s myanecdotal experience, but thefindings of the study make meconcerned, especially if you hadincorrectly assumed that theinflammation would resolve.”

The research appears In thejournal Ophthalmology, Gritz,David C., and Wong, Ira G.,Incidence and prevalence ofuveitis in Northern California,March 2004, (111;3: 491-500).

[email protected]

Uveitis may be more prevalent than previously thought18

PROMISING UVEITIS TREAT-MENT TO GO TO TRIAL

Daclizumab, a novel treatmentfor uveitis is poised to enter thePhase III clinical trial stage.Initial results indicate that thedaclizumab is effective with farfewer side effects than currenttreatments, such as systemic cor-ticosteroids and cytotoxic agents.

Researchers at the USNational Eye Institute conducteda long-term (more than fouryears) phase I/II single armedinterventional study using intra-venous anti-interleukin-2 (anti-IL-2) receptor alpha treatments(daclizumab) and a short-term(26 weeks) phase II study evalu-ating the use of a subcutaneousdaclizumab formulation. Thedata appeared in the Journal ofImmunology (21 (2004) 283-293).

Patients were tapered off sys-temic immunosuppressive thera-py and received daclizumab infu-sions or subcutaneous injectionsat intervals varying from two tosix weeks. In the long-term study,patients were treated exclusivelywith daclizumab.

The researchers found that six-week injection intervals led to arecurrence of uveitis, while two-to four-week intervals did not.One patient developed resistance,but this disappeared once subcu-taneous treatment was begun.

In the short-term study, four ofthe five patients met study suc-cess points within the first 12weeks, and all five were success-ful by 26 weeks.

The studies offered prelimi-nary evidence that regularlyadministered long-term daclizum-ab therapy can be given in lieu ofstandard immunosuppression foryears to treat severe uveitis. Italso appears that subcutaneouslyadministered daclizumab may bea clinically viable treatmentoption.

The results are promisinggiven the apparent rise in casesof uveitis (see main story) andthe side effects associated withcurrent treatments. Further, thesubcutaneous treatment mayopen the way for self-adminis-tered medication.

“The initial results sound verypromising. I’m anxious to see thefull analysis. I am encouraged bythe original research that is goinginto uveitis treatment,” saidDavid Gritz MD.

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EuroTimes September 2004

Pippa Wysongin Vancouver

THE Neosonix® handpiece, acomponent of the Infiniti™ phacosystem (Alcon) is living up to itspromise of reducing phaco timeand reducing corneal trauma,report Canadian researchers.

The researchers conducted aprospective study comparing thenovel hybrid technology to treat-ment with conventional ultra-sound in patients undergoingcataract surgery.They presenteddetails of the study at the annualconference of the CanadianOphthalmological Society.

"Neosonix is a hybrid technolo-gy based on a specialised hand-piece that combines both conven-tional linear ultrasound and low-frequency rotational oscillations ofthe hand-piece tip," explainedRickesh Sood MD, who is a mas-ters student in epidemiology atHarvard School of Public Health.

He was part of a research teamheaded by Ike Ahmed MD, fromthe University of Toronto.Theteam did what is believed to bethe first prospective study com-paring the outcomes of patientstreated with either Neosonix or

conventional ultrasound alone.The study randomised 84

cataract surgery patients, with anaverage age of 74 years, to treat-ment with either ultrasound pha-coemulsification plus Neosonixtechnology, or standard ultra-sound treatment alone.Therewere 44 eyes and 40 eyes in thetwo groups respectively, and therewere no differences in baselinecharacteristics.

Main outcome measures weretotal ultrasound time, averageultrasound power, effective pha-coemulsification time, cornealoedema, and uncorrected visualacuity on post-operative day one.

Mean total ultrasound time inthe Neosonix group was 55.2 sec-onds, compared with a mean of63.8 seconds in the ultrasoundonly group.The mean effectivephacoemulsification time was 7.83seconds in the Neosonix groupcompared with 11.91 seconds forthe ultrasound only. Neosonixalso required less ultrasoundpower.

Statistically significant differ-ences were also seen in patientfindings on the first post-operativeday.The proportion of eyes thathad no corneal oedema was

92.4% in the Neosonix group, and80.2% in the ultrasound group.Asfor uncorrected visual acuity of20/40 or better, the proportionswere 83.2% and 76.4% in thegroups, respectively.

The reduction of ultrasoundintraocularly has been shown tobe associated with reduced nega-tive clinical outcomes. Clinically,this is particularly important inpeople with pre-existing cornealdystrophies, said Dr. Sood.

An advantage of the Neosonixtechnology is that it allows thesurgeon to simultaneously useboth sonic and ultrasonic energy,at varying levels; or to choose asingle modality and togglebetween the two.This allows sur-geons to reduce the amount ofpotentially harmful thermal energythat can come from exposure totoo much high-frequency ultra-sound, he explained.

“Corneal oedema caused byendothelial damage duringcataract surgery has been shownto be related to the amount andduration of exposure to ultra-sound energy," he said.

Another ophthalmologist whohas used the technology is WilliamFishkind MD, who is based in

Tucson,Arizona but teaches at theUniversity of Utah. He toldEuroTimes he is not surprised bythe findings in the Canadian study.

“In my own experience theNeosonix technology is a uniqueaddition to the phaco armamen-tarium. It actually improves boththe jackhammer and the cavita-tional effect," he said.

The device is most effectivewhen emulsification is being per-formed on a nucleus that is heldin place. It's effective duringsculpting, and divide and conquer,or stop and chop techniques, heexplained.

He cautioned that the systemwas less effective for fragments. Infragment removal, Neosonix canknock the fragment off the tipduring the emulsification. On theother hand, cavitational energy ismore pronounced and aids in cav-itation of fragments.

"Since it makes both the sculpt-ing and the fragment removalmore efficient, you can almost betthat there is going to be less timespent during phaco, and lesspower going into the anteriorsegment.This means less potentialdamage to the blood aqueousbarrier and less damage to the

endothelium," he said.But while there are numerous

advantages to the Neosonixdevice, Dr. Fishkind has opted notto use it in his own practice. Hesaid that he finds the hand-pieceis too heavy for his personal pref-erence. "I do a lot of cases in theday and my hands get tired.Tohave a bigger, heavier hand-piecedoesn't appear to be worth it tome," he said.

The Neosonix handpiece isdesigned to work with the AlconLegacy and Infiniti machines.Thetrimodal Infiniti system offers sur-geons the option of using ultra-sound phacoemulsification alone,the combination of ultrasoundand oscillation provided by theNeosonix handpiece, or theAqualase® liquefaction tool.

[email protected]

Sonic phaco system may be less traumatic to the eye

19

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Across Europe,ophthalmolo-

gists are leadingtheir health sys-tems into the eraof day case sur-gery.

New statisticsfrom theOrganisation ofEconomicCooperation and

Development show that the day case ratefor cataract surgery far surpasses that ofthe overall rate of day surgery in virtuallyevery European county.

Also, the statistics show that the day caserates for cataract surgery also surpass theday case rates of four operations tracked bythe Paris-based government think tank. Invirtually every country, the day case rate forcataract surgery surpassed that of inguinaland femoral hernia repairs, ligation and vein-stripping operations, tonsillectomies, andlaparoscopic cholecystectomies.

In 2002, the percentage of cataract oper-ations carried out as day case procedureswas far higher than the percentage of alloperations carried out as day cases inDenmark, Finland, Italy, Portugal, and theUnited Kingdom.

The overall cataract day surgery rate forthose five countries was just under 75% in2002. By comparison the overall day sur-

gery rate for all operations in those fivecountries was just under 40%. Only inIreland and Luxembourg did cataract sur-geons perform a lower percentage of daycase surgery than the overall national daycase surgery average.

In 2002, the rates of day case cataract sur-g e ry rose to as high as 96.5% in Denmark,92% in Finland, and 89.6% in the UK. By com-p a r i s o n , the overall rates of day case surgeryrose only as high as 61.7% in D e n m a r k , 37.45% in Finland, and 53% in theU K .

In some countries, the rate of day casecataract surgerywas twice orthree times thatof the overallnational day caseaverage. InPortugal, forexample, the rateof day casecataract surgeryin 2002 was34.7% comparedto an overall daycase surgery rateof 10.4%.

In Finland, the

rate of day case cataract surgery was 92%,compared to an overall day case rate of37.4%.

In 2002, Italy recorded a day case cataractsurgery rate of 62.1% and an overall daycase surgery rate of 28.8%.

The OECD figures also showed thatcataract surgery is more commonly per-formed as a day case than are four otheroperations.

For example, the combined average daycase cataract surgery rate for Denmark,Finland, Ireland, Italy, Portugal and

Switzerland was 62% in 2002.

By contrast, the combined average daycase rate for those six countries in 2002was:

• 8.5% for laparoscopic cholescystec-tomies;

• 42% for ligation and vein-stripping;• 33.5% for inguinal and femoral hernia

repairs;• 22% for tonsillectomies.

In general, those European countries withthe highest rates of day case cataract sur-gery were the countries with the highestrates of day surgery for the other four

operations tracked by the OECD.Also,those European countries with the lowestrates of cataract surgery were the coun-tries with the lowest rate of day surgery foringuinal and femoral hernia repairs, ligationand vein-stripping operations, tonsillec-tomies, and laparoscopic cholecystectomies.

For example, Denmark, which postedEurope’s highest rate of day case cataractsurgery in 2002, also posted Europe’s high-est rates of day case surgery for three ofthe four procedures tracked by the OECD.

Danish surgeons performed 85.8% oftheir ligation and vein-stripping operationsas day cases in 2002. In same year, Danishsurgeons also posted Europe’s highest daycase rate for inguinal and femoral herniarepairs – 78.3%.

In addition, Denmark posted the highestday case rate for laparoscopic cholecystec-tomies in 2002 – 38.6%. By comparison,Danish ophthalmologists in 2002 performed96.5% of cataract operations as day cases

Finland, which posted Europe’s second-highest rate of day case cataract surgery in2002, also posted the second-highest ratesof day case surgery for laparoscopic chole-cystectomies, and inguinal and femoral her-nia repairs, and the third highest rate for lig-ation and vein-stripping.

EU Matters

Ophthalmologists lead the way in performing day case surgery

Percentage of All OperationsPerformed as Day Cases – 1997-2002

1997 1998 1999 2000 2001 2002Australia 35.7 41.9 44.1 43.5 44.4Canada 51.7 52.7 52.7Denmark 53.7 54.7 56.4 57.9 59.3 61.7Finland 28.7 30.5 33.2 34.6 35.4 37.4Ireland 41.8 42.4 41.2 40.9 42 44.5Italy 10.6 14.8 17.3 20.8 24.2 28.8Luxembourg 40.4 40.6 40.4 39.9 39.5 39.4Mexico 25.7 20.6 20.5Netherlands 41.7 44 45.1 46.3 48 49.5New Zealand 34.1 35.9 37.4 37.5 37.5 35.6Portugal 6.4 7 10.4United Kingdom 48.4 49.9 51.2 51.5 52

Copyright OECD HEALTH DATA 2004, 1st edition

By Paul McGinn

Percentage of Cataract Operations Performed as Day Cases – 1992-2002

1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002Australia 76.8 80.3 84.1 87.1Canada 97.8 98.2 98.6Denmark 79.6 87.1 88.3 90.8 93.4 95.8 96.5Finland 4.2 14.7 20.7 33.3 42.4 58.7 67.0 74.7 81.6 86.9 92.0France 9.8 18.9 22.8 27.4 31.8 35.8Ireland 10.9 15.1 20.7 21.1 27.8 28.8 33.3 36.3Italy 5.7 9.4 17.7 27.0 37.6 47.1 62.1Luxembourg 27.8 29.3 28.0 30.8Mexico 68.1 68.1Netherlands 71.6 82.8 88.9New Zealand 89.6 89.2 90.9Portugal 9.1 30.9 34.7Switzerland 52.7United Kingdom 21.7 33.7 45.7 71.8 77.7 83.1 89.6

Copyright OECD HEALTH DATA 2004, 1st edition

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EuroTimes September 2004

For more than a decade, Europe’scataract surgeons sprinted toward theelusive finish line of efficiency as they dis-charged in-patients sooner and performedmore day surgery.

If the newest statistics from theOrganisation for Economic Cooperationand Development are any indication, oph-thalmologists are still striving for the effi-ciency finish line. However, the OECD’sstatistics also reveal that sprint to reducethe average length of stay for cataract sur-gery and increase the percentage of daycases has slowed to a walk and even to acrawl in many European countries.

One reason for the slowdown is obvi-ous in a number of countries.There, thepercentage of cataract surgery performedas day cases in nearing 100%. But even inthose countries where the percentage ofday case cataract surgery is under 50%,the rate of out-patient surgery is slowing.Although it is too early to interpret pre-cisely why the pace has slackened, theOECD figures seem to indicate thatcataract surgeons in a number of coun-tries are finding it difficult to increase daycase surgery and reduce the length of stayfor their patients.

For instance, the country with Europe’sshortest length of stay – Finland – actuallyincreased its average length of stay,according to the most recent OECD fig-

ures. In 2002, Finland posted an averagelength of stay of 1.2 days for cataract sur-gery, thanks to Europe’s second highestrate of day cataract surgery – 92%. In2001, however, Finland recorded a loweraverage length of stay – of 1.1 days –when ophthalmologists performed 86.9%of cataract operations as day cases.

Finland’s experience of an increase in itslength of stay for cataract surgery was notunique. Between 2001 and 2002, cataractsurgeons in New Zealand also saw anincrease.The New Zealand average lengthof stay actually grew by 0.3 days between2001 and 2002. Over the same period,the percentage of day case cataract sur-gery rose to 90.9% from 89.2%.

In the UK, the average length of stay forcataract surgery doubled between 2001and 2002 to 2.2 days, according to theOECD figures. However, a closer exami-nation of the figures revealed that the2002 statistics – unlike the 2001 statistics– excluded day cataract surgery cases andcataract surgery performed in a privatehospital. Between 2001 and 2002, thepercentage of cataract surgery performedas day cases rose significantly in the UK –to 89.6% from 83.1%.

The length of stay for cataract surgeryin Ireland, Italy, and Switzerland was stag-nant between 2001 and 2002. In bothyears, Ireland recorded an average length

of stay of 2.3 days; Italy recorded an aver-age length of stay of 2.1 days; andSwitzerland recorded an average length ofstay of 2.8 days.

Although most countries continued toreport reductions in the average length ofstay for cataract surgery, those reductionsare nowhere near the reductions of theearly and mid-1990s.Then, some countriesreduced their length of stay by two orthree days in a single year. Now, reduc-tions rarely exceed 0.2 days or 0.3 daysper year. For instance, the average lengthof stay for cataract surgery fell by threedays – to 9.7 days – between 1993 and1994 in Hungary. Between 2001 and2002, the average length of stay fell by 0.3days to 3.6 days.

EU Matters

PACE OF EFFICIENCY SLOWING AS OPHTHALMOLOGISTS CONSOLIDATE GAINS

Average Length of Stay (in Days) in Hospitalfor Cataract Operation – 1992-2002

1 9 9 2 1 9 9 3 1 9 9 4 1 9 9 5 1 9 9 6 1 9 9 7 1 9 9 8 1 9 9 9 2 0 0 0 2 0 0 1 2 0 0 2

A u s t r a l i a 2 2 . 1 2 1 . 6 1 . 4 1 . 5 1 . 3 1 . 2 1 . 3A u s t r i a 8 . 9 8 . 3 7 . 6 6 . 8 6 . 5 5 . 7 5 . 2 4 . 8 4 . 5 4C a n a d a 1 . 9 1 . 7 1 . 6 1 . 5 1 . 9 1 . 5 1 . 4 1 . 5Czech Republic 7 . 4 6 . 2 5 . 5 5 4 . 2 3 . 8 3 . 7 3 . 4 3 . 1D e n m a r k 2 . 5 2 . 5 2 . 6 2 . 5 2 . 1 1 . 8 1 . 8 1 . 8 1 . 7 1 . 5 1 . 4F i n l a n d 3 . 6 2 . 9 2 . 2 2 . 4 2 . 2 1 . 6 1 . 3 1 . 2 1 . 2 1 . 1 1 . 2F r a n c e 3 . 2 2 . 1 2 1 . 9 1 . 8 1 . 7H u n g a ry 1 3 . 6 1 2 . 7 9 . 7 8 . 4 7 . 3 6 . 7 5 . 7 5 . 2 4 . 6 3 . 9 3 . 6I re l a n d 5 . 2 4 . 2 3 . 8 3 . 6 3 . 3 3 . 2 3 2 . 9 2 . 6 2 . 3 2 . 3I t a ly 6 . 9 6 . 5 5 . 9 3 . 5 3 . 1 2 . 8 2 . 5 2 . 3 2 . 1 2 . 1Ko re a 2 1 . 2L u xe m b o u r g 2 . 8 2 . 5 2 . 4 2 . 2M e x i c o 2 . 2 2 1 . 9 2 1 . 7N ew Zealand 2 . 5 2 . 1 1 . 5 1 . 4 1 . 4 1 . 4 1 . 5 1 . 8 1 . 2 1 . 4 1 . 7N o r w ay 2 . 3 1 . 9 1 . 7 1 . 5Po rt u g a l 6 . 3 5 . 6 5 4 . 6 4 . 5 4 . 1 3 . 8 3 2 . 5 1 . 8 1 . 6S l ovak Republic 1 2 . 8 1 1 . 6 1 0 . 5 9 . 7 9 8 . 4 7 . 7 6 . 7 5 . 7 4 . 9 4 . 4S we d e n 2 . 2 2 . 1 2 . 1 2 . 2 2 2 2 2 1 . 9 1 . 8 1 . 7S w i t z e r l a n d 6 . 2 5 . 7 5 . 2 4 . 5 2 . 8 2 . 8 2 . 8Tu r key 7 . 2 6 . 6 6 . 3 5 . 7 5 . 1 6 . 9 4 . 7 4 . 4 4 3 . 8 3 . 5United Kingdom 3 . 3 2 . 3 1 . 3 1 . 3 1 . 3 1 . 2 1 . 2 1 . 1 1 . 7 1 . 1 2 . 2United States 1 . 1 1 . 3 1 1 1 . 1 1 . 1 1 1

C o pyright OECD HEALTH DATA 2004, 1st edition

The UK, which posted Europe’s third-highest rate of day case cataract surgery in2002, also posted the highest day case ratefor tonsillectomies – 85.9%. The UK alsoposted the third-highest rate of day casesurgery for inguinal and femoral herniarepairs – 43.8% – and the fourth-highestrate of day case surgery for ligation andvein-stripping – 53.1%.

In that same year, UK ophthalmologistsperformed 89.6% of cataract operations asday cases.

Although it did not report cataract sur-gery statistics to the OECD in time to beincluded in the study for 2002, theNetherlands is expected to remain aleader in day case surgery for cataractsand other conditions. For example, theNetherlands posted Europe’s second-high-est rate of day case cataract surgery in2001 – 88% – and Europe’s third-highestoverall rate of day case operations –49.5% – in 2002.

Luxembourg and Portugal, which postedcomparatively low rates of day casecataract surgery in 2002, also posted someof the lowest rates of day case surgery foringuinal and femoral hernia repairs, ligationand vein-stripping operations, tonsillec-tomies, and laparoscopic cholecystec-tomies. For example, the day case rate forlaparoscopic cholecystectomies in Portugaland for tonsillectomies in Luxembourg didnot even reach 1%.

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EuroTimes September 2004

In virtually every country, cataract surgeonsperformed more operations per capita in 2002than ever before.

Of the 10 European countries with statisticsfrom the Organisation for Economic coopera-tion and Development, all but one reported anincrease in the number of cataract operationsperformed per 100,000 of population between2001 and 2002.

For instance, the rate of cataract surgerybetween 2001 and 2002 increased in:

• Belgium by 4%;• Denmark by 14%;• Finland by 24%;• Hungary by 3%;• Italy by 7%;• Luxembourg by 5%• Portugal by 13%• United Kingdom by 8%.

Only in Ireland did the rate of cataract sur-gery fall in 2002. The rate in Ireland fell by 9%to 441.6 from 485.6 operations per 100,000 in2001. The 2001-2002 gains in the rest of theEuropean countries surveyed came on top ofhuge gains in the early and mid-1990s.

For instance, the rate of cataract surgeryhas:

more than doubled in Portugal since 1993;more than doubled in Finland since 1992;more than doubled in Italy since 1996;nearly doubled in the UK since 1995;nearly doubled in France since 1993;risen by 43% in Denmark since 1995;risen by 26% in the Netherlands since 1999;risen by 25% in Ireland since 1995;risen 11% in Hungary since 1999.Of the 10 European countries with OECD

statistics from 2002, Italy reported the highestrate of surgery – 783.8 operations per100,000 of population. That figure representedan increase of about 6.5% over the 2001 figureof 735.2 operations per 100,000.

Although 2002 figures aren’t available forFrance, it is conceivable that French cataractsurgeons performed in 2002 substantially morethan the 2001 rate of 757.5 operations per100,000 of population. Even a modest increaseof 4% in the French cataract surgery statisticsfrom 2001 to 2002 would have eclipsed theItalian 2002 statistics.

Of those countries who reported statistics

for 2002, Luxembourg was not far behind Italy,with a rate of 766 operations per 100,000 ofpopulation. That figure represented anincrease of about 5% over the 2001 figure of730.4 operations per 100,000.

Hungary was third in 2002, with 745.1 oper-ations per 100,000 of population; that figurerepresented a 3% increase over the 2001 fig-ure of 723.6 operations.

However, the surgery rates of Europeancountries that reported to the OECD are stillbehind those of Canada. In 2001, the latestyear for which statistics were available fromCanada, ophthalmologists there performed

1,109.3 cataract operations for every 100,000persons. On the bottom of the list was NewZealand, with its rate of 199.8 cataract opera-tions per 100,000 of population.

Even within Europe, however, the rates ofcataract surgery vary considerably. Comparedto Italy’s rate of 783.8 operations per 100,000of population, Portugal recorded a cataractsurgery rate of 221.3 per 100,000; Irelandrecorded a rate of 441.6 per 100,000; andDenmark recorded a rate of 514.1 per100,000.

EU MattersCataract surgery rates make huge gains across Europe

NUMBER OF CATARACT OPERATIONS PERFORMED PER 100,000 OF POPULATION – 1992-2002

1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002Australia 896.5 667.9 712.3 752.8Belgium 604.9 673.2 701.3Canada 1191.0 1237.9 1109.3Denmark 358.6 364.2 382.4 428.3 429.5 451.2 514.1Finland 323.9 372.8 441.6 457.3 536.8 589.5 620.9 650.0 638.9 582.9 723.3France 430.3 625.3 656.5 683.5 726.2 757.5Hungary 669.5 698.7 723.6 745.1Ireland 354.2 364.6 361.4 363.4 366.0 446.7 485.6 441.6Italy 356.7 431.0 507.4 579.5 659.9 735.2 783.8Korea 315.8Luxembourg 589.5 622.3 745.1 666.1 713.7 730.4 766.0Mexico 44.0 47.3Netherlands 469.1 548.6 591.7New Zealand 243.2 219.5 199.8Portugal 83.1 93.7 97.8 106.0 114.5 111.7 140.7 145.6 195.8 221.3Switzerland 476.6United Kingdom 282.0 318.9 341.8 424.6 444.7 512.4 553.8

Copyright OECD HEALTH DATA 2004, 1st edition

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EuroTimes September 2004

Sean Henahanin Florence

IT’S not just about intraocular pressureany more.With the current flood of newfindings on the pathogenesis, diagnosis andtreatment of glaucoma, researchers at the7th Congress of the European GlaucomaSociety declared the existence of a newparadigm for glaucoma management.

The new paradigm considers glaucomaas a progressive optic neuropathy ratherthan simply a disease involving elevatedintraocular pressure and impaired outflow.The new paradigm looks at glaucoma as acontinuum, beginning with the impercepti-ble loss of retinal ganglion cells, followedby structural changes in the retinal nervefibre layer and then in the optic disc,according to Robert Weinreb MD PhD,Director of the Hamilton GlaucomaCentre, University of California, SanDiego.

Those neuropathological changes mayprecede by many years the visual fieldchanges that are still often the first clinicalindication of glaucomatous disease.Theobjective of the new paradigm is to identi-fy at-risk patients and initiate potentiallyvision-preserving treatment well beforeperimetric changes appear, explained DrWeinreb, who is also the current presi-dent of the Association of InternationalGlaucoma Societies.

“The future is bright for being able todetect glaucoma at an early stage.The rea-son we want to detect glaucoma at anearly stage and treat progression at anearly stage is that there is a convergenceof information from numerous clinicalstudies showing that treatment by lower-ing IOP has benefits across the glaucomacontinuum.This is true whether you aretreating early in the continuum, as demon-strated in OHTS, later as in the EMGTS,or even in advanced disease as in the

CIGTS. Each of these trials has demon-strated the benefit of IOP lowering,” headded.

Early detection is a key component ofthe new glaucoma paradigm. In addition tooptic disc measurement, IOP and visualfield testing, clinicians can now utilize sev-eral important new digital imaging modali-ties that have emerged in recent years.These techniques, including scanning lasertomography (e.g. Heidelberg RetinalTomograph), scanning laser polarimetry(e.g. GDx VCC, Laser DiagnosticTechnologies), and optical coherencetomography, allow clinicians to identify andtrack changes in the optic nerve head andretinal nerve fibre layer.

Glaucoma specialists have not aban-doned field testing. On the contrary,recent developments in perimetry includ-ing short wavelength automated perimetry(SWAP), frequency doubling perimetryand automated flicker perimetry can beused to identify the loss of specific gan-glion cell populations, allowing earlierrecognition of field loss, and more accu-rate monitoring of disease progression.

There was considerable discussion anddebate during the congress regarding how

to best integrate the diagnostic tools nowavailable.A consensus is forming that thetools are complementary and togetherwill help glaucoma specialists to recogniseglaucomatous changes many years beforesymptoms appear, and will improve moni-toring of treatment and disease progres-sion.

"Glaucoma that is detected early is per-haps easier to stabilise than late glaucoma.Treatment goals include the preservationof visual field to allow patients to maintaintheir quality of life, including the ability todrive, to continue working or stay inde-pendent. But other issues need to be con-sidered as part of a comprehensive treat-ment approach, including side effects,treatment costs and the inconvenience ofmedication," stressed Clive Migdal MD,Head of the Glaucoma Service at theWestern Eye Hospital, London, andSecretary of the European GlaucomaSociety.

Presentations during the congress alsosuggested a growing consensus that cur-rent tonometry techniques, includingGoldman applanation tonometry, are inad-equate.Attendees heard about severalnew experimental devices for measuring

IOP including a pressure-sensing contactlens and a pressure sensor telemetrictonometry device.

The availability of new diagnostic instru-ments that can identify pre-symptomaticstructural changes comes at time whenresearchers are anxious to improve

screening for glaucoma, according toCarlo Traverso MD, a glaucoma specialistfrom the University of Genoa, Italy.

"It is known that about 50% of individu-als with unquestionable glaucoma areunaware of their condition.As a result,many throughout Europe present late withirreversible vision damage. Every individualover 40 years of age should have theopportunity of at least one examinationby an experienced eye doctor."

Dr Traverso called for a comprehensiverisk assessment strategy based on meas-urement of corneal thickness, presentingIOP and the degree of optic nerve headdamage.

New paradigm for glaucoma management

23

"It is known that about50% of individualswith unquestionable glaucoma are unawareof their condition. As aresult, many throughout Europepresent late with irreversible vision damage” Carlo Traverso MD

European Glaucoma Society Congress report

“The future is bright for being able to detect glaucoma at an early stage. The reason we want todetect glaucoma at an early stage and treat progression at an early stage is that there is a convergence of information from numerous clinicalstudies showing that treatment by lowering IOPhas benefits across the glaucoma continuum”Robert Weinreb

"Glaucoma that is detected early is perhaps easierto stabilise than late glaucoma. Treatment goalsinclude the preservation of visual field to allowpatients to maintain their quality of life, including the ability to drive, to continue workingor stay independent”Clive Migdal MD

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"We know that thin-ner corneas, higher levels ofintraocular pressure and perhapsa larger cup disc ratio are inde-pendent risk factors for diseaseprogression.Treatment decisionsshould be based on a detailedassessment of individual risk."

The conference also served tointroduce the EuropeanGlaucoma Society’s updated glau-coma treatment guidelines.The

new edition incorporates the lat-est clinical research and thinking

on glaucoma, together with anupdate on the evidence for thelatest therapies and surgical tech-niques.

"These updated guidelines havebeen based on the most currentglaucoma literature, conferencesand clinical experiences available.They're critical for physiciansbecause glaucoma treatment andmanagement is unique for everypatient, which the second edition

of the guidelines emphasiseseven more strongly," explainedProfessor Roger Hitchings MD,

President of the EuropeanGlaucoma Society.

The new EGS guidelines incor-porate recent results from sever-al large, randomised controlledtrials (OHTS, EMGT, CNTGS,AGIS, CGITS), which clarify thevalue of current treatments. Ingeneral, those trials concludedthat lowering IOP early in thecourse of the disease slowedprogression of visual loss andblindness later on.

"Much of what we thought ofas good practice in treating glau-coma had now been strength-ened by evidence from ran-domised controlled trials.Thesetrials confirm the benefit of low-ering and stabilising eye pressurein slowing disease progression.Evidence also shows the benefitof early treatment in preventingfurther vision loss due to glauco-ma," Dr Hitchings commented.

The new EGS guidelines alsoemphasize the role of patientcompliance and the measure-ment of quality of life in treat-ment decisions and outcome.The followed the growing recog-nition among glaucoma special-ists that glaucoma patients arefrequently elderly and may haveconcomitant health problemsthat interfere with their ability totake their medicines correctly.

"Although hard to quantify,quality of life is an important

outcome measure for patientsand the effect of both diagnosisand treatment on the individualhave to be considered.Visualfunction is closely linked to qual-ity of life. treatment side effects,dosing schedule and cost all haveto be taken into account whenchoosing a therapy," said JohnThygesen MD,AssociateProfessor in the Department ofOphthalmology,

University Hospital ofCopenhagen, Denmark.

The Congress highlighted theevolutionary step forward nowtaking place in glaucoma science.However, it also confronted themany unanswered questions stillfacing glaucoma researchers,including: the pathogenesis ofganglion cell loss; the utility ofneuroprotective drug strategies;the genetics of glaucoma; theneed for objective tonometryand perimetry methods; and theimportance of 24 variations inIOP.

24

"Much of what we thought of as good practice in treating glaucoma had now beenstrengthened by evidence from randomisedcontrolled trials. These trials confirm thebenefit of lowering and stabilising eye pres-sure in slowing disease progression.”Roger Hitchings MD

"Although hard toquantify, qualityof life is animportant out-come measure forpatients and theeffect of bothdiagnosis andtreatment on the

individual have to be considered.

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Regulatory MattersHoward Larkin

International pressure builds for unified clinical trials registry

Accusations that a major drug manu-facturer may have suppressed somenegative drug trial results are lending

new urgency to calls by ophthalmologistsfor establishing a unified clinical trial reg-istry.

Such a registry would likely build onexisting national and private registries toestablish a one-stop online list of all ongoingand concluded clinical trials.A description ofthe methodology, status and results of alltrials would be included, whether theirresults were published or not.

Such a trial registry would be useful notonly for keeping tabs on off-label uses ofdrugs approved by various national andinternational agencies, it could make it easi-

er for ophthalmologists to check out newimplantable lenses and other devices thatare not regulated in every country, said oph-thalmologist Emanuel S. Rosen, FRCS,European editor of the Journal of Cataractand Refractive Surgery. “Particularly in thetabloids you get people extolling the virtuesof new lenses without the proper trials hav-ing taken place.”

A unified registry of all trials would alsohelp balance what many believe – and somestudies have confirmed – is a bias towardpublishing favorable trial results in the peer-reviewed literature.“Every once in awhilesomething leaks out that the clinical resultsthat don’t get published are at variance withthose that do get published,” said Dr.

Richard E. Bensinger, MD, who is aspokesperson for the American Academy ofOphthalmology and director of the institu-tional review board overseeing research atthe 700-bed Swedish Hospital in Seattle,Washington.

Dr. Bensinger pointed to a case of a well-known anti-infective agent used in oph-thalmic procedures that has been shownineffective in children. Most new drugs arenot tested on children before they reachthe market, he notes.“As clinicians, we needto have this information, and it doesn’talways get published,” Dr. Bensinger added.

Single information source could reduce publishing bias and improve research efficiency

BUDDING SCANDALSPARKS RENEWEDACTION

Calls for publicly available registries of clin-ical trials are nothing new. Organisations suchas the Cochrane Collaboration and theWorld Health Organisation have advocatedtheir development for more than a decade.Now they’re being joined by the powerfulAmerican Medical Association, which in Junecalled on the U.S. government to create apublicly available registry of all trials in theU.S.The measure has support from severalkey members of the U.S. Congress, thoughno action is likely before next year.

The AMA’s move followed allegations by astate prosecutor in New York that the UK-based drug manufacturer, GlaxoSmithKline,suppressed studies suggesting that the antide-pressant paroxetine was ineffective in chil-dren and adolescents, and may be associatedwith increased suicidal behavior.GlaxoSmithKline denies the allegations andhas since adopted a policy of posting resultsof all trials involving its products on theInternet.

Other drug companies that haveannounced they will make information on alltrials publicly available include US-basedMerck & Co. and Eli Lilly and Company.Merck has also backed a unified registryapproach. Despite the openness of such com-panies, significant resistance to publishingremains in the pharmaceutical industry. Oneconcern is that publishing the details of earlytrials could provide valuable data to compet-ing developers, according to Court Rosen, aspokesperson for the PharmaceuticalResearch and Manufacturers Association.

While many doctors acknowledge thatmanufacturers have legitimate commercialinterests in keep trade secrets, they believe

the public good argues compellingly for dis-closure.

“The concept is difficult to oppose,” saidMetin Gulmezoglu, MD, a WHO researcher.“There are ethical arguments as well as thosefor evidence-based decision-making in favorof a unified clinical trials registry. However,different groups understand or expect differ-ent things and we need to communicate ouraims appropriately.”

WHO is working with its member statesto develop a unified trials registry, which ithopes to unveil in November.

“Posting the results of such trials wouldaddress growing concerns over publicationand outcome bias in clinical trials,” saidJoseph A. Heyman, a member of the board oftrustees of the American Medical Association.“The public and physicians have a right and aneed to know the results of clinical trials ifthey are to make informed treatment deci-sions.”

That’s difficult with existing registries. Manycountries maintain multiple registries. Forexample, the U.K. maintains separate reg-istries for private and publicly fundedresearch; a number of countries that havenational registries also restrict access, so theycan’t be used by many physicians.The U.S.National Library of Medicine currently main-tains a Web site, www.clinicaltrials.gov, whichlists about 10,000 trials. However, the mainpurpose of the website is to recruit patients,and the list is not comprehensive.

More than 300 public and private clinicaltrial registries currently exist in the U.S.,making it difficult to track all research in agiven area. In addition, many trials are com-pleted and never reported anywhere.

Support for clinical trials registries is alsocoming from the medical publishing commu-nity.The International Committee of MedicalJournal Editors is considering a policy thatwould require studies to be registered as acondition of publication.

WHO TARGETS UNIFIEDTRIAL RELEASE FORNOVEMBER

A World Health Organisation adviso-ry committee is developing a proposalfor a unified clinical trial registry.

The proposal is slated to be unveiledat the World Health Forum in Mexicothis November.

The most likely approach is to rec-ommend upgrades to national registriesthat are already in place in many coun-tries, and to set up an online portal thatwould enable researchers to access themall, said Metin Gulmezoglu, a WHOresearcher who is leading the registryeffort. In addition, an international uni-form numbering system would beadopted so that each trial would have aunique identifier to eliminate confusionabout whether a trial at a given locationis one part of a multi-center effort, or astand-alone study.

Dr. Gulmezoglu and other WHO staffare currently working with representa-tives in member countries to iron outthe details. “There are technical issuesthat are not trivial but can beaddressed, there is an advocacy side;that we need to inform, consult thestakeholders especially our memberstates, and then there are the resource-related issues. Our aim is to have a con-crete plan by November.”

While no country now has a registryin place that can serve as a completemodel for the proposed WHO system,several are well on their way, said KayDickersin, a professor at BrownUniversity in the United States, and aconsultant to the WHO registry com-mittee. The Netherlands, the UnitedKingdom, Germany, and South Africaare countries with well-developednational registries, said Dr. Dickersin,who is also director of the U.S.Cochrane Collaboration. The CochraneCollaboration is an international organ-isation committed to making reviews ofpublished medical literature and trialsavailable to all.

If established, the unified registry willprovide a global resource for conduct-ing clinical trials and disseminatingimportant medical information to less-developed counties, both importantWHO goals.

“Research is international,” Dr.Gulmezoglu said. “We should avoidduplication, base our decisions on bestavailable evidence, both positive andnegative, and we have an ethical duty toinform the public about what researchis being conducted and their results.”

RECOMMENDATIONSFOR A UNIFIED TRIALSREGISTRYAccording to the CochraneCollaboration:

1. All randomised controlled trials should registered from the time they are approved by an ethics committee or approved for funding;

2. Registered information should be potentially accessible to all interested parties;

3. Registration should be with a register that complies with anappropriate minimum standard of practice;

4. Prospective registration of trials should be part of ethicalguidelines for clinical trials;

5. Government agencies should ensure that ade quate mechanisms and infrastructure are provided so that all randomised controlled trials can be registered prospectively;

6. Government agencies should explore legislative and other strategies to mandate prospective registration as a condition of, for example, funding, ethics, or regulatoryapproval.

Source: Cochrane Collaboration, 2004

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Stefanie Petrou-Binder MDin Heidelberg

AUTOMATING patient docu-mentation using an electronic plat-form can simplify the physician’sroutine and work flow, particularlywith the increased bureaucracyassociated with outpatient surgery,according to Amir-Mobarez ParastaMD PhD,Technical University EyeClinic, Munich, Germany “Thereare certain tedious steps associat-ed with out-patient surgery that

often become repetitive and couldbe automated to ease the workflow, such as: making appointments,documentation of pre-operativeexams, the OR report, documenta-tion of follow-up exams, and thenow obligatory quality assurancedocumentation,” Dr Parasta toldlisteners at the annual Congress ofthe DGII (German-SpeakingSociety for Intraocular LensImplantation and RefractiveSurgery).

In ophthalmic surgery, ‘telemedi-cine’ includes the ever-more popu-lar use of electronic appointmentcoordination between referringphysicians and clinics, transferral ofdata, and postoperative manage-ment, while ensuring privacy pro-tection, easy use, and low costs.

The flow of information is gen-erally between the referring physi-cian and the surgical centre.Themost basic function of the elec-tronic platform that Dr Parastadescribed would allow the refer-ring physician to see a mutualappointment calendar from hisoffice PC, enabling him to make anappointment for his patient forcataract surgery or another ambu-latory procedure, directly.Thereferring physician can see whichtime slots are free and claim a timeslot for his patient.

The notion of ‘friendly, fast serv-ice’ is now an important attributein German medicine. Providingcataract patients with the simpleservice of organising an appoint-ment for surgery from the com-forts of his doctor’s office is some-thing that some patients havecome to expect.

In addition, the physician canelectronically provide patient datato the hospital, such as the diagno-sis and all data relevant to the sur-gery. Once documented electroni-cally, this data does not need to betaken down again, which saves boththe patient and the surgeon timeand energy.

After surgery, the OR report isentered into the system and can berecalled directly by the attendingphysician. Data can be added orchanged.The system supportsimages and video data, for instanceslit-lamp pictures for analysis orcomparative purposes.

There are currently two differ-ent ophthalmologic organisationsthat use this electronic platform inGermany to store, transfer, andwork with patient data.TheGlaucoma Plus Diagnostic Centres(ADCs) that work together withPfizer Ophthalmics and AMD-Netfor quality assurance in PDT patients in association withNovartis.

AMD-Net features a completelyelectronic patient chart that can bedocumented by clicking, which is

used to assure quality of PDTtreatments.

ADCs are specialised glaucomacentres that offer glaucomapatients examinations that theirhealth premiums do not coverrefers patients.Their attendingophthalmologist to an ADC foradditional, periodic testing.

Helmut Binder MD, an ophthal-mologist based near Frankfurt,Germany, makes appointments forhis glaucoma patients at his partici-pating ADC from his office PC. Healso analyses the examinationresults and images online.

“ADCs are designed for glauco-ma patients who require increasedsurveillance, although their healthinsurances don’t cover the costs.Scheduling an appointment elec-tronically is simple.The system isuser-friendly and the service I canoffer patients through the use ofan electronic platform makes goingfor check-ups easier for them.

“Before each first visit, I amrequired to fill in the electronicpatient chart, which is then savedand used for future visits. I canamend it at any time.What’s more,I can check the HRT results direct-ly online after the visit, with theuse of a system key that is provid-ed to ensure patient privacy.Whenthe patient returns to my office forhis follow-up visit, I can explain andshow the exam outcome to him bysimply logging on,” he explained.

The Technical University inMunich developed this concept(The Medtrix Project) to simplifydata exchanges.The Medtrix con-cept was carried out in an industri-al partnership with the GermanEpitop Medical Group. Ideally, theelectronic platform should beadapted for all medical informationtransfers.

Dr Parasta explained that theMedtrix electronic platform allowsfor patient-oriented files that canbe retrieved at any place of treat-ment, giving physicians access to allprevious patient data.

He pointed out that duplicateexams could be avoided.Furthermore, the information thatis required for quality assurance issimplified and documentation islimited to the newly gained data.This way, physicians no longer haveto fill out lengthy, repetitive forms.

Dr Parasta proposed that thepatient health chip-card, already inuse in Germany or patient identifi-cation, could be transformed into apatient service card, storing admin-istrative and emergency data, andsignatures and keys for access tothe patient file on the system.Thedata are not stored on the carditself but on the system, for securi-ty reasons.

A prototype of the patient serv-ice card, called the‘Gesundheitspass Auge’ (Eye HealthPassport), has been developed.Also, the identification of the physi-cian in the system is possiblethrough electronic identification.The system was first tested inBavaria, he said.

“Although not yet in widespreaduse, automated electronic appoint-ment coordination with the trans-ferral of relevant treatment databetween physicians and clinics isthe direction that data processingis taking in today’s medical environ-ment, which involves high expecta-tions of quality and service.Thecosts seem almost negligentlysmall, compared to what was spentup to now on personnel and timeinvestment. Even postoperativemanagement and statistical analysesfor quality insurance are no prob-lem. Once obligatory electronicpatients chip cards are issued, themedical web will be the standard.We must set the standards todayin order to influence the course oftomorrow,” Dr Parasta said.

Further information about the Medtrix project:www.medtrix.de

[email protected]

[email protected]

Electronic patient-charts aid “friendly, fast”practice in Germany

26

1/3 pgAsiconew

Amir-Mobarez Parasta

“There are certain tedious steps associated with out-patient surgery thatoften become repetitive and could beautomated to ease the work flow,”

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Stefanie Petrou-Binder MDin Heidelberg

LASIK surgery is proving to bean effective method for correctingresidual refractive error and astig-matism after phakic IOL implanta-tion, report German researchers.

Christian Meltendorf MD andcolleagues at the Johann WolfgangGoethe University Clinic implant-ed the Artisan iris-fixated anteriorchamber lens (Ophtec) in 170eyes with high levels of myopiaand astigmatism.With follow-upLASIK, all of the eyes reached 0.8or better.

“LASIK appears to be a safe andeffective means to treat residualmyopia and astigmatism followingthe implantation of iris fixatedphakic IOLs.We were able to

reduce the mean astigmatism by14% with Artisan phakic IOLimplantation and by a further 67%following LASIK,” he reported atthe Congress of the GermanSpeaking Society for IntraocularLens Implantation and RefractiveSurgery (DGII).

The investigators performedLASIK corrections on seven eyesof six patients (4.1%) after anaverage of nine months followingthe implantation of the phakicIOL. Patients ranged in age from29 to 49 years, averaging 37 years.All LASIK procedures were per-formed using the Hansatomemicrokeratome (Bausch & Lomb)and a Technolas Keracor 217 scan-

ning-spot-excimer laser, (Bausch &Lomb).

Dr Meltendorf reported thatthe implantation of a phakic IOLled to a reduction of the sphericalequivalent and a decrease in themean astigmatism in all sixpatients. Only 14% achieved

uncorrected visual acuity of 0.8 orbetter, before LASIK. One monthfollowing LASIK however, allpatients achieved at least 0.8.None of the patients experienceda reduction in vision followingLASIK retreatments.

The researchers evaluatedpatients prior to implantation ofthe Artisan lens, three months fol-lowing phakic IOL implantation,before LASIK, and one month fol-lowing LASIK surgery.Theyanalysed refractive data with theDatagraph medical outcomesanalysis software program.

Before phakic IOL implantation,the mean spherical equivalent ofthe study participants was –9.13D,

ranging from -6.38 D to -13.13D.The mean sphere was –8.32 D,ranging from –5.25 D to -12.00 D.The mean amount of cylinder was-1.61 D, ranging from -0.25 D to -2.25 D.

After phakic IOL implantation,but prior to LASIK, the mean

spherical equivalent and meansphere were greatly improved, at–1.09 and –0.39 D ± 0.80 Drespectively. However, the meanamount of astigmatism remainedhigh at -1.39 D, ranging widelyfrom -0.75 D to -2.00 D.

Dr Meltendorf said that onemonth after LASIK, the meanspherical equivalent was reducedto +0.05 D, the mean sphere wasreduced to +0.29 D, and the meancylinder to -0.46 D.

The researchers said that thevisual results of LASIK as seen inseven eyes one month followingtreatment was good. Fourteenpercent showed visual acuity of1.2 or better; 71% had vision of0.9 to 1.0, and another 14% hadvision of 0.8. By comparison, 29%of the patients had vision of 0.32or worse, 29% had 0.5, 20% werebetween 0.6 - 0.7, and only 14%had 0.8, before LASIK.

“In terms of safety and pre-dictability, 71% of patients hadunchanged BCVA after LASIK andthe remaining 29% have improvedvision of one line.The sphericalequivalent following LASIK waswithin a dioptre of intendedrefraction in 100% of cases andwithin 0.5 D in 86%,” he said.

The investigators reported avery low complication rate.Twopatients developed transient grade

I or II diffuse lamellar keratitis andanother two developed dry eye.There were no long-lasting com-plications.There were no cases ofendothelial decompensation,halos, blinding, cataract develop-ment, incision complications, IOLdecentration, epithelial ingrowth,or increased IOP.

Dr Meltendorf commented thatalthough LASIK appeared to be asafe and effective treatment in thecorrection of residual error fol-lowing the implantation of phakicIOLs, larger case studies wereneeded to verify these results.

[email protected]

LASIK enhancement corrects residual refractive error in phakic IOL patients

27

Christian Meltendorf

We were able to reduce the meanastigmatism by 14% with Artisan phakic IOL implantation and by a further 67% following LASIK,”

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Dermot McGrathin Monte Carlo

SYSTEMIC corticosteroids andimmunosuppressants are potentagents in the treatment of ocularinflammatory diseases with bestresults achieved when physiciansadhere to proper dosing tech-niques, according to Douglas A.Jabs MD, Johns Hopkins UniversitySchool of Medicine, Baltimore,Maryland, US.

Speaking at the 5thInternational Symposium onOcular Pharmacology andTherapeutics (ISOPT), Dr Jabssaid that while the use of suchdrugs has the potential for seriousside effects, their undoubted effi-cacy provided an acceptable riskbenefit profile for most patientswith serious ocular inflammation.

Most common problems associ-ated with taking oral corticos-teroids such as sleeplessness,mood swings, cushingoid habitusand elevated intraocular pressureare reversible and typically resolvewith dose reduction, said Dr Jabs.

Other side effects that must bemonitored more carefully includeweight gain, hypertension, fluidretention and osteoporosis.Athird category of side effects,which includes ischaemic necrosisof bone, psychosis, osteoporosisand myopathy, have more adverseeffects on patient health and markthe point of departure intoimmunosuppressive therapy, hesaid.

Oral corticosteroid therapy canbe used reasonably safely in theintermediate term if you canadminister them at low doses, butat high doses these type of sideeffects are unacceptable andrequire the addition of animmunosuppressive agent, said DrJabs.

“The initial dose of steroids Iwould typically recommend is inthe range of 1.0 mg/kg/day butrarely above the 60 mg to 80

mg/day range. Once the disease isquiet the goal is really to get thattarget dose for chronic diseaseless than 10 mg a day,” he said.

To illustrate the risks of dosesof steroids above the 80 mgrange, Dr Jabs presented datashowing how ischaemic necrosisof bone increased depending onthe amount of prednisone takenby patients.

“The recommendations to usedoses of prednisone over 60 mgto 80 mg per day are inappropri-ate. If the dose is up over 60 mg,the necrosis starts to get high andup over 100 mg it becomes unac-ceptably high.The same is truewhen we look at the data for thefirst six months doses of pred-nisone and underlines why it isvital to get the dose of pred-nisone down below 10 mg/daywithin the first three months andtry to keep it there,” he said.

Osteoporosis is another knownside effect of corticosteroids, evenat low doses, and he recommend-ed that ophthalmologists couldlessen its impact by advisingpatients to exercise regularly andtake calcium supplements. He alsorecommended that patientsreceive annual bone densityscreenings and be given a bisphos-phonate if they are osteoporoticor osteopoenic.

Reviewing the range ofimmunosuppressive agents cur-rently in use, Dr Jabs said thatthey are very effective in treatinginflammation but required carefulmonitoring and individualisedtreatments to obtain optimalresults.

He explained that theseimmunosuppressive drugs broadlydivided into three classes: anti-metabolites (azathioprine,methotrexate, mycophenolate,),T-cell inhibitors (cyclosporine,tacrolimus) and alkylating agents(cyclophosphamide, chlorambucil).While objective data on the effica-cy of a lot of these drugs in ocu-

lar inflammatory disease remainedelusive, some general trends wereemerging in terms of known sideeffects of these therapies.

The anti-metabolite azathio-prine, for example, had demon-strated its efficacy in randomisedcontrolled trials and seemed tobe relatively safe, said Dr Jabs.Known issues with the agentwere gastrointestinal upset inabout one-in-five patients as wellas isolated incidences of liverfunction abnormalities and bonemarrow suppression in about 1.0

% of cases exposed to longer-term treatment.

Side effects of methotrexate,another corticosteroid sparingagent, include gastrointestinalupset, fatigue, hepatitis and psoria-sis. In a large study atMassachusetts Eye and EarInfirmary, methotrexate wasstopped for side effects in about20% of patients.

Substantial case series data wasavailable on the use of T-cellinhibitor cyclosporine in diseasessuch as Behcet’s and uveitis, notedDr Jabs. Side effects to watch outfor include hypertension, hirsutismand, in particular, nephrotoxicity.

Less data from controlled clini-cal trials were available fortacrolimus, but known toxicitiesassociated with the drug includenephrotoxicity, gastrointestinalproblems, hypertension, hepatitis,metabolic abnormalities and dia-betes.

“Each of these side effects hasbeen reported at somewherebetween 15% and 40% in uncon-trolled case series and they reallyhave limited the use of tacrolimus

for the moment as an immuno-suppressive drug for uveitis,” hesaid.

Dr. Jabs noted that alkylatingagents are the most potentimmunomodulatory drugs used intreatment of uveitis and couldinduce long-term drug-free remis-sion if used appropriately.Theirprincipal drawback was their sideeffects, which included bone mar-row suppression, infection, sterilityand an increased risk of malignancy.

Although acknowledging that

the risk of malignancy under-scored the need for very carefulmonitoring of patients taking alky-lating agents, he said that the riskbenefit profile was neverthelessacceptable for most patients withserious ocular inflammation.

“With some diseases such asmucous membrane pemphigoid,an alkylating agent really can makea huge difference.When we putplainly to patients the relativerisks and benefits of alkylatingtherapy for their condition, over90% agree to the treatmentbecause they value their visionmuch above the possible remoterisk of malignancy. I think it is atestament to the value of vision inevery patient that we see,” hesaid.

The means of administeringdrugs also plays an important partin determining the type and sever-ity of side effects associated withcorticosteroid use, said WilliamAyliffe FRCS PhD, Croydon EyeUnit, Mayday University Hospital,Surrey, UK.

“There are almost as manyways of administering these drugs

as there are steroids themselves,”said Dr Ayliffe.

He noted that regional injec-tions of steroids were now beingused in an attempt to deliver thedrug to the posterior segmentwhile avoiding complications asso-ciated with systemic delivery, butsaid that this assumption was notnecessarily correct.

Intracameral injections werealso becoming increasingly popu-lar, not just for uveitis but also forthe potential treatment of diabeticcystoid macular oedema andchoroid neovascularisation.

Known side effects with topicalsteroids include cataracts, elevat-ed IOP and glaucoma, said DrAyliffe. He said that while somephysicians were now proposing“non-penetrating steroids” toavoid such complications, the real-ity was actually more complex.

“We have to bear in mind thatwhile these drugs are non-pene-trating in animal models which arenot inflamed; if you administer itto a child with severe inflamma-tion you might be surprised tofind a significant incidence ofraised IOP and glaucoma.A recentstudy from China highlightedshowed this swap from inflamma-tory eye disease to glaucoma,which is not a good thing at all,”he said.

Systemic side effects of corti-costeroid use included anincreased risk of infection (varicel-la, tuberculosis) gastrointestinalproblems (peptic ulcer, candidiasis,pancreatitis), fluid balance prob-lems, skin changes, metabolic dis-turbance, musculoskeletal prob-lems and psychiatric disturbance,noted Dr Ayliffe.

“The aim of steroid therapyshould be to minimise dosingduration by using steroid sparingstrategies whenever possible.Maybe what we will be doing inthe next few years is not usingsteroids as a first-line drug at all.

Douglas A. Jabs MD

Systemic medications effective in treatinguveitis, but need careful monitoring

28

“The aim of steroid therapy should beto minimise dosing duration by usingsteroid sparing strategies wheneverpossible”

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Cheryl Guttmanin Fort Lauderdale

A RECENT study confirms thatintravitreal triamcinolone can sig-nificantly improve visual acuity andreduce retinal signs in patientswith macular oedema, althoughphysicians need to be alert to itspotential for serious side effects,according to Ramin SarrafizadehMD PhD,Williamsburg, Michigan,US.

In a series of 143 eyes of 129patients with macular oedemawho underwent treatment with4.0 mg to 20 mg of intravitreal tri-amcinolone, mean visual acuityimproved significantly from 20/128to 20/62 (P<0.0001) after a meanfollow-up of 17 months (range: 6-30 months), Dr. Sarrafizadeh toldthe annual meeting of theAssociation for Research in Visionand Ophthalmology

In addition, mean foveal thick-ness as measured by opticalcoherence tomography decreasedsignificantly (P=0.0014), from abaseline level of 460 microns to227 microns, he said.

Some 62% of eyes in the studyhad diabetic macular oedema, ofwhich 77% had undergone priorfocal laser treatment.The remain-ing eyes had non-diabetic macularoedema, which was most com-monly associated with macularpucker, Irvine-Gass syndrome, andmacular pucker after retinal

detachment repair. One-third ofthe eyes underwent vitrectomywith membrane peeling at thetime of intravitreal steroid treat-ment.

A sub-group analysis based oncurrent treatment received(steroid alone or steroid plus sur-gery), diagnosis (diabetic, non-dia-betic, and diagnostic subgroups ofnon-diabetic macular oedema),and prior history of treatment(focal laser or no focal laser) con-sistently showed statistically signif-icant improvements in visual acu-ity in all groups.Among the vari-ous subgroups, mean visual acuitylevels ranged from 20/106 to20/159 at baseline with improve-ments to levels between 20/58and 20/70.

“Our study represents a largeseries of eyes with diverse diag-noses and relatively long durationof follow-up.These results suggestintravitreal triamcinolone offersanatomic and functional benefitsindependent of a variety of base-line features.As more evidencecomes to light regarding improve-ments achieved with intravitrealtriamcinolone, clinicians maydevelop new paradigms for inte-grating this modality into theirtreatment armamentarium,” saidDr. Sarrafizadeh.

Complications included elevat-ed IOP (above 21 mmHg) in halfof the eyes in the study However,even in those eyes, mean visualacuity increased significantly from20/123 preoperatively to 20/58 atthe last visit.All of the eyes thatdeveloped elevated IOP requiredtopical glaucoma medications andthree eyes underwent trabeculec-tomy because of poor IOP con-trol.

“When offering intravitreal tri-amcinolone, we need to be verycandid with these patients inwarning them about the potentialcomplications, including IOP eleva-tion and uveitis, and the interven-tions that may be needed to man-age those events,” Dr. Sarrafizadehsaid.

Other complications includedhypopyon/fibrinoid uveitis whichdeveloped in 5% of eyes.

He noted that the rate ofinflammation development in thisseries was relatively high com-pared with previous reports ofintravitreal triamcinolone-treatedeyes. He also acknowledged thatwhile mean visual acuity improvedfrom 20/132 to 20/70 in thoseeyes, it did not reach statisticalsignificance.

However, he pointed out thatall of the seven cases of hypopy-on/fibrinoid uveitis occurred inpatients treated early on in thestudy, and that no new cases haveoccurred since they adopted apractice of removing most of thepreservative from the formulation.The preservative was the mostlikely cause of the inflammatoryresponse, he said.

Dr. Sarrafizadeh now preparesthe formulation by first withdraw-ing a 20 mg dose and allowing thetriamcinolone particles to settle.He then decants the preservative-containing supernatant.

“Initially we were only injectinga dose of 4.0 mg, but Europeaninvestigators had reported that upto 25 mg of triamcinolone couldbe injected safely, and we saw noadded risk from using the 20 mgversus the 4.0 mg dose,” he said.

Other alternatives are to washthe triamcinolone particles or touse preservative-free prepara-tions. However, Dr. Sarrafizadehconsiders washing a too cumber-some process and since the 20mg dose has not increased com-plication rates, he has not beencompelled to switch to the non-preserved product.The USNational Eye Institute is now con-

ducting a study with a preserva-tive-free product.

Based on his experience andavailable results from clinical trials,Dr. Sarrafizadeh has developed atreatment protocol for the man-agement of patients with diabeticmacular oedema. He now takes anumber of factors into considera-tion before deciding whether totreat a patient initially with intrav-itreal steroids, laser photocoagula-tion, or combined vitrectomy withintravitreal steroids on a range offactors.These include standardvisual acuity assessment, fluores-cein angiography to evaluateischaemia and leakage features,and OCT to determine macularthickness and the presence of vit-reomacular interface abnormali-ties.

“While the benefits of focallaser treatment are well-estab-lished, we do have other tools in

our armamentarium.Therefore,rather than starting everybodywith just laser treatment or at theother extreme, using everything ineverybody, we believe it is betterto target our approach based onthe individual clinical situation.Tothat end, we have developed asimple list of recommendationson how to initiate intervention.We recognise, however, that is theeasy part. Knowing what to donext if the treatment fails is moredifficult and a decision that willrequire additional clinical trialdata,” Dr. Sarrafizadeh said.

According to his algorithm,laser photocoagulation is consid-ered the first-line for treatment ofdiabetic macular oedema in eyeswith discrete areas of leakage onfluorescein angiography accompa-nied by good visual acuity, or atworst a moderate decrease inacuity, along with mild to moder-ate macular thickening on OCTbut without vitreomacular inter-face abnormalities.

In contrast, intravitreal triamci-nolone is his treatment of choicefor diabetic macular oedema char-acterised by diffuse leakage, mod-erate to severe macular thicken-ing, moderate to severe loss ofvisual acuity, but when there areno vitreomacular interface abnor-malities.

“Once the steroid has causedthe swelling to settle down,patients are brought back forlaser treatment, which I feel canbe more effective if the retina isnot excessively boggy with fluid,”Dr. Sarrafizadeh said.

If there is co-existing vitreoustraction, vitrectomy is performedconcomitantly with intravitrealsteroid injection.

“Treating medically with intrav-

itreal steroid only in this situationwould be like putting a bandageover the wound without address-ing the real problem, which is theneed to relieve the vitreous trac-tion,” Dr. Sarrafizadeh said.

[email protected]

Intravitreal steroid effective in treatment ofmacular oedema

29

Ramin Sarrafizadeh

“These results suggest intravitreal triamcinolone offers anatomic and functional benefits independent of avariety of baseline features”

“While the benefits of focal laser treatment are well-established, we dohave other tools in our armamentarium

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EuroTimes September 2004

Dermot McGrathin Barcelona

THE toric implantable contactlens (ICL, Staar) provides safe andstable correction of moderate tohigh myopic astigmatism, accord-ing to a study presented at the8th Winter Refractive meeting ofthe ESCRS.

Tobias Neuhann MD reportedoutcome data from a series of 58eyes with a mean follow-up of 21months and a maximum follow-upof four years. Patients presentedwith myopia ranging from

-4.0 D to -14 D and regularastigmatism between 1.5D and8D.All eyes had a minimum ante-rior chamber depth of 2.8 mmand a corneal diameter of at least12.0 mm.

The toric ICL predictably cor-rected sphere and cylinder in themajority of eyes and was associat-ed with good functional out-comes.The phakic IOL maintaineda stable position after implanta-tion and was associated with afavourable safety profile so far aswell.

“We now have reasonably long-term follow-up for the toric ICLand it has proved its efficacy andsafety to date.The toric ICL dealswith one of the key issues for anyphakic refractive lens, which isastigmatism, and it also helps

other refractive procedures tostay in their safety zones,” said DrNeuhann.

Postoperative uncorrected visu-al acuity was 20/40 or better in92 % of eyes.A small number ofthe implants (5.0 %) had to bereadjusted because of inaccurateaxis alignment during the surgery.Some 39% of patients experi-enced a gain in best spectacle-corrected visual acuity of betweenone and four lines. No loss ofBSCVA was observed.

One patient developed an intu-mescent cataract two weeks aftersurgery, which Dr Neuhann saidwas probably surgically induced.

Discussing the properties of thelens, Dr Neuhann said that thetoric version of the ICL is con-structed of the same collamermaterial as its spherical counter-part and also has the same plate-haptic design, size, thickness andconfiguration.

The lens is implanted through a3.0 mm temporal clear cornealincision and positioned behind theiris posterior to the iris plane andinto the sulcus. However, the toricICL features a central convex/con-cave optical zone design withspherical cylinder in a specifiedaxis location to address theunique astigmatic conditions ofeach individual patient.

Additional measurements are

necessary for the toric ICL beforesurgery, since in addition to thedioptre values, the axis is centralto the correction of astigmatism.The surgeon must ensure that theimplanted lens does not rotateinside the eye and that the cor-rect position of the axis is main-tained long-term.

A recent Swiss study, presentedat the ESCRS Congress in Munichlast September, suggested that thedesign and material of the toricICL made implantation more chal-lenging and led to iatrogeniccataract in a high proportion ofpatients who had been implantedwith the toric ICL.

“Compared with the sphericalversion, insertion of the toric ICLis overall more traumatic andseems to increase the risk forcontact with the crystalline lens,”commented Dr. Bornet, one ofthe chief researchers of the study.

She explained that the toric ICLis more rigid than its sphericalcounterpart and sometimesunfolds asymmetrically in theanterior chamber, a phenomenonthat may occur because of thepresence of the cylinder correc-tion. Furthermore, the ICL lacksmanipulation holes, and that fea-ture makes the insertion of thefootplates more complex.

The lens is available in powerranges of -6.0 D to -23.0 D and

for correction of +1.0 to +6.0 Dof cylinder.While initial lenspower calculation were per-formed by Staar Surgical based onsubjective refraction along withinformation from automated ker-atometry and corneal topography,Dr Neuhann said that since 2002an electronic calculation programhas enabled him to perform thepower calculations himself.

He also noted that while theindications allowed corrections upto –23.0 D he personally pre-ferred not to perform ICL implan-tation in patients beyond therange of –15.0 D with somedegree of astigmatism present.

“Intraoperative complicationsare rare but the potential risk ofthis unique phakic refractiveimplant is the loss of accommoda-tion if cataract formation occurs,”he said.

In selecting best-case scenariosfor using the toric ICL, DrNeuhann said that his clinicalexperience suggested that thelens was ideal for “rehabilitation”after lamellar or penetrating ker-atoplasty, in patients with highametropias combined with astig-matism, or for bioptics, a com-bined procedure in which the ICLis implanted before a subsequentLASIK treatment.

“In my view, it is currently theonly genuine customised implant,

although we know that other cus-tomised ICLs are on the way andmay offer additional treatmentoptions for conditions such askeratoconus in the future,” hesaid. “The nomogram is very reli-able and the postoperative refrac-tion remains stable even after fouryears.

[email protected]

Toric posterior chamber phakic IOL effective overlong term for myopic astigmatism

30

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Laurent Castellucciin Fort Lauderdale

IMPROVED wavefront measure-ment techniques are revealing thesubtle effects of factors such asheartbeat and neural adaptationon optical aberrations, reportedresearchers at the annual meetingof the Association for Research inVision and Ophthalmology(ARVO).

As wavefront aberrations havebecome more and more impor-tant considerations in refractivesurgery, interest has grown in thepossible interaction of other fac-tors with those aberrations andvisual acuity, noted Pablo ArtalPhD.

“From the beginning of usingthis technology, we have had someindication that perhaps the visualsystem may be adapting somehowto the particular aberrations,” DrArtal said.

Last year, his group at theUniversity of Murcia in collabora-tion with David William’s group atUniversity of Rochester, con-firmed this, presenting resultsusing blur-matching that showedthe neural visual system is adapt-ed to the eye’s particular mono-chromatic aberrations.Theseresults were published in theJournal of Vision (http://jour-nalofvision.org/4/4/4/).

But this work left many ques-tions unanswered. For example:for what amount and what typesof aberrations can the systemcompensate? How does it do it?What is the temporal scale of thisadjustment?

Some clinicians have suggestedin different experiments that thevisual system needs months orweeks to adjust to changes inaberrations. Other experimentsshowed adaptation taking place inonly minutes.

“We didn’t know exactly whatthe rate was. If we had adaptationin minutes, we could probably doexperiments with adaptive optics.If we had to wait weeks ormonths, it would not be possibleto do these experiments withadaptive optics,” Dr Artal said.

Dr Artal’s group performedadditional experiments using adap-tive optics to further explore thetemporal dependence of thisadaptation process.They used anadaptive optics system to inducewavefront aberrations with associ-ated changes in the point spreadfunction in eight healthy volun-teers.

The researchers measured visu-al acuity through an artificial pupilof 6.0 mm.Volunteers wereshown the letter E in one of 4possible orientations, (to the left,to the right, up, or down).Theyviewed the stimulus through theadaptive optics system with theirown aberrations or with a rotatedversion of their aberrations.Visualacuity was measured after periodsof continuous adaptation to therotated version of the aberra-tions.

All of the volunteers had initiallogMAR acuities lower than 1.0.After rotating the aberrations 45degrees, average visual acuitydecreased 25%.After 15 minutesof continuous viewing through therotated aberrations, visual acuity

returned to near normal, with upto 70% of the normal acuity.Recovery increased to near nor-mal total after 25 minutes.Interestingly, in every subject thevisual acuity got worse again after30 minutes.

“Each subject does have his orher own values, but you see onaverage that you have an expo-nential increase, and at 30 min-utes, you get extremely high errorbars.We think this can be attrib-uted to them getting tired,” DrArtal said

Testing in both monochromaticand polychromatic light showedsimilar results, as did using lowcontrast VA and blur matching.

Dr Artal suggested that theresults follow a double-exponen-tial model, with some rapid decayand then some further decay thatcontinues over longer time.

“We did a nice fitting with oneexponential, and it fits very well.But the problem is that becauseof the one exponential, in aboutone hour, it projects that you willhave recovered your normal visualacuity, but in about three hours, itprojects that you will have infiniteresolution.”

Dr Artal acknowledged that instudies such as prism inversion,patients have taken a day to adapt,which may mean the time neededto adapt may have to do with thetype of aberration. More experi-ments will be needed to addressthe many questions still unan-swered. But all these results mayhave very important practicalapplications for refractive surgeryin the future, he stressed.

THE DYNAMICS OFPULSE

The aberrations of the eyethemselves display dynamic behav-iour.While the cause of thedynamic aberrometric behaviourremains a mystery, there is somecorrelation with the pulse and eyemovements, corneal pulsation, thehigh frequency component of themicrofluctutions in accommoda-tion, and intraocular pressure,noted Karen Hampson of theImperial College in London.

She attempted to discovermore about the links betweenpulse and RMS (root meansquare) error. She measured thewavefront aberrations of five vol-unteers with a Shack-Hartmannsensor operating at 21.2 Hz.Thepulse-pressure wave was simulta-neously measured, as was theheart rate variability. Furtherexperiments were carried out ontwo volunteers in whom theproperties of the pulse and heartrate variability were changed tosee if corresponding changes

could be observed in the RMSwavefront error. One exampleincluded a comparison between asubject holding their breath andbreathing deeply.

Some correlations wereobserved between the aberrationsand some components of thepulse and heart rate variability.However, the particular frequen-cies and aberrations varied widelyfrom person to person, with noapparent causal relationship. Forexample, the study showed noreal contribution to the RMSerror from holding one’s breathor changing heart rate.

“The pulse is not sufficient toaccount for the shape of thepower spectrum of the RMSwavefront error. So while pulseplays a role in the dynamic char-acteristics of the higher-orderaberrations, it can’t account for allof them,” she said.

[email protected]

[email protected]

EuroTimes September 2004

Hearts and Minds: Effects of pulse and neural adaptation on aberrations

31

You can get anupdate on the clinical applicationsof wavefront sensing at theESCRS Congress inParis. Events include: theWorkshop in VisualOptics on Sunday19th September;and the ESCRS symposium “Using WavefrontTechnology ToMaintain ThePhysiology Of TheCornea” onTuesday 21September

Schematic example of how adaptive optics can be used to modify the eye's aberration Visual acuity with normal and rotated aberrations. The same amount of aberrations that are unfamiliar(rotated) reduced visual acuity.

Professor Artal trying his adaptive optics research instrument.

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32

All pulse data for one subject

Coherence function for the pulse and rms wavefront error for two subjects.

Coherence function for the HRV and rms wavefront error for two subjects.

Comparison of rms wavefront error, pulse, and HRV PSD for one subject deep breathing and holding theirbreath.

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Cheryl Guttmanin Miami

RECENT research on thepathogenesis of exudative age-related macular degeneration(AMD) is suggesting new targetsfor innovative approaches to bothtreatment and prevention, accord-ing to Scott W Cousins MD,Bascom Palmer Institute,University of Miami, Miami,Florida, US.

“Angiogenesis inhibition is atthe foundation of most ongoingclinical trials of investigationalagents for the treatment of AMD-related choroidal neovascularisa-tion.

However, there are a number ofother paradigms for conceptualis-ing this disease. Over the next tenyears, we can expect those newideas will fuel a pipeline of alter-native interventions that will pro-pel us into an exciting new era inthe management of this potential-ly blinding disease,” said DrCousins.

In his own laboratory, DrCousins and his co-workers havebeen focusing on the role ofinflammation in the developmentof AMD-related CNV with specialattention to the involvement ofmacrophages. Other research inthis field is concentrating on con-tributions of various environmen-tal factors, such as exposure tocigarette smoke, and systemichealth factors, including hormonalinfluences.

However, among the newpathogenesis paradigms that areunder investigation, Dr Cousinscharacterises the role of inflam-mation as the one most likely tofirst result in new therapeuticapproaches.

“There are already a few clinical

trials underway investigating theuse of anti-inflammatory drugsplus anti-angiogenic agents orother modalities, and we canexpect that in a few years ourmanagement will be based on dualtherapy rather than treatmentwith a single drug,” Dr Cousinssaid.

Realisation that AMD may be aninflammatory disease is an exten-sion of the growing recognition inmedicine that inflammation andinfection play an important role inthe development of a variety ofdegenerative diseases, includingAlzheimer’s disease and athero-sclerosis.With respect to AMD,two areas of intense research arethe roles of complement andmacrophages.

Dr Cousins and colleagues havedocumented the presence ofblood-derived, highly activatedmacrophages in the retina andneovascular membrane in eyeswith exudative AMD.Their studiesin animal models of laser-inducedchoroidal neovascularisation showthat treatment to deplete bloodmonocytes and lymph nodemacrophages was effective indecreasing choroidal macrophagedensity and CNV severity.

Dr Cousins speculates that the“savage” white blood cells havebeen recruited into the choroidsfrom the circulation where theyare playing a detrimental role inpromoting progressive retinaldegeneration rather than beinghelpful scavengers.That hypothesishas led him to develop a test forcategorising AMD patients intorisk groups based on analysis ofthe macrophages in blood speci-mens.

“Currently, we are studying thepotential value of that test foridentifying patients who would be

the best candidates for risk mod-ulation with anti-inflammatorytreatment,” Dr Cousins said.

Also in the area of anti-inflam-matory treatment for AMD,knowledge that verteporfin(Visudyne) photodynamic therapyelicits a significant inflammatoryresponse has provided a rationalefor studies of combination treat-ment with anti-inflammatorydrugs. Results will be availablesoon from a recently completed,National Eye Institute-sponsoredstudy that randomised patientsundergoing PDT to treatmentwith celecoxib (Celebrex, Pfizer)or placebo. Celecoxib offers anti-inflammatory activity via its inhibi-tion of cyclo-oxygenase-2, but ofadded interest, it appears to haveanti-angiogenic properties as well.

Preliminary reports of datafrom that trial are encouraging,and meanwhile, results from anumber of case series suggest abenefit from using intravitreal tri-amcinolone acetonide as anadjunct to PDT, he noted.

“More extensive trials are beingplanned for both of those dualapproaches with the idea that avariety of different anti-inflamma-tory agents can be combined withPDT to improve the functionaland anatomic results of that inter-vention,” Dr Cousins said.

Related to the role of inflamma-tion, there is also interest in thecontribution of infectious agentsto the pathogenesis of AMD.Against the background that bothbacterial and viral agents havebeen implicated as triggers in pro-moting increases atherosclerosisseverity, Dr Cousins notes that hisgroup and other researchers havefound the same provocative con-nection between the presence ofexudative AMD and high antibody

titres for cytomegalovirus and thebacteria Chlamydia pneumoniae.

“One theory about the mecha-nisms of immune system amplifi-cation in AMD and other neu-rodegenerative diseases cites aninfectious trigger. Confirmation ofthat association would suggest apossible therapeutic role for anti-infective agents, particularly asprophylactic intervention to pre-vent neovascularisation in high-risk AMD patients,” Dr Cousinssaid.

Interest in environmental riskfactors is centring particularly oncigarette smoke as accumulatingevidence points to cigarettesmoking as the most potentlifestyle risk factor for the devel-opment of both dry and wetAMD.

“It has been well-known forfour decades that direct and pas-sive exposure to cigarette smokecontributes to increased severityof a number of vascular diseases.As AMD is an ocular vascular dis-ease, it is not unexpected that cig-arette smoke is toxic to the mac-ula,” Dr Cousins said.

Results from animal modelspoint to nicotine as playing a par-ticularly harmful role in promotingprogression of CNV.That informa-tion suggests that advice topatients about smoking cessationshould include a recommendationabout avoiding nicotine-based ces-sation aids, such as patches orchewing gum.

However, Dr Cousins notesthat the role of cigarette smoke inAMD pathogenesis may haveimplications relevant to non-smokers, not only because of thehazards of passive cigarette smokeexposure but considering that ofthe 4,000 toxic substances com-

prising cigarette smoke, many arefound as pollutants in the air ofdeveloped countries.

“Elucidation of the potentialimplications of that information isthe focus of a number of investi-gators around the world,” DrCousins said.

Just as the roles of post-menopausal oestrogen loss andoestrogen replacement therapy incardiovascular disease have beenthe focus of many studies, so toois attention being directed to theeffect of that hormone on AMDdevelopment and progression. Forexample, the Women’s HealthInitiative-Sight Exam study that iscurrently underway is evaluatingthe effect of oestrogen replace-ment on the risk of developingAMD-related blindness.

While the results from that trialare still pending, relevant preclini-cal studies show that loss ofoestrogen predisposes female ani-mals to more severe manifesta-tions of macular degeneration,while treatment with pharmaco-logical doses of oestrogen furtherexacerbates the pathology.

“Currently, it remains unclearwhat to recommend to AMDpatients about oestrogen therapyas well as about ingestion of soyand plant-derived phytoestrogensupplements that are being widelyused as natural remedies for hotflashes. Hopefully, that informationwill be available soon so that wecan better counsel our patients,”Dr Cousins said.

[email protected]

Research into AMD pathogenesis suggestsnew treatment and prevention strategies

33

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Daithí Ó hAnluainin Chester, UK

FOR many years physicians and artistshave debated the role of visual disturbanceand the creative process. Some have heldthat eye dysfunction could be at the heartof some of the world's greatest art, withdifferent disorders contributing to variousart schools and the artistic styles of somepainters.

Impressionism, for example, with itsfocus on contours and colour at theexpense of detail, could be the product ofmyopia. It is already widely known thatcataracts cause colour distortion towardsthe red end of the spectrum, and it veryprobably influenced the art of Monet.Astigmatism, on the other hand, could have

contributed to the elongated figures insome of the works by El Greco.

The list of artists who may have beeninspired by their handicaps to create uniqueworks is impressive, including Renoir,

Cassatt,Turner, Cezanne, Pissarro, Degas,Dufy, Derain, Braque,Vlaminck, Rodin,Segonzac and Matisse.

Speaking at UKISCRS 2003, ChintanSanghvi MD reported that cataracts have along history in art. He told the congressthat the style of the later works by ClaudeMonet, Mary Cassatt and Joseph WilliamTurner, may have been influenced bycataracts.

"As we know, cataracts impair visual acu-ity and contrast sensitivity and cause glare.For the artist with a cataract, these effectscan result in a loss of fine detail and diffi-culty resolving form, but perhaps the mostimportant effect is on colour perception,"she said.

For example, Monet's 'Japanese Bridge,'done in 1900 isrich in detail,while anotherpainting of thesame scene,done in 1922,reveals muddyand darkertones and thebridge is nowbarely recognis-able, Dr. Sanghvitold the confer-ence.

"Many ofthese laterpaintings vergeon the abstract,with coloursbleeding intoeach other,"she said.

Similarly,Mary Cassatt,probably the

most famousfemale impres-sionist, wasaffected bycataracts at 56years of ageand Sanghvinoted thatcharacteristicdetail of herearlier workdisappeared.

"This can beseen in herpastel of'Margot' whichwas done atage 58," shesaid. "Althoughit is a greatpainting in itsown right, incomparison to'Lydia', it ismarked by a

limited use of colour and relatively littledetail. In her later work her canvassesbecame much larger, coinciding with herloss of visual acuity."

With Joseph William Turner there was a

colour shift in his paintings in the latterpart of his career and this might beexplained by nuclear cataracts, whichabsorb blue light.

"The paintings done at an earlier ageillustrate the distinct outline of the sub-jects, in contrast to the hazy appearanceand predominant yellow of his later works,"said Dr. Sanghvi.

Ocular pathology in art is a perennialtheme, and not only in ophthalmology.Apaper in the Journal of ClinicalNeuroscience by Australian neurosurgeonDr. Noel G. Dan MD synthesised the theo-ries and research that links defective sightto artistic vision.

"Edgar Degas was a high myope whichinfluenced his art throughout his life. Hisloss of vision became so great that in thelatter part of his life he used photographsof models and horses to bring them withinhis visual range," writes Professor Dan.

Degas moved to pastels when he couldno longer work with oils, and towards theend of his life he sculpted by feel ratherthan sight.

Similarly, another theory links the workof El Greco to astigmatism. It has beenargued that the elongated figures for whichEl Greco is famous were due to his astig-matism, notes Dr Dan.

Less controversially, Dr. Dan demon-strates, like Dr. Sanghvi, how cataractsaffected the sight of Monet.

"Interestingly, after Monet's vision wasrestored, he felt that [his paintings] shouldbe overpainted and his friends and advisershad to restrain him from overpainting thepictures with more normal colour values,"Dr. Dan wrote.

Cataracts, astigmatism and myopia arenot the only pathologies to affect majorartistic styles, Dr. Dan believes. Internaldeformities can affect both the style andthe subject matter of an artist's work.Afterhe suffered from a vitreous haemorrhage in1930, Edvard Munch used the lens of hiseye as a magic lantern to project the pic-ture of his damaged eye directly ontopaper.

"Art is a personal passion," Professor.Dan told Eurotimes in an interview byemail. "The Clinical Neuroscience paperwas a lecture to a group of neurosurgeonswho asked that it be published.Art oftengives certain insights and patients showmany of the features which also presentthemselves in artists."

However, the theory linking defectivesight to artistic styles causes controversy inthe art world and his paper has sincedrawn sharp criticism.

"I strongly disagree! I am convinced thatthe artists discussed knew exactly whatthey were doing, and that their reasons forpainting as they did were part of their basicartistic programmes, and had nothing to dowith eyesight problems. Except, perhaps, afew late works by Monet which do seem toreflect the impact of his cataracts," saidProfessor John House of CourtauldInstitute of Art, London.

The sensitivities of the art world werenot lost on Dr. Sanghvi.

"Of course, all this is speculative and

these paintings may actually represent amature change in style, but given the evi-dence the theory of visual problems shouldnot be dismissed," she told the conference.

Nonetheless, the topic has drawn sus-tained academic interest.The University ofCalgary's Division of Ophthalmology has awebsite, developed by its Vision and AgingLab, where visitors can view a permanenttutorial on art and defective vision, (avail-able online atwww.psych.ucalgary.ca/pace/va-lab/AVDE-Website/default.html).

Professor Donald Kline, the lab's directorbelieves that while visual problem have hadan effect, Dan's article is unhelpful.

"The Dan article does not appear tohave done a very thorough job of investi-gating the fascinating potential relationshipsbetween visual loss and artistic output.Agreat deal of care needs to be exercised inadvancing these relationships since theyalmost inevitably draw a lot of criticismfrom the art community, many of whomwould like to see all change as wholly"muse-inspired".While I too believe thatvision loss can play a role in artistic work,even a few mistakes can lead to the inap-propriate rejection of the "real" effects ofvision loss."

Certainly scientific evidence supportssome of the theories. "O.Alsthrom demon-strated that the use of -1.0 D. astigmatismcorrecting lens at 15 (degrees) axis wouldnormalise the shape of the figures [in someof El Greco's paintings]," Dr. Dan wrote.

"Ultimately the broader implication is thequestion raised by embodying deformationsinto mainstream artistic practice and thenmarketing them as happened withImpressionism initially. I suspect that pho-tography also set the circumstances forrealism not to be so important in artisticrepresentation," said Dr. Dan.

At the conference, Dr. Sanghvi was alsokeen to emphasise that these paintings rep-resent an opportunity for ophthalmologists.

"For art, these paintings provided thetemplate for change and a natural evolutionof 20 century abstract art.And for us (oph-thalmologists), I think these paintings giveus a unique insight into the world as ourpatients see it."

Dr Dan's paper, "Visual Dysfunction inArtists appeared in the March 2003 Journalof Clinical Neuroscience V. 10 n. 2, pp.168–170. It is currently available to down-load free from Science Direct (www.sci-encedirect.com/science/journal/09675868).

If you would like to read more about artand vision, you might want to have a lookat The Eye of the Artist - (1997 - Mosby)by Michael Marmor & James Ravin;TheArtful Eye - (1995 - Oxford UniversityPress) Richard Gregory, John Harris,Priscilla Heard & David Rose (eds.) and"Vision of the Famous; the artist’s eye",Ophthalmic & Physiological Optics, 1992, p.82-90, David Elliott and Amanda Skiff.

[email protected]

e-mail: [email protected]

Defective sight inspires artistic vision34

While Monet's 'Japanese Bridge,' done in 1900 is rich in detail, another painting of the same scene, done in1922, reveals muddy and darker tones and the bridge is now barely recognisable

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EuroTimes September 2004

AT CHRISTMASTIMEGOUDA SWAPS CHEESE FOR CAROLS AND CANDLES

One night a ye a r, an already magicalm e d i eval city in Holland adds music to itsGothic arc h i t e c t u re and becomes a place ofe n c h a n t m e n t . On December 14, the peopleof Gouda forget cheese, switch off the elec-tricity and sing carols by candlelight in them a r ket square.A round them, the 300 or sohistoric buildings of the city, including thev a s t , pinnacled town hall dating from the15th century and the 123-metre-long St.Jo h n ’s Church with its 16th-century stained-glass windows once again appear as they didon the long winter nights when they we refirst built, when Gouda was one of the fivemost important cities in Holland and as bigas A m s t e rd a m .A f t e r w a rds singers can fe a s ton Goudse Stro o p w a fe l s , the thin syrupywaffles that are a local delicacy.

For details, see www. v i s i t h o l l a n d . c o m .

P R O B A B LY THE BEST DANISHCOLLECTION GOES TO LONDON

Masterpieces from the CarlsbergG lyptotek museum in Copenhagen are ond i s p l ay in Britain for the first time at theR oyal A c a d e my in London until December1 0 .Ancient A rt to Po s t - I m p re s s i o n i s ms h ows the collection of antiquities andF rench and Danish 19th-century paintingand sculpture built up by father and sonCarl and Helge Jacobsen, descendants of thefounder of the Danish brewe ry Carlsberg.Among some 250 works on show will beexceptional examples of Gre e k , Roman andEtruscan sculpture collected by Carl, w h oalso acquired contemporary works byDanish Golden Age painters.After hisf a t h e r ’s death in 1914, Helge continu e damassing the Impressionists and Po s t -I m p ressionists his father derided as "aw f u l ,m a n n e red and ghastly." Eve n t u a l ly, H e l g ebequeathed the museum a fine collection ofworks by Monet, M a n e t , D e g a s , Cézanne andG a u g i n .For details see www. roy a l a c a d e my.org andw w w. g ly p t o t e ke t . d k.

C E L E B R ATE DYNAMITE ANDCANDLELIGHT IN SWEDEN

Depending whether you are a child or anexceptional adult, t h e re are two re d - l e t t e r

d ays in the Swedish calendar in December.The first date, December 10, is when theKing of Sweden aw a rds the Nobel Prizes.For more than a century, the prizes havem a r ked the wo r l d ’s greatest achievements inp hy s i c s , c h e m i s t ry, m e d i c i n e, l i t e r a t u re, a n dpeace as decreed in the will of A l f red Nobel,the inventor of dynamite. But what if yo ua re not part of the august gathering for theprize-giving at the Stockholm Concert Hall?T h e n , l i ke eve ryone else in Swe d e n , you cancelebrate St Lucia’s Day on December 13. I nm e d i eval times, St Lucia, a 4th-century mar-tyr from Syracuse, on the island of Sicily, w a sreve red as the patron saint of sight and ofthe blind.A rtists often depicted her holdinga dish containing her eye s . In pre s e n t - d ayS we d e n , her festival marks the beginning ofthe Christmas season.Wearing a crown oflighted candles, a school girl assumes therole of St Lucia. Fo l l owed by boys and girlsd ressed in white, S t . Lucia visits schools, h o s-p i t a l s , shops and offices singing traditionalsongs and handing out coffe e, g i n g e r b re a dbiscuits and saffron buns known as "Luciacats." For details, see www. v i s i t - swe d e n . c o m .

SEE FRENCH FOWL ON THEM O V E

In the village of Licques, a short distanceinland from Calais in northern France, a dif-fe rent kind of procession heralds the com-ing of Christmas. O ver the we e kend ofDecember 11 and 12, the village celebratesthe rearing of free-range poultry, p a rt i c u l a r lyt u r key s . First farmed here by monks, t h eb i rds arr i ved here via Latin America thro u g hSpanish explore r s .This area of France is stillk n own as Les Trois Pays – the three lands –because it was where, in the 16th century,the borders of the English, F rench andSpanish kingdoms met. N ow that the Fre n c heat almost as much turkey eve ry year as theA m e r i c a n s , connoisseurs come to Licquesto buy the best bird s . But befo re they cangrace the Christmas table, the condemnedb i rds must parade through the streets ofL i c q u e s , accompanied by local officials, to bea d m i red by onlookers fo rtified with thelocal liqueur, also known as licques.For details, telephone +33-3-21 35-80-03 orsee www. c c - t ro i s - p ay s . f r / l i c q u e s.

FOLLOW THE DUTCH DEEPINTO CHRISTMAS

The spa-town of Va l kenburg in Hollandhas been a tourist destination for more than150 ye a r s .Va l kenburg is well set up for win-ter visitors with not only heated pave m e n t

cafés but also two Christmas marke t s , r u n-ning from mid-November until December2 1 . U n i q u e ly, both markets take place under-g round in the caves and once-secret pas-sages that run through the ye l l ow marlstoneon which the tow n ’s now-ruined castle wasbuilt in 1050.The Gemeentegrot market inthe passagew ays of Town Cave is the largest,with bars and seasonal mu s i c.This has beenso popular that another market has openedin the Fluwe e l e n g ro t , or Ve l vet Cave, w i t htableaux on the theme of Christmas aro u n dthe wo r l d , t h rough which Father Christmasm a kes his rounds accompanied not by are i n d e e r, but by a suitably subterranean bat.For details, see www. ke r s t s t a d v a l ke n b u r g . n land www. v v v z u i d l i m b u r g . n l .

WALK THROUGH AN ALPINEADVENT CALENDAR

It can sometimes seem as if the whole ofE u rope has been given over to Christmasm a r kets in December. But the village ofR e i t h , near the picturesque ski re s o rt ofK i t z b ü h e l , in A u s t r i a , has devised a uniqueseasonal attraction. On the night of

December 1, one house in the villagelights up a window decorated with aChristmas scene. Each night as the monthgoes on, another house illuminates a deco-rated window until, on Christmas Eve, 2 4houses around the village display brightly litChristmas scenes in their windows and thewhole of Reith becomes an A d vent calendarfor visitors to walk aro u n d .The A d vent cal-endar of light continues until the Feast ofthe Epiphany on Janu a ry 6.For details, see www. k i t z b u e h e l . c o m .

P L AY AN IRISH MEGALITHIC L O T T E RY

To experience the pre-Christian spirit ofw i n t e r, ap p ly for tickets to visit theN ewgrange passage tomb in Ireland at thewinter solstice. N ewgrange is the mostfamous of a group of megalithic burial sitesnamed for their position in a bend of theR i ver Boy n e. For a few minutes during sun-rise on the winter solstice, the rays of thesun filter through a narrow opening at theentrance of the chamber and down a nar-row 19 metre-long passagew ay to the ve ryc e n t re of the tomb.The tomb, which datesf rom 3,200 BC, is cove red with a quarter ofa million tons of earth and ro c k . One of thefinest examples of Stone Age mounds inE u ro p e, the tomb fe a t u res stones carve dwith spirals, c h ev rons and lozenges. E a c hye a r, the tomb’s visitor centre holds a lot-t e ry for about 20 tickets for each sunrisef rom December 19 to 23. Depending on theye a r, the solstice falls on December 21 or2 2 . "By tradition, we celebrate it here on the21st," explains one tourist guide. " T h e re ’sve ry little diffe rence on the amount of sun-shine seen in the chamber any w ay." For details, see http://www. k n ow t h . c o m / w i n-t e r- s o l s t i c e. h t m .

Out and AboutBY RENATA RUBNIKOWICZ

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EuroTimes September 2004

by Maryalicia Post

Reach Tr a s t eve re via Rome’s two oldestbridges across the T i b e r; you can also pay

your mental respects to the Greek god ofmedicine on your way. Ponte de Fabricio setsyou down on a small island, Isola T i b e r i n a ;f rom the island, Ponte de Cesto completesthe link with the mainland and Tr a s t eve re. B yl e g e n d , the small island was where a serpentsent by A e s c u l apius wriggled on to dry landto help out during a plague. That was in 289B C ; the island has been dedicated to medi-cine ever since; one of pre s e n t - d ay Rome’smajor medical institutions, the OspedaleF a t e b e n e f r a t e l l i , has been on Isola T i b e r i n asince the Middle A g e s .

Once across the Ponte de Cesto,Tr a s t eve re begins.Walk aw ay from the rive r,d own Via della Lungaretta and you’ll sooncome to the heart of the district, the PiazzaS . Maria de Tr a s t eve re. On the steps of thefo u n t a i n , c h i l d ren play and teenagers eat icec ream indiffe rent to the medieval structurebehind them – the Basilica of Santa Maria inTr a s t eve re. E rected in 337 A . D. , i t ’s thoughtto be the oldest Christian church in Rome.Most of the present building dates from justafter the first millennium but above the por-tico is the city’s only surviving example of am e d i eval church facade: a 12th century go l d -g round mosaic.The curious fragments ofc a rved and engraved stone set into the wallunder the portico we re scavenged from thecatacombs and from the original Basilica.

Inside the church are still more bre a t h t a k-

ing mosaics.To see the apse revealed in all itsmagnificence switch on the overhead illumi-n a t i o n . To do this, d rop a €1 coin in the boxby the side of the altar rail. Santa Maria inTr a s t eve re is located on the Piazza di S. M a r i ain Tr a s t eve re ; open 07:30 to 19:00

B e fo re you leave the piazza, you could stopat Di Marzio at No. 14 for coffe e. In finewe a t h e r, e n j oy it on the terrace with a viewof the Basilica.Then continue your stro l ld own the Via della Scala. On the Piazza diS a n t ’ E g i d i o, you’ll see steps up to theentrance to the unassuming Museum ofRome of Tr a s t eve re. Fo r m e r ly a conve n t , i t ’sn ow an eclectic museum harbouring astrange collection of bits and pieces.Yo ucould skip the re s t , but it would be a shameto miss the re a l ly engaging series of 18th and19th century prints and paintings upstairs.The works depict eve ry day life in Rome andseem to echo the street life still going on inTr a s t eve re.The Museo di Roma in Tr a s t eve re

is located at Piazza di Sant Egidio; o p e nTu e s d ay - S u n d ay, 10:00 to 20:00; a d m i s s i o n€ 2 . 5 0 .

The small piazza of the Church of SantaMaria della Scala is a bit further along thes t reet bearing its name.The Church is openo n ly for Mass but at one side of the piazzayou’ll spot a modern pharmacy.The monks ofthe Carmelite monastery run it and will, i fa s ke d , s h ow you the complete 18th centurypharmacy still pre s e rved in the building.

And finally, for an idea of what unlimitedwealth could buy in Tr a s t eve re in the ye a r1 5 0 0 , you need only continue along Via dellaScala until it turns into Via della Lungara. A tN o. 230 is the Villa Farnesina, a monument tothe extravagant lifestyle of the nouveau richA gostino Chigi. H e, it is said, would instructhis servants to chuck the gold plate on whichhis guests had just banqueted into the T i b e r.When the suitably impressed guests hadd e p a rt e d , the servants re c ove red the go l dplate for their master (who was rich, but notcrazy) by hauling in the nets prev i o u s lys t retched under the water. A more enduringl i festyle statement we re the frescoes Chigicommissioned from Rap h a e l , Sebastiano delPiombo and others that still ornament theinterior of the villa.The V i l l a ’s arc h i t e c t ,B a l d a s s a re Pe r u z z i , decorated one of theupstairs rooms with an astounding tro m p el’oeil painting of arches enclosing views of

16th century Tr a s t eve re.The V i l l aFarnesina is located at Via dellaL u n g a r a , 2 3 0 ; open Monday -S a t u rd ay 9:00-13:00; a d m i s s i o n€ 3 . 0 0

If Tra s t ev e re is sleepy by day, i thums at night.This is where tre n d yRomans come to dine. If you wishto join them, h e re are some sugge s-t i o n s :

• RO M O L O. Once the home ofR ap h a e l ’s mistre s s , La Fo r n a r i n a(the bake r ) , close enough to theVilla Farnesina to distract him fro mhis wo r k . In good we a t h e r, you cane n j oy your meal in the gard e n .V i adi Po rto Settimania, 8 ; t e l e p h o n e+39-06- 581- 8284; open Tu e s d ay -S u n d ay 12:00 to 15:00 and 19:00 to2 4 : 0 0 .

An Eye on Travel

Strollthrough avillagewithina city -

Neither monumental nor chic, Trastevere has the feel of aMediterranean village. The narrow streets and alleys of the“People’s Rome” are where you come to wander, enjoying chancediscoveries, anonymous ancient buildings, tiny fruit and vegetablemarkets, and vine-wreathed courtyards. In Trastevere, you arefree from the pressure of serious sightseeing, although even on anidle stroll you come upon some of Rome’s most charming and least

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EuroTimes September 2004

Il Palazzetto has its feet on the ground onVicola del Bottino but its head in the air. Itsrooftop terrace looks out across Rome’sfamous Spanish Steps. In between are the fiveelegant floors of the International WineAcademy of Roma.For centuries, Il Palazzetto was one of thefavourite residences of an aristocratic Romanfamily. Abandoned in 1980, it lay empty until1998, when film director Bernardo Bertolucciused it as the setting for L’assedio (TheBesieged), the story of a pianist’s romantic pur-suit of a beautiful African servant.

In September 2002, Il Palazzetto opened as the "WineAcademy of Roma," an informal club and meeting place forwine lovers. Today, a pre-dinner guided wine tasting in thelibrary, or a gastronomic lunch or dinner in the garden(roofed and heated in winter), is the kind of refined delightwhich makes Rome "Rome."

The work of transforming an abandoned historical buildinginto a luxurious and welcoming setting for the appreciationof fine wine took three years. It began when Roberto Wirth,owner and manager of Rome’s ultra-prestigious HotelHassler, acquired Il Palazzetto in 1999. He decided, alongwith a group of like-minded friends, to express his ownenthusiasm for fine wines and food by making Il Palazzettothe headquarters of an International Wine Academy.

The subsequent renovation of the palazzo brought to lightancient materials and finishes such as the original marblepavement of the ground floor which dates from the year500AD, and the wrought iron of the magnificent spiral stair-case, dating to the end of the 1800s.As other architecturaldetails were uncovered, they were restored and reinstated,bringing the building back to harmonious life.

Responsibility for coordinating the educational activities ofthe Academy was entrusted to Steven Spurrier, who estab-lished the Wine Academy of Paris in 1973 and the winecourse at Christie’s in 1982. He orchestrates the daily winetastings, the lunches and dinners at which food and wine arecarefully matched, and the various educational courses,which are held at the Academy on a half-day, weekly or fullweek basis.

Recently, three beautiful bedrooms – one with frescoedwalls – have been opened on the upper floors of IlPalazzetto making it possible for a lucky few to stay in anhistorical palace in the heart of Rome.

TO SAMPLE THE WINE:

Wine tastings, guided by a master sommelier, are heldMonday to Friday between 6 and 7 pm.A platter of gourmetcheeses and cured meats accompanies the tastings. €20 per

person; reservations are essential. For those who prefer totaste wine on their own, Il Palazzetto’s wine bar is ideal for acasual glass of wine; there are 400 to choose from, alongwith a cheese and meat platter or an appetiser.

Il Palazzetto’s restaurant, under Chef Antonio Martucci,serves modern Italian fare combining fresh ingredients inadventurous ways. Dinner costs about €50 per person, pluswine. For more information, or to make a reservation for awine tasting, lunch or dinner: telephone +39-06-699-0878;email [email protected]; visit www.wineacademy-roma.com; or write Il Palazzetto,Wine Academy of Roma,Vicolo del Bottino, 800187, Rome, Italy.

Il Palazzetto’s bedrooms, each with stylish bath en suite, costfrom €200 to €250 per night, including tax and continentalbreakfast.To book, contact Monica at the Hotel Hassler.Telephone +39-06-69-93-40.

The 9th ESCRS Winter Refractive Surgery Meeting willbe held in Rome from Feb 4 - 6 2005For more information visit www.escrs.org

Great wine and good food createla dolce vita in Rome

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Dermot McGrathin Paris

WAVEFRONT-GUIDED customised abla-tion is capable of improving both quantityand quality of vision for patients, but sur-geons should be aware of its limitations andnot consider it a silver bullet solution for allrefractive ills.

That was the broad message to emergefrom a number of papers presented here atthe annual meetings of the French Implantand Refractive Surgery Association (SAFIR)and the French Society of Ophthalmologists(SFO).

“Using customised ablation, the conceptis to correct not only sphere and cylinderas with traditional laser refractive proce-dures but also the higher order aberrations(HOAs) that can really impact on a patient’squality of vision,” said Olivier Prisant MD.

Dr Prisant, who works in theOphthalmology Department of theFoundation Rothschild in Paris, said that itwas crucial for surgeons to appreciate thatwhile excellent results were achievable withthe latest customised ablation systems,there were limitations to be borne in mindfor such procedures.

In particular, he noted that the final abla-tion could only ever be as accurate as thecurrent measurement systems permittedand that there were certain uncontrollablevariables that made it more difficult to con-sistently achieve the desired refractive out-come.

To illustrate the point, Dr Prisant citedthe problem of obtaining repeatable andpredictable aberrometric measurements.

“The problem of achieving consistentaberrometry measurements has been wellanalysed by Larry Thibos who effectivelydemonstrated that while repeatability isgood over the course of the same day, it isless good from one day to the next, andeven less so when evaluated from onemonth to the next,” he said.

Another important factor which can playa role in giving variable measurements isaccommodation of the eye, noted DrPrisant, since when the eye accommodates,the lens changes shape which may alsoinduce changes in higher order aberrations.

Similarly, the fact that most aberrometricmeasurements are taken through dilatedpupils after cycloplegia also means that thesystem is not capturing the eye’s HOAsunder normal physiological conditions.Furthermore, pupil size, which can alter as aresult of varying conditions of light, dark,

accommodation and convergence, alsoaffects HOAs and makes repeatable meas-urements all the more problematic toobtain.

The time factorThe ageing process introduces another

important variable into the equation, notedDr Prisant.“At a certain point we can takea profile of HOAs in the eye, but we haveto appreciate that over time the ageingprocess induces changes in the lens andcornea that will significantly alter the aber-rometric profile,” he said.

Biomechanical factors also have to betaken into account, in particular the condi-tion of the ocular surface and tear filmproperties. Dr Prisant pointed out thatcorneal pachymetry tends to change duringthe course of the day, introducing anotherpotentially crucial variable into the proce-dure.

Another technological limitation con-cerns the fact that aberrometers takemeasurements using monochromatic light,whereas the eye perceives the world usingmultiple wavelengths. Current wavefrontsensors are therefore unable to detectpolychromatic aberrations, which mighthave a role to play in determining apatient’s overall quality of vision.

Beyond the limitations imposed by aber-rometric measurements and other physio-logical and biomechanical factors, deliverysystems are another vital component inobtaining desired refractive outcomes.

Dr Prisant cited the importance of usinga small-spot Gaussian beam laser withadvanced eye-tracking technology to ensurepinpoint ablation, proper axis alignment andto minimise the effects of cyclotorsion.

He further noted that the creation of theflap in LASIK procedures may itself beresponsible for inducing its own aberrationsand that LASEK and PRK may thereforeoffer superior outcomes in terms of cor-recting eyes with higher order aberrations.

According to Dr Prisant, the role of neu-roophthalmology in vision also has to betaken on board by surgeons.

“Even if we achieve what appears to be aperfect optical result, we still have to deter-mine to what extent the brain is actuallycapable of capturing these perfect images.Perfect optics do not necessarily assureperfect vision,” he said.

Despite these limitations, Dr Prisantbelieved that custom ablation has much tooffer in improving the quality of vision ofrefractive patients.

“As the research of Dr David Williamshas demonstrated, a subjective improve-

ment in the patient’s quality of vision can beachieved, as well as an improvement in visu-al acuity and contrast sensitivity,” he said.

In a separate presentation, BéatriceCochener MD, who works at the head ofthe ophthalmology department at BrestUniversity (France) told delegates that cus-tom ablation marked a clear point of depar-ture from conventional refractive surgery.

“The ability to connect an aberrometerdirectly to an excimer laser for an integrat-ed system that takes account of both quan-titative and qualitative data marks an impor-tant technological development for refrac-tive procedures,” she said.

Dr Cochener said that as recently as twoyears ago, customised ablation was anapproach that had fallen short of its earlypromise.“Initial results were less than satis-factory. Procedures were long and costly,the results were not markedly different toconventional ablation, there was a tendencyto undercorrect and the fact that we wereunable to treat irregular astigmatism wereamong some of its more obvious limita-tions,” she said.

Marketing outstripping clinical realityShe noted that while much had improved

in the intervening period, surgeons stillneeded to be cautious in their deploymentof such systems as the marketing was stillrunning ahead of the clinical reality.

She stressed that more randomised, con-trolled, multi-centre trials were needed toobjectively validate the claims of the manu-facturers and objectively compare variousavailable systems. Moreover, the fact thatthe systems used non-standardised meth-ods of measuring and treating aberrationsmeant that no meaningful direct compari-son was possible between different sys-tems.

Like Dr Prisant, she noted the high num-ber of variables that made it difficult toobtain reproducible and predictable aberro-metric measurements.

“We know that the physiology of the eyemodulates and influences the type anddegree of aberrations. It varies from oneindividual to the next, over the course of aday, depending on pupil size, accommoda-tion, age and other factors.We also have toappreciate the existing natural aberrationsof the eye which might in fact be neededfor obtaining perfect vision, and we are stillnot sure which aberrations might be worthkeeping to maintain a patient’s quality ofvision. Definitely,“SuperVision” appears tobe defined in terms of vision quality andnot only in terms of best visual acuityincrease,” she said.

She added that there were certain obsta-

cles that remained to be overcome forwavefront-guided custom ablation to fullydeliver on its promise. For example, shepointed out that there was a considerablegap between the aberrations that could bedetected by wavefront sensors (up to 18thorder and beyond) and those that couldactually be treated by the current genera-tion of lasers (up to the 8th order).

Irregular astigmatism also continued topose an ongoing problem for custom abla-tion platforms, she said, as it was not possi-ble to take accurate wavefront measure-ments of corneas that were very irregular.She added that more research was neededon establishing whether certain aberrationsstemmed from the retina, the lens or thecornea in certain cases, as this was vital forensuring predictable outcomes.

“We need wavefront maps which takeinto account the aberrations of the entireoptical system, not just the cornea.We alsoneed to understand more about the role ofthe brain in vision and how it deals withoptical aberrations,” she said.

While the current system of Zernikepolynomials had served refractive surgerywell in categorising higher order aberra-tions, she felt that more advanced tech-niques and technology would ultimatelyexpose its limitations and give surgeonsnew treatment options for their patients.

She emphasised that custom ablationplatforms had improved a great deal inrecent years and that while there were stillobvious limitations on their performance,ongoing upgrades and improvements to thesystems brought the promise of‘SuperVision for all’ closer to reality.

[email protected]

[email protected]

Custom ablation puts the focus on quality of vision 38

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Stefanie Petrou-Binder MDin Nürnberg

LASER photocoagulation canprovide a very useful preservationof vision in some cases of diabeticmacular oedema, but patientsmust be carefully selected or theprocedure can do more harmthan good, said retina specialistJohann Roider MD, UniversityClinic Schleswig-Holstein,Germany.

At present, the general guide-lines for laser coagulation therapyare based on the extent of clini-cally significant diabetic macularoedema.Therefore, the conven-tional indication for the interven-tion is thickening of the retinawithin 500 microns of the fovea,with or without hard exudates.However, a more specific set ofselection criteria may better opti-mise the procedure’s risk/benefitratio, Dr Roider told the annualCongress of the GermanOphthalmic Surgeons (DOC) inNürnberg.

“The classification is based onstatistical analyses.The question is,should the definition alone be theoverriding indication for lasertreatment? Is it wise to wait forthe oedema to spread and possi-bly include the fovea before initi-ating laser treatment? Sometimes,it may be best to treat cases with-out exudates,” he commented.

Dr Roider explained that expe-rience shows that the anatomicstructure of the retina plays a rolein fluid motion.The fluid build-upin the retina inevitably movestoward the fovea. He argued thatearly laser treatment could curboedema and help save the fovea.

However, the examiner has todistinguish between focal, diffuse,or ischaemic diabetic maculopathy,and cystoid macular oedema, aseach conditions need to be treat-ed differently.

For example, several studies

have verified that focal maculaoedema responds to laser coagu-lation.Those eyes profit fromlaser therapy and vision is pre-served. In contrast, the value ofrepeat photocoagulation treat-ment for diffuse macula oedema isstill under dispute.The same situa-tion prevails with cystoid macularoedema.

The cardinal signs for focalmacular oedema are circum-scribed zones of oedema, focalcapillary lesions seen with fluores-cent angiography, microaneurysms,and dilated capillary segments.Meanwhile, in cases of diffuse dia-betic macula oedema and of cys-toid macular oedema there is usu-ally evidence of diffuse leakage,which is often due to ischaemicmaculopathy.This common patho-logical feature explains why pho-tocoagulation isoften ineffectivein such cases.

“There aremany diabeticmaculopathiesthat areischaemic.They show substantialexudation.The evidence suggeststhat the higher the capillary lossis, the less likely laser coagulationwill work.”

He noted furthermore thatalthough the fundus may look bet-ter in such cases after laser pho-tocoagulation, the patient’s visionis generally neither preserved norimproved. In fact, the proceduremay even destroy the patient’sremaining central vision.

Dr Roider advised cautionwhen performing a third photoco-agulation. Otherwise there is thedanger of overcoagulating theretina leaving the patient withdecent distance vision but unableto read.Therefore, in such casessurgeons should set the beammuch lower, so that it is hardlyvisible, he said.A therapeuticeffect could come about even

without actually seeing the beam.Laser parameters for a thirdtreatment are set at a maximumof 100 microns from the foveaand 200 microns from the out-side.This is considered a modifiedthird coagulation, he said.

Dr Roider noted that a diabeticpatient with significant visual dete-rioration resulting from a fovealcyst due to a microaneurysm mayrespond best to treatment withspecial unconventional lasers. Suchdevices specifically target thecoagulation of microaneurysms inthe deeper avascular areas, there-by causing a resorption of thecyst fluid.

Dr Roider emphasised thatangiography is critical to deter-mine the need for repeat treat-ments. It helps evaluate the thera-peutic effect of previous treat-

ments. Digital angiography is par-ticularly useful as it enables theexaminer to visualise exudatesthanks to image enhancementwith light and dark options.

To best method available to fol-low the course of exudations anddecide on retreatment, however, isOCT. It allows the examiner tosee the extent of exudation anddecide the further therapeuticcourse. One can also visualise thepresence of fluids both cross-sec-tionally and topographically.

Dr Roider mentioned thatpatients frequently present a com-bination of diabetic maculopathywith proliferative changes. Hisguidelines were clear for thesecases, with treatment either at thesame time, or first treatment ofdiabetic maculopathy (with laser)followed six weeks later by treat-ment of proliferative changes

(panretinal laser coagulation), andnever the other way around.

As a rule, Dr Roider advisedthat re-lasering should not bedone prior to three months afterthe first laser treatment, to allowfor the effects of therapy to playout.

We followed our patients sys-tematically and found that changesin the autofluorescence effectwere to be seen at three, six, even12 months after laser treatment.We can assume that there arelong-term reconstructive effectsin the tissues, as a reaction tolaser coagulation.”

Dr Roider said that laser coagu-lation effects changed over timethrough the atrophic effects onthe pigment epithelium.Whatmight look like poor laser treat-ments years later, are in reality

the successivedemise of neigh-bouring pigmentepithelial cellscausing largeatrophic areas.

He said thatalthough it was not quite clearwhat the mechanism of action oflaser photocoagulation is, thereare a few theories. One theoryproposes that the procedureallows more oxygen to enterfrom the polycapillaris into theretinal tissue.This leads to a sec-ondary vasoconstriction andreduced exudation.

Another theory is related tothe pathophysiological mechanismof disease. It is known that exuda-tions occur due to a loss of peri-cytes.This theory postulates thatlaser coagulation causes the lowerretinal pigment epithelial cells towander in from the peripherytoward the centre.They prolifer-ate and stimulate certain growthfactors while at the same timeinhibiting other growth factors,which all seems to achieve thetherapeutic affect.

Its better to use lower doselaser strength to avoid damage tocells, especially the photoreceptorcells, which when damaged areresponsible for local visual fielddefects and reading problems, hesaid.

Dr Roider highlighted the bene-fits of SRT (Selective RPE-Therapy) laser.This method pro-vides a therapeutic option thatallows the therapist to avoid reti-nal damage, as only the retinal pig-ment epithelium is treated.Thedifference between SRT and con-ventional laser is that the SRTlaser shoots in microseconds sothat the retina per se is not dam-aged.

Specialists implement SRT laserin the earlier stages of diabeticmacula oedema. It accounts forimproved vision in 50% of casesand thinning out of the retina thatis seen on OCT, he noted.

[email protected]

Photocoagulation works best in non-ischaemic diabetic macular oedema

39

“The evidence suggests that the high-er the capillary loss is, the less likelylaser coagulation will work.”

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CK GAINS MOMENTUM

Refractec reports recordsales and procedure numberswith its ViewPoint conductivekeratoplasty system since itgained FDA approval in Marchof this year. Gross revenuesurged by more than 64% to$7.9 million in the first half of2004, compared to $4.8 millionin the same time period lastyear. The number of presbyopicconductive keratoplasty proce-dures increased by more than131%. This translated into arise in gross revenue of morethan 175%. The company alsosold 97 systems, an increase of35% over the same time perioda year ago.

AMO EXPANDS CLBUSINESS

Advanced Medical Optics(AMO) announced it wouldmarket Complete Aquavisionlong-wear contact lenses inEurope and Asia. The companymade a deal with Coopervisionto sell the hydrogelHEMA/GMA contact lens inthose markets. It will sell thelenses along side its completeline of eye care solutions. AMOalso markets the Sensar,Tecnis, Array and VerisyseIOLs, as well as the Sovereignphaco machine and Amadeusmicrokeratome.

INSPIRING STOCKSALE

Inspire Pharmaceuticals isone of the latest ophthalmicproduct companies to test thewaters of the US stock market.The company announced theclosing of its follow-on commonstock offering of 6,900,000shares of common stock,including 900,000 shares soldupon the underwriters' exerciseof their over-allotment optionin full. The shares were at$12.00 per share. The companyhas two products on the mar-ket, Elestat™ for the treatmentof allergic conjunctivitis andRestasis® for the treatment ofdry eye. Both products aremarketed under co-promotionagreements with Allergan.Inspire receives royalties onnet sales of both Elestat andRestasis. Inspire also hasdevelopment and commerciali-sation arrangements withSanten Pharmaceutical.

OCCULOGIX IPOOccuLogix, formerly Vascular

Sciences, announced its inten-tion to file a registration state-ment with the SEC for an ini-tial public offering of stock.OccuLogix is an ophthalmictherapeutic company foundedin 1996 to commercialise inno-vative treatments for eye dis-eases, initially targeting thedry form of AMD. The company

is developing the rheopheresisblood filtration method withthe goal of halting progressionof the dry AMD.

RNAI DRUG TOCLINIC

Acuity Pharmaceuticals filedan Investigational New Drugapplication with the FDA toinitiate Phase I clinical trials ofCand5, its lead product candi-date for treatment of wet age-related macular degeneration.Cand5 is the first of a novelclass of compounds called smallinterfering RNA to reach theclinical trial stage. These com-pounds use RNA interference(RNAi) to shut down genes thatpromote the overgrowth ofblood vessels that leads tovision loss in wet AMD. Cand5shuts down the production ofvascular endothelial growthfactor, shown to be the centralstimulus in the development ofwet AMD and diabeticretinopathy. Phase I studiesare scheduled to begin as earlyas September 2004, pendingthe FDA review.

GDX DEVELOPERSREACHING RECORDLEVELS

Laser DiagnosticTechnologies, developer of theGDxVCC retinal nerve fiberlayer imaging system for thedetection and tracking of glau-coma, announced a record 35%increase in revenue in the pastsix months. The companyattributes the record sales toseveral factors including pub-lished support of the GDxVCCtechnology by leading glauco-ma specialists; improved per-formance including reliability,speed, clinical benefits, andease of use; and customer cen-tered Practice Building pro-grams.

VISUDYNE SALESINCREASE

QLT increased revenues andearnings per share for the sec-ond quarter compared with oneyear before. The increases areattributed to increasing successof the AMD photodynamictreatment Visudyne, which had$109.3 million in sales in thesecond quarter, an increase of23% form the prior year.Visudyne sales outside the U.S.were $57.2 million, up 30%over the same period last year.

NEW DISPOSABLEFROM OASIS

Oasis Medical has intro-duced a new instrument, thedisposable Stromal Hydrationcannula to their line of dispos-able instruments. The new 27gcannula was designed to irri-gate the external portion of thestroma for improved sealing ofclear cornea cataract incisions.It has a closed, flattened tipand an anterior 0.2mm port.The closed tip ensures that tis-sue will not clog the port uponentry into the incision. Theanterior port location forceshydration to move to the exter-nal segment of the stroma, pro-viding improved sealing of theincision.

BOTOX GOESUNDER COVER

Botox (botulinum toxin typeA, Allergan), which began itscareer as a treatment for ble-pharospasm and has sincebecome a major cosmetic treat-ment has received FDAapproval for treatment ofsevere primary axillary hyper-hidrosis that is inadequatelymanaged with topical agents.The FDA approval was basedon the results of two Phase IIIclinical studies, one conductedin the U.S. and one in Europe

Industry Briefs Recent Developments in the Vision Care Industry

40

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EuroTimes September 2004

For two decades,scientists have stud-ied how to trans-plant cells into theeye to correct avariety of visual dis-orders.The acidtest for such an

approach is whether call transplants canactually maintain spatial vision. New jointAmerican and Canadian research in thisfield provides encouraging results suggest-ing that transplanting cells into the retinacan significantly limit the deterioration ofspatial vision in rats.

Blindness can occur when photoreceptorcells in the retinal cell layer or retinal pig-ment epithelium cells in the adjacent layerof cells deteriorate.The retinal pigmentepithelium (RPE) layer, under normal condi-tions, provides a supportive housekeepingrole to the rod and cone photoreceptorcells. If the RPE does not function correctly,the environment for the rods and conescan deteriorate rapidly.

One approach to counter such deterio-ration would be to provide a fresh supplyof either healthy RPE cells or other typesof healthy cells that could provide the samefunctions as RPE cells. Many researchgroups worldwide have conducted suchtests and have shown considerable pho-toreceptor protection, sustained visualthreshold responses, and improved behav-ioural responses using cell transplantation.

The newest research, from theDepartment of Psychology andNeuroscience in the Canadian Centre forBehavioural Neuroscience at the Universityof Lethbridge, and from the Moran EyeCentre at the University of Utah, nowdemonstrate that such cell transplantationtreatments can have a significant impact onvisual acuity.The research team publishedtheir findings in the journal Vision Researchthis summer.

The research group used Royal Collegeof Surgeon (RCS) rats as their model ofretinal degeneration. In these rats, thedegeneration results from a mutation in agene known as “Mertk.” Mertk is expressedin the RPE where it encodes a tyrosinereceptor kinase protein believed to beinvolved in the recognition and binding ofouter segment debris produced as a by-

product of photoreceptor cell activity.Thedefect in Mertk compromises the ability ofthe RPE to dispose of the outer segmentdebris from photoreceptor cells; the result-ing accumulation of debris leads to pho-toreceptor degeneration and blindness.

The group’s data have shown that deliv-ery of human RPE cells and humanSchwann cells into the retina of the ratscan preserve spatial vision, in some casesup to 70% of normal.The study providesfurther support that cell transplantationmay become a viable treatment for retinaldegenerative disease.

The researchers used two different celltypes for transplantation – human RPE cellsand human Schwann cells. Schwann cells

were used in the study because they areknown to produce many of the growth fac-tors that provide a healthy environment forthe photoreceptor neuronal cells.Theresearchers grew the two cell types in thelab in culture dishes before concentratingthem into a small volume of liquid to deliv-ery to the rats’ eyes.

Using a fine glass pipette attached bytubing to a Hamilton syringe, the cell sus-pensions were delivered to the sub-retinalspace through a small scleral incision.Either 200,000 RPE cells or 20,000Schwann cells were delivered in 2microlitres of fluid to the retina of the rats.

The visual acuity of the animals was test-ed using a visual perception task known asthe Visual Water Task.The apparatus torecord such data consists of a trapezoidal-shaped pool with a mid-line divider extend-ing into the pool to create a Y-shaped mazewith a stem and two arms.Two computermonitors face into the wide end of thepool; the animals are trained to discrimi-nate between different visual stimuli pro-jected on the computer screens.The ratsreadily learn to swim towards the platform

that allows escape from the water.After transplantation with the human

RPE cells, the rats were tested from fourto seven months of age; the results demon-strated that transplanted animals had ahigher acuity than control animals at allages.The visual acuity of animals receivingSchwann cell transplants were tested atfour and five months of age and alsoshowed that the acuity of the transplantedanimals was significantly better than thecontrols.

The researchers concluded that the useof either immortalized human RPE cells orfreshly harvested Schwann cells were capa-ble of providing a significant benefit tovision in an animal model.

The report claims to be the first to pres-ent a systematic quantitative study examin-ing spatial vision thresholds in animals fol-lowing sub-retinal cell transplantation.

Using either of the cell types carriesboth advantages and disadvantages.Thehuman RPE cells have the obvious advan-tage of replacing into the retina the samecell type that normally resides in this tissueunder normal conditions. However, thesource of such cells will likely require aparallel use of immuno-suppressants toinsure that the transplanted RPE cells arenot attacked and destroyed by the body’simmune system.Also, because RPE cells arederived from a laboratory immortalizedcell line, there is the risk that such cellsmay replicate in an uncontrolled manner,leading to an additional pathology.

On the other hand, Schwann cells wouldcarry no such replication risks. Schwanncells may be harvested from another partof the patient’s body, such as a peripheralnerve. Because such cells come from thesame patient, no immunosuppressant drugswould be required.

From their findings, the researchers com-

mented that because Schwann cells “havebenefit to vision not very different fromthe RPE cells in an animal model of retinaldegenerative disease, it is clear that withthe potential of performing autologoustransplantation, the path from laboratoryinvestigation is significantly simplified withthis cell type.”

Although using Schwann cells in such atreatment approach does not address theprimary defect of the Mertk gene, theapproach does clearly extend the length ofuseful vision. In the absence of a “cure,”extending such useful vision in a humanpatient would represent a significant “sec-ond best” and, as such, represents a mostwelcome advance.

GlossaryRetinal pigment epithelium: refers to a pig-ment cell layer situated behind the pho-toreceptors that nourishes the retinal cells.The retinal pigment epithelium is attachedto the choroid, a layer filled with bloodvessels that nourish the retina.

Royal College of Surgeon (RCS) rats: are awidely used animal model of inherited reti-nal degeneration.

Mertk: Mertk is a protein expressed in theRPE where it is believed to be involved inthe recognition and binding of outer seg-ment debris produced as a by-product ofphotoreceptor cell activity. Mutations inMertk disrupt the ability of the RPE tophagocytose debris from photoreceptorcells resulting in accumulation of un-want-ed material eventually leading to cell degen-eration and blindness

Tyrosine receptor kinase protein: proteinsthat play an important role in mediatingcell signalling processes.

Schwann cells: A type of cell of the periph-eral nervous system that helps separateand insulate nerve cells.

Visual Water Task: a specialised trainingtask used to assess behavioural response inrodents under specific experimental condi-tions.

Bio-ophthalmology

Cell transplants now potential treatment for retinal degenerationBY GEAROID TUOHY PHD

“New joint American and Canadian research inthis field provides encouraging results suggest-ing that transplanting cells into the retina cansignificantly limit the deterioration of spatialvision in rats.”

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EuroTimes September 2004

Leigh Page

The European refractive surgerymarket will be sluggish for theforeseeable future, if EuropeanUnion consumer confidence meas-ures are any predictor.

The European Union recentlyreported that consumer confi-dence for all EU countries in Julymeasured a pessimistic -12, whereit has been stuck since late 2003.The index is based on a survey of25,000 households.

Such a measure is a good pre-dictor of future volume of refrac-tive surgery procedures, accordingto David Harmon, president ofMarket Scope, a St. Louis, MissouriUS company that measures theUS ophthalmology market. Mr.Harmon says his company haslinked changes in volume of LASIKprocedures to changes in con-sumer confidence measures inevery quarter for the past fouryears.

Although he has not comparedEuropean consumer confidencemeasures to LASIK demand inEurope, Mr. Harmon says that thelink he has found in the UnitedStates may well apply in Europe.As in United States, refractive sur-gery procedures in Europe areprimarily financed by patientsthemselves, making the demandfor procedures easily influenced bythe level of consumer confidence,he notes.

The European market hasshown sluggishness in somerecently released reports for thesecond quarter of 2004.

For example, Bausch & Lombreported that sales for refractivesurgery products were flat inEurope, even as they were up bynearly 30% in the Americas.

Alcon reported that sales forrefractive products fell 16.8% inthe second quarter.Although thereport said nothing specificallyabout Europe, the report noted anincreased demand for LASIK andcustom procedures in the UnitedStates.

Reflecting the surge in salesalready apace in the United States,consumer confidence measuresthere – including the ConferenceBoard and AP-Ipsos surveys –show a booming U.S. consumerappetite this summer.

Reports in Europe, however, aregloomier.

The European Union’s July con-fidence measure showed slightlypositive figures for only five coun-tries: Denmark, Finland, Ireland,Luxembourg, and Sweden. Majorrefractive surgery markets, howev-er, showed negative consumerconfidence in the economy. Forexample, Germany reported -17consumer confidence rating;France reported a -16 rating; Spainreported a -11 rating; and the UKreported a -4 rating.A number ofcountries, including Portugal,Greece, Italy, and Poland reported

consumer confidence ratings of -20 or worse.

“While households were some-what more optimistic concerning

future unemployment, their viewson their own future financial situa-tion darkened slightly,” theEuropean Commission comment-

ed in their survey. “Households’views on the general future eco-nomic situation remainedunchanged.”

European consumer confidenceA positive number indicates an overall positive level of confidence in the economy.A negative number indicates an overall negative level of confidence in the economy.The numbers reflect the differences betweenthe percentages of respondents giving positive and negative replies.

Dec 03 Jan 03 Feb 04 Mar 04 Apr 04 May 04 Jun 04 Jul 04

European Union -13 -12 -11 -11 -11 -13 -12 -12Euro area -16 -15 -14 -14 -14 -16 -14 -14Belgium -7 -5 -4 -3 -4 -6 -1 -4Czech Republic -20 -21 -26 -24 -21 -15 -14 -10Denmark 6 9 5 7 11 10 11 11Germany -15 -16 -13 -16 -17 -18 -15 -17Estonia -18 -12 -16 -16 -16 -21 -18 -14Greece -42 -34 -32 -19 -18 -22 -23 -27Spain -11 -12 -12 -11 -8 -9 -11 -11France -24 -15 -16 -15 -15 -17 -18 -16Ireland -10 -8 -7 -5 -6 -5 -6 3Italy -15 -18 -21 -19 -18 -19 -19 -20Cyprus -30 -33 -36 -35 -34 -34 -41 -44Latvia -14 -16 -18 -21 -19 -19 -16 -14Lithuania -12 -15 -14 -12 -13 -13 -8 -8Luxembourg -2 1 3 2 -1 1 5 5Hungary -29 -33 -33 -33 -32 -27 -25 -25Netherlands -10 -13 -6 -10 -8 -11 -6 -3Austria -2 -3 -2 -2 -3 -5 -2 -1Poland -29 -31 -33 -32 -30 -25 -23 -26Portugal -36 -36 -37 -36 -38 -35 -31 -32Slovenia -23 -21 -26 -22 -22 -19 -19 -18Slovakia -34 -32 -35 -27 -26 -26 -22 -22Finland 14 11 11 13 13 14 15 13Sweden 4 6 6 2 6 6 6 4United Kingdom -3 -3 -2 -2 -2 -5 -6 -4

Source: European Commission

European refractive surgery volume expected to remain sluggish

Big epithelial defects a big problem Large central epithelial defects resulting from LASIK can

lead to significant problems including diffuse lamellar ke r a t i t i s ,i rregular astigmatism, f l ap micro fo l d s , and delayed visual re h a-b i l i t a t i o n , re p o rt German re s e a rc h e r s .The inve s t i g a t o r srev i ewed a series of 1650 LASIK operations performed at asingle centre, finding 22 eyes of 14 patients who deve l o p e ds eve re central epithelial defects as a result of surgery.T h i sincluded 20 eyes with diffuse lamellar keratitis (DLK), 17 eye swith irregular astigmatism, and 12 with micro fo l d s . Eight casesi nvo l ved both eye s . N e a r ly all of the eyes lost some degree ofb e s t - c o rrected visual acuity in the postoperative period.Visual acuity did improve slow ly, and no eye lost more thanone line of vision at the one-year fo l l ow-up point.Two - t h i rd sof the affected eyes had moderate to seve re dry - eye symp-toms befo re surgery.J C R S,A . M i rshahi et al., ‘Clinical course of sev e re central epitheliald e fects in laser in situ ke ra t o m i l e u s i s ’ ,August 2004;Vo l . 3 0 , Issue 8,1 6 3 6 - 1 6 4 1 .

B l o cking gr owth factor enhances graft surv i va lA growth factor called vascular endothelial growth factor

re c e p t o r-3 (VEGFR-3) plays a key role in corneal transplantre j e c t i o n , s ay Harv a rd scientists. M o re ove r, animal studiess h ow that blocking the growth factor enhances the surv i v a lof corneal grafts.The finding is an important deve l o p m e n tt ow a rds understanding the immune system pathway linkingthe eye to the rest of the body.The team was able to showthat VEGFR-3 was responsible for mobilising antigen-pre s e n t-

ing cells to move into the lymphatic system. Blocking V E G F R -3 by using immunoglobulin blocked the antigen-pre s e n t i n gcells and prevented them from entering the lymphatic sys-t e m , blocking the immune re s p o n s e.The re s e a rchers believethe findings may extend well beyond ophthalmology to otherf i e l d s , p a rticular organ transplantation and cancer therapy.N a t u re Medicine, R . Dana et al., ‘ Vascular endothelial growth fa c t o rreceptor-3 mediates induction of corneal alloimmu n i t y ’ ,August 2004;1 0 , 813 – 815.

Tumour patients see clearly nowPatients undergoing plaque radiation therapy for tre a t m e n t

of ocular tumours can continue to see during tre a t m e n t ,thanks to new clear lead glasses. R e s e a rchers at theManhattan Eye and Ear Infirmary tested the glasses in a seriesof patients undergoing treatment with palladium 103 plaquer a d i o t h e r apy. Until now patients have been re q u i red to we a ropaque lead patches during tre a t m e n t .The glasses are ase f fe c t i ve as the patch in blocking radiation from escaping intothe env i ro n m e n t . Patients ap p reciated the ability to fe e dt h e m s e l ves and otherwise function at home with gre a t e rf re e d o m .A m e rican Journal of Ophthalmolog y, PT Finger et al., ‘ R a d i a t i o n - b l o ck i n gglasses allow vision during ophthalmic plaque radiation thera py ’ , J u n e,2 0 0 4 ;Vo l . 1 3 7 , Issue 6, 1 1 4 9 - 1 1 5 1 .

AMD gene discov e re dGenetics re s e a rchers re p o rt the identification of defects in

a single gene that underlie a here d i t a ry form of age-re l a t e d

macular degeneration.The re s e a rchers recruited 402 peoplewith AMD and 429 healthy vo l u n t e e r s .T h ey then examinedthe patients’ DNA, looking for variations in genes that codefor fibulins, p roteins prev i o u s ly implicated in A M D. S even ofthe 402 AMD patients each had a diffe rent change in theFBLN5 gene that was not found in the healthy control gro u p.Six of these seven changes altered an amino acid in the fibulin5 pro t e i n .Although the genetic mutations affect only aboutt wo percent of patients with A M D, the re s e a rchers believethat the findings offer important insights tow a rds understand-ing the pathogenesis of A M D.N E J M , EM Stone et al. ‘Missense Va riations in the Fibulin 5 Gene andA ge-Related Macular Dege n e ra t i o n ’ , Jul 22, 2 0 0 4 ; 3 5 1 : 3 4 6 - 3 5 3 .

P e r i m e t ry promising for PK patients F requency-doubling perimetry may prove useful in postop-

e r a t i ve glaucoma screening of penetrating ke r a t o p l a s t yp a t i e n t s . German re s e a rchers used the technique to assessp o s t o p e r a t i ve corneal topographic changes in 36 penetratingkeratoplasty patients.

Patients with pre-existing glaucoma or any postoperativeintraocular pre s s u re elevation we re excluded. F i e l d - t e s t i n gwas equally effe c t i ve in PK patients and contro l s . Po s t - o p e r a-t i ve corneal topographic changes including ke r a t o m e t r i ca s t i g m a t i s m , t o p o g r aphic astigmatism, spherical equivalent,and central corneal thickness did not appear to interfe rewith perimetry testing.C o r n e a , NX Nguyen et al., ‘ Fre q u e n cy-doubling peri m e t ry in patients fo l-l owing penetrating ke ra t o p l a s t y ’ , 2 0 0 4 ; 2 3 ( 5 ) : 4 3 3 - 8 .

Journal Watchby Sean Henahan

Vision science highlights from the world’s leading journals of medicine and science

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EuroTimes September 2004

Dermot McGrathin Monte Carlo

STEROID therapy to treat traumaticlaser retinal injury should be used with cau-tion in order to avoid potentially severecomplications with wound healing, accord-ing to an American researcher.

In a presentation here at the 5thInternational Symposium on OcularPharmacology and Therapeutics (ISOPT),Stephen T Schuschereba PhD, said that hehad set out to test the hypothesis thattreatment with the glucocorticoid methyl-prednisolone would reduce short-term sec-ondary injury from laser retinal injury aswell as improve long-term outcomes.

“No evidence-based therapeutic regimenshave been developed for traumatic laserretinal injury, but most clinical interventionscurrently involve the use of glucocorticoidtherapy.The purpose of this study was todetermine if high-dose steroid use is justi-fied for medical management of traumaticlaser retinal injuries.We concluded that insevere laser-induced retinal trauma, theimmunosuppressive effects of high dosemethylprednisolone therapy contributed toa variety of untoward wound healing out-comes, thereby suggesting caution in its useto treat similar injuries in humans,” DrSchuschereba said.

Dr Schuschereba, who works at the U.S.Army Medical Research Department in SanAntonio,Texas, said that primary laser-induced retinal damage such as photo-ther-mal and photo-mechanical processesinduced the onset of early stage secondarydamage such as oedema, ischaemia-reperfu-sion injury, lipid peroxidation and inflamma-

tion.These in turn can lead to late stagetertiary damage such as scarring, scarremodelling and neovascularisation, whichcan contribute to retinal traction, retinalhole formation, detachments, continued tis-sue degeneration and vision loss.

Although damage events responsible fortissue degeneration and vision loss arebecoming better understood, DrSchuschereba pointed out that no effectiveor results-based therapeutics can be confi-dently recommended for therapy to sparevision.

In the study, 37 New Zealand Red rabbitswere either dosed with methylprednisolonesodium succinate about 20 minutes beforelaserirradia-tion orwereleft

untreated. Dosing with methylprednisolonewas tapered from 30 mg/kg/day to 10mg/kg/day for five consecutive days.A multi-line argon laser was then used to produceretinal injuries near haemorrhaging levels.Avariety of funduscopic and histologic assess-ments were made from 10 minutes to sixmonths after injury.

Fluorescein angiography showed thatcontrol lesions stopped leaking at threedays post injury, but methylprednisolone-treated lesions leaked for two to four dayslonger.After one month, methylpred-nisolone-treated lesions increased in areawhile controls became reduced.

Histologic analysis showed no effect onreduction of neutrophils (PMN) in methyl-prednisolone-treated lesions over controlsat three hours.After 24 hours, retinal PMNvalues in hemorrhagic lesions of the methyl-prednisolone group were significantly ele-vated (p<0.05) while monocyte/macrophagecounts were reduced (p<0.05) compared tocontrol.

After just four days, retinal lesions treat-ed with methylprednisolone showed sup-pressed cell proliferation and lack of cellfilling-in for lost retinal elements.There wasalso evidence of early stage retinal holedevelopment in all lesions types, leading todefinitive retinal hole development at one

monthfollowedby exten-sive scar-ring inboth theretinaand thechoroidat six

months.Putting the data into perspective, Dr

Schuschereba said that the key findings ofthe study included the fact that the blood-retinal barrier is delayed by methylpred-nisolone, suggesting suppression of RPE cellactivity.

It was noteworthy also that the acuteinflammatory response after trauma – lead-ing to secondary damage – was not cur-tailed by methylprednisolone and thatdebris clearance in the wound may beimpeded by the steroid due to suppressionof macrophage activity.

Furthermore, he said that the inhibitionof retinal glial cell proliferation by methyl-prednisolone contributed to retinal holesthat resulted around one month aftertreatment.After six months, increasedchorio-retinal scarring occurred, and bear-ing all these points in mind, methylpred-nisolone therapy to treat laser-induced reti-nal injuries should be used with due cau-tion, he added.

[email protected]

Caution urged in steroid treatment for laserretinal injuries

43

The purpose of this study was todetermine if high-dose steroid use isjustified for medical management of

traumatic laser retinal injuries.

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Stefanie Petrou-Binder MDin Nürnberg

PROLIFERATIVE vitreoretinopa-thy has a propensity for the inferi-or fundus and vitreoretinal investi-gators are therefore searching formore effective ‘sinking’ agents tohelp seal retinal breaks in thelower fundus.

The use of a model eye cham-ber to study the behaviour oftamponade agents seems to indi-cate that heavier liquids such asF6H8-silicone oil solutions makegood contact with the inferiorfundus and may be better atexcluding aqueous from inferiorretinal breaks. Because the vitre-ous cavity is nearly spherical, it isdifficult to totally fill the eye withany tamponade agent. Therefore,while conventional silicone oil iseffective for retinal breaks situat-ed at the superior fundus, heavysilicone oil (such as F6H8-siliconeoil solutions) is more effective forinferior retinal breaks, said DavidWong, Consultant vitreoretinalsurgeon at Royal LiverpoolHospital.

“It may be serendipity that stan-dard silicone oil is just a littlelighter than water. Nonetheless, ithas served us well for 40 years. Itis for this reason that we recom-mend silicone oil solutions thatare just a bit heavier than water.Winter et al suggested thatPerfluorocarbon liquids may betoxic because they are too effi-cient at excluding water from theretinal surface, thereby causinghistological damage to the retina,”he said.

Dr Wong spoke at a retina sem-inar at the annual Congress of theGerman Ophthalmic Surgeons(DOC). He commented that notamponade agent could be com-pletely effective, as none canachieve and sustain a 100% tam-ponade effect.

Break closure is best achievedby excluding access of water toretinal breaks thereby stopping orreducing bulk flow of aqueousthrough the retinal breaks.

Tamponade agents form bubblesthat make contact with the retinaand keep water away, he said.

The shape of the bubbles, pri-marily determined by the specificgravity of the substance, plays adeciding role in the ability of atamponade agent to make contactwith the retina.Additionally, tam-ponade agents that float are moreuseful for breaks in the superiorfundus. Dr Wong has been work-ing with his colleagues TheodorStappler and Dr Rachel Williamsof the Clinical EngineeringDepartment in Liverpool. Hereported that using two agents(conventional followed by heavysilicone oil) in two successiveoperations, one for the upper andthen one for the lower fundus,might be a new strategy for treat-ing proliferative retinopathy(PVR).

He said that tamponades onlyapply a little mechanical force onthe retina, and that the word ‘tam-ponade’ (suggesting packing orcompletely filling) was, in a way, amisnomer. Because the vitreouscavity was nearly spherical, it canbe impossible to completely fill itto achieve a ‘total tamponade’.Earlier attempts at double fillingthe vitreous cavity with a combi-nation of agents that float andsink did not achieve overall suc-cess, as a slight under-fill can leavea large area of the retina withoutcontact with the tamponadeagent.

“Break closure is a nebulousconcept. It has the connotation ofpushing against, as in closing adoor. It reality there is very littlemechanical force acting on theretina,” Dr Wong commented.

He explained that the buoyancypressure of an air bubble is theproduct of water density, gravityacceleration, and the height of thebubble. Even for large bubbles orPerfluorocarbon liquids or gas, thebuoyancy pressure would still below.

He said that surgeons wereconcerned that heavy liquidsneeded to be ‘heavy enough’ to beeffective. However, even the heavi-

est fluid, perfluorophenanthrene,exerts a maximum downwardpressure of only 3.4 mmHg in anormal size globe, he said.

“It is highly doubtful whethersuch small pressures play animportant part in break closure. Itis even more controversial toattribute the trophic changes ofthe retina to the specific gravity ofheavy liquids,” Dr Wong com-mented.

He maintained that the abilityof a tamponade agent to makecontact with the retina andexclude bulk flow of aqueousthrough retinal breaks was theone crucial factor that determinesthe efficacy of the agent to closeretinal breaks. Contact dependson the buoyancy of the agent andon the interfacial tension.

As the retinal surface ishydrophilic, it determines theshape of bubbles coming ontocontact with it.Air bubblesbecome flat bottomed and sili-

cone bubbles assume a nearspherical shape. Even though airhas a higher interfacial tensionagainst water than silicone, bub-bles of air assume a much more‘useful’ shape than silicone.

Since tamponade agents sealretinal breaks through contactwith the retina, agents that floatshould be more effective in clos-ing superior fundus breaks andagents that sink should be moreeffective for inferior fundus retinalbreaks.

He noted that, overall, liquidswith higher specific gravities aremore effective in making contactwith the retina and thereforemore effective at closing retinalbreaks. Semifluorinated alkanesand other fluorocarbons that aremiscible with silicone allow sur-geons now to use homogeneoussolutions of two or more liquids

as a single tamponade agent.

Dr Wong pointed out thatintraocular gases were satisfactoryin making close to maximum con-tact with the retina. He would liketo identify agents that werespecifically more effective in theinferior fundus.

He said that his clinical experi-ence with over 70 cases withDensiron (Fluoron GmbH, Neu-Ulm, Germany) was very positive.The use of this agent focused oncases of retinal detachment com-plicated by PRV and in which ini-tial surgery with gas or silicone oilhad failed.The re-detachmentinvariably involved inferior pathol-ogy either in the form of epireti-nal membrane formation orunclosed retinal breaks.

Nevertheless, Dr Wongstressed that patients with retinaldetachments complicated by PVRprofited from inferior fundusagents that are heavier thanwater. He stated that this asser-

tion needed to be verified in con-trolled trials. One such interna-tional trial led by Profs Kirchhofand Joussen of Cologne is under-way.

[email protected]

Searching for heavier-than-water tamponades44

Model eye chamber filled with F6H8-silicone oilsolutions a specific gravity of 1.01 g/cm3

Model eye chamber filled with F6H8-silicone oilsolutions a specific gravity of 1.06 g/cm3.

Note that the bubble of the lighter silicone oil ismore rounded, taller and makes less contact with

the chamber.

“It is highly doubtful whether suchsmall pressures play an importantpart in break closure”

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Roibeard O’hEineacháinin San Diego

MICROKERATOME-ASSISTEDlamellar keratoplasty can result inrapid and stable visual rehabilita-tion with a low amount ofinduced astigmatism in patientswith superficial corneal opacities,Massimo Busin MD told the annu-al meeting of the AmericanSociety of Cataract and RefractiveSurgeons.

In a study that involved 20 eyesthat underwent microkeratome-assisted superficial anterior lamel-lar keratoplasty, all achieved a

postoperative BCVA of 20/40 orbetter within the first two post-operative months and none of theeyes had postoperative astigma-tism greater than 4.0 D, said DrBusin,Villa Serena Hospital, Forli,Italy.

“The corneal mechanics withthis technique are essentially sameas with a LASIK flap, the only dif-ference is that the flap comesfrom a donor.As a result, the visu-al recovery is quick and stabiliseswell after the first few monthsand in some patients there is fullrecovery of vision after a fewweeks,” he told EuroTimes in aninterview.

The patients in the study had amean preoperative visual acuity of20/100 (range: 20/40-20/400).Thisvalue improved to about 20/30 atone month’s follow-up andappeared to remain stable there-after for up to two years.

After one month, best correct-ed visual acuity was 20/40 in sixeyes(30%), 20/30 in seven eyes(35%), 20/25 in five eyes (25%)and 20/20 in two eyes (10%).

Similarly, in 13 eyes that had 12months of follow-up, BCVA was20/40 in three eyes (23%), 20/30in five eyes (38%), 20/25 in foureyes (30%) and 20/20 in one eye(8.0%). Furthermore, in six eyes

with two years of follow-up, threeeyes were 20/30, two were 20/25,and one was 20/20.

The patients in the studyincluded 12 with corneal dystro-phy and degeneration, six withsubepithelial scarring followingPRK, and two with superficialstroma opacities following kerati-tis.

Dr Busin’s surgical techniqueconsists of using the Moria ALTKmicrokeratome system to firstremove a lamella 130 microns -160 microns in thickness and 9.0-9.5 mm in diameter from therecipient cornea and then prepa-ration of a similar donor lamellafrom the donor cornea using thesame microkeratome head and anartificial anterior chamber. Hethen uses overlying sutures, ratherthan radial 10/0 nylon sutures tohold the implant in place on therecipient’s stroma, and thenremoves the sutures two dayslater.

Because the overlying suturesdo not actually penetrate thedonor lamella they do not induceastigmatism, Furthermore, suturesare not always necessary as thedonor “flap” adheres quite firmlyto the recipient stroma, he noted,adding:

“Since we remove andexchange such a thin layer, the

new layer that comes on top ofthe cornea seals on top of therecipient’s stroma in a way that issimilar to a LASIK flap.Thatmeans you don’t need radialsutures with the graft, you canjust put over-lying stitches thatmay be removed two days aftersurgery and the healing is veryfast, so it provides very quick visu-al rehabilitation and minimalchange in refraction.”

Dr Busin acknowledged thatthe respective lamellae of thedonor and recipient may not becompletely identical because - justas with the creation of LASIKflaps - there is usually some varia-tion between the depth of micro-keratome cuts even when usingthe same microkeratome head.

However, he maintained thatthe difference is well-tolerated bythe cornea and he pointed outthat many of his patients werestrongly handicapped before theprocedure but had near normalvision from the early postopera-tive period onward.

Complications included fivecases where the donor flap andthe recipient stroma were ofunequal diameter. When thedonor lamella was smaller thanthe recipient bed (3 eyes), thesurface epithelium simply grewover the thin annular area of barestroma around the graft, with nofurther consequences. In the twografts with a diameter larger thanthe recipient bed, the tissue inexcess, hanging over outside themicrokeratome cut, necrotisedcausing irregularity of the periph-eral edge, but, again, no significantside effect.

Epithelial interface ingrowthwas seen in four eyes.As theepithelial cysts lay outside of thevisual axis, they were left untreat-ed. In general, treatment is need-ed only in those cases with theinterface epithelium communicat-ing with the surface through a“feeding” channel, which keeps on

maintaining the ingrowth. In theother cases the epithelium dies offwith time and simple observationis sufficient.

Dr Busin said the advantages ofmicrokeratome-assisted superficiallamellar keratoplasty compared tophototherapeutic keratectomywere similar to those of LASIKcompared to PRK. Namely, withthe microkeratome-assisted tech-nique there is no scar formation,patients have an intact Bowman’slayer, there is negligible hyperopi-sation, and subsequent LASIK sur-gery is possible by simply partiallylifting the donor lamella.

“With this technique you havethe quality of the microkeratomedissection, the speedy rehabilita-tion with longterm stability, andrepeatability. If you’re not happywith the result you’ve got, you canalways take it off and put a newone on. It’s a little like a livingcontact lens.”

[email protected]

Flap transplants effective in treatment ofsuperficial corneal opacities

45

Massimo Busin

Post-PRK scar Post PRK scar treated with superficial lamellar keratoplasty

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Stefanie Petrou-Binder MDin Heidelberg

A NEW customisable iris pros-thetic system (IPS) appears to beuseful for the repair of many dif-ferent types of iris damage,reported iris prosthesis specialistHeino Hermeking MD at theCongress of the German-SpeakingSociety for Intraocular LensImplantation and RefractiveSurgery (DGII).

The IPS®, designed by DrHermeking offers different modu-lar ‘building blocks’.The speciallydesigned elements are made ofpigmented PMMA (green, blue,black, and brown), and can beused to fulfil any number ofanatomic, pathologic, or functionalcriteria.

“This new iris prosthetic build-ing block system is applicable inany case scenario.The systemincludes both a novel foldablediaphragm-positioned IPS (dIPS)and a capsular, sulcus-positionedIPS (kIPS). It was developed foruniversal application and to doaway with the requirement of acustomised finishing of the prod-uct,” said Dr HermekingWuppertal, Germany

The building blocks include sin-gle and double elements (both

available for either 3.0 mm and4.0 mm pupil widths) for eithersulcus or diaphragm fixation.All ofthe building blocks can be com-bined with an IPS fixation ringthat serves to counteract second-ary capsule shrinkage and stabilisethe artificial aperture.

The elements are used alone orin combination, depending on theindividual needs of the patient, tocreate a new iris diaphragm (pupilreconstruction) or correct partialand total iris defects.They offeroptimal control of postoperativeartificial pupil diameter.The stan-dard designs and availability in dif-ferent dioptric powers allow forin-house inventories.

Dr Hermeking explained thatthe biggest advantages of the IPSwere that the iris surgeon couldaccommodate any anatomic orpathologic situation with this sys-tem.Also, the surgery is per-formed using small-incision tech-niques, as only a 3.5 mm width isrequired for implantation, whichmakes surgery using this buildingblock IPS minimally invasive.

The IPS system (capsular ordiaphragmatic) is chosen accord-ing to what is needed by thepatient in a given situation.Thesystem allows elements to befixed with any of the standard fix-

ation options, allowing for whatcan be most easily and safelyachieved by the surgeon, such asiris enclavation, ciliary sulcus posi-tion, endocapsular position, andtransscleral suture.The latter isonly used as a last resort, henoted.

“Although, 90% of the ocularfindings are 10 years or older, weneed a system that satisfies theanatomical, pathological and func-tional criteria of patients whorequire spontaneous care.Thisprosthetic system is feasible foruse in acute traumatic situationsas well as for chronic iris patholo-gies,” he said.

Functional criteria for irisreconstruction or replacementinclude reducing glare and photo-phobia, and improving depthvision.As the implants augmentthe iris diaphragm, they reduceboth photophobia and glare,which are the most commoncomplaints in patients with dam-age to the iris.

Anatomically, an iris prosthesishas to form a diaphragm, withseparation of anterior and poste-rior segments of the eye.Thepathologic and anatomic findingscan be genetic or pathological,ranging from aniridia, to irisdefects such as coloboma, and iris

dysfunctions like traumatic mydri-asis.

Dr Hermeking noted thatalthough the role of a diaphragmin aqueous fluid dynamics and theformation of secondary glaucomaare still not clear, a diaphragm toseparate the anterior and posteri-or segments is mandatory in thesurgical realm for silicone oil sur-gery in PVR ablations.

A prosthetic iris also needs tobe cosmetically acceptable, whichis challenging in an extremely vari-able patient population.

The system can be applied in arange of ways, Dr Hermeking said.For example, the capsular IPS maybe fixated in the sulcus while thediaphragmatic IPS can be posi-tioned in the sulcus or fixed tothe iris, or both combined whilealso fixed by transcleral sutures.

“Iris prosthetics are central tothe traumatological care of theeye.They must be adaptable,attainable, conform to small-inci-sion surgery, and must adequately

replace the iris. Biocompatibilityand the degree of light transmis-sion (glare reduction) are impor-tant issues for the coloured irisprosthesis. Colour elements mustbe bound to the prosthesis; other-wise toxic pigments could be setfree leading to chronic intraocularirritation. Pigments must be inte-grated into the PMMA,” he said.

Dr Hermeking explained thatprolonged rehabilitation times andminor bleeding, which usuallyresolve completely within one ortwo weeks could be expected

postoperatively. He urged sur-geons to monitor for haemato-clastic glaucoma and increasedIOP due to lens swelling.

[email protected]

Iris prosthetic system with ‘building blocks’customises iris replacement

46

“This new iris prosthetic buildingblock system is applicable in any casescenario.”

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EuroTimes September 2004

Pippa Wysongin Vancouver

THE use of Dacron mesh mayimprove retention and appearanceduring replacement of goldweights in the eyelid for patientswith facial nerve palsy, but con-cerns remain about long-terminflammation, according to DanDeAngelis MD, Mount SinaiHospital,Toronto, Ontario,Canada.

In a presentation at the annualmeeting of the CanadianOphthalmological Society, DrDeAngelis described the outcomeof three patients who underwentimplant replacements withDacron mesh used in an effort tostop the implant from migrating.

Dacron mesh is a polyesterpolymer (polyethylene terephtha-late) that has been used for vari-ous medical applications for morethan 50 years. Uses range fromimplantable sutures, vascular graftsand as a surgical mesh used forpatching and repairs.

“It’s the strongest suture manu-factured.We often see it in differ-ent forms and it does maintain athreshold integrity over time,” DrDeAngelis said.

The material is inert, and themesh is porous allowing for tissuein-growth and greater stabilisa-tion.All these features pointed tosomething worth trying in termsof minimising recurrent extrusionsof implanted gold weights in eye-lids.

Dr DeAngelis and colleaguesfrom the University of CaliforniaSan Francisco conducted aprospective study with threepatients to evaluate the effective-ness of Dacron mesh for this pur-pose.The patients were allreferred with a failed primary gold

eyelid implantation and an extru-sion.The extruding weights wereremoved, and then the eyelidswere allowed to heal for about sixweeks before re-implantation wasattempted.

“After the initial gold weightremoval, we did a lid crease inci-sion and the gold weight wasplaced over the tarsus,” heexplained.

A piece of Dacron mesh wascut to shape. Fixation was doneby suturing the mesh to a hole inthe gold weight.

Outcome measures were reten-tion of the implant, its position,stability, the aesthetic appearanceof the lid and patient satisfaction.Follow-up was for at least twoyears.

The patients presented withprimary gold weight extrusions.After re-implantation with themesh, they initially all had excel-lent results and the weights werestable. But at four to 30 monthspost-operatively, problems devel-oped and two of the threepatients had to have gold weightremoval, Dr DeAngelis reported.

In one patient, the gold weightwas centred and stable at 18months.

“Unfortunately he presented2.5 years after the initial insertionwith a sudden erosion of the goldweight through the Dacron meshin the skin. He gave no antecedenthistory of trauma or any otherinjuries,” Dr. DeAngelis said.

The weight was removed, andsigns of an inflammatory responsewere seen in the tissue.

The second patient developedoedema and erythema at threemonths, though there was no signof infection. Steroid injectionswere tried to reduce the inflam-mation, but eventually the gold

weight had to be removed.As for the third patient, at

three years out, the gold weightwas still centred and stable withno signs of inflammation.The skinis well healed and the patient issatisfied with the result, he said.

Initially the researchers thoughtthe Dacron mesh alone would beenough to stabilise gold implants,but the inflammatory responseseen in the two patients was wor-risome.

“Overall, I think initially it’s areasonable material to use, butover a long period of time, or atleast in our follow-up of two anda half to three years, two of thethree patients did have to have itremoved,” he said.

He believes that studies needto be done of larger series ofpatients, in order to find outwhether the delayed inflammatoryreaction is common and whetherit can be prevented.

[email protected]

Dacron mesh may prevent rejection of gold

Postoperative photo showing a well-healed wound with no evidence of infection or inflammation.

Intraoperative photo of dacron mesh overlying a re-implanted gold weight that had extrudedv

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EuroTimes September 2004

Dermot McGrathin Monte Carlo

THE occurrence of ocularinflammatory diseases (OIDs) andtheir vision-threatening complica-tions is not being given due atten-tion by the ophthalmology profes-sion, according to a leading expertin the field.

Speaking at the 5thInternational Symposium onOcular Pharmacology andTherapeutics (ISOPT),ArndHeiligenhaus MD said that whilemost practitioners believed non-infectious OIDs and associatedcomplications to be extremelyrare, a review of the published lit-erature shows that its incidencehas in fact been significantlyunderestimated.

Dr Heiligenhaus marshalled awide range of evidence in supportof his contention, drawing onexamples as diverse as allergy-related ocular complications, con-junctivitis, scleritis, Mooren’s ulcer,Behcet’s disease and uveitis todemonstrate the range and fre-quency of such pathologies.

Starting with the example ofallergies, Dr Heiligenhaus saidthere was a misconception thatmost eye complications arisingfrom allergies were relativelybenign. He cited atopic dermatitis,a genetic skin disorder commonin paediatric patients, as a case in

point.Complications such as skin dry-

ness and intense itching on theinside and outside of the eyelidsand the inner corner of the eyesare found in 25% to 42% ofpatients with atopic dermatitis.

In severe cases, inflammation onthe inside of the eyelids can dam-age the cornea leading to visualloss in 15% to 30% of suchpatients.Atopic keratoconjunctivi-tis, which is most commonlyfound in young patients, can alsolead to substantial vision loss,noted Dr Heiligenhaus.

Severe ocular complications arealso associated with rare diseasessuch as Stevens-Johnson syn-drome, a chronic immune-com-plex–mediated hypersensitivitydisorder caused by drugs, viralinfections and malignancies.

Ocular sequelae may includecorneal ulceration and anterioruveitis. Blindness may also developsecondary to severe keratitis orpanophthalmitis in 3.0% to 10% ofpatients and some vision loss isreported in up to 30% of cases.

Ocular cicatricial pemphigoid(OCP) is another rare inflamma-tory syndrome involving primarilythe oral and ocular mucous mem-branes, reported Dr Heiligenhaus.

The inflammatory lesions of theocular surfaces may result in scar-ring, loss of tear film, adhesions ofthe lids to the eye, corneal ulcera-

tion and perforation.Visionimpairment has been estimated in20% of patients in stage three ofthe disease and 76% in stage-fourpatients. In the most relentlesslyprogressive or untreated cases,loss of the eye may occur.

Among the keratitic morbidi-ties, Dr Heiligenhaus said thatMooren’s ulcer and rheumatic dis-eases such as rheumatoid arthritisand Sjogren’s syndrome could alllead to substantial visual loss andeven blindness in more chroniccases.

Although necrotising and poste-rior scleritis are relatively rare, hesaid that visual loss and pain arefrequently found in such patients.

The prevalence of variousforms of uveitis differs clearlywith race, genetic background andgender, said Dr Heiligenhaus.Uveitis, an umbrella term coveringa wide range of inflammatory ocu-lar conditions, causes symptomsbased on the part of the eyeinvolved and may include a redeye, pain, decreased vision, sensi-tivity to light, increased floaters,blind spots in the vision, or some-times no symptoms at all.

The disease in all its variousforms is responsible for an esti-mated 10% to 15% of the legalblindness in the United States, andeven more in the developingworld. In adults, idiopathic acuteanterior uveitis is the most fre-

quent form of the disease, but theprognostic factors that are appro-priate to predicting poor finaloutcome are not well defined.

Among patients with inflamma-tion localised primarily to theanterior chamber, 52% or moreare HLA-B27 positive, noted DrHeiligenhaus. In addition, a num-ber of these patients with HLA-B27-associated anterior uveitishave, or will develop, an associat-ed systemic disorder such asankylosing spondylitis, reactivearthritis (formerly known asReiter’s syndrome), inflammatorybowel disease, or psoriatic arthri-tis.

While intermediate uveitis waswidely considered a less problem-atic disease to treat compared tothe acute anterior form, therewas no room for complacency.

“Intermediate uveitis has a rep-utation as quite a benign diseasebut this is not completely true.Eye complications occur in up to50% of patients according tosome studies, with cystoid macu-lar oedema responsible for visualloss in 6% to 18% of these typesof patients,” he said.

Finally, Dr Heiligenhaus citedpatients with Behcet’s disease, ofwhom 95% suffered some form ofassociated eye disease. In chroniccases, permanent loss of visionmay result from relapsing ocularinflammation and occlusion of the

retinal blood vessels.Dr Heiligenhaus reiterated his

view that the occurrence of ocu-lar inflammatory diseases andvision-threatening complications isunder-appreciated by most oph-thalmologists. He said that posi-tive measures were needed tominimise the risks to patientsfrom OIDs.

“Differentiation of the patientsis very important in helping todefine subgroups at high risk ofOID and drawing up effectivetreatment strategies that keepvision loss to an absolute mini-mum,” he said.

arnd.heiligenhaus@uni-essen

New approach needed to tackle severe ocular inflammation

48

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EuroTimes September 2004

Dermot McGrathin Barcelona

A NEW computer-based system providesa reliable, sensitive and valid means of test-ing contrast sensitivity (CS) at differentluminance levels with and without glare,according to a German ophthalmologist.

Jens Bühren MD told delegates at the 8thWinter Refractive Meeting of the EuropeanSociety of Cataract & Refractive Surgeonsthat the new system, known as theFrankfurt-Freiburg Contrast and Acuity TestSystem (FF-CATS), compared extremelywell with other established CS tests in clini-cal trials.

“We all recognise the importance of test-ing optical quality after refractive surgery,and are aware that just testing for Snellenvisual acuity may not necessarily give us agood indication of a patient’s quality ofvision.We wanted to set up a CS systemthat could test in different luminance condi-tions in a way that is observer-independent,reliable and reproducible,” he said.

Dr Bühren explained that FF-CATS,implementing the FrACT (Freiburg Acuityand Contrast Test) originally developed byDr Michael Bach at the University ofFreiburg, has several theoretical advantagesover existing CS systems.

“The computer determines contrastthresholds by an algorithm called ‘bestPEST’ (Best Parameter Estimation bySequential Testing, Lieberman & Pentland1982). It has a low probability of guessingbecause of a forced-choice method thatgives patients eight alternatives, and it isobserver independent because the patientinputs his or her answers by keypad,” hesaid.

Dr Bühren said that the system allowedthe researchers to test visual acuity at dif-ferent contrast levels as well as determinecontrast thresholds at different spatial fre-quencies.

Patients were tested using Landolt ringoptotypes displayed at different contrastsettings on a high-resolution black-and-white monitor. For testing at scotopic lumi-nance level (0.167 cd/m_), a neutral filterwas used to reduce monitor luminance.

Forty eyes of 40 volunteers were exam-ined with the FF-CATS and, for comparison,with the Functional Acuity Contrast Test(FACT) and the Pelli-Robson chart (PRC).There were two subgroups, one ranging inage from 21 to 47 years, the other rangingin age from 54 to 69 years.A control groupof 20 eyes of patients with nuclearcataracts were also included in the study.

The Functional Acuity Contrast Testdeveloped by Dr Arthur P. Ginsburg usessine wave gratings, which measure specificvisual channels.The Pelli-Robson chartdetermines the contrast required to readlarge letters of a fixed size.

Tests were performed with and withoutglare in a randomised order, and the testsequence was repeated at least one hourlater.Tests were assessed concerning dis-crimination between group I and II, repeata-bility factor and also validity in terms oftheir correlation with higher order wave-front aberrations.

The results showed that the FF-CATSdiscriminated better between the twogroups than FACT or the Pelli-Robsonchart. Coefficients of repeatability [logCS]were 0.38 for the FF-CATS, 0.25 for theFACT and 0.21 for the Pelli-Robson chart.

The FF-CATS also showed the highestcorrelation with higherorder aberration RMS val-ues (r=–0.55, p<0.001),compared to FACT(r=–0.14, p=0.46) and Pelli-Robson (r=–0.45, p<0.01).

Dr Bühren concludedthat the results thus farwere encouraging and thatthe FF-CATS will be used in future clinicaltrials comparing standard and wavefront-guided algorithms, post-LASIK CS and pha-kic lenses in high myopia.

The growing need for an accurate andstandardised means of measuring CS wasfurther echoed by Miguel Angel Teus MD,who presented a separate study on con-trast sensitivity with or without photostress after LASIK to correct low to mod-erate myopia.

“Measurement of visual function afterLASIK is quite problematic because we allhave seen patients with good Snellen visualacuity who still have significant visual com-plaints such as glare, haloes, and night visiondisturbances.At the present time we donot know which is the most sensitive orspecific method to measure these particularaspects of the visual function,” he said.

Dr Teus’prospective sin-gle-masked studyincluded 31 eyesof 23 consecutivepatients whounderwent LASIKand 23 eyes of 23 patients with a UCVA20/20 or better that served as the controlgroup. Inclusion criteria were myopia lowerthan –8.75D, astigmatism lower than 3.0Dand best-correct visual acuity of 20/20 orbetter.

The mean age was 30 years for bothgroups (range 22-38 years), the averagemyopia corrected was -3.96D (range –0.5Dto –8.75D), and the average cylinder cor-rected was –0.5D.The researchers usedanother computer-based system, the INDOCGT-1000 (INDO International), to assess

contrast sensitivity.A Technolas 217excimer laser and the Hansatome micro-keratome were used for all procedures anda single surgeon treated all patients.

Contrast sensitivity, with or without pho-tostress, was tested with the INDO CGT-1000, before LASIK and 3 months after sur-gery. Six spatial frequencies (0.7, 1.0, 1.6,2.5, 4.0 and 6.3 cycles per degree) weretested.The pupil size measured in mesopicconditions with Colvard pupillometer was5.5 mm or larger and the optical zone was6.0 mm to 7.0 mm.

The statistical comparison of CS withphoto stress showed a significant decreasein every frequency analysed at threemonths after surgery for the study group(p<0.05), while there no statistically signifi-cant difference for the CS study groupwithout photostress.

“We found that after LASIK to correctlow to moderate myopia, CS with photo-stress as measured with CGT-1000 was sig-nificantly decreased.This fact may explainsome of the common complaints in visualquality after LASIK, in spite of good UCVA,”he concluded.

[email protected]

[email protected].

New contrast sensitivity tests let computers do the grading

49

“We all recognise the importance oftesting optical quality after refractivesurgery,” Jens Bühren MD

“We all have seen patients with goodSnellen visual acuity who still havesignificant visual complaints”Miguel Angel Teus MD

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EuroTimes September 2004

Stefanie Petrou-Binder MDin Heidelberg

OPTICAL coherence tomogra-phy is a useful tool for assessingcapsule closure after cataract sur-gery, report Austrian surgeons.

A new study presented at theCongress of the DGII (German-Speaking Society for IntraocularLens Implantation and RefractiveSurgery) found that optical coher-ence tomography (OCT) can beuseful to visualise cross-sectionaltomograms of capsule-intraocularlens contact during the early post-operative period followingcataract surgery.

The development of posteriorcapsule opacification seems to bestunted by quick capsule fusionand early IOL-capsule contact.Todetermine the time required forcapsule closure following cataractsurgery, ophthalmic surgeons test-ed OCT as a new means to docu-ment and quantify pseudophakiccapsule bend formation.

In a randomised, prospectivetrial, Stefan Sacu MD, Departmentof Ophthalmology, MeducalUniversity of Vienna,Austria, stud-ied 33 eyes of 33 patients withage-related cataract who werescheduled to undergo cataractsurgery. Using OCT (OCT 1020,Zeiss Humphrey), he was able toevaluate the precise time at whichthe anterior and posterior lenscapsules became directly apposedto the optic, as well as themoment at which capsule bendwas created at the optic edge, fol-lowing the implantation of threedifferent sharp-edge IOLs.

All of the eyes underwent stan-dard phacoemulsification surgeryfollowed by the implantation ofone of three different types ofopen-loop IOL with a sharp opticedge: one-piece acrylic IOL(SA60AT,Alcon), three-piece

acrylic IOL (Acrysof MA60BM,Alcon), and three-piece siliconeIOL (911A, AMO).

The patients were randomisedinto three groups of 11 eyes each.He performed slit-lamp examina-tions and used the OCT scan toevaluate the contact of the lenscapsule with the IOL optic, andcapsule bend formation, at one

day, three days, one week, two,three weeks and one month after-surgery (average of three meas-urements at each time). He alsodetermined on which postopera-tive day the capsule came intocontact with the IOL optic andwhen capsule bend formationoccurred.

One day postoperatively, themean distance between the ante-rior capsule and the IOL was161.0 microns for the three-pieceacrylic IOL, 197.0 microns theone-piece acrylic IOL, and 220.0microns for the three-piece sili-cone IOL. By day three, the dis-tance was 64 microns, 88.0

microns, and 157 microns respec-tively.At one week, distancesbetween the anterior capsule andthe IOL diminished to 27 microns,10 microns, and 60 microns.Attwo weeks post-operatively, bothacrylic IOLs had contacted theIOL surface and the three piecesilicone IOL was at a distance of27 microns.

The posterior capsule cameinto contact with the IOL on thesame day or earlier than the ante-rior capsule in 85% of all patients.

“The short-term reproducibilityof OCT was excellent.The threelens types we implanted in thisstudy revealed a mean capsulefusion at approximately twoweeks following cataract surgery.OCT was able to show that therewas no significant differenceregarding capsule bend formationtime, however, it was noted earlierin eyes implanted with the onepiece acrylic IOL than with threepiece silicone IOL,” Dr Sacureported.

Dr Sacu noted that capsulebend formation occurred withinapproximately ten days for theone-piece acrylic IOL, 13 days forthe three-piece acrylic IOL and 15days for the three-piece siliconeIOL.

The researchers implementedthe OCT scan method in a stan-dardised fashion.The scan dura-tion lasted 1.0s; the scan lengthwas 2.8 mm-3.2 mm; the scanmeridian was 90° to the optic-haptic junction. Fixation was onthe central green fixation point.

The average patient age in eachgroup was 72 years for the one-piece acrylic IOL recipients, 71 forthe three-piece acrylic IOL recipi-ents and 75 for the three-piecesilicone IOL recipients.The aver-age dioptric power of the threetypes of IOL was 23.0 D, 22.0 D,and 21.0 D respectively.

The study excluded eyes withuveitis and pseudoexfoliation.Theresearchers used the ANOVA/T-Test for the statistical analysis ofthe results.

[email protected]

OCT useful for post-operative evaluation ofcapsule/IOL contact

50

Stefan Sacu MD “The short-term reproducibility of OCTwas excellent.”

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EuroTimes September 2004

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MEETINGS AD

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CalendarEditorial Advisory Board

Medical EditorsClive Peckar, UKPaul Rosen, UK

Editorial CommitteeEmanuel Rosen, UKJosep Güell, SpainThomas Kohnen, GermanyMichiel Luger, The NetherlandsOlivia Serdarevic, USADimitrios Siganos, GreeceMarie-José Tassignon, Belgium

ESCRS BoardMarie-José Tassignon, Belgium!President"Josep Güell, Spain !Secretary"Peter Barry, Ireland !Treasurer"Jorge Alió, SpainCamille Budo, BelgiumJoseph Colin, FranceJörg Krumeich, GermanyRichard Packard, UKIoannis Pallikaris, GreeceEmanuel Rosen, UKPaul Rosen, UKOlivia Serdarevic, USAUlf Stenevi, SwedenCharlotta Zetterstrom, Sweden

Executive EditorCarol Fitzpatrick

Associate EditorsSean HenahanPaul McGinn

Assistant EditorRoibeard Ó hÉineacháin

Contributing JournalistsLaurent CastellucciCheryl GuttmanNick LaneDermot McGrathStefanie Petrou-BinderMaryalicia PostGearóid TuohyDaithí Ó hAnluain

Colour and PrintW&G Baird

Design & ProductionRosalind Hartney

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ESCRS, Temple House, Temple RoadBlackrock, Co. Dublin, IrelandTel: 353 1 209 1100 Fax: 353 1 209 1112email: [email protected]

Published by the European Society of Cataract and Refractive Surgeons Temple House, Temple Road,Blackrock, Co Dublin, Ireland. No part of this publicationmay be reproduced without the permission of the managingeditor. Letters to the editor and other unsolicited contribu -tions are assumed intended for this publication and are sub -ject to editorial review and acceptance.ESCRS EuroTimes is not responsible forstatements made by any contributor. Thesecontributions are presented for reviewand comment and not as a statementon the standard of care. Althoughall advertising material is expectedto conform to ethical medical stan -dards, acceptance does not imply endorse -ment by ESCRSEuroTimes.

Editorial Staff

ISSN 1393-8983

O C TOBER 2004

23-26 NEW ORLEANS, LA.US American Academy of Ophthalmologyand European Society ofOphthalmology Annual Meeting; NewOrleans, Louisiana, USA Contact :AAOTe l : +1(415) 561-8500 - Fa x : +1(415) 561-8533E-mail: [email protected]: www.aao.org

N OVEMBER 2004

5-6 MOSCOW, RUSSIAFifth Annual Conference "ModernTechnologies of Cataract Surgery2004"Contact: Boris Malyugin, MD,PhDTel: +7(095) 488-851- Fax: +7(095) 906-1775Email: [email protected]

25-26 ST THOMAS’ HOSPITAL LONDON, UKTrends in OphthalmologyContact:Trends in OphthalmologyPO Box 598, Stockton on Tees, UKTelephone: +44 603 - 7956 3113 Fax: + 44 603 - 7960 8297 Email: [email protected]

F E B UA RY 2005

4-6 ROME, ITALYESCRS 9th Winter Refractive SurgeryMeetingContact: ESCRSTemple House,Temple RoadBlackrock, Co Dublin, IrelandTel: +353 1 209 1100Fax: +353 1 209 1112Email: [email protected]: www.escrs.org

25 Feb FT. LAUDERDALE, FL, USAMarch 01

The American College of Eye Surgeonsand the Society for Excellence inEyecare present the "SEE Island/QualitySurgery XIX Seminar" Sponsored byOpthalmology Times and the DulaneyFoundation. Contact :ACESACES at 727-480-8542 orSEE at 630-699-1929

MARCH 2005

27-31 KUALA LUMPUR, MALAYSIAThe 20th Asia Pacific Academy ofOphthalmology CongressWeb: www.apao2005.com.myE-mail: [email protected]: +603-7956 3113Fax: +603-7960 8297

March 30- CAPE TOWN,April 02 SOUTH AFRICA

5th International GlaucomaSymposium –Contact : Kenes InternationalTel: +41 22 908 04 88 / Fax: +41 22 7322850 E-mail: [email protected]: www.kenes.com/glaucoma

MARCH 31 – APRIL 2 2005

KESZTHELY, HUNGARYXVI Congress of the SHIOL(Hungarian Society of Cataract andRefractive Surgery)Tel + 36 72513993Fax + 36 [email protected]

A P R I L 2005

7 – 10 DUBAI, UNITED ARABEMIRATES

Joint Meeting of the VIII InternationalCongress of the Pan Arab AfricanCouncil of Ophthalmology and the XIIUAE International OphthalmicConference of the Emirates MedicalAssociationContact: PAACO 2005C/O World of Events – UAENew Airline Centre, Sheikh ZayedRoad, PO Box 1515, Dubai, UAETel 97 143166004Fax 97 [email protected]

13-15 WASHINGTON, DCWorld Cornea CongressContact :ASCRS Tel: +1 703 591 2220 - Fax: +1 703 591 0614Email: [email protected]/ Web: www.ascrs.org

16-20 WASHINGTON, DCASCRS/ASOA Meeting Congress Contact: ASCRSTel: +1 703 591 2220 / Fax: +1 703 591 0614Web: www.ascrs.org

JUNE 2005

23-26 NÜRNBERG, GERMANY18th Annual Meeting of GermanOphthalmic SurgeonsContact : [email protected]: www.doc-nuernberg.de

SEPTEMBER 2005

10-14 LISBON, PORTUGALXXIII Congress of the ESCRS Contact: ESCRSTemple House,Temple RoadBlackrock, Co Dublin, IrelandTel: +353 1 209 1100Fax: +353 1 209 1112Email: [email protected]: www.escrs.org

O C TOBER 2005

5-8 VILAMOURA, PORTUGAL EVER 2005 European Association for Vision andEye ResearchWeb: www.ever.be Email: [email protected]

15-18 CHICAGO ILL USAAmerican Academy of OphthalmologyTel +1 415 561 8500 Ext 304Fax +1 415 561 8583 Web: www.aao.org

D E C E M B E R 2 0 0 5

( CHRISTMAS & NEW YEAR),EGYPTThe International Symposium ofPediatric Ophthalmology, 2005The Egyptian Group of Pediatric EyeSurgery ( EGPES)Contact: Mohamed Elsada, Professorof Pediatric Ophthalmology, CairoUniversityTel no.: +2 012 2142416E-mail address: [email protected]: www.egpes.org

F E B R UA RY 2006

17-19 MONTE CARLOESCRS 10th Winter Refractive SurgeryMeetingContact: ESCRSTemple House,Temple RoadBlackrock, Co Dublin, IrelandTel: +353 1 209 1100Fax: +353 1 209 1112Email: [email protected]: www.escrs.org

MARCH 2006

18-22 SAN FRANCISCO, CAASCRS/ASOA Meeting Congress Contact: ASCRSTel: +1 703 591 2220Fax: +1 703 591 0614Web: www.ascrs.org

SEPTEMBER 2006

9-13 LONDON, UKXXIV Congress of the ESCRSContact: ESCRSTemple House,Temple RoadBlackrock, Co Dublin, IrelandTel: +353 1 209 1100Fax: +353 1 209 1112Email: [email protected]

SEPTEMBER 2007

8-12 STOCKHOLM, SWEDENXXV Congress of the ESCRSContact: ESCRSTemple House,Temple RoadBlackrock, Co Dublin, IrelandTel: +353 1 209 1100Fax: +353 1 209 1112Email: [email protected]

N OVEMBER 2007

10-13 NEW ORLEANS, LA. USAAmerican Academy of OphthalmologyTel +1 415 561 8500 Ext 304Fax +1 415 561 8583Web: www.aao.org

Published by the European Society of Cataract and Refractive Surge o n s

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