12 study suggests femtosecond laser offers advantages over ......steven schallhorn md performed all...

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Dermot McGrath in Lisbon WAVEFRONT-guided LASIK performed with the IntraLase femtosecond laser offers slightly better clinical results, faster visual recovery and an improvement in low light contrast acuity compared to procedures performed with mechanical keratomes, according to David Tanzer MD. Presenting the results of a prospective, parallel group comparison trial, Dr Tanzer said the goal of the study was to compare the performance of the femtosecond laser to mechanical keratomes in terms of flap characteristics, refractive and visual outcome, quality of vision and wavefront aberrations. He set out to evaluate the best technology for the creation of a LASIK flap in preparation for studying the efficacy of LASIK surgery in Naval aviators.At the moment, PRK is the only treatment we use for aviators, said Dr Tanzer, Surgical Director, Refractive Surgery Center, Department of Ophthalmology, Naval Medical Center, San Diego. Dr Tanzer and colleague Steven Schallhorn MD performed all surgeries with the AMO/VISX Star S4 CustomVue™ platform using the Zernike-based software upgrade.The study included 600 eyes of 300 patients who underwent LASIK flap creation with the femtosecond laser (IntraLase), the Amadeus microkeratome (AMO), or the Hansatome (Bausch & Lomb) microkeratome. Dr Tanzer noted that all groups were closely matched in terms of age and refractive spherical equivalents. Staged and unstaged procedures Half of the patients in each keratome group received wavefront-guided LASIK in the standard fashion with the flaps created and lifted, followed by immediate application of wavefront-guided excimer ablation.The other half of the patients underwent a staged procedure, where the flaps were cut, lifted and immediately laid back into position.These patients had wavefront measurements obtained at the one-month post-operative examination and, based on that measurement, the flaps were lifted and the ablation was performed. The idea of the staged approach was to take into account any aberrations induced by the creation of the flap,said Dr Tanzer. Measurements were completed preoperatively and one day, one week, one and three months postoperatively. Flap thickness variance was greater for mechanical keratomes than the femtosecond laser keratome. Patients had more symptoms such as foreign body sensation and photophobia on day one in the femtosecond laser group (p<0.001), but these differences were nullified after one week, reported Dr Tanzer. Faster visual recovery with femtosecond Uncorrected visual acuity was better in the femtosecond group at one day, one week and one month postoperatively (p<0.001), but not significantly different from mechanical keratomes at the three-month follow-up visit. The clinical visual acuity results at one day, one week and one month favoured the IntraLase, although there was no statistical difference between the three keratomes by three months. However, gain in mesopic 25% contrast acuity at three months post op compared to preop was significantly better in the femtosecond group (+0.03 logMAR loss for Amadeus, -0.01 logMAR gain for Hansatome and -0.04 logMAR gain for IntraLase). The best-corrected acuity results at three months showed no losses of more than one line in any group. However, 45% of IntraLase eyes compared with only 33% of eyes in either mechanical microkeratome group experienced a gain of one line. Dr Tanzer noted that analysis of higher order aberration (HOA) induction solely by the creation of the flap indicates that the IntraLase induces less HOA than either the Hansatome or the Amadeus.The IntraLase resulted in neither a gain nor loss of HOA at one month compared to induction of HOA for the Amadeus and Hansatome (+0.03 microns for both). While there were no statistically significant differences in overall RMS values, the study found that the Amadeus keratome induced more spherical aberration, and both the Amadeus and the Hansatome induced more horizontal coma compared to IntraLase,said Dr Tanzer. He added that a comparative analysis between the consecutive and staged approach indicated no significant improvement in clinical outcomes by taking into account aberrations induced by the creation of the flap. Dr Tanzer said that while the researchers had originally hypothesised that a staged approach taking into account the aberrations induced by creation of the flap might result in better visual outcomes, the clinical results thus far suggests no discernible difference between the two approaches. He concluded that there were beneficial effects to using the femtosecond keratome, in terms of clinical results, faster visual recovery and improved mesopic contrast acuity. The staged approach to LASIK offered no clinical advantages over the traditional approach, regardless of the keratome used. Finally, there were no significant differences in overall HOA induced by any keratome, but the Amadeus induced more spherical aberration and both mechanical keratomes induced more horizontal coma than the femtosecond keratome. Based on the results of this study, further studies will be conducted to evaluate the safety and efficacy of LASIK in Naval aviators. David J Tanzer MD [email protected] Study suggests femtosecond laser offers advantages over mechanical keratomes in wavefront-guided ablations EuroTimes December 2005 12 Courtesy of David Tanzer MD David Tanzer

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Page 1: 12 Study suggests femtosecond laser offers advantages over ......Steven Schallhorn MD performed all surgeries with the AMO/VISX Star S4 CustomVue™ platform using the Zernike-based

Dermot McGrathin Lisbon

WAVEFRONT-guided LASIKperformed with the IntraLasefemtosecond laser offers slightlybetter clinical results, faster visualrecovery and an improvement inlow light contrast acuity comparedto procedures performed withmechanical keratomes, accordingto David Tanzer MD.

Presenting the results of aprospective, parallel groupcomparison trial, Dr Tanzer saidthe goal of the study was tocompare the performance of thefemtosecond laser to mechanicalkeratomes in terms of flapcharacteristics, refractive and visualoutcome, quality of vision andwavefront aberrations.

He set out to evaluate the besttechnology for the creation of aLASIK flap in preparation forstudying the efficacy of LASIKsurgery in Naval aviators.At themoment, PRK is the onlytreatment we use for aviators, saidDr Tanzer, Surgical Director,Refractive Surgery Center,Department of Ophthalmology,Naval Medical Center, San Diego.

Dr Tanzer and colleagueSteven Schallhorn MDperformed all surgeries with theAMO/VISX Star S4CustomVue™ platform usingthe Zernike-based softwareupgrade.The study included 600eyes of 300 patients whounderwent LASIK flap creationwith the femtosecond laser(IntraLase), the Amadeusmicrokeratome (AMO), or theHansatome (Bausch & Lomb)microkeratome. Dr Tanzernoted that all groups wereclosely matched in terms of ageand refractive sphericalequivalents.

Staged and unstagedproceduresHalf of the patients in eachkeratome group receivedwavefront-guided LASIK in thestandard fashion with the flapscreated and lifted, followed byimmediate application ofwavefront-guided excimerablation.The other half of thepatients underwent a stagedprocedure, where the flaps werecut, lifted and immediately laidback into position.Thesepatients had wavefrontmeasurements obtained at theone-month post-operativeexamination and, based on thatmeasurement, the flaps werelifted and the ablation wasperformed.

The idea of the staged approachwas to take into account anyaberrations induced by thecreation of the flap, said Dr Tanzer.

Measurements were completedpreoperatively and one day, oneweek, one and three monthspostoperatively. Flap thicknessvariance was greater formechanical keratomes than thefemtosecond laser keratome.Patients had more symptoms suchas foreign body sensation andphotophobia on day one in the

femtosecond laser group(p<0.001), but these differenceswere nullified after one week,reported Dr Tanzer.

Faster visual recovery withfemtosecond Uncorrected visual acuity wasbetter in the femtosecond group atone day, one week and one monthpostoperatively (p<0.001), but notsignificantly different frommechanical keratomes at thethree-month follow-up visit.

The clinical visual acuity resultsat one day, one week and onemonth favoured the IntraLase,although there was no statisticaldifference between the threekeratomes by three months.However, gain in mesopic 25%contrast acuity at three monthspost op compared to preop wassignificantly better in thefemtosecond group (+0.03 logMARloss for Amadeus, -0.01 logMARgain for Hansatome and -0.04logMAR gain for IntraLase).

The best-corrected acuityresults at three months showed nolosses of more than one line in anygroup. However, 45% of IntraLaseeyes compared with only 33% of

eyes in either mechanicalmicrokeratome group experienceda gain of one line.

Dr Tanzer noted that analysis ofhigher order aberration (HOA)induction solely by the creation ofthe flap indicates that the IntraLaseinduces less HOA than either theHansatome or the Amadeus.TheIntraLase resulted in neither a gainnor loss of HOA at one monthcompared to induction of HOA forthe Amadeus and Hansatome(+0.03 microns for both).

While there were no statisticallysignificant differences in overallRMS values, the study found thatthe Amadeus keratome inducedmore spherical aberration, andboth the Amadeus and theHansatome induced morehorizontal coma compared toIntraLase, said Dr Tanzer.

He added that a comparativeanalysis between the consecutiveand staged approach indicated nosignificant improvement in clinicaloutcomes by taking into accountaberrations induced by thecreation of the flap.

Dr Tanzer said that while theresearchers had originallyhypothesised that a staged

approach taking into account theaberrations induced by creation ofthe flap might result in better visualoutcomes, the clinical results thusfar suggests no discernibledifference between the twoapproaches.

He concluded that there werebeneficial effects to using thefemtosecond keratome, in terms ofclinical results, faster visualrecovery and improved mesopiccontrast acuity. The stagedapproach to LASIK offered noclinical advantages over thetraditional approach, regardless ofthe keratome used. Finally, therewere no significant differences inoverall HOA induced by anykeratome, but the Amadeusinduced more spherical aberrationand both mechanical keratomesinduced more horizontal comathan the femtosecond keratome.Based on the results of this study,further studies will be conductedto evaluate the safety and efficacyof LASIK in Naval aviators.

David J Tanzer [email protected]

Study suggests femtosecond laser offers advantages overmechanical keratomes in wavefront-guided ablations

EuroTimes December 2005

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