the save sight keratoconus registry · 2017. 11. 25. · the save sight keratoconus registry:...
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TheSaveSightKeratoconusRegistry:Trackingtreatmentoutcomesinpatients
withKeratoconusProfessorStephanieWatson
SaveSightInstituteBondiJunction
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KERATOCONUS
• Affects1in2000,progressivelyreducesvision
• Onsetinchildhood/youngadult
• Life-longvisualdisability
• Evidencelackingontreatments
• asidefromcornealtransplantation(
• ACGRthankyou!
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2007 2013 2015
RIGHTEYE
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CORNEALCROSS-LINKING?
• Cornealstroma
• Collagenlayersconnectedtogetherbybridges‘x-links’
• Topicalriboflavin(VitaminB2)andUVlight(370nm)• Cornea300%strongerandmorestable
Wollensak,Spoerl andCataractRefractSurg 2003;29:1780–1785
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MECHANISMSOFACTION
• Biological• Stimulationofkeratocyte apoptosisandrepopulation
• Mechanical• Increaseincrosslinkedcollagenfibre diameter• Increasedresistancetodegradation
• Chemical• Directelectrontransferorreactiveoxygenspecies
Mazzotta et al Eye, 2014;28:1179
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• Riboflavin0.1%in20%Dextran
• q3to5minfor30min
• UVirradiation:3mW/cm2 30min
• Riboflavinq4to5min
Spoerl E,etlaCornea2007;26:385–389
HOWISITITDONE?
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PROTOCOLVARIATIONS
• Treatthinnercorneas
• Avoidepithelialdebridement
• ‘Flash-linking’/AXL
• Combinedrefractivesurgery
• Iontophoresis
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KERATOCONUS
• Progression• stabilizesby30’s
• Over3years
• 14to40%ofadults
• Children• moresevereKC
• morelikelyprogress
Godefrooij.Cornea2016;35:954–958
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Ectasiaprogression
• consistentchangeinatleast2
• magnitudeofthechange• abovethenormalnoiseofthetestingsystem:
• Steepeningoftheanteriorcornealsurface
• Steepeningoftheposteriorcornealsurface
• Thinningand/oranincreaseintherateofcornealthickness
changefromtheperipherytothinnestpoint
Gomes etal,Cornea2015;34:359–369)
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Ectasiaprogression
• Changesconsistentovertimeandabovethe
normalvariability(ie,noise)ofthemeasurement
system(thiswillvarybysystem).
• ChangeinuncorrectedvisualacuityandBSCVAis
notrequiredtodocumentprogression
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Howaccurateistopography?
Eyes(KCgrade) Kmax (D)95%interobserver limits
Normal 0.78AllKC 1.51,2.30EarlyKC(1-2) -0.90to1.01AdvancedKC(>2) -3.71to3.86
EarlyKCK1,K2,orKmax >1Dlikelytobesignificant
Flynn,Sharma,Bunce,Wilkins.Br JOphthalmol 2016;100:1183–1187McAlinden etal.InvestOphthalmol VisSci.2011;52:7731–7737Hashemi K etal Ophthalmology 2015;122:211–12.Epstein RLetal JRefractSurg 2012;28:890–4.
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Topographicprogression
• Sameoperator
• Sameequipment
• Repeatunreliablemeasurements
• Adjustparametersdependingthedegreeofectasia
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Contraindications
• Pachy <400microns• Herpetickeratitis• Concurrentocularinfection• Severescarring• Neurotrophia• Historypoorcornealwoundhealing• Severedryeye• Pregnancy• Autoimmunedisorders
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YOUR PATIENTS?
©2010– 2015SaveSightInstitute,TheUniversityofSydney.
Don Peggy Sally
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• Prospective,randomized,controlledclinicaltrial
• n=179
• Cornealectasiaafterpreviousrefractivesurgery
• StandardCXLvsriboflavinepitheliumintact
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Outcomes
• EyeswithsteeperKmax >55.0D
• morelikelytohave>2Dormoreofflattening
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Correcteddistancevision
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RegistriesvsClinicalTrials
• Realworldtreatment• Realworldpatients
• Co-morbidities
• Largepatientnumbers
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©2010– 2015SaveSightInstitute,TheUniversityofSydney.
AimToestablisharegistryofoutcomesoftreatmentofoculardiseasestodeterminewhetherthesetreatmentsworkaswellintherealworld astheydidinclinicaltrials
MethodEfficientWeb-basedsoftwaretoolQualityassurancemeasuresSophisticatedstatisticalback-endTracksoutcomesthatpatientscareabout(vision,numberofinjections)
Save Sight Registries!
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©2010– 2015SaveSightInstitute,TheUniversityofSydney.
Design Goals• Basicanonymised patientdatamanagementsystem
• Compatiblewithdataentryinroutinepractice• Baselinevisitentry:30sec• Followupvisitentry:15sec
• Generategraphs“onthefly"ofvision,treatmentandrelevantaudit-specificclinicalmarkers
• Selfaudittool
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• OptoutconsentinAustralia– patientgivenabrochure
• Patientdataremainsunidentifiable
• Doctor’sdataisidentifiableONLYbythetreatingDoctor
• Thecopieddataisownedbythecollaborationbutmaybewithdrawnatanytimewithoutnoticeorreasonbythecontributingpractitioner
Consent, Anonymity and Ownership
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Tracking treatment outcomes in nAMD
FRB!MacularDegeneration
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©2010– 2015SaveSightInstitute,TheUniversityofSydney.
©2010– 2015SaveSightInstitute,TheUniversityofSydney.
Save Sight Registries
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FCB:KERATOCONUS• Nationalregistryto
• Collecthighqualitydataoutcomes
• Determineclinicaleffectivenessandsafetyofemergingtherapiesandsurgicaltechniques
• Patientsinreallifeclinicalsettings
• BasedonthenationalandinternationalsuccessoftheFRB!ProjectdevelopedbyProfMarkGilles
FCB!Keratoconus
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©2010– 2015SaveSightInstitute,TheUniversityofSydney.
Quick comparisonofclinicaloutcomesagainstpeers
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©2010– 2015SaveSightInstitute,TheUniversityofSydney.
Patienttreatmentoutcomesbydoctorpracticereport:• informativereport• selfaudittool• anonymouslygeneratedwithinthesystemuponrequest
• evaluatingeffectivenessoftreatment
GeneratingDoctor’sActivityReport
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BENCHMARKING
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FCB!Keratoconus
Patientjourney
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KORQ
• Benefittopatients
oftreatments
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Orthopaediccentre
UniversityofRochester
MedicalCentre
USA
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INTHECLINIC
• Orthoptic review• Vision• Topography• Dataentry
• KORQcompletedonIpad• Clinicianconsult
• Finalise data• Review• Discuss
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©2010– 2015SaveSightInstitute,TheUniversityofSydney.
RANZCOApprovedCPDAuditTheProjectisaRANZCOapprovedCPDAuditactivity.Participatingfellowsare
potentiallyabletoclaim30pointsinclinicalexpertiselevel2.
TOQUALIFYFORCPDPOINTS
Institutingchangesinyour
practice
Auditingatleast85%ofpatientstreatedinyourpracticewithAMD/DME/KC
Reflectingonresults
generatedfromyourowndata
Attendingmeetings
Sharingorcomparingfindingswith
peers
Generatingdoctor's
activityreports
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Publications accepted in following journalsOphthalmologyRetinaBJO IVOS
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Global Implementation
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Recruitment Update
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Eyes 2298
Patients 1228
AllVisitsTotal 11349
Sites 37
X link 1062
SaveSightRegistries
©2010– 2015SaveSightInstitute,TheUniversityofSydney.
RECRUITMENTUPDATE
©2010– 2015SaveSightInstitute,TheUniversityofSydney.
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ADVERSEEVENTS
Haze MicrobialkeratiitisPersistentepitheilaldefect ScarringSterileinfiltrates Stromaloedema
FCB!Keratoconus
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COMPLICATIONS
• Loss≥ 2SnellenlinesVA 2.9%(95%CI,0.6%-8.5%).• Riskfactors
• Ageolderthan35yearsand
• Preop CDVA> 20/25
• Continuedprogression 8%- 11%• Riskfactors
• HighpreKmax Ê 54D
• Centralcone
• Pachy Ê 450microns
Koller etal JCataract Refract Surg 2009;35:1358–1362
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HAZE
• Common
• Decreasesinfirstyear
• Extendsto60%depth(300microns)
• PRKhazeissubepithelial
Koller etal JCataract Refract Surg 2009;35:1358–1362
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SCARRING• Centralstromalscarsin2.8%
• Infectionacquiredpostop
Koller etal JCataract Refract Surg 2009;35:1358–1362
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BENEFITSFORYOURDOCTOR
• Individualise patienttreatment
• Patientdatagraphed
• Practicelevelsummaries
• Contributetodevelopmentofnationaltrends
• Compareowndatatobenchmarks
FCB!Keratoconus
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REGISTRYINPRACTISE
• Individualise patienttreatment
• Patientdatagraphed
• Practicelevelsummaries
• Compareowndatatobenchmarks
• Contributetodevelopmentofnationaltrends
FCB!Keratoconus
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BENEFITSTOYOU
• Trackyourtreatmentjourney
• Contributetobestpractise
• Impactsofkeratoconus
• Datareferral
• Yourdatacanbereferredtoanotherpractitioner
FCB!Keratoconus
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Keratoconusinayoungadult
Year 2007 2013 2015
Unaided 6/6 6/18Glasses +0.25/-3.50at65º
6/7.5+0.25/-3.50at70º6/5
Year 2007 2013 2015
Unaided 6/36 6/18Glasses - /-1.25 at120º
6/12-1.50/-1.00at150º6/30
-2.50/-3.50at135º6/12
LEFTEYE
RIGHTEYE
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2007 2013 2015
RIGHTEYE
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2007 2013 2015
LEFTEYE
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• StableKCN• VAsatisfactoryinglasses
• Glassesalone• +/- CLsorCXL
• ProgressiveKCN• VAsatisfactoryinglasses
• CXL• Glasses+/- CL
Gomes etal,Cornea2015;34:359–369
Keratoconusinyoungadult
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Keratoconusinayoungchild
• Progressioncanberapid
• Highqualityevidencelacking
• Caseseriesshowprogressioncanbestopped
• Risks:progression
• Over5years:25%mayprogress
• Infectionandscarring
Wisse RP,Godefrooij DA,Soeters N.Reply.Cornea.2016;35(11):e36.
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Keratoconusinayoungchild
• Mildcases• VA6/6
• Fewtopographicsigns
• Followup:1- 3months
• AdvancedKCN• ConsiderCXL
• AsymmetricKCN• Monitorgoodeye
• Casebycasedecision• Risksvsbenefits
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Keratoconusinanadult
• 55yearold• c/oreducedvision• Pohx:
• Glassessinceteenager
• Usetorubeyesbuthasstopped
• RVA6/12 LVA6/12
-1.50/-1.25at84º +0.25/-4.50at109º
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RIGHTEYE
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LEFTEYE
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Keratoconusinolderadult
• StableKCN• VAsatisfactoryinglasses
• GlassesorCL
• ProgressiveKCN• VAsatisfactoryinglasses
• CXL
Gomes etal,Cornea2015;34:359–369
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• CurrentlyonlyRxabletohaltprogressiveectasia
• Evolvingmethods
• Newindications
• Monitoroutcomes
CXL
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©2010– 2015SaveSightInstitute,TheUniversityofSydney.
CIB: DanielBarthelmesProjectManager: AmparoHerrera-BondCoordinators: AmandaDinhBiostatisticians: VuongPhuc
RichardWalton
ENQUIRIES– [email protected]
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Prof Mark GillesAProf Mark DaniellDr Elsie ChanDr Daniel BarthelmesDr Martina BoschDr John Males Dr Yves Kerdraon
Dr Nigel MorletDr John Males Dr Yves KerdraonDr Richard MillsDr Andrew ApelDr Peter Beckingsale
• ORIA• KeratoconusAustralia
• Claffy Foundation