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Myopia,TheRefrac5veMarketandPhakicIOLsinModernRefrac5veSurgery
DavidW.Friess,OD,FAAO
HeadofGlobalProfessionalAffairsStaarSurgicalCompany
President,OCCRS
OptometricCornea,CataractandRefrac5veSociety
FinancialInterestDisclosures
• STAARSurgicalCo.–Employee,Shareholder
• Op5musClinicalPartnersLLC–President/Owner
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PhakicIOLProductInforma5on
• ATTENTION:ReferencetheVisianICL™andVerisyse™ProductInforma5onforacompletelis5ngofindica5ons,warningsandprecau5ons.
Refrac5veMarketSta5s5cs
• IncludesUS/Canada/MexicoLASIK,PRK/surfaceabla5on,phakicIOLs,andrefrac5velensexchange
• 20071M+refrac5veprocedures• 2013600,0001
• 2015visioncorrec5onmarketintheUS2:– Over60%requirevisioncorrec5on(nearly200Mpeople)– Spectacles,contactlenses– Refrac5vesurgerypenetra5onremainsatlessthan3%– 600,000refrac5veproceduresin2015
• 2016Q1MarketScope:– 172,000refrac5veprocedures
1.Cataract&Refrac5veSurgeryToday,July20142.TheVisionCouncil.heps://www.thevisioncouncil.org/topic/problems-condi5ons/adults
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Refrac5veOpportunity:Boomersvs.Millennials
• USCensusBureauEs5mates1:– 75.4millionBabyBoomersin2014.Ages51to69in2015.– 74.8millionMillennialsin2014.Ages18to34in2015.– By2015,Millennialsincreasedto75.3millionandbecamethebiggestgroup.
1.hep://www.pewresearch.org/fact-tank/2015/01/16/this-year-millennials-will-overtake-baby-boomers/
MyopiaResearchandCoverageinMainstreamMedia
• HuffingtonPost,03/22/2016:NearsightednessHasaFar-ReachingImpactAstheMyopiaEpidemicSpreadsAroundtheGlobe
– ReferencesnewresearchfromtheBrienHoldenVisionIns5tute(AUS)studyontheprevalenceofmyopia
• HoldenBA,etal.GlobalPrevalenceofMyopiaandHighMyopiaandTemporalTrendsfrom2000through2050.Ophthalmology.2016May;123(5):1036-42.– Myopiaisprojectedtoaffectalmosthalfoftheworld’spopula5onby2050—
asevenfoldincrease– 5billionwithmyopia– 1billionwithhighmyopia(>-6D)– UnitedStatesandCanadaincreaseto260million,orclosetohalfofthe
popula:on,upfrom89millionin2000– Highmyopiacasesincreasebyfive:mesto66million
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KeyMyopicTreatmentGoals• Desiretreatmentswith…
– HighSafetyIndexPostopBCVA/PreopBCVA– HighEfficacyIndexPostopUCVA/PreopBCVA– Aeemptedvs.AchievedRx-accurateandstable– Lowrateofcomplica5ons– Preservecornealintegrityandlensforfutureprocedures– Lowdryeyerisk– Similartreatmentacrossabroadrangeofrefrac5ons– Highpa5entsa5sfac5on
PhakicIOLs• Variablematerials
– Plas5c– Silicone– Collagen(Collamer)-STAARVisianICL
• VariabledesignsAnteriorChamber● Acrysof,Alcon● GBR,IOLTech● KelmanDuet,Tekia● MemoryLens,Ciba● NewLife,IOLTech● NuVita,B&L● ThinOptX● VisionMembrane● 6H2,Oll
IrisSupported● Ar>san,Ophtec● Verisyse,AMO
PosteriorChamber● PRL,Ciba● VisianICL,STAAR
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FDAApprovalsforPhakicIOLsforMyopia
• 2004–Verisyse®anteriorchamberphakicIOL(AMO,Inc.)• 2005–VisianICL™posteriorchamberphakicIOL(STAAR
SurgicalCo.)
www.allaboutvision.com/visionsurgery/implantable-lenses.htm
Verisyse™Anteriorchamberirisfixated
phakicIOL(AMO,Inc.)
8.5mmonepiecePMMA5.0mmand6.0mmop5c
hep://abboemedicalop5cs.com/products/cataract/refrac5ve-iols/verisyse-phakic-iolLouisJ.Catania©2007NicolitzEyeConsultants
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Verisyse®PhakicIOLProductLabeling
• Indica5on:• Verisyse®intraocularlensesareindicatedforthereduc5onorelimina5on
ofmyopiainadultswithmyopiarangingfrom-5.0to-20.0diopterswithlessthanorequalto2.5dioptersofas5gma5smatthespectacleplaneandwhoseeyeshaveananteriorchamberdepthgreaterthanorequalto3.2millimeters;and,pa5entswithdocumentedstabilityofrefrac5onfortheprior6months,asdemonstratedbysphericalequivalentchangeoflessthanorequalto0.50diopters.
hep://abboemedicalop5cs.com/products/cataract/refrac5ve-iols/verisyse-phakic-iol
Louis J. Catania © 2007 Nicolitz Eye Consultants
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VisianICL™V4DesignPosteriorChamberPhakicIOL
ICLDesign• PosteriorChamberPhakicIOL• Hap5csplacedinsulcus-stability• Op5cVaultbydesign
– 500umoverthecentralcrystallinelens
• Orienta5onmarksforproperplacementandalignmentininjector
• Smallincisionrefrac5vesurgery• Foldableandinjectablethrougha3.5mmorlessincision
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COLLAGEN COPOLYMER
CollamerSummary• Collagenmatrix• Hydrophilic• Biocompa5bility• Refrac5veindex=1.44• Elas5c:Gentleunfolding• Tensilestrength:Strong,resiststearing• UVblockingchromophore• Lathecutdesign• StoredinBSS
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PeripheralIridotomy
• TwoYAGiridotomies(0.5mm;placedsuperiorly,90degreesapart)shouldbeperformed2to3weekspriortosurgerywithconfirma5onofthepatencyoftheiridotomiespriortolensimplanta5on.
STAARFDAMICLDirec5onsforUse(DFU)
Direc5onof
Implanta5on
Orienta5onMarks
TrailingLew
LeadingRight
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VisianICL–ImplantableCollamerLens
Indica5onsforUse• TheVisianICLisindicatedforuseinadults21-45yearsofage:1. Forthecorrec5onofmyopiainadultswithmyopiaranging
from-3.0Dto≤-15.0Dwithlessthanorequalto2.5Dofas5gma5smatthespectacleplane;
2. Forthereduc5onofmyopiainadultswithmyopiarangingfromgreaterthan-15.0Dto-20.0Dwithlessthanorequalto2.5Dofas5gma5smatthespectacleplane;
3. Withananteriorchamberdepth(ACD)of3.00mmorgreater,andastablerefrac5vehistory(within0.5Diopterfor1yearpriortoimplanta5on).
STAARFDAMICLDirec5onsforUse(DFU)
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VisianICL™(ImplantableCollamerLens)forMyopiaForthecorrec5on/reduc5onofmoderatetohighmyopia
• FDADirec5onsforUse(DFU)DeviceDescrip5on
STAARFDAMICLDirec5onsforUse(DFU)
Contraindica5ons• TheVisianICLiscontraindicatedinpa5ents:
1. Withananteriorchamberdepth(ACD)of<3.00mm;2. WithanteriorchamberanglelessthanGradeIIIasdeterminedby
gonioscopicexamina5on;3. Whoarepregnantornursing;4. Lessthan21yearsofage;5. Whodonotmeettheminimumendothelialcelldensity.
STAARFDAMICLDirec5onsforUse(DFU)
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Packer,2016:Meta-AnalysisofICLPapers
• Broadrangeofcorrec5ons• Highquan5tyofvision• Highqualityofvision• Lowincidenceofcomplica5ons
withgoodpa5entselec5on• Highbenefittoriskra5o
PackerM.Meta-analysisandreview:effec5veness,safety,andcentralportdesignoftheintraocularcollamerlens.ClinOphthalmol.2016;10:1059–1077.
VISIANICL™QUALITYOFLIFEVS.GLASSES,CONTACTLENSESANDLASIK
53.850.2
46.744.1
0
10
20
30
40
50
60
PostICL(n=34) OtherRefrac5veSurgery(n=104)
ContactLenses(n=104) Spectacles(n=104)
QIRCScores
1.IeongA,Hau,S,RubinGS,Allan,B.QualityofLifeinHighMyopiabeforeandawerImplantableCollamerLensImplanta5on.Ophthalmology2010;117:2295-23002.PesudovsK,GaramendiE,EllioeDB.Aqualityoflifecomparisonofpeoplewearingspectaclesorcontactlensesorhavingundergonerefrac5vesurgery.JRefractSurg2006;22:19–27.
Ieongetal Pesudovsetal
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• EfficacyIndex:Post-opUCVA/Pre-opBCVA1
• Seeingwell“rightoffthetable”5
• Long-Term(5yr)Refrac5veStability4
Procedure EfficacyIndex
VisianICL™ 0.96–1.011,2,3
1. UCVA=UncorrectedVisualAcuity,BCVA=BestCorrectedVisualAcuity2. LisaC,AlfonsoJF,Alfonso-BartolozziB,Fernández-VegaL,Pérez-VivesC,Montés-MicóR.Collagencopolymerposteriorchamberphakicintraocularlenssupportedbythe
ciliarysulcustotreatmyopia:one-yearfollow-up.JCataractRefractSurg.2015Jan;41(1):98-104.3. HuseynovaT,OzakiS,IshizukaT,MitaM,TomitaM.Compara5vestudyof2typesofimplantablecollamerlenses,1withand1withoutacentralar5ficialhole.AmJ
Ophthalmol.2014Jun;157(6):1136-43.4. ShimizuK,KamiyaK,IgarashiA,KobashiH.Long-TermComparisonofPosteriorChamberPhakicIntraocularLensWithandWithoutaCentralHole(HoleICLandConven5onal
ICL)Implanta5onforModeratetoHighMyopiaandMyopicAs5gma5sm.Medicine.2016Apr;95(14):e3270.5. StevenS.Lane,MD,quotedinHelznerJ,PhakicIOLs:ReadyforaBreakthrough?OphthalmologyManagementMarch1,2011.
hep://www.ophthalmologymanagement.com/ar5cleviewer.aspx?ar5cleid=105346(AccessedAugust6,2016).
WELLESTABLISHEDBENEFITS
USMILITARYWARFIGHTERS1
1.ParkhurstGD,PsolkaM,KezirianGM.PhakicIntraocularLensImplanta5oninUnitedStatesMilitaryWarfighters:ARetrospec5veAnalysisofEarlyClinicalOutcomesoftheVisianICL.JRefractSurg.2011;27(7):473-481.
• Retrospec5ve,interven5onalconsecu5vecaseseriesassessingshort-term(3months)clinicaloutcomesawerVisianICL™implanta5oninUSmilitarywarfighters
• 135eyesof69pa5entswhowerenotgoodcandidatesforlaservisioncorrec5on
• Age:30.9+/-6.6years• Pre-OpMRSE:-6.00+/-1.92D
(range:-2.63to-11.50D)
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USMILITARYWARFIGHTERS1
1.ParkhurstGD,PsolkaM,KezirianGM.PhakicIntraocularLensImplanta5oninUnitedStatesMilitaryWarfighters:ARetrospec5veAnalysisofEarlyClinicalOutcomesoftheVisianICL.JRefractSurg.2011;27(7):473-481.
• ICLPredictability:• 90%+/-0.50D• 99%+/-0.75D
USMILITARYWARFIGHTERS1
• ICLVisualAcuity
1.ParkhurstGD,PsolkaM,KezirianGM.PhakicIntraocularLensImplanta5oninUnitedStatesMilitaryWarfighters:ARetrospec5veAnalysisofEarlyClinicalOutcomesoftheVisianICL.JRefractSurg.2011;27(7):473-481.
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VISIANICL™VS.WFG-LASIK1:CONTRASTSENSITIVITY(HIGHMYOPIA)
1.IgarashiA,KamiyaK,ShimizuK,KomatsuM.VisualPerformanceawerImplantableCollamerLensImplanta5onandWavefront-GuidedLaserInSituKeratomileusisforHighMyopia.AmJOphthalmol2009;148:164-170.
• ICL:SignificantIncrease(p<0.001) • WFG-LASIK:Significantdecrease(p=0.001)
VISIANICL™VS.WFG-LASIK1:CONTRASTSENSITIVITY(LOWTOMODERATEMYOPIA)
1.KamiyaK,IgarashiA,ShimizuK,MatsumuraK,KomatsuM.VisualPerformanceAwerPosteriorChamberPhakicIntraocularLensImplanta5onandWavefront-GuidedLaserInSituKeratomileusisforLowtoModerateMyopia.AmJOphthalmol2012;153:1178-1186.
• ICL:SignificantIncrease(p<0.001) • WFG-LASIK:Nochange(p=0.11)
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Publica5onReview:Aprospec5vecomparisonofphakiccollamerlenses
andwavefront-op5mizedlaser-assistedinsitukeratomileusisforcorrec5onofmyopia.
ParkhurstGD.Aprospec5vecomparisonofphakiccollamerlensesandwavefront-op5mizedlaser-assistedinsitukeratomileusisforcorrec5onof
myopia.ClinOphthalmol.2016Jun29;10:1209-15.
StudyMethods• Refrac5veSurgeryCenter,CarlRDarnallArmyMedicalCenter,FortHood,
TX• Prospec5ve,non-randomizedcomparisonof48militarypersonnel(95
eyes)whounderwenteitherVisianICLimplanta5onorwavefront-op5mizedLASIKwithWaveLightAllegreeoEye-Q400Hzexcimerlasersystem– Allthepa5entscompletedthe3-monthfollow-upperiod
• Subjectswereincludedwith:– Stablerefrac5veerror(changeofsphericalequivalent<0.50Dforatleast1
year)– Myopia>−3.00D(range:–3.00Dto–11.50D)withas5gma5sm<3.00D
ParkhurstGD.Aprospec5vecomparisonofphakiccollamerlensesandwavefront-op5mizedlaser-assistedinsitukeratomileusisforcorrec5onofmyopia.ClinOphthalmol.2016Jun29;10:1209-15.
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StudyMethods• Agewascomparablebetweenthetwogroups
– ICL=27.6±7.3years(range=19–46years)– LASIK=27.0±5.9years(range=20–41years)
• Nosignificantdifferencebetweentwogroupsinpreopera5vesphericalequivalent– ICL=−6.10±1.76D(range:−3.25Dto−11.50D)– LASIK=−6.04±1.72D(range:−3.00Dto−9.50D)
• Scotopicpupildiameterswerealsocomparable– ICL=6.37±1.01mm(range=4.5–8mm)– LASIK=6.23±0.88mm(range=4–8mm)
ParkhurstGD.Aprospec5vecomparisonofphakiccollamerlensesandwavefront-op5mizedlaser-assistedinsitukeratomileusisforcorrec5onofmyopia.ClinOphthalmol.2016Jun29;10:1209-15.
StudyMethods
• RabinSuperVisionTest– PrecisionVision,LaSalle,IL,USA– High-contrastvisualacuity– Leeercontrastsensi5vity
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StudyMethods• RabinSuperVisionTestwasusedtocomparethevisualacuity
andCSineachgroupundernormalandlowlightcondi5ons,usingafilterforsimulatedvisionthroughnightvisiongoggles(NVG).– NVGspresentpar5cularlychallengingviewingcondi5ons
• lowluminance• lossofcolordiscrimina5on• diminishedcontrast
– Tes5ngwasconductedwithbestspectaclecorrec5on,firstusingNVGwithlow-luminancefilter,thenwithoutfilter(methodusedtopreventlearning)
ParkhurstGD.Aprospec5vecomparisonofphakiccollamerlensesandwavefront-op5mizedlaser-assistedinsitukeratomileusisforcorrec5onofmyopia.ClinOphthalmol.2016Jun29;10:1209-15.
StudyResults• Allsurgerieswereuneven�ul,andnovision-threatening
complica5onswereseenthroughouttheobserva5onperiod• Bothgroupswerecomparablewithrespecttopreopera5ve
visualacui5esandcontrastsensi5vi5es
ParkhurstGD.Aprospec5vecomparisonofphakiccollamerlensesandwavefront-op5mizedlaser-assistedinsitukeratomileusisforcorrec5onofmyopia.ClinOphthalmol.2016Jun29;10:1209-15.
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StudyResults:SuperVisionAcuity(SVa)
• Sta5s5callysignificantimprovementfrompreopera5ve-to-postopera5velevelobservedinbothgroups.
• At3months,meanimprovementsinSVa(LogMAR)intheICLandLASIKgroupswerecomparable(P=0.154;errorbarsrepresentSD).
ParkhurstGD.Aprospec5vecomparisonofphakiccollamerlensesandwavefront-op5mizedlaser-assistedinsitukeratomileusisforcorrec5onofmyopia.ClinOphthalmol.2016Jun29;10:1209-15.
StudyResults:SuperVisionContrast(SVc)
• Postopera5veimprovementfrompreopera5velevelswassta5s5callysignificantinbothgroups.
• Sta5s5callysignificantgreaterimprovementfornormalillumina5onandnightvisionsimula5onintheICLcomparedtoLASIKgroup.
ParkhurstGD.Aprospec5vecomparisonofphakiccollamerlensesandwavefront-op5mizedlaser-assistedinsitukeratomileusisforcorrec5onofmyopia.ClinOphthalmol.2016Jun29;10:1209-15.
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StudyResults:SuperVisionAcuitywithGoggles(SVaG)
• At3months,meanimprovementinSVaG(LogMAR)intheICLgroupwassta5s5callysignificantlygreaterthanthemeanimprovementintheLASIKgroup(P=0.032*;errorbarsrepresentSD).
ParkhurstGD.Aprospec5vecomparisonofphakiccollamerlensesandwavefront-op5mizedlaser-assistedinsitukeratomileusisforcorrec5onofmyopia.ClinOphthalmol.2016Jun29;10:1209-15.
StudyResults:SuperVisionContrastwith(lowluminance)Goggles(SVcG)
• At3months,meanimprovementinSVcG(LogCS)wassta5s5callysignificantlygreaterintheICLgroupascomparedtotheLASIKgroup(P=0.024*;errorbarsrepresentSD).
ParkhurstGD.Aprospec5vecomparisonofphakiccollamerlensesandwavefront-op5mizedlaser-assistedinsitukeratomileusisforcorrec5onofmyopia.ClinOphthalmol.2016Jun29;10:1209-15.
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Conclusion• Inthisstudy,low-luminancevisualacuityandlow-luminance
CSsignificantlyimprovedfollowingICLimplanta5on,andtheimprovementsweresignificantlybeeerthanthoseobservedawerwavefront-op5mizedLASIK.
ParkhurstGD.Aprospec5vecomparisonofphakiccollamerlensesandwavefront-op5mizedlaser-assistedinsitukeratomileusisforcorrec5onofmyopia.ClinOphthalmol.2016Jun29;10:1209-15.
ASACOMPREHENSIVEREFRACTIVEPRACTICE…
...yourresponsibilityistounderstandthepoten5alrisks1:• EarlyIOPSpike• LateCataract
…andbepreparedtomanagethem.
1. STAARFDAMICLDirec5onsforUse(DFU)
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EARLYIOPSPIKE• FDAStudyMICLDFU6:“RaisedIOPRequiringInterven5on”
§ 3.2%(n=17/526)addi5onalLPI§ 0.6%(n=3/526)repeatirriga5onandaspira5onat1daypost-op
• Mi5ga5on/Management6:§ ImportanttomonitorIOPat24hourspostopera5vely§ ImportanceofpatentLPIs§ ThoroughremovalofOVD
• Literature:§ Incidenceofpupillaryblock0.01,3,4,5–0.7%2
1. IgarashiA,ShimizuK,KamiyaK.Eight-yearfollow-upofposteriorchamberphakicintraocularlensimplanta5onformoderatetohighmyopia.AmJOphthalmol2014;157:532–9.2. LeeJS,KimYH,ParkSK,LeeSU,ParkYM,LeeJH,LeeJE.Long-termclinicalresultsofposteriorchamberphakicintraocularlensimplanta5ontocorrectmyopia.ClinExperimentOphthalmol.2015Dec12.
doi:10.1111/ceo.12691.[Epubaheadofprint]3. Higueras-EstebanA,Or5z-GomarizA,Gu5érrez-OrtegaR,Villa-CollarC,Abad-MontesJP,FernandesP,González-MéijomeJM.Intraocularpressureawerimplanta5onoftheVisianImplantableCollamer
LensWithCentraFLOWwithoutiridotomy.AmJOphthalmol.2013Oct;156(4):800-54. HuseynovaT,OzakiS,IshizukaT,MitaM,TomitaM.Compara5vestudyof2typesofimplantablecollamerlenses,1withand1withoutacentralar5ficialhole.AmJOphthalmol.2014Jun;157(6):1136-43.5. LisaC,AlfonsoJF,Alfonso-BartolozziB,Fernández-VegaL,Pérez-VivesC,Montés-MicóR.Collagencopolymerposteriorchamberphakicintraocularlenssupportedbytheciliarysulcustotreatmyopia:
one-yearfollow-up.JCataractRefractSurg.2015Jan;41(1):98-104.6. STAARFDAMICLDirec5onsforUse(DFU)
MULTIPLEETIOLOGIESOFCATARACT
Patient Related Factors1 Surgeon Related Factors1 Visian ICL™ Related Factors1
Age2,3 Surgical trauma Insufficient Vault2,4,5
Refractive status3 • Early onset (< 3M) associated with surgical trauma
• Disturbance of aqueous flow1
• Interference with lens metabolism1
Anterior Subcapsular Cataract (ASC)
1. Chenetal.MetaanalysisofcataractdevelopmentawerPIOLsurgery.JCataractRefractSurg2008;34:1181–1200.2. Gonversetal.Implantablecontactlensformoderatetohighmyopia:rela5onshipofvaul5ngtocataractforma5on.JCataractRefractSurg2003;29:918–243. SandersDR.Anteriorsubcapsularopaci5esandcataracts5yearsawersurgeryinthevisianimplantablecollamerlensFDAtrial.JRefractSurg.2008Jun;24(6):566-704. Schmidingeretal.Long-termchangesinposteriorchamberphakicintraocularCollamerlensvaul5nginmyopicpa5ents.Ophthalmology2010;117:1506–15115. Alfonsoetal,Centralvaultawerphakicintraocularlensimplanta5on:Correla5onwithanteriorchamberdepth,white-to-whitedistance,sphericalequivalent,andpa5entageJCataractRefractSurg2012;
38:46–53
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INCIDENCEOFMICL/V4ASCCATARACTS
ASCandCataractSurgery N MRSE
(D)FollowUp
ClinicallySignificant
ASC
STAARFDAMICLDFU 526 -10.06 3years 0.4%
KamiyaArchOphthalmol2009 56 -9.83 4years 1.8%
SandersJRefractSurg2007 311 -10.06 5years 1.3%
AlfonsoJCataractRefractSurg2011 188 -10.76 5years 0.5%
AlfonsoJCataractRefractSurg2015 1531 -7.27 5years 1.4%
BrarECOphthalmology2015 615 NR 5years 0.7%
SchmidingerOphthalmology2010 84 -16.40 6years 17%
LeeClinExpOphthalmol2015 281 -8.74 7years 1.8%
0
2
4
6
8
10
12
14
16
18
0 1 2 3 4 5 6 7 8 9
%
Years
IncidenceofV4ASCCataracts
MICLDFU Kamiya2009 Sanders
Alfonso2011 Alfonso2015 Brar2015
Schmidinger2010 Lee2015
PhakicIOLsforMyopia
• Wellestablishedbenefits• Lowrateofcomplica5ons• Broadrangeoftreatment• Preserva5onofcornealorlen5cular5ssue• Highpa5entsa5sfac5onandimprovementinqualityoflife
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Summary:Myopia,TheRefrac5veMarketandPhakicIOLsinModernRefrac5veSurgery
• Myopiaaffectsalargeandgrowingdemographicinneedofvisioncorrec5on
• Refrac5vesurgeryisaviableop5onformanypa5ents• PhakicIOLshavealonghistorywithhighbenefittoriskra5o• Keysincludeproperpa5entselec5on,me5culoussurgeryandgoodclinical
follow-uptoensurepa5entsa5sfac5onandqualityoflifeisdelivered
Thankyou