the aao – fda task force on premium iol’s: accommodating ... · on premium iol’s:...
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The AAO – FDA Task Force on Premium IOL’s:
Accommodating, MF, EDOF IOL’s
Scott MacRae MD Flaum Eye Institute
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AAOTaskForceAAOmembers:• Chair,JackHolladay,MD• AdrianGlasser,PhD• Sco:MacRae,MD• SamuelMasket,MD• WalterStark,MD
FDA members: • Malvina Eydelman, MD • Don Calogero, MS • Gene Hilmantel, OD, MS • Tieuvi Nguyen, PhD, RAC • Eva Rorer, MD • Michelle Tarver, MD, PhD
DevelopingNovelEndpointsforPremiumIntraocularLenses
§ FDA/AAOWorkshopheld–3/28/14
§ Primarygoals:» ToimprovetheregulatoryscienceforevaluaOngpremium
IOLs,
» Todevelopbe:erstandardizedmethodstomoreefficientlyevaluatepremiumIOL’sandacceleratestudies.
WorkshopRecomendaCons• SubjecCveAssessmentsforAccommodaCon/DepthofFocus
TesCng» ProposedmethodstoreducetesOngbias(e.g.,standardizingcomputerized
VAchartswithle:errandomizaOon,standardluminance,etc.)
• ExtendedDepthofFocus» Minimumcriterion:atleast0.5Dgreaterdepthoffocusthanamonofocal
IOLcontrol(at0.2logMAR)» DevelopnewpreclinicaltesOngtomoreaccuratelymodeltheclinical
environment
• ObjecCveAssessmentofAccommodaCon» OpOcalorbiometricmethodsacceptableifappropriatelyvalidated
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WorkshopRecommendaCons(cont’d)
• Adverseevents(AEs)forsafetyandperformanceendpoints(SPE)inclinicaltrials» ClarifydefiniOons» AddnewAE’s(e.g.,dysphotopsias,malposiOons)» EvaluatepubliclyavailablePMAdatabytypeofIOLforapprovedpremiumIOLs
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WorkshopRecommendaCons(cont’d)
• PaCent-ReportedOutcome(PRO)Measures» DeveloppaOent-focuseddefiniOonsandimagesforsymptomareas,includingdysphotopsias
» EvaluaOonofvisualfuncOontailoredforpaOentswithhighervisualfuncOoningandupdatedfornewertasks(e.g.,smartphoneusage)andIOLdesigngoals(e.g.,intermediatevision)
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Optical Symptoms Classified
Dysphotopias
• Negative Dysphotopia • Positive Dysphotopia
Entopic Phenomenon
• Floaters • Blue entopic phenonenon
–WBC’s • Flashing Lights
The Dysphotopsias • SubjecOve(Undesired)OpOcalImagesAssociatedwithOtherwiseUncomplicatedIOLSurgery–PhoOcPhenomena» PosiOve(PD)lightstreaks,arcs,flashes,starbursts» NegaOve(ND)temporaldarkshadow» MulOfocal(DiffracOve)–halos,rings
Dysphotopsia • PosiOveDysphotopsia
» PaOentreportslightstreaks,halos,centralflashesthatinterferewithvisionlasOngmorethan3monthspostop
» Excludingentopicphenomena
• NegaOveDysphotopsia» PaOentreportsatemporaldarkcrescentlasOngmorethan3monthsagersurgery
Positive Dysphotopsia • BrightarOfacts:
» Arcs» Streaks» Rings» Halos» OnreOnacentrallyormidperipherally
Negative Dysphotosia • Notedwith“PerfectSurgery”• Ogendescribeashaving“horseblinders”• SymptomsabatewithpupildilaOon• Ascociatedwith:
» HighindexofrefracOonIOLs» NasallocaOonofthepupil» Sharpedgedesign(toinhibitPCO)
Post Surgical Entopic Phenomenon
• FromGreekἐντός“within”ὀπτικός“visual”meaningthesourceiswithintheeyeitself.
IndustryEngagement• TheMedicalDeviceManufacturersAssociaOon(MDMA)distributedthefollowingforcomment(10/14):» Whatshouldthestandardthresholdbeforadefocuscurvethatwould
permitanIOLtoachieveaclaimasanEDFIOL?» WhatisanappropriatecriteriontousetocorrelateopOcalbenchdatato
actualclinicalresultsfortheEDFIOLs?• CollaboraOononthedevelopmentoftoolstobe:ermeasurepaOent-reportedoutcomes
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Task Force Progress: Extended Depth of Focus IOLs § CriteriaforExtendedDepthofFocusIOLs:
» Nostandardizedmonofocalcontrol,thereforeintermediateacuityperformancecriteriawasaddedtocriteriarecommendedatworkshop:50%shouldachieveatleast0.2logMAR(20/32)at67cm
» Distanceacuitynon-inferiortomonofocalcontrol
§ DevelopedspecificmethodologyforEDFdefocuscurvetesOng
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Task Force Progress: Extended Depth of Focus IOLs § Recommenduseofcomputerizedvisionchartswithrandomizedle:erstominimizebiasduetomemorizaOon
§ Non-clinicallaboratorytesOngforEDF:MTFopOcalbenchwithwhitelightusingamodeleye
§ DragfordisseminaOontoindustry
– Optical Compromises of Multifocal Designs – Loss of Distance Image Quality – (Compared to a Monofocal IOL)
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0.6
0.8
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-1 0 1 2 3 4 5
Imag
e Q
ualit
y M
etric
(CC
)
Defocus [D]
4mm Pupil Size SN60AT
SN6AD1
SN6AD3
ZM900
NXG1
– monofocal
– ReSTOR
– Tecnis
– ReZoom
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-4 -2 0 2 4
Focus(D)
NoaberraOon
– Near – Beyond ∞ – Distance
– Hyperopia ß Defocus (D) à Myopia – -2 – -1.5 – -1 – -0.5 – 0 – 0.5 – 1 – 1.5 – 2 – No aberration
– Zernike SA shifts subjective refraction.
– No SA – Defocus Curve
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-4 -2 0 2 4
Focus(D)
NoaberraOon
PosiOveSA
– Near – Beyond ∞ – Distance
– Hyperopia ß Defocus (D) à Myopia – -2 – -1.5 – -1 – -0.5 – 0 – 0.5 – 1 – 1.5 – 2
– +SA
– No aberration
– Zernike SA shifts subjective refraction.
– Positive SA à Hyperopic shift
– More IOL power
– No SA – Defocus Curve
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-4 -2 0 2 4
Focus(D)
NoaberraOon
PosiOveSA
NegaOveSA
– Near – Beyond ∞ – Distance
– Hyperopia ß Defocus (D) à Myopia – -2 – -1.5 – -1 – -0.5 – 0 – 0.5 – 1 – 1.5 – 2
– -SA
– +SA
– No aberration
– Zernike SA shifts subjective refraction.
– Negative SA à Myopic shift
– Less IOL power
– Positive SA à Hyperopic shift
– More IOL power
– No SA – Defocus Curve
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Extend Depth of Focus - Spherical Aberration -
– beyond infinity ß distance à near – -2 – -1.5 – -1 – -0.5 – 0 – 0.5 – 1 – 1.5 – 2 – Defocus (D):
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Adverse Events
§ SPErate(SafetyandPerformanceEndpoint):PercentofsubjectswithAE
§ BenchmarksfortheperformanceofnewIOLsbasedonhistoricalmonofocalIOLclinicaltrialdata
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Current SPE AEs CumulaOveAEs:§ EndophthalmiOs§ Lensdislocatedfromposteriorchamber/anteriorchamber
§ Pupillaryblock§ Hypopyon§ ReOnaldetachment§ Cystoidmacularedema
§ SecondarysurgicalintervenOon(excludesposteriorcapsulotomies)
PersistentAEs:§ Cornealstromaedema§ IriOs§ RaisedIOPrequiringtreatment
§ Cystoidmacularedema
AsymmetricRefracCve
Mplus,OculenCs
distance focus
near focus
– McAlinden et al. (2011)
DiffracCveBifocal
ReSTOR,Alcon
DiffracCveTrifocal
MicroF,FineVision
– Gatinel et al. (2011)
ZonalRefracCve
ReZoom,AMO
– Far– Near
– Presbyopic Correction: Multifocal Approaches – Extending Depth of Focus (IOL)
Tecnis,AMO
ATLisa,CarlZeiss
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Task Force Progress: Clinical - Adverse Events
§ IdenOfiedneweventstobeincludedassafetyandperformanceendpoints(SPE)inclinicaltrialsofpremiumIOLs
§ DevelopedAEdefiniOonsforstandardizaOon
§ DragfordisseminaOontoindustry
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Patient-Reported Outcome (PRO) Questionnaire Development
§ DysphotopsiasarenotadequatelyassessedwithcurrentPROmeasures
§ RecommenddevelopingaquesOonnairetobe:ermeasuredysphotopsiasfollowingcataractsurgerywithIOLimplantaOon
MedicalDeviceDevelopmentTools(MDDT)Program
§ Purpose:ToqualifytoolsthatareusedinthedevelopmentandevaluaOonofmedicaldevicesoutsideoftheregulatorysubmission
• DragguidancepublishedonNovember2013» h:p://www.fda.gov/medicaldevices/deviceregulaOonandguidance/
guidancedocuments/ucm374427.htm
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MedicalDeviceDevelopmentTools
MDDTQualificaCon
ClinicalOutcomeAssessments*
BiomarkerTests
NonclinicalAssessmentModels
Qualification is a regulatory conclusion that within a specified context of use, the results of an assessment that uses an MDDT can be relied upon to support device development and regulatory decision-making
subjecOvemeasuresofhowapaOentfeelsorfuncOons,ormeasuresbasedonsubjecOveclinicaldecision-making.alabtest,medicalimagingmethod,orotherobjecOveclinicalassessmentmethodusedtodetectormeasureabiomarker.anonclinicaltestmethodormodel.
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FDAQualifiedMDDT• TheDeviceindustrydoesnotneedtoreconfirmthesuitabilityofaqualifiedMDDT
• Deviceindustryusersmayneedtodemonstratethetoolisusedaccordingtothespecifiedcontextofuse
Device or Product
Area
Specific Role of the
MDDT
Stage of Develop-
ment Contextofusedefinestheboundarieswithinwhichevidence&jusCficaConsupportstooluse
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BenefitstoMedicalDeviceManufacturers&FDA
• QualificaOonwillfacilitate:» MorepredictableproductevaluaCon.MedicaldeviceindustrycanusequalifiedtoolswithouttheneedtoreconfirmvalidityinindividualsubmissionstoFDA,potenOallyreducingOmeandotherresourcesneededtodevelopnewproducts
» MoreefficientregulaCon.FDA’seffortstoqualifyoneMDDTcouldbysurpassedbytheOmeandresourcessavedwhentheMDDTisappliedtoseveraldevicesubmissionsordevicedevelopmentprograms
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PRO Development
§ ResourcesrequiredfromallstakeholderstodevelopPROmeasures
§ H.DunbarHoskinsCenterforQualityEyeCareservesasneutralforumtorequestandbringtogetherfinancialresourcesandexperOsefromdifferentstakeholderscollecOvelytofacilitatePROmeasuredevelopment» Contact:FloraLum,[email protected]
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Task Force Deliverables
§ Developdragconsensusstatementsforcomments
§ SubmitfinalconsensusstatementsforpublicaOoninOphthalmology
§ Developapsychometrically-evaluatedPROmeasure» AcceptedintoPilotProgramforQualificaOonofMedicalDeviceDevelopmentTools(h:ps://www.federalregister.gov/arOcles/2014/08/15/2014-19360/pilot-program-for-qualificaOon-of-medical-device-development-tools)
Thank you!