Posterior chamber phakic IOL and its manufacturing process

Description

BE2024 / 5938 -2- sizecorrespondsaproportionaldimensioningofthephakicIOLcorrespondingto onechoiceofitsexternaldiameter.ThepositioningoftheIOLalongtheoptical axisinthepatient’seye(definingitspositioningwithrespecttotheeye’sirisand crystallinelens)istargetedbasedonanexpectedradialcompressionontheIOL intotheeye,asitisrepresentedonFigure6hereafterintroduced.Thissolution,5 however,suffersfromshortcomingsintermsofthestabilityofthepositionofsuch anIOLonceitisimplantedinaneyeduetouncertaintiesonradialcompressions exertedonIOLhaptics.Furthermore,anatomicalmeasuringerrors,irregularities oftheciliarybodyand / orsulcusandIOLmisplacementsduringtheimplantation arealsolikelytoleadtobadIOLpositioningintheeye’sposteriorchamber,so10 thatimprovementsarestillneededregardingthis“sizingissue”.

[0005] Asanattempttosolvethisproblem,documentWO2020 / 035534A1 disclosesasinglesizedposteriorchamberphakicIOLcomprisingadoublehaptic structuremadeofaperipheralhapticpartcomprisingsupportelementsarranged tolieontheciliaryzonuleandelongatedthinflexiblehaptics,eachwithaproximal15 extremitymountedonaproximalportionoftheperipheralhapticpartandwitha freedistalextremitytohooktheIOLintotheeye’sciliarysulcus.Thehapticsare deemedtoallowforcompensatingany(oralmost)sizevariationoftheposterior chamberanatomicalspace,sothattostabilizetheIOL’spositionintheeye.The hapticsasbeingthin,flexibleandelongatedareneverthelessquitedifficulttosee20 andtomaneuverduringtheimplantationprocessintheeye,sothattheyarealso likelytoleadtoIOLmisplacements.

[0006] ThedocumentWO2023 / 021225A2thenfurtherdisclosedaposterior chamberphakicIOLeasiertoimplantinaneyeandstilladaptedtoawideclass ofeye’sanatomy,withoutnecessarilybeingadaptedtoalleye’sanatomyandall25 posteriorchambersizevariations.ThisIOLcomprisesadoublehapticstructure,butthistimeelongatedflexiblehapticshavetheirtwoextremities(consideredas fromanextensioncurve)mountedonadistalsupportelementoftheperipheral hapticpart,sothatdefiningsocalledfootplates.TheIOLcanbestabilizedinthe eye’sciliarybodybyadistallateralborderofeachfootplate.Althoughmounting30 saidextremitiesonthedistalsupportelementreducesthefootplatesadaptability 2024 / 5938 BE2024 / 5938 -3- incomparisonwithlong,thinandfreelyendedflexiblehapticsasinthedocument WO2020 / 035534A1,thisnewgeometrymakesthefootplateseasiertoseeand tomaneuverduringtheIOLimplantationprocess.AsmallamountofIOLsizes1- to-1associatedtothesameamountofexternaldiameters(forinstancethree externaldiametersof12.7,13.2and13.6mm)forsuchaposteriorchamber5 phakicIOLaredisclosedasbeingsufficienttocoverpossibleeyesanatomies.

[0007] AlthoughthedisclosureofdocumentWO2023 / 021225A2isamajor achievementinthetechnicalfield,theinventorsnoticesthatimprovementsmay stillbeneededwithrespecttothe“sizingissue”asthephakicIOLpositioninginto theposteriorchambermaynotpreciselybedeterminedonlyonbasisoftheIOL10 diametersizingandcorrespondingexpectedradialcompressionsexertedonthe IOLhapticstructuresasmentionedabove. Disclosureoftheinvention

[0008] AnobjectoftheinventionistoprovideaposteriorchamberphakicIOL withamorepredictable,preciseandstablepositioningintheposteriorchamber15 ofaneyewithrespecttothepriorart.Forthispurpose,theinventionprovidesa posteriorchamberphakicIOLhavingavaultheightinherenttotheIOL(herein referredtoasthe“inherentvaultheight”oftheIOL)whichisindependentfroman externaldiameteroftheIOL.

[0009] Asknownbytheskilledperson,theinherentvaultheightistypicallya20 datameasuredalongtheIOLopticalaxis,preferablyfromaposteriorsurfaceof anIOLoptics(i.e.alens),typicallyfromtheintersectionofthisposteriorsurface withtheopticalaxis,tothefurther(i.e.moreposterior)pointofIOLhaptics.As knownbytheskilledperson,theexternaldiametertypicallyisadatameasured perpendicularlytotheIOLopticalaxis,andcorrespondstothefurthestdistance25 betweentwopointsoftheIOL.

[0010] TheIOLaccordingtotheinventionhasthereforeanaxialdimension andaradialdimensionindependentonefromtheother.Thesetwodegreesof freedomallowstocompensateuncertaintiesonexpectedradialcompressionsof thephakicIOLintoaneye’sposteriorchamberasitdissociatesaxialandradial30 2024 / 5938 BE2024 / 5938 -4- movements.Asaconsequence,itispossibletochooseanIOLexternaldiameter whichfitstotheanatomyoftheeye’sposteriorchamber,forinstancetoaciliary body-to-ciliarybodydistance,whileprovidingapreciseIOLvaultingwithrespect tothecrystallinelensbyanotherchooseofIOLinherentvaultheightindependent fromtheIOLexternaldiameter,yieldingthentoapredictable,preciseandstable5 positioningoftheIOLintheeye’sposteriorchamber.

[0011] ThisapproachdifferssignificantlyfromthepriorartprescribinganIOL sizingbasedonasinglechoiceofIOLexternaldiameterwithaninherentvault height(andmoregenerally,anIOLdimensioning)dependingproportionallyon thisexternaldiameter,limitingthentheIOLsizingtoasingledegreeoffreedom10 solelybasedonuncertainradialcompressions.

[0012] ThephakicIOLaccordingtoinventionisdimensionedtobeimplanted intoaposteriorchamberofaneye.Theexternaldiameterandtheinherentvault heightoftheIOLcanthereforebechosenbasedonpreoperativelydetermined parameterstoinduceapredictable,preciseandstablepositioningoftheIOLinto15 thiseye.Preferably,theexternaldiameterisdeterminedbased(e.g.corresponds toafirstfunctionof)awhite-to-whitedistance(WtW)oftheeye.Asknownbythe skilledperson,theWtWismeasuredperpendicularlytotheopticalaxis(then “horizontally”facingtheeye,asahorizontalcornealmeasurement)between bordersoftheeye’scorneallimbus.Itisgenerallycomprisedbetween11and1320 mm.Severalknowntechnicscanbeusedtoobtainthismeasurementsuchas calipers,slit-lamp,ultrasonicbiomicroscopy,magneticresonanceimaging(MRI),opticalcohencetomography(OCT)andsoon.TheWtWisknowntobeeasyto measureandtorelatetotheciliarybody-to-ciliarybody(ortothesulcus-to- sulcus)distancemakingitpossibletoestimatepreciselythelater,andthenalso25 anappropriateIOLexternaldiameter,basedontheWtW.Thefirstfunctionmay beexpressedasWtW+ε,whereεisacorrectionfactorpreferablycomprised between0.50and1.00mm,dependingonothereye’sanatomicalparameters thatcanbemeasuredpreoperatively.

[0013] Equivalently,theexternaldiametercanbedirectlydeterminedbased30 onaciliarybody-to-ciliarybody(orsulcus-to-sulcus)distancemeasurement(in 2024 / 5938 BE2024 / 5938 -5- placeofaWtWmeasurement).Thismeasurementcane.g.bealsoperformedby ultrasonicbiomicroscopy.Althoughthisembodimentcanleadtoamoreprecise IOLexternaldiameterdetermination,theWtWmaybeeasiertomeasurewith moresimpletechnics.Otherequivalentmeasurementssuchastheangletoangle (AtA)andsulcus-to-sulcus(StS)distancesaccordingtothesameeyedimension5 canfullybeenvisagedinthescopeoftheinventionasitwillbeunderstoodby theskilledperson.Theabovedeterminationoftheexternaldiameterbasedon WtWcanthenberephrasedgenerallyas“theexternaldiametercorrespondsto afirstfunctionofaciliarybody-to-ciliarybodydistanceand / orassociateddistance oftheeyemeasuredperpendicularlytoanopticalaxisoftheIOL”.10

[0014] Preferably,theIOLinherentvaultheightisdeterminedonbasis(e.g. ascorrespondingtoasecondfunction)oftheanteriorchamberdepth(ACD)of theeye.Asknownbytheskilledperson,theACDismeasuredinparalleltothe opticalaxis(i.e.“indepth”facingtheeyeand / orlaterallysideway)andgenerally comprisedbetween1and4mm.Manyknowntechnicscanbeusedtomeasure15 theACDsuchasslit-lamp,ultrasonicbiomicroscopy,Scheimpflugphotography, OCTandsoon.AstheACDrelatestoanaxialdistancebetweenthecorneaand thecrystallinelens,itisanindexofacceptableinherentvaultheightfortheIOL (aswellaspreferablyvaultinducesbytheIOLabovethecrystallinelensonceit isimplanted)withouttheneedforunreasonablyrelyingonradialcompressions20 exertedontheIOLonceitisimplanted.Otheranalogous,complementaryand / or equivalentmeasurementssuchasthecrystallinelensriseortheretroiridean spaceaccordingtothesameeyedimensioncanalsofullybeenvisagedinthe scopeoftheinventionasitwillbeunderstoodbytheskilledperson.Theabove determinationoftheinherentvaultheightbasedonACDcanthenberephrased25 moregenerallyas“theinherentvaultheightcorrespondstoasecondfunctionof ananteriorchamberdepthand / orassociateddepthoftheeyemeasuredalong theopticalaxis”.ConsideringtheACD,thesecondfunctioncanbeexpressedas afractionofACD,forinstanceabout1 / 4ACD.Abovementionedothereye’s anatomicalparametersrelatedtothefirstfunctionofWtWcancompriseACD,30 givenitisadvantageouslymeasuredandavailable. 2024 / 5938 BE2024 / 5938 -6-

[0015] Accordingtoapreferredembodiment,thephakicIOLcomprises: -ananteriorsurfaceandaposteriorsurface; -acentralopticalpart(oroptics)comprisingalens,andextendingradially relativetoanopticalaxisdirectedfromtheanteriorsurfacetotheposterior surface;5 -aperipheralhapticpartcircumferentiallymountedonthecentralopticalpart andcomprisingdistalsupportelementsarrangedforsupportingtheIOLona ciliaryzonulewhentheIOLisinanimplantationpositioninaneye;and -footplatesmountedontheperipheralhapticpartandcomprisingadistal borderarrangedforstabilizingtheIOLintoaciliarybodywhentheIOLisin10 theimplantationpositionintheeye. Inthisdocument,theterm“supportelement(s)”isalsousedasreferringshortly tothe“distalsupportelement(s)”.

[0016] Preferably,theIOLperipheralhapticpartextendsradiallyoutwardand posteriorlyrelativetothecentralopticalpartofadepthdependingon(preferably15 being)theinherentvaultheight.Preferably,thefootplatesand / orthedistal supportelementsextendsradially(beyondtheproximalborderofthesupport elements)ofalengthdependingontheexternaldiameter,i.e.sothattoreach saidexternaldiameter.Eachfootplateisinparticularpreferablymountedonone supportelementoftheperipheralhapticpart,andextendsradiallyoutwardfrom20 saidsupportelementtotheIOLexternaldiameter.Hence,thefootplatesextend fromamostdistalpartoftheperipheralhapticpart,thenreducingthefootplates lengthforreachingtheciliarybodyandimprovingtheirmaneuverabilityduringan implantationprocess.Thefootplatescanhaveageometry(and / orradiallength) independentfromtheexternaldiameterpriortotheIOLimplantationsothatto25 haveadvantageouslyasamepredictablebehaviorundercompression.Inthis case,theradialextensionofthedistalsupportelementsfullyvaryinorderforthe IOLtohavetheexternaldiameter.Alternatively,thedistalsupportelementscan alsobedesignedindependentfromtheexternaldiameter,sothatthefootplates extendmoreorlessradiallyfromthedistalsupportelementstoreachtheexternal30 2024 / 5938 BE2024 / 5938 -7- diameter.Alternatively,boththefootplatesandthedistalsupportelementscan alsohavevariableradialextensionsdependingontheexternaldiameter.

[0017] ThisIOListhenequippedwithtwodistinctandcomplementaryhaptic structures:firstly,theperipheralhapticparthavingthedistalsupportelements, andsecondly,thefootplates.Theperipheralhapticpartformstogetherwiththe5 centralopticalparta“dome”(orequivalently“domeassembly”),thefeetofwhich arethesupportelementsarrangeddistallyinordertosupporttheIOLonthe ciliaryzonule.Asthefootplatesextendradiallybeyondthisdome,italsoallows tostabilizetheIOLintotheciliarybody.TheIOLisparticularlystableaxially(i.e. inparalleltotheopticalaxis),radially(i.e.inperpendiculardirectionswithrespect10 totheopticalaxis)andcircumferentially(i.e.inrotationsaroundtheopticalaxis) inimplantationposition.

[0018] TheperipheralhapticpartallowstostabilizetheIOLinparalleltothe opticalaxis.Thesupportelementsarearrangedatthedistalextremitiesofthe peripheralhapticpartanddesignedforsupportingthedomeontheciliaryzonule.15 Thedomeisconfiguredtobeanteriorlyabovetheeyecrystallinelenssothatit enclosesthelensatleastanteriorly.Asaconsequence,thedistance,called“the vault”,measuredinparalleltotheopticalaxisbetweenthecrystallinelensanterior surfaceandtheIOLposteriorsurface,isdefinedandstabilized.Thevaultcanbe assimilatedtoasafetydistancerequiredinordertoavoidacontactortoomuch20 proximitybetweenthecrystallinelensandtheIOL.Asafetydistancebetweenthe IOLandtheirisissimilarlydefinedandstabilizedasbeingthedistancebetween theIOLanteriorsurfaceandtheposteriorsurfaceoftheirisconceivedasavirtual irisplanoccupyingthepupileye(inriseopening).Ofcourse,bothdistancesare dependingontheIOLinherentvaultheightwhichisadvantageouslydecoupled25 fromtheIOLexternaldiameterandrelatedradialcompressionsexertedonthe IOLintotheeye,andischosenpreferablybasedontheACD,sothattoensure anappropriatecompatibilityoftheIOLwiththeeyeanatomy.

[0019] Thevaultispreferentiallycomprisedand / oradjustablebetween100 and1000µm,morepreferablybetween250and750µm,withorwithoutradial30 and / oraxialcompression.EnoughspaceisthenavailablebetweentheIOLand 2024 / 5938 BE2024 / 5938 -8- boththecrystallinelensandtheiris,whichcompensatespotentialanatomical sizedefectsintheeyeposteriorchamber,orpossiblepositioningdefectsofthe IOL,tosharplyreducetherisksofcomplicationforthepatient.Thevaultcanbe titratedbysculptingtheIOLposteriorsurfacesuchthatitfollowsacontourofa naturalcrystallinelensforwhichitisintendedtobeimplanted.5

[0020] Thestructureofthedomeisadaptedtoawiderangeofeyeanatomy baseonachoiceofaposteriorsurfacecurvedasanaverageanteriorsurfaceof anycrystallinelensandonachoiceofperipheralhapticpartexternaldiameter (measuredperpendicularlytotheopticalaxis),e.g.comprisedbetween9.50and 11.50mm,andcompatiblewithawiderangeofeyeposteriorchamberanatomy.10 Preferably,thedomegeometry(withoutthefeet)isgloballydefinedbythe inherentvaultheightasasinglevariableparameter.Inparticular,thedistal supportelementspreferablyextendfromacirclearoundtheopticalaxis(defining theirproximalborder)withadiameter(thatcanbecalled“internaldiameter”in thisdocument)independentoftheexternaldiameteroftheIOL.Thisgivesa15 concreteexpressiontothemainindependenceofthedomewithrespecttoIOL externaldiametercontrarytoknownphakicIOL,thiscontributingtoamore predictable,preciseand(notablyaxiallyregardingsaiddome)stablepositioning oftheIOLintheeye.Alternatively,thedomegeometrycanvaryaccordingtoits posteriorsurfaceradiusofcurvature.Insuchcase,theinternaldiametercanalso20 beindependentfromtheinherentvaultheight.

[0021] Thedomehasaposteriorsurfacepreferablysmoothand(posteriorly) concave.Theposteriorsurfaceatthejunctionbetweenthecentralopticalandthe peripheralhapticpartspreferablydoesnotcompriseirregularityorangularpoints. Theradiusofcurvatureofthedomeposteriorsurfaceisalsopreferably25 independentoftheIOLinherentvaultheightandoftheIOLexternaldiameter, makingthedomegeometryindependentfromtheexternaldiameterasdescribed hereabove.Alternatively,theinherentvaultheightcanbeobtainedbyvarying (solely)thisradiusofcurvaturebetween6and16mm.Theradiusofcurvature canbechosene.g.asasmallestaverageradiusofcurvatureofananterior30 surfaceofacrystallinelens.Itisthenpreferablycomprisedbetween9and10 2024 / 5938 BE2024 / 5938 -9- mm.Accordingtosomeembodiments,thedomeposteriorsurfacecancomprise anreliefvariationatthejunctionbetweenthecentralopticalandtheperipheral hapticparts,and / ortheradiusofcurvatureoftheposteriorsurfaceofoneorthe otherpartcandifferslightlydependingontheopticalrequirementsfortheIOL.

[0022] Preferably,athicknessoftheperipheralhapticpart(beingmeasured5 inparalleltotheopticalaxis)istargetedtoallowtheIOLtoresideatadetermined distancefromtheanteriorsurfaceofthecrystallinelensbyselectivelytitratingthe curvatureoftheIOLanteriorand / ortheposteriorsurfacessuchthattheposterior surfacemimicsthe(anterior)curvatureofthecrystallinelens.Fromthis,theradii ofcurvatureofthedomeanteriorandposteriorsurfacescanalsobeoptimized10 regardingthetargeteddioptricpower,andinasuchwaythatthethicknessatthe levelofthecentralopticalpart(oroptics)issubstantiallyconstantacrossadiopter range,e.g.beingofabout0.20mmforalensdioptricpowercomprisedbetween -5and-20Dandvaryingfrom0.40to0.20mmforlensdioptricpowersvarying from-0.5to-5Drespectively.Thecentralopticalsurfacecanbeanteriorlyconvex15 and / orsubstantiallyplanarand / orperpendiculartotheopticalaxis.Thisallowsto deliveradvantageouslyavaultwithouttheneedforcompressionandtherefore flexingofIOLanteriorly.

[0023] ThedometopsthecrystallinelenswhentheIOLisinanimplantation positionintheeye(namely,whentheIOLisinanormaluseintheeye),resting20 ontheciliaryzonule,andstabilizingtheIOLinparalleltotheopticalaxis.The footplates,fortheirpart,extendradiallysubstantiallybeyondthedomeintheeye posteriorchamber,forlayingintotheciliarybody.Thefootplateshavetypicallya geometryallowingtocontributetotheIOLstabilityinitsimplantationposition.In particular,thefootplatesextendsradiallyoutwardfromthedomesothatreaching25 anIOLexternaldiameterwhichischosenonthebasisoftheposteriorchamber availableanatomicalspacefortheIOL,whichispreferablyestimatedbyaWtW orciliarybody-to-ciliarybodydistancemeasurementasexplainedhereabove,by takingpreferablyintoaccountaelasticitypenetrationfactorofthefootplatesin theeyeciliarybody.Thisadvantageouslylimitsradialcompressionsexertedon30 thefootplatesandtheirimpactonthevault(orIOLaxialpositioning).Moreover, 2024 / 5938 BE2024 / 5938 -10- theflexibilityofthefootplatescancontributetotheIOLadaptabilitytointernalsize variationsoftheposteriorchamberanatomicalspace.Asthedomedimensions remainsubstantiallyconstantforaninherentvaultheight,theexternaldiameter oftheIOLcanthenvaryatthefootplatesand / ordistalsupportelementslevel.

[0024] ThefootplatesfurtherenablethestabilizationoftheIOLinrotationin5 aplaneperpendiculartotheopticalaxissothatthevariationinthisanatomical space(acknowledgedtobegreaterinoneorientationthananotherbecauseof its“oval”shape)canbefullycompensated.Thesefootplatesaremorepreferably circumferentiallyandradiallyextendedsuchthattheirdistalbordersareadjusted and / orconfiguredtolayand / orhookand / orstabilizethemselvesintotheciliary10 body,playingaroleofcircumferentialanchorsfortheIOL.Thisisimportantinthe embodimentforwhichtheIOLisatoricimplantcomprisingaopticwithacylinder tocorrectastigmatism.Indeed,inthiscase,thestabilityoftheangularpositionof theIOLlensintheperpendicularplane,socalledthe“rotationalstability”,allows toguaranteetheexpectedIOLopticalresults.Thefootplatesallowtomaintain15 theIOLlensinanexpectedopticalzoneandthentoavoidpossibledecentering oftheIOLwithrespecttotheeyeopticalaxiswhichcouldaffecttheIOLoptical results.

[0025] Eachofthefootplatescanbeofanykindaccordingtothepriorart, includingamassivedistalfootplate,alongthinfreelyendedflexiblehapticora20 flexiblehapticelongatedfromafirstextremitytoasecondextremitybothdirectly mountedononeofthesupportelement.Thislastcaseishoweverpreferredand thedistalborderofafootplateisthereforepreferablya“distallateralborder”of theelongatedflexiblehaptic.Thefixationofthefirstandsecondextremitieson thesupportelementallowsthefootplatetoextendfromandtoamostdistalpart25 oftheperipheralhapticpart,thenreducingthefootplateslengthforreachingthe ciliarybodyandimprovingtheirmaneuverabilityduringanimplantationprocess.

[0026] Thefirstandsecondextremitiesaretypicallythefootplate’sonlypart mountedontheIOLperipheralhapticpart.Moregenerally,thefootplatesarenot mountedovertheir(entire)lengthontheperipheralhapticpart.Asthefirstand30 secondextremitiesofeachfootplatearemountedontheasupportelement,the 2024 / 5938 BE2024 / 5938 -11- footplateextendsgloballyalongapartialloopreachingsoadistalextremityofthe loopattheIOLexternaldiameter.Thedistalborderhasthenaformofaportion ofthispartiallooparrangeddistallytostabilizetheIOLintotheciliarybody.The distalborderadvantageouslyproposesapotentiallywidecontactsurfacewiththe ciliarybody.5

[0027] The“elongated”featureofthehapticsformingthefootplatesrefersto apreferredthingeometry,whichcontributestoitsflexibilityasdescribedabove. Eachfootplatehaspreferablythreedimensionsamongwhichitslengthalonga maintrajectoryofextension,itsthickness,andawidthmeasuredorthogonallyto thetwootherdimensions.This“elongated”featurecanbetranslatedbyalength10 (atleasttwiceoratleastthreetimes)greaterthanthe(average)thicknessand the(average)widthofthefootplate.Thisprovidestothefootplateagreatability todeformunderaxialand / orradialcompressionsoftheIOL,contributingtomore stabilityadaptabilitytooftheIOLtotheanatomyoftheeyeposteriorchamber.

[0028] Thefootplatespreferablyborders(preferablyopen)cavitiesextending15 fromtheanteriortotheposteriorsurfacesoftheIOL.Preferably,eachcavityis completelyborderedbyafootplateandoneofthesupportelementonwhichitis mounted.Theterm“cavity”ishereusedasanequivalenttoaspaceemptyofthe materialconstitutingtheIOL.Thecavitiesarepreferablynotholesmadeinsaid materialbutsimplyafeaturearisingfromthefootplatesgeometry.20

[0029] Eachfootplatecanoptionallycompriseamaterialfoldand / oralateral recess,e.g.atitsextremities,arrangedtofacilitateand / ortodirectthefootplate curvatureand / ororientationwhenaxialand / orradialpressureisexertedonthe IOL.Inparticular,suchmaterialfoldand / orlateralrecesscanplaytheroleofa failsafemechanismarrangedtopreventanexcessiveforcetransmissionfromthe25 footplatestothecentralopticalpart.

[0030] Thedistalborderofeachfootplateoptionallycomprisessmoothripples arrangedtosmoothlyhookintotheeyeciliarybody.Advantageously,theripples facilitatethestabilizationoftheIOLintoaciliarybodywhenitisintheimplantation positionintheeye.Theripplesgivearoleofapintothedistalbordertolayand30 2024 / 5938 BE2024 / 5938 -12- stabilizeeasierintoaciliarybody.Theseripplesarepreferablysmoothsothat theircontourscannotirritatetheciliarybodyorotherpartoftheeyeanatomy.

[0031] TheIOLand,specifically,theperipheralhapticpartandthefootplates arepreferablymadeofabiocompatible,flexibleandhighlyresistantmaterial.This materialispreferablyanhydrophilicmaterial.The“rigid”structureofthedomeis5 typicallyinducedbyagreaterthickness(measuredinparalleltotheopticalaxis) inmaterialinaveragethanthatofthefootplates,and / orbyaflaredand / orwide and / orthickshapeofthesupportelements.Incontrast,the“flexibleelongated” featurerelatedtohapticsofthepreferredfootplatesembodimentisinducedby thenatureofthematerialcombinedwithanelongatedgeometryaswellasalow10 averagethickness,notablyincomparisonwiththatofthedome.Inthisdocument, theterm“flexible”referringtothehapticsmayhoweverbeomittedasbeingmore qualitativelyinducedbytheabovedescribedhapticsgeometry.

[0032] Thetwohapticstructuresdescribedconstituteacompromisebetween ononehand,theneedforstabilityandcompliancewithintraocularstructures,15 andontheotherhand,theneedforrigidity,avoidingexcessiveexertionofforce andtraumatodelicateintraocularstructures,manyofwhicharecomplexandnot visibleduringorpriortoimplantation.Theyarestructuredtoensurethatthevault asdescribedaboveisnotsignificantlyaffectedfromcompressionsexertedonthe edgesoftheIOLbytheeyeinternalanatomy.20

[0033] ThisstructurefollowsfromtheindependenceoftheIOLinherentvault heightfromtheIOLexternaldiameter,thisallowingtochoosebothparameters asbeingthemostappropriatetoeyeinternalanatomy(e.g.ACDandciliarybody- to-ciliarybodydistanceasabove)limitingthensuchcompressionsandimpacts onthevault.Inparticular,thedoubledegreeoffreedomallowstominimizethis25 whileensuringabetterharmonizationofthecompressionsforeachIOLsizing.

[0034] Intheframeworkofthepresentdocument,an“opticalaxis”ofaneye consistspreferentiallyinavectorcrossingtheeyefromonesidetotheother, directedbyits“anteriorsegment”,comprisingsuccessively,thecornea,theiris andthelens,toits“posteriorsegment”,comprisingtheretina.ForaphakicIOL30 accordingtotheinventioninanimplantationpositioninaneye,theopticalaxis 2024 / 5938 BE2024 / 5938 -13- oftheeyeisdirectedfromtheIOLanteriorsurfacetotheIOLposteriorsurface andpreferablycorrespondstotheopticalaxisdefinedintrinsicallywithrespectto theIOL.Inparticular,theterm“opticalaxis”ispreferablyusedinthepresent documentasthereferenceaxiswithrespecttotheeyeand / ortotheIOL.

[0035] Intheframeworkofthisdocument,an“anterior”(orresp.“posterior”)5 sideand / orsurfaceofaneyeorIOLpartorconsistspreferablyinasideand / or surfacelocatedupstream(orresp.downstream)ofsaidpartwithrespecttothe vectordefinedbytheopticalaxis.Thisdefinitionextendsnaturallytotheterm “anteriorly”(orresp.“posteriorly”).Bythewayofexamples,inaneye,theirisis locatedanteriorlywithrespecttothecrystallinelens;aposteriorsurfaceofthe10 irisisthenapartoftheiristhatistheclosesttothecrystallinelens.

[0036] Likewise,suchsideand / orsurfaceissaid“anteriorlyconcave”(resp. “anteriorlyconvex”)whenitisseenasconcave(resp.convex)bylookingatthe opticalsurfaceinthesamedirectionandthesamesenseasthevectordefined bytheopticalaxis(i.e.followinglightrayspropagations).Itissaid“posteriorly15 concave”(resp.“posteriorlyconvex”)whenitisseenasconcave(resp.convex) bylookingattheopticalsurfaceinthesamedirectionandtheoppositesenseas thevectordefinedbytheopticalaxis.Inthisdocument,theterm“concave”is generallyusedascorrespondingto“posteriorlyconcave”whenthecontextofits usemakeitclearfortheskilledpersonthatthisisitsmeaning.20

[0037] Theaforementionednotionsofanteriority,posteriorityorevenofan opticalaxisrelativetopartsofaneyeand / orofanIOLarewellknowntoperson skilledintheart.Inparticular,theIOLaccordingtotheinventionisconfiguredto bepositionedintheposteriorchamberofaneye,sothatitsanteriorsurfaceisat leastpartiallyfacingtheirisoftheeyeandsothatitsposteriorsurfaceisatleast25 partiallyfacingthecrystallinelensoftheeye.

[0038] Intheframeworkofthisdocument,theterm“axial”and“axially”refer todirectionsinparalleltotheopticalaxis.ItispreferablysaidthatpartofanIOL extends: -“radially”ifitextendsaccordingtovectorsperpendiculartotheopticalaxis,30 2024 / 5938 BE2024 / 5938 -14- -“radiallyoutward”ifthevectorsaredirectedfromapointincommonwiththe opticalaxistopointsofacirclecenteredatthiscommonpoint;and -“radiallyinward”ifthevectorsaredirectedintheoppositesense. ItisalsopreferablysaidthatapartofanIOLextends“circumferentially”whenit extendspreferablyaccordingtoacirculararconaplaneperpendiculartothe5 opticalaxiscenteredonanintersectionpointofthisplaneandtheopticalaxis. Thesenotionsofradialandcircumferentialextensionsrefertoknownsystemsof polarcoordinatesineachplaneperpendiculartotheopticalaxis.

[0039] Itiswellknownbyapersonskilledintheartthattheadjective“distal” referstoapartofaportionofabodythefurthestformareferenceorganorfrom10 atrunkofabody,andthattheadjective“proximal”referstoaportionofapartof abodytheclosesttoareferenceorganortoatrunkofabody.Intheframework ofthisdocument,thesedefinitionsalsoapplytopartsofaneyeand / orofanIOL, relativetoadistancewithrespecttothereferentialopticalaxis.Bythewayof examples,preferably,aproximalportionofanIOLaccordingtotheembodiment15 abovementionedmaycomprisethecentralopticalpartand / orapartoftheIOL aroundacentralpart,andadistalportionofanIOLaccordingtotheinvention maycomprisethefootplates,oratleasttheirdistalborders.Inparticular,theterm “distal”concerningthe“distal(lateral)border”ofafootplatereferspreferentially tothesetofpointsofthefootplateeachbeingthefurthestfromtheopticalaxis20 alongaradiusperpendiculartotheopticalaxis.

[0040] Intheframeworkofthisdocument,theuseoftheverbs"comprise", “have”,“include”orvariants,doesnotexcludethepresenceofotherelements thanthosementioned.Theuseinthisdocumentoftheterms“a”,"an"or"the",to introduceanelementalsodoesnotexcludethepresenceofseveralofthese25 elements.Also,inthisregard,thepresentapplicationmayusetheterm"plurality" toreferenceaquantityornumber.Inthisregard,theterm"plurality"ismeantto beanynumberthatismorethanone,suchastwo,three,four,five,etc.Unless otherwiseindicated,theterms“about",“approximately”orvariants,inreference toavalue,meansthatthevalueisprovidedwithanerrormarginof10%.30 2024 / 5938 BE2024 / 5938 -15-

[0041] Inthisdocument,theterms“first”,“second”,“third”,andthelikeare usedfordistinguishingsimilarelementswithoutnecessarilyinducingsequential orchronologicalorder,unlessotherwiseindicated.Inthisdocument,thestepsof amethodarepreferablyexecutedintheirpresentationand / ornumberingorder.

[0042] ForlimitingmanipulationsneededtopositiontheIOLbetweentheeye5 crystallinelensandtheirisandmakingmoreeasythefootplatesmaneuverability duringtheimplantationprocess,theperipheralhapticpartispreferablyendowed withamanipulationpocketontheIOLanteriorsurface,radiallyalignedwithone ofthefootplates.Thepocketispreferablydimensionedforcooperatingwithatip ofamanipulationtoolbyakeyedengagementofthetipintothepocket,sothat10 amovingofthefootplatecanbeinducedbyamovingofthetool.Thepocketis typicallyarrangedclosetothefootplateasbeingradiallyalignedwithit.

[0043] Advantageously,nodirectmanipulationofthefootplatesisnecessary whichstronglyreducestheriskofmanipulationerror.Indeed,asthefootplates canbethinandclear,itmaybeeasytomissout,topassthroughtheIOLposterior15 surfaceandtotouchsensibleintraoculartissues,suchasthecrystallinelens.By circumscribingthetipmovementinsuchapocketatlevelofthesoleIOLanterior surface,nosuchhandlingerrorcanoccur.Thepocketisadvantageouswhenthe IOLhastobemanipulateundertheeyeiriswhichisopaque.Indeed,itallowsto guidethetipofthetoolontheanteriorsurfacebyakeyedengagementofthetip20 intothepocket.So,itisnotnecessaryforthesurgeontoseethefootplateunder theirisforpositioningitcorrectly.Itisadvantageouslyenoughforthesurgeonto performappropriate(known)movementswiththetool,whenthetipisengaged inthepocket,forpositioningadequatelythefootplate,withoutnecessarilyseeing it,asdescribedindetailsinthedocumentWO2023 / 021225A2,thecontentof25 whichisintegratedhereinbyreference.Inparticular,thetoolthatcanbeusedis describedindetailsinthisdocument,aswellasthecorrespondingmovements tobeperformedduringtheimplantationprocess.Withthisrespect,thepocketis preferablyespeciallydimensionedforfittingwiththesemovementsandguiding thesurgeonduringtheimplantationprocess.AnextremeslipperinessoftheIOL30 materialdesignmakestheIOLsafeandpainlessfortheeyeintraoculartissues 2024 / 5938 BE2024 / 5938 -16- andmanipulationdifficultiesthatcanarisetherefromisfullycompensatebythe presenceofmanipulationpockets.

[0044] Preferably,thepocketisarranged(atleastpartially)on(theanterior surfaceof)asupportelementtowhichthefootplateismountedwhenitapplies. Thepocketcanhoweveralsoslightlyextendpartiallyonthefootplateitself.Each5 footplateispreferablyassociatedwithsucha(morepreferablyspecific)pocket asmentionedandthehereindescribedembodimentsrelatingto“thepocket”can applytoallthepockets.Thenumberofpocketscancorrespondtothenumberof footplates,eachpocketbeingdedicatedtothemanipulationofasinglefootplate.

[0045] Accordingtoapreferredembodimentoftheinvention,theinherent10 vaultheightoftheIOLischosenamongN>1possiblevalues,andtheexternal diameteroftheIOLischosenamongM>1otherpossiblevalues.TheseNand Mvaluesarepreferablychoseninordertocoveradequatelyinaveragealleye anatomiesasdescribedabove,providingthenonlyN+MIOLmodelsto manufactureandatwodegreeoffreedomforthesurgeontochoosethe15 appropriateIOLtobeimplantedintoaspecificeye.Itcanthenbeprovidedinthe frameworkoftheinventionasetofsuchposteriorchamberphakicIOLs, comprising(preferablyconsistingin)NxMIOLs,allhavingdistinctpairof inherentvaultheightandexternaldiameter.Intheset,twoIOLscanthenhave thesameexternaldiameterbutadifferentinherentvaultheight,ensuringto20 offeringtwoindependentparametersforamorepredictable,preciseandstable positioningofeachIOLinacorrespondingeye’sposteriorchamber.

[0046] Inparticular,thepresentinventionprovidesamethodforchoosinga IOLtobeimplantedintoaposteriorchamberofaneyeamongsuchasetofIOLs,themethodcomprising:25 afirststepof: •measuringtheWtWoftheeye; •selectingtheexternaldiameteroftheIOLastheclosestvaluetoafirst functionofthemeasuredWtWamongsaidMpossiblevalues; asecondstepof:30 •measuringtheACDoftheeye; 2024 / 5938 BE2024 / 5938 -17- •selectingtheinherentvaultheightoftheIOLastheclosestvaluetoasecond functionofthemeasuredACDamongsaidNpossiblevalues; andathirdstepof: •choosingtheIOLamongthesethavingtheselectedinherentvaultheight andexternaldiameter.5

[0047] Thedescriptionandadvantagesregardingtheprecedingembodiment forwhichtheIOLexternaldiameter(resp.inherentvaultheight)isdetermined basedonWtW(resp.ACD)applytothismethod.Thelatterallowstochoosea phakicIOLaccordingtoinventionadequatelydimensionedtobeimplantedinto aposteriorchamberofaneyebasedonsaidpreoperativelydetermined10 parameterssoastoinduceapredictable,preciseandstablepositioningofthe IOL,withouttheneedformanufacturingspecificallytheIOLaccordingtothese parameters.TheaboveembodimentisnotlimitedtotheWtWmeasurementand extendstoequivalentoranalogousdistancesmeasurementperpendicularlyto theIOLopticalaxis,e.g.theciliarybody-to-ciliarybody,asexplainedhereabove.15 ThisembodimentisnotlimitedtotheACDmeasurementandextendstoother equivalentoranalogousdepthmeasurementalongtheIOLopticalaxis,e.g.the crystallinelensrise,asexplainedhereabove.

[0048] IthasbeenconsideredbytheinventorsthatM=3or4,N=2,3or4, provideenoughIOLsinthesettoreachthistechnicaleffect.TheIOLexternal20 diameterispreferablycomprisedbetween11.50and14.50mmwhiletheinherent vaultheightispreferablycomprisedbetween1.00and2.00mmwhenno compressionisexertedontheIOL.ItispreferablyproposedM=3valuesthese beingabout12.70mm,13.20mmand13.60mmormorepreferablyM=4values thesebeingabout11.70mm,12.50mm,13.30mmand14.10mm,eachthen25 coveringawideclassofeye’sposteriorchamberanatomy.Itispreferably proposedN=3values,correspondingtothreedomeheights,“small”,“medium” or“large”,thesebeingabout1.15mm,1.45mmand1.75mm,eachadaptedto awideclassofACD.

[0049] Anotherobjectoftheinventionistoprovideamanufacturingmethod30 ofaphakicIOLtobeimplantedintoaneye’sposteriorchamberinducingamore 2024 / 5938 BE2024 / 5938 -18- predictable,preciseandstablepositioningoftheIOLintheeye.Tothisend,itis providedsuchamethodcomprising: (i)determininganexternaldiameteroftheIOL; (ii)determiningavaultheightinherenttotheIOLindependentlyfromthe externaldiameter;5 (iii)manufacturingtheIOLhavingtheexternaldiameterandtheinherentvault height. ThemethodthereforeprovidesaphakicIOLhavingavaultheightinherenttothe IOLindependentfromanexternaldiameteroftheIOL,sothattheembodiments andtheadvantagesoftheIOLaccordingtotheinventionasdescribedhereinare10 transposedmutatismutandistothepresentmethod.

[0050] Inparticular,preferably,theIOLisdimensionedtobeimplantedintoa posteriorchamberofaneye,andthemanufacturingmethodcomprises: •measuringaWtWtheeyebeforethestep(i),and •measuringanACDoftheeyebeforethestep(ii).15 Theexternaldiameteristhendeterminedatstep(i)dependingonthemeasured WtWandtheinherentvaultheightisdeterminedatstep(ii)dependingonthe measuredACD.ThisembodimentisnotlimitedtotheWtWmeasurementand extendstoequivalentoranalogousdistancesmeasurementperpendicularlyto theIOLopticalaxis,e.g.theciliarybody-to-ciliarybody,asexplainedhereabove.20 ThisembodimentisnotlimitedtotheACDmeasurementandextendstoother equivalentoranalogousdepthmeasurementalongtheIOLopticalaxis,e.g.the crystallinelensrise,asexplainedhereabove.

[0051] Accordingtoapreferredembodiment,asbefore,theIOLto manufacturecomprises:25 -ananteriorsurfaceandaposteriorsurface; -acentralopticalpart(oroptics)comprisingalens,andextendingradially relativetoanopticalaxisdirectedfromtheanteriorsurfacetotheposterior surface; 2024 / 5938 BE2024 / 5938 -19- -aperipheralhapticpartcircumferentiallymountedonthecentralopticalpart andcomprisingdistalsupportelementsarrangedforsupportingtheIOLona ciliaryzonulewhentheIOLisinanimplantationpositioninaneye;and -footplatesmountedontheperipheralhapticpart,preferablyonthesupport elements,andcomprisingadistalborderarrangedforstabilizingtheIOLinto5 aciliarybodywhentheIOLisintheimplantationpositionintheeye. Inthiscase,themanufacturingmethodpreferablycomprises: •betweenthesteps(i)and(iii),designingthefootplatesand / orthesupport elementsasextendingradially(beyondtheproximalborderofthesupport elements)ofalengthdependingontheexternaldiameter;and10 •betweenthesteps(ii)and(iii),designingtheperipheralhapticpartas extendingradiallyoutwardandposteriorlyrelativetothecentralopticalpart ofadepthdependingontheinherentvaultheight. AlltheembodimentsandcorrespondingadvantagesrelatedtothispreferredIOL accordingtotheinventiondescribedabovealsoextendsmutatismutandistothis15 preferredembodimentofthemethod.Inthisdocument,theperipheralhapticpart ispreferablyconstitutedbyamainproximalportion(definingmainlythedome)to whichismounteddistallythedistalsupportelements.Thefootplatesand / orthe distalsupportelementsarethendesignedasabovebetweensteps(i)and(iii)as extendingradiallybeyondthemainproximalportionofalengthdependingonthe20 externaldiameter.ThesameappliestothecorrespondingembodimentoftheIOL objectoftheinvention.Theterms“proximalborderofthedistalsupportelements” canalsobereplacedby“ajunctioncurve(beingtypicallyacircle)betweenthe distalsupportelementsandthemainproximalportion.

[0052] Accordingtoanembodimentofthemanufacturingmethodaccording25 totheinvention,itfurthercomprisesbetweenthesteps(ii)and(iii),designing opticalsurfacesoftheIOLdependingonrefractiveefficienciestobeachieved, theIOLbeingmanufacturedatstep(iii)ascomprisingtheseopticalsurfaces.In particular,theopticalsurfacesasbeingtherestrictionoftheanteriorandposterior surfacesoftheIOLatthecentralopticalpart(orlens)levelcanbeoptimized30 2024 / 5938 BE2024 / 5938 -20- regardingatargeteddioptricpowerandbasedonacrystallinesurfacetomimic asexplainedhereinbefore.

[0053] Thisallowsadesignofalensofthecentralopticalpartthatisbest adaptedtoadefectinvisiontobecorrected.Forinstance,itcanbeamonofocal lensallowingacorrectionofmyopia,hypermetropia,presbyopiaand / orcorneal5 astigmatism.Thelenscanberefractiveordiffractive,and / oratextendeddepth offocus,inordertotreatpresbyopia.Thelenscanbeselectedaccordingtothe stateoftheart.

[0054] Thedisclosedsubjectmatterisfurtherintroducedintheclaims.Asit willbeeasilyunderstoodbyaskilledpersonfromthedisclosureoftheinvention,10 thedependencyoftheclaimscanbeconsideredinabroadermannersothatany possiblecombinationoftheclaims–asfarastheyaretechnicallypossibleand understoodbythepersonskilledintheartinviewofthepresentdisclosure–are partofthepresentdisclosure. Briefdescriptionofthefigures15

[0055] Otherfeaturesandadvantagesoftheinventionwillappearonreading thefollowingdetaileddescription,fortheunderstandingofwhich,referencetothe attacheddrawingsismade.ThedrawingsareincorporatedintheFigures1to8 asintroducedbelow: -Figure1illustratesaglobaltridimensionalanteriorandlateralviewofanIOL20 accordingapreferredembodimentoftheinvention; -Figure1Aillustratesaglobaltridimensionalanteriorandlateralviewofan IOLaccordinganalternativeembodimentoftheinvention; -Figure2illustratesaplanartopviewoftheIOLillustratedinFigure1; -Figure3illustratesasideshadowviewoftheIOLillustratedinFigure1witha25 relativepositioningofanIOLinduceddomeandaneyecrystallinelens; -Figure4illustratesatridimensionalenlargedviewofasectionofasupport elementandafootplateoftheIOLillustratedinFigure1 -Figure5illustratesasectionalviewofpartofaneyewhereinisfittedtheIOL illustratedinFigure1,thelatterbeingillustratedbyasideshadowview;30 2024 / 5938 BE2024 / 5938 -21- -Figure6illustratesinterferencesbetweenradialcompressionsintotheeye andaxialpositioninganIOLaccordingtotheinventiononpartofFigure5; -Figure7illustratesanexecutionofthemanufacturingmethodaccordingto theinventiononsideshadowviewsoftheIOLtomanufacture; -Figure8illustratestheindependenceofthevaultheightinherenttoanIOLof5 theinventionfromitsexternaldiameteronasideshadowviewoftheIOL.

[0056] Thedrawingsaretypicallynotscaled.Similarelementsaregenerally assignedbysimilarreferences.Inthisdocument,identicaloranalogouselements mayhavethesamereferences.Referenceinthedrawingscannotbeconsidered tobelimiting,comprisingwhenthesereferencesareindicatedintheclaims.10 Detaileddescriptionofspecificembodimentsoftheinvention

[0057] Thispartofthisdocumentpresentsafulldescriptionofspecificand preferredembodimentsofthepresentinventionwithreferencestothedrawings. Theinventionishowevernotlimitedbythesereferences.TheFiguresthatwere introducedaboveareinparticularonlyschematicandnotlimitinginanyway.15

[0058] SomeoftheFiguresareprovidedwithabstractgeometricmarksand correspondingreferencessubstantiallyusedtoquantifyand / orvisualizetechnical characteristicsofembodimentsoftheinventionsuchasmeasuresorgeometric characteristics.Thesegeometricmarksgenerallydonotcorrespondtoconcrete materialobjects.20

[0059] TheinventionprovidesaposteriorchamberphakicIOLadaptedtoa broadrangeofeyeanatomies,easytoimplantandpostoperativelystableinan implantationpositioninaneye9,axiallyalonganopticalaxisZ,radiallyandin rotationinaplaneperpendiculartotheopticalaxisZbasedonvectors(oraxis) XandY.Inparticular,asillustratedinFigure1,theaxisX,YandZforman25 orthogonalbasisoftheEuclidiantridimensionalspace.Asconventionally,the opticalaxisZisdirectedfromananteriorsurface11toaposteriorsurface12 (referencedonFigures1and3)oftheIOL1.

[0060] AsrepresentedonFigure5,theIOL1isintendedtobepositionedin theposteriorchamber96ofaneye9.Otherelementsoftheeye9anatomyare30 2024 / 5938 BE2024 / 5938 -22- illustratedonFigure5:acornea91,aniris92,apupil93,acrystallinelens94, ananteriorchamber95,aciliaryzonule97andaciliarybody98oftheeye9.The white-to-whitedistanceisrepresentedbyWtW,andtheanteriorchamberdepth byACD(measuredpriortotheIOL1implantation).

[0061] AsillustratedinFigures1and2,theIOL1hasacentralopticalpart25 extendingradiallyrelativetotheopticalaxisZonamaximalexternaldiameter comprisedbetween4.5and6.7mm,preferablyofabout5.8mm.Itcomprisesa throughbore21extendingalongtheopticalaxisZbetweentheanterior11and posterior12surfaces,sothatafluidcommunicationispossiblebetweenthese surfaces.Thecentralopticalpart2alsocomprisesorientationmarks22inform10 oftwopairofdiametricallyopposedtinysuperficial(nonthrough)holesaligned alongaxisYontheanteriorsurface11.Thosemarks22canbeusedfororienting theIOL1duringitsimplantation,whichisinparticularusefulfortoricIOL1.The orientationmark22cantakevariousotherformssuchasatleastonesuperficial linemadebylaser,mild,orengravingontheanteriorsurface11oftheIOL1.15 Exemplarydiametersvaluesofthethroughbore21andeachsuperficialholeare respectivelyabout0.36and0.12mm.Otherorientationmarks(notshown)such assmalllateralbarsontheperipheralhapticpart3canbeusedtoavoidupside- downimplantation.

[0062] Thecentralopticalpart2issurroundedbyhapticstructuresamong20 whichaperipheralhapticpart3circumferentiallyandproximallymountedonthe centralopticalpart2.Theperipheralhapticpart3extendsradiallyoutwardand posteriorlyrelativetothecentralopticalpart2ofadepthmeasuredalongthe opticalaxisZdependingonadesiredIOL1inherentvaultheight89Aillustrated onFigure3and5.ThelatterisdeterminedpriortotheIOL1implantationbased25 ontheACDasexplainedinthedisclosure.Theperipheralhapticpart3extends furtherradiallyalongaxisYthanalongaxisX,sothattheIOLhasaglobalplanar formelongatedalongaxisYasillustratedonFigure2.

[0063] Theperipheralhapticpart3iscomposedofamainproximalportion 34andtwodiametricallyopposeddistalsupportelements4.Themainproximal30 portion34comprisestwoperi-opticalholes33arrangedproximallyclosetothe 2024 / 5938 BE2024 / 5938 -23- boundarywithcentralopticalpart2,alongaxisY,symmetricallywithrespectto theopticalaxisZ.Theperi-opticalholes33crosstheIOL1throughtheanterior 11andtheposterior12surfacessothattheyallowafluidflowduringtheIOL1 implantationprocess.AsrepresentedonFigure2,theperi-opticalholes33are comprisedinaIOL1partcenteredontheopticalaxisZofadiametercomprised5 between7.2to8.0mm,preferablyofabout7.45mm.Theperi-opticalholes33 arepreferablyquitesimilartothethroughbore21intermsofsize.

[0064] Thesupportelements4areattachedondiametricallyopposeddistal extremitiesofmainproximalportion34,inmirrorsymmetrywithrespecttoaplane basedonaxisXandontheopticalaxisZ.Theyhavetheformofaringportion10 extendingcircumferentiallyaroundtheopticalaxisZ,eachalonganarcofcircle withacentralangleβbetween60°and80°,e.g.ofabout70°(visibleonFigure 2).Asitisknown,theterm“centralangle”refersgenerallytotheanglesubtended bythecirculararc.Inparticular,itistheangleatacenterofcircleofthecircular arcofatrianglewhosevertexaresaidcenterandthetwoextremitiesofthe15 circulararc.An(distally)extremalborder41ofeachsupportelement4extends inparticularalonganarcofcircleofaradius82comprisedbetween4.5and5.8 mm,thevalueofwhichcandependontheIOLexternaldiameter81.

[0065] Inparticular,thewholeperipheralhapticpart3andthecentraloptical part2areinscribedinacylinderoftheradius82whichextendsaroundtheoptical20 axisZ,sotoformadomeK(ordomeassembly)withadesiredinherentvault height89Awhichissupportedposteriorlybythesupportelements4.Also,the mainproximalportion34andthecentralopticalpart2areinscribedinacylinder ofadiameter83(thatcanbealsocalled“internaldiameter”intheframeworkof thisdocument)whichextendsaroundtheopticalaxisZ,sotoformthedomeK25 (withoutthefeet)withadesiredinherentvaultheight89A.Thisdiameter83is independentfromtheIOLexternaldiameter81andcanhavee.g.threevaluesof about9.0,10.2and11.3mm,respectivelyforthethreedomeheights(ordomes) hereindescribed.AsshownonFigures3and5,thedomeKhasaposterior surfacetotopacrystallinelens94whentheIOL1isinitsimplantationposition30 2024 / 5938 BE2024 / 5938 -24- inaneye9.Thedistalsupportelements4arethenarrangedforsupportingthe IOL1onaciliaryzonule97oftheeye9.

[0066] ThedomeKposteriorsurfaceisconcave,smooth,andcurvedwitha preferredradiuskofcurvatureofabout10mmcompatiblewiththecurvatureof thecrystallinelens94anteriorsurface,sothatavault89Badjustablebetween5 250and750µmcanbeensuredbetweentheIOL1andthecrystallinelens94 whentheIOL1isinitsimplantationpositionasshownonFigure5.

[0067] A“wallthickness”confersrigiditytothedomeKsothatitisresistant underaxialand / orradialcompression.ThethicknessofthedomeKaroundthe opticalaxisZmaybeabout0.20mm,thenitincreasesradiallytillreachingthe10 proximalboundaryoftheperipheralhapticpart3,havingforinstanceathickness ofabout0.60mm,andfinallydecreasesradiallytillthesupportelements4having athicknessgenerallycomprisedbetween0.15to0.30mm(withouttakinginto accountthepocketsintroducedhereafter).Thesevaluesareselectedsothatthe domeKisabletoconstituteasufficientlyrigidandbroadstructuretosurround15 andtopanteriorlyacrystallinelens94,andtherebytobeimplantedinabroad rangeofeyeanatomies,whilebeingstableinparalleltotheopticalaxisZ.

[0068] AsillustratedclearlyinFigures1,2and4,theIOL1alsocomprises twopairofdiametricallyopposedfootplates5asflexiblehapticseachelongated fromafirstextremity51toasecondextremity52bothdirectlymountedonone20 ofthedistalsupportelements4.ThefootplatesextendradiallyalongaxisYfrom andbeyondtheperipheralhapticpart3ofalengthwhichcandependornoton adesiredexternaldiameter81oftheIOL1anddependsonradialcompression exertedontheIOL1.Theexternaldiameter81isdeterminedpriortotheIOL1 implantationbasedontheWtWoronaciliarybody-to-ciliarybody(orequivalent)25 measurementasexplainedinthedisclosureoftheinvention,sothatitiswell adaptedtotheeye9anatomy.AsshownonFigure2,theextremalborder41 extendsbetweenthefirst51andthesecond52extremitiesalongacirculararc oftheradius82withacentralangleδcomprisedbetween15°and45°,e.g.of about20°to25°.Eachfootplate5hasaformofapartialloopborderingacavity30 32extendingfromtheanterior11totheposterior12surfaces. 2024 / 5938 BE2024 / 5938 -25-

[0069] Eachcavity32ismoreextendedintermsofareaperpendicularlyto theopticalaxisZthanthecorrespondingfootplate5.Inparticular,asshownon Figure4,amaximalradiallength86ofeachcavity32is(much)greaterthana maximaldiameter87ofanycrosssectionCofthefootplate5.Thisradiallength 86iscomprisedbetween0.60and0.90mm,preferablyofabout0.70mm,and5 theradiallengthofsaidcrosssectionCispreferablycomprisedbetween0.20 and0.40mm.ThesurfaceoftheIOL1extendingradiallyfurtherthanthecircle ofradius82isthereforeemptierofasolidmatterthatfullofasolidmatter.Each footplate5canhaveaconstantthickness83A(shownonFigure3)comprised between0.10and0.30mm,preferablyofabout0.17mm.Thesedatacontributes10 togiveagreatflexibilitytothefootplates5.

[0070] TheIOL1isinscribedinacylinderoftheexternaldiameter81witha preferredvaluebetween11.5and14.5mmpriortoimplantation,whennoaxial orradialcompressionisexertedontheIOL1.Eachfootplate5extendsbetween thecircleofradius82andthecircleofexternaldiameter81,sothatitsflexibility15 allowstocompensatesizevariationsofananatomicalspaceavailableintheeye posteriorchamber96fortheIOL1whenthelatterisinitsimplantationposition withoutsignificantlyaffectingthedomeKpositioningasexplainedaboveinthe disclosureoftheinvention.Withthisrespect,theinherentvaultheight89Aand theexternaldiameter81areindependentonefromtheotherforensuringamore20 predictable,preciseandstablepositioningoftheIOL1.

[0071] Indeed,thisindependenceavoidstotargetthepositioningoftheIOL 1alongtheopticalaxisZbasedonanexpectedradialcompressionsontheIOL 1intotheeye9whichleadtoerrorsandunstablepositioning.Suchpositioning isshownonFigure6withdoublearrowsandfictivehingesonjunctionsbetween25 thecentralopticalpart2andtheperipheralhapticpart3,andbetweenthelatter andthefootplates5:whenaradialcompressionisexertedtowardtheIOL1(left arrow),theIOL1structures(schematizedbysaidhinges)inducesapushingof thecentralopticalpartanteriorly(uparrow),andreversely.BytargetingtheIOL 1inherentvaultheight89A(andconsecutivelythevault89B)independentlyfrom30 theexternaldiameter81,eachoftheseparametersismoreadaptedtotheeye9 2024 / 5938 BE2024 / 5938 -26- anatomyforrespectiveaxialpositioning(bythedomeK)andradial / rotational positioning(bythefootplates5)oftheIOL1asdetailedhereabove,sothatthe axialpositioningoftheIOL1isindependentoratleaststronglylessdependent onradialcompressionsonthefootplates5accordingtothemechanismshown onFigure6.5

[0072] Eachfootplate5isspeciallydesignedforfoldingand / orcurvingwhen compressionisexertedaxiallyand / orradiallyonIOL1,insuchawaythatan adjustableanglebetweentheopticalaxisZandanormalvectortoaplaneof extensionofthefootplate5isgenerallycomprisedbetween-15°and15°.Each footplate5comprisesadistalborder53extendingcircumferentiallyandradially10 outwardrelativetothesupportelement4onwhichitismounted.Thisdistal border53isinparticulararrangedforstabilizingtheIOL1intotheciliarybody98 whentheIOL1isinitsimplantationpositionasillustratedonFigure5.Itactsas ananchorforstabilizingtheIOL1inrotationinaplaneperpendiculartothe opticalaxisZasdetailedinthedisclosureoftheinvention.Thedistalborder5315 mayoptionallybearrangedforstabilizingtheIOL1intotheciliarysulcusofthe eye9,ormoregenerallywithinacorrespondingeyestructure(takingintoaccount possiblepracticalpositionvariationinthefootplatesduringIOLimplantation),so thattheterms“ciliarybody”inthepresentdocumentcouldoptionallybereplaced by“ciliarybodyand / orsulcus”.20

[0073] Thedistalborder53iscomposedofafirst54andasecond55portions particularlyvisibleonFigure1.AsrepresentedonFigure2,thesecondportion 55extendsalongacirculararcoftheexternaldiameter81withacentralangleγ comprisedbetween7.5°to20°,andtypicallyofabout10°whennoaxialorradial compressionisexertedontheIOL1.Itconsiststhereforeinthemostdistalpart25 ofthedistalborder53.Thefirstportion54,foritspart,extendsfromthesecond extremity52tothesecondportion55.

[0074] TheIOL1hasasmoothlateralchamfer31extendingsmoothlyand continuously,fromasupportelement4onwhichismountedafootplate5,tothe firstportion54ofthedistalborder53.Thischamfer31extendsonthesupport30 element4andonthefirstportion54ofthedistalborder53,sothatasproviding 2024 / 5938 BE2024 / 5938 -27- acontinuousandsmoothlateraltransitionbetweentheperipheralhapticpart3 andfootplates5viaoneofthefootplateextremity,e.g.thesecondextremity52. ThistransitionisparticularlyhelpfulforimplantingtheIOL1becauseitallowsto insertsmoothlythefootplates5undertheeyeiris92.Optionally,thechamfer31 canextendonallthedistalborder53(notshown).5

[0075] Eachfootplate5mayconsistsubstantiallyinthreeportions:anatural firstwidthextensionofthefirstportion54,anaturalsecondwidthextensionof thesecondportion55,andathirdportion56visibleonFigure1connectingthe naturalsecondwidthextensionandthefirstextremity51.Themainextension trajectoryofthesefootplateportionsextendsrespectivelybothcircumferentially10 andradially,substantiallyonlycircumferentiallyandsubstantiallyonlyradiallyin adirectionhavingasmalleranglewithaxisY(correspondingtypicallyto(1 / 2)(β- 2δ))comprisedbetween5and60°,e.g.ofabout7.5°inthecaseoftheillustrated embodimentoftheinvention.Thisangleallowsadvantageouslytodecreasethe exertedcompressionforcesontheIOL1whenitisinitsimplantationposition.In15 particular,ahigheranglethan7.5°,suchas10°,12.5°,15°,17.5°,20°,25°,30° or40°isalsopreferredasthegreateritis,theloweraretheexertedcompression forcesontheIOL1.

[0076] Theglobaldesignofthefootplates5isdeterminedtofacilitatetheIOL 1implantationprocess.Inparticular,thechamfer31canhaveaconcavesmooth20 externalsurfacesothateachfootplate5isdistallyorientedinaconvergentway towardtheaxisY.Movementstoinsertthefootplates5undertheiris92arethen greatlyeasier.Theextremalborder41ofeachdistalsupportelement4extends furtherbetweenthefirstextremities51offootplates5oftwodifferentpairsalong acirculararcoftheradius82withacentralangleofabout15to20°.25

[0077] TheillustratedembodimentoftheIOL1hastwodiametricallyopposed supportelements4andfourfootplates5,symmetricallyarranged,forensuringa goodstabilityoftheIOLunderaxialand / orradialcompressions,aswellasin rotation.Inparticular,whenacompressionlateralforceoccurs,theIOL1design absorbsefficientlythelatterpartiallywithinthefootplates5arrangedaccording30 toapredeterminedexternaldiameter81,sothatthedomeKisadvantageously 2024 / 5938 BE2024 / 5938 -28- axiallystablewithaninherentvaultheight89Adedicatedtotheeye9anatomy. Theuseoffourfootplates5symmetricallyarranged(e.g.onthecornersofa rectangle)isfurtherpreferredbecausethismitigatesanypossibletiltingeffect. However,thescopeoftheinventionisnotlimitedtothisspecificnumbersand arrangementsofsupportelements4andfootplates5.5

[0078] Giventhatthefootplates5areparticularlyflexible,itisadvantageous toprovidetheIOL1withastructureforhelpingtocontrolthemovementsofthe footplates5duringtheimplantationprocessandtoinsertthemundertheiris92. Tothisend,thesupportelements4cancomprisemanipulationpockets6onthe IOLanteriorsurface11seenonFigures1,2and4.Eachpocket6isassociated10 withafootplate5structurallyandfunctionally.Inparticular,structurallyspeaking, eachpocket6facestheassociatedfootplate5,sothatonlytheextremalborder 41separatesthecavity32fromthepocket6.Eachpocket6isalsoradially alignedbetweenthefirst51andsecond52extremitiesofthecorresponding footplate5,whichimprovefurtherthefootplate5manipulationbyanengagement15 ofthetooltipintothepocket6.Thepockets6remainhoweveroptionalandthe scopeoftheinventionisnotlimitedtotheirpresenceorform.Acircumferential trench63canbedefinedtherefromontheIOLanteriorsurface11extendingin paralleltothefootplate5andcomprisingradiallyinwardsextensions64arranged attwocircumferentialextremitiesofthetrench63,inmirrorsymmetrieswiththe20 footplateextremities51and52.

[0079] Thetrench63hasaroughbottomsurface61andlateraledges62of anaxialheightofabouthalfofathicknessofthecorrespondingsupportelement 4.Thecorrespondingaxialheightiscomprisedbetween0.075and0.125mm, preferablybetween0.08and0.09mm.Amostdistallateraledge,attheboundary25 withtheextremalborder41,maybeshapedinahalfcylindricalformwithradius 0.06mm.Suchapocketiseasytomanufactureandisfullysatisfactoryforthe describedmanipulationpurpose.Thesegeometricalfeaturesofthepockets6are providedinordertoallowafunctionalcooperationwithatipofamanipulationtool byageometricalkeyedengagementofthetipintothepocket6,soappropriate30 2024 / 5938 BE2024 / 5938 -29- movingofthefootplate5duringtheimplantationprocessoftheIOL1canbe inducedbyamovingofthetoolasexplainedindetailedinWO2023 / 021225A2.

[0080] Asmentionedhereabove,theinventionisnotlimitedtothefootplates 5ofFigure1andtothepresenceofmanipulationpockets6.Forinstance,Figure 1AillustratesanotherembodimentoftheIOL1accordingtotheinvention,where5 thefootplates5aremassivefootplates,withoutcavities32,andwithoutpockets 6,whichisfullypartofthescopeoftheinvention.

[0081] AnembodimentofthephakicIOL1manufacturingmethodaccording totheinventionisrepresentedonFigure7.Continuouslinesrepresentpartofthe IOL1designedatapendingstep(A),(B)or(C)ofthemethod,beforetheIOL110 tobemanufactureafterwards.DottedlinesrepresentotherpartoftheIOL1.For eachstep,threedesignoptionsfortheIOL1partdesignedatthestepareshown butmoreorlesscanbeconsidered.Inthissense,althoughitishereinreferred toasamanufacturingmethodaccordingtotheinvention,thiscanalsobeseen asanexecutionoftheIOLchoosingmethodaccordingtotheinvention(wherein15 M=N=3,forsaidthreedesignoptions),(A)beingthefirststep,(B)thesecond step,and(C)beinganextrastepofchoosinganappropriateopticsorlens.Steps (A),(B)and(C)canalsobereferredtoasa“designmethod”oftheIOL1priorto itsmanufacturingintheframeworkofthisdocument.

[0082] Atstep(A),the“best”externaldiameter81oftheIOL1isdetermined.20 ThiscanbedoneonthebasisoftheWtWoftheeye9preoperativelymeasured intheX-Yplane(i.e.horizontally),oronthebasisofothermeasuresasexplained inthedisclosureoftheinvention.Basedonstep(B),thefootplates5andthe supportelements4willthenbedesignedasextendingradiallyfromandbeyond thedistalextremityofthemainproximalportion34oftheperipheralhapticpart325 (orequivalentlyfromandbeyondthesupportelements4proximalborder,i.e. fromandbeyondacylinderextendingaroundtheopticalaxisZwithadiameter 83accordingtothedomegeometrysetatstep(B)),totheexternaldiameter81. Forinstance,thesupportelements4extendradiallymoreorlessdependingon theexternaldiameter81toreach,sothattheradius82isvariable,whilethe30 footplates5keepthesamegeometryandsize(priortoimplantation).Thisavoids 2024 / 5938 BE2024 / 5938 -30- compressionuncertaintiesonthefootplates5iftheirradiallengthhadtobe changeddependingontheexternaldiameter81.However,consideringfootplates 5ofvariableradiallength(withorwithoutaradius82thatmaybeconstant)for reachingthedesiredexternaldiameter81isalsofullypartoftheinvention.

[0083] The“best”vaultheight89AinherenttotheIOL1isdeterminedatstep5 (B)independentlyfromtheexternaldiameter81ofstep(A).Itisconsideredfor thisdesignstep(B)onlythedomeKoftheIOL1.Theinherentvaultheight89A canbedeterminedonbasisoftheACDoftheeye9preoperativelymeasured alongtheopticalaxisZ.ThedomeKisthencustomizedsothattheperipheral hapticpart3extendsradiallyoutwardtothecylinderofradius82(oralso10 specificallysothatthemainproximalportion34extendsradiallyoutwardtothe cylinderofappropriatediameter83)andposteriorlyrelativetothecentraloptical part2ofadepth(measuredalongtheopticalaxisZ)correspondingtothe inherentvaultheight89A.Optionally,thedomeKisbasedontheanteriorsurface radiusofcurvatureofthecrystallinelens.15 [0084,