已阅读5页，还剩40页未读， 继续免费阅读
版权说明：本文档由用户提供并上传，收益归属内容提供方，若内容存在侵权，请进行举报或认领
文档简介
EUROPEANSTANDARDNORMEEUROPENNEEUROPISCHENORMENISO119797SEPTEMBER2014ICS1104070SUPERSEDESENISO1197972006ENGLISHVERSIONOPHTHALMICIMPLANTSINTRAOCULARLENSESPART7CLINICALINVESTIGATIONSISO1197972014IMPLANTSOPHTALMIQUESLENTILLESINTRAOCULAIRESPARTIE7INVESTIGATIONSCLINIQUESISO1197972014OPHTHALMISCHEIMPLANTATEINTRAOKULARLINSENTEIL7KLINISCHEPRFUNGENISO1197972014THISEUROPEANSTANDARDWASAPPROVEDBYCENON18JULY2014CENMEMBERSAREBOUNDTOCOMPLYWITHTHECEN/CENELECINTERNALREGULATIONSWHICHSTIPULATETHECONDITIONSFORGIVINGTHISEUROPEANSTANDARDTHESTATUSOFANATIONALSTANDARDWITHOUTANYALTERATIONUPTODATELISTSANDBIBLIOGRAPHICALREFERENCESCONCERNINGSUCHNATIONALSTANDARDSMAYBEOBTAINEDONAPPLICATIONTOTHECENCENELECMANAGEMENTCENTREORTOANYCENMEMBERTHISEUROPEANSTANDARDEXISTSINTHREEOFFICIALVERSIONSENGLISH,FRENCH,GERMANAVERSIONINANYOTHERLANGUAGEMADEBYTRANSLATIONUNDERTHERESPONSIBILITYOFACENMEMBERINTOITSOWNLANGUAGEANDNOTIFIEDTOTHECENCENELECMANAGEMENTCENTREHASTHESAMESTATUSASTHEOFFICIALVERSIONSCENMEMBERSARETHENATIONALSTANDARDSBODIESOFAUSTRIA,BELGIUM,BULGARIA,CROATIA,CYPRUS,CZECHREPUBLIC,DENMARK,ESTONIA,FINLAND,FORMERYUGOSLAVREPUBLICOFMACEDONIA,FRANCE,GERMANY,GREECE,HUNGARY,ICELAND,IRELAND,ITALY,LATVIA,LITHUANIA,LUXEMBOURG,MALTA,NETHERLANDS,NORWAY,POLAND,PORTUGAL,ROMANIA,SLOVAKIA,SLOVENIA,SPAIN,SWEDEN,SWITZERLAND,TURKEYANDUNITEDKINGDOMEUROPEANCOMMITTEEFORSTANDARDIZATIONCOMITEUROPENDENORMALISATIONEUROPISCHESKOMITEEFRNORMUNGCENCENELECMANAGEMENTCENTREAVENUEMARNIX17,B1000BRUSSELS2014CENALLRIGHTSOFEXPLOITATIONINANYFORMANDBYANYMEANSRESERVEDWORLDWIDEFORCENNATIONALMEMBERSREFNOENISO1197972014EBSENISO1197972014ENISO1197972014E3FOREWORDTHISDOCUMENTENISO1197972014HASBEENPREPAREDBYTECHNICALCOMMITTEEISO/TC172“OPTICSANDPHOTONICS”INCOLLABORATIONWITHTECHNICALCOMMITTEECEN/TC170“OPHTHALMICOPTICS”THESECRETARIATOFWHICHISHELDBYDINTHISEUROPEANSTANDARDSHALLBEGIVENTHESTATUSOFANATIONALSTANDARD,EITHERBYPUBLICATIONOFANIDENTICALTEXTORBYENDORSEMENT,ATTHELATESTBYMARCH2015,ANDCONFLICTINGNATIONALSTANDARDSSHALLBEWITHDRAWNATTHELATESTBYMARCH2015ATTENTIONISDRAWNTOTHEPOSSIBILITYTHATSOMEOFTHEELEMENTSOFTHISDOCUMENTMAYBETHESUBJECTOFPATENTRIGHTSCENAND/ORCENELECSHALLNOTBEHELDRESPONSIBLEFORIDENTIFYINGANYORALLSUCHPATENTRIGHTSTHISDOCUMENTSUPERSEDESENISO1197972006ACCORDINGTOTHECENCENELECINTERNALREGULATIONS,THENATIONALSTANDARDSORGANIZATIONSOFTHEFOLLOWINGCOUNTRIESAREBOUNDTOIMPLEMENTTHISEUROPEANSTANDARDAUSTRIA,BELGIUM,BULGARIA,CROATIA,CYPRUS,CZECHREPUBLIC,DENMARK,ESTONIA,FINLAND,FORMERYUGOSLAVREPUBLICOFMACEDONIA,FRANCE,GERMANY,GREECE,HUNGARY,ICELAND,IRELAND,ITALY,LATVIA,LITHUANIA,LUXEMBOURG,MALTA,NETHERLANDS,NORWAY,POLAND,PORTUGAL,ROMANIA,SLOVAKIA,SLOVENIA,SPAIN,SWEDEN,SWITZERLAND,TURKEYANDTHEUNITEDKINGDOMENDORSEMENTNOTICETHETEXTOFISO1197972014HASBEENAPPROVEDBYCENASENISO1197972014WITHOUTANYMODIFICATIONBSENISO1197972014ISO1197972014EISO2014ALLRIGHTSRESERVEDIIICONTENTSPAGEFOREWORDIV1SCOPE12NORMATIVEREFERENCES13TERMSANDDEFINITIONS14JUSTIFICATIONFORACLINICALINVESTIGATION15ETHICALCONSIDERATIONS16GENERALREQUIREMENTS161GENERAL162DESIGN263CHARACTERISTICS264INVESTIGATIONDURATION465ENROLLMENT466BILATERALIMPLANTATION467SURGICALTECHNIQUE468EXAMINATIONANDTREATMENTOFSUBJECTS569ADVERSEEVENTSREPORTS5610INCLUSIONANDEXCLUSIONCRITERIA5ANNEXAINFORMATIVEELEMENTSOFACLINICALINVESTIGATION7ANNEXBINFORMATIVEEVALUATIONOFPOSTOPERATIVEADVERSEEVENTANDVISUALACUITYRATES15ANNEXCINFORMATIVEADDITIONALELEMENTSFORTORICIOLS19ANNEXDINFORMATIVEADDITIONALELEMENTSFORACCOMMODATINGIOLS26ANNEXEINFORMATIVECLINICALTESTS35BIBLIOGRAPHY41BSENISO1197972014ISO1197972014EFOREWORDISOTHEINTERNATIONALORGANIZATIONFORSTANDARDIZATIONISAWORLDWIDEFEDERATIONOFNATIONALSTANDARDSBODIESISOMEMBERBODIESTHEWORKOFPREPARINGINTERNATIONALSTANDARDSISNORMALLYCARRIEDOUTTHROUGHISOTECHNICALCOMMITTEESEACHMEMBERBODYINTERESTEDINASUBJECTFORWHICHATECHNICALCOMMITTEEHASBEENESTABLISHEDHASTHERIGHTTOBEREPRESENTEDONTHATCOMMITTEEINTERNATIONALORGANIZATIONS,GOVERNMENTALANDNONGOVERNMENTAL,INLIAISONWITHISO,ALSOTAKEPARTINTHEWORKISOCOLLABORATESCLOSELYWITHTHEINTERNATIONALELECTROTECHNICALCOMMISSIONIECONALLMATTERSOFELECTROTECHNICALSTANDARDIZATIONTHEPROCEDURESUSEDTODEVELOPTHISDOCUMENTANDTHOSEINTENDEDFORITSFURTHERMAINTENANCEAREDESCRIBEDINTHEISO/IECDIRECTIVES,PART1INPARTICULARTHEDIFFERENTAPPROVALCRITERIANEEDEDFORTHEDIFFERENTTYPESOFISODOCUMENTSSHOULDBENOTEDTHISDOCUMENTWASDRAFTEDINACCORDANCEWITHTHEEDITORIALRULESOFTHEISO/IECDIRECTIVES,PART2WWWISOORG/DIRECTIVESATTENTIONISDRAWNTOTHEPOSSIBILITYTHATSOMEOFTHEELEMENTSOFTHISDOCUMENTMAYBETHESUBJECTOFPATENTRIGHTSISOSHALLNOTBEHELDRESPONSIBLEFORIDENTIFYINGANYORALLSUCHPATENTRIGHTSDETAILSOFANYPATENTRIGHTSIDENTIFIEDDURINGTHEDEVELOPMENTOFTHEDOCUMENTWILLBEINTHEINTRODUCTIONAND/ORONTHEISOLISTOFPATENTDECLARATIONSRECEIVEDWWWISOORG/PATENTSANYTRADENAMEUSEDINTHISDOCUMENTISINFORMATIONGIVENFORTHECONVENIENCEOFUSERSANDDOESNOTCONSTITUTEANENDORSEMENTFORANEXPLANATIONONTHEMEANINGOFISOSPECIFICTERMSANDEXPRESSIONSRELATEDTOCONFORMITYASSESSMENT,ASWELLASINFORMATIONABOUTISOSADHERENCETOTHEWTOPRINCIPLESINTHETECHNICALBARRIERSTOTRADETBTSEETHEFOLLOWINGURLFOREWORDSUPPLEMENTARYINFORMATIONTHECOMMITTEERESPONSIBLEFORTHISDOCUMENTISISO/TC172,OPTICSANDPHOTONICS,SUBCOMMITTEESC7,OPHTHALMICOPTICSANDINSTRUMENTSTHISSECONDEDITIONCANCELSANDREPLACESTHETHIRDEDITIONISO1197972006,WHICHHASBEENTECHNICALLYREVISEDITALSOINCORPORATESTHEAMENDMENTISO1197972006/AMD12012ISO11979CONSISTSOFTHEFOLLOWINGPARTS,UNDERTHEGENERALTITLEOPHTHALMICIMPLANTSINTRAOCULARLENSESPART1VOCABULARYPART2OPTICALPROPERTIESANDTESTMETHODSPART3MECHANICALPROPERTIESANDTESTMETHODSPART4LABELLINGANDINFORMATIONPART5BIOCOMPATIBILITYPART6SHELFLIFEANDTRANSPORTSTABILITYTESTINGPART7CLINICALINVESTIGATIONSPART8FUNDAMENTALREQUIREMENTSPART9MULTIFOCALINTRAOCULARLENSESPART10PHAKICINTRAOCULARLENSESIVISO2014ALLRIGHTSRESERVEDBSENISO1197972014INTERNATIONALSTANDARDISO1197972014EOPHTHALMICIMPLANTSINTRAOCULARLENSESPART7CLINICALINVESTIGATIONS1SCOPETHISPARTOFISO11979SPECIFIESPARTICULARREQUIREMENTSFORCLINICALINVESTIGATIONSFORPOSTERIORANDANTERIORCHAMBERINTRAOCULARLENSESIOLS2NORMATIVEREFERENCESTHEFOLLOWINGDOCUMENTS,INWHOLEORINPART,ARENORMATIVELYREFERENCEDINTHISDOCUMENTANDAREINDISPENSABLEFORITSAPPLICATIONFORDATEDREFERENCES,ONLYTHEEDITIONCITEDAPPLIESFORUNDATEDREFERENCES,THELATESTEDITIONOFTHEREFERENCEDDOCUMENTINCLUDINGANYAMENDMENTSAPPLIESISO119791,OPHTHALMICIMPLANTSINTRAOCULARLENSESPART1VOCABULARYISO1197910,OPHTHALMICIMPLANTSINTRAOCULARLENSESPART10PHAKICINTRAOCULARLENSESISO14155,CLINICALINVESTIGATIONOFMEDICALDEVICESFORHUMANSUBJECTSGOODCLINICALPRACTICEISO14971,MEDICALDEVICESAPPLICATIONOFRISKMANAGEMENTTOMEDICALDEVICES3TERMSANDDEFINITIONSFORTHEPURPOSESOFTHISDOCUMENT,THETERMSANDDEFINITIONSGIVENINISO119791ANDISO14155APPLY4JUSTIFICATIONFORACLINICALINVESTIGATIONIFTHENEEDFORACLINICALINVESTIGATIONISIDENTIFIED,THEREQUIREMENTSOFISO14155SHALLAPPLY,WITHADDITIONALREQUIREMENTSGIVENBELOWIFANEWIOLMODELISAMODIFICATIONOFAMODELFORWHICHTHESAFETYANDPERFORMANCEHAVEBEENESTABLISHEDTHROUGHCLINICALINVESTIGATIONINACCORDANCEWITHTHISPARTOFISO11979NOORLIMITEDCLINICALINVESTIGATIONISNEEDEDISO/TR229791PROVIDESGUIDANCEINDETERMININGWHETHERORNOTAMODIFICATIONISMINOR5ETHICALCONSIDERATIONSFORCLINICALINVESTIGATIONSOFMEDICALDEVICESFORHUMANSUBJECTS,THEREQUIREMENTSINISO14155SHALLAPPLY6GENERALREQUIREMENTS61GENERALTHEREQUIREMENTSFORACLINICALINVESTIGATIONGIVENINISO14155SHALLAPPLY,WITHADDITIONALREQUIREMENTSGIVENBELOWISO2014ALLRIGHTSRESERVED1BSENISO1197972014ISO1197972014E62DESIGN621GENERALACLINICALINVESTIGATIONSHALLBEDESIGNEDTOCOMPARERESULTSTOHISTORICALDATAONADVERSEEVENTSANDVISUALACUITYRATESANNEXAPROVIDESGENERALGUIDANCEFORTHEDESIGNOFACLINICALINVESTIGATIONHISTORICALDATACANBEFOUNDINANNEXB622ADDITIONALREQUIREMENTSFORTORICIOLSFORALLTORICIOLS,THEROTATIONALSTABILITYOFANONTORICVERSIONTHATISMECHANICALLYANDGEOMETRICALLYEQUIVALENTTOTHETORICIOLSHALLBEDEMONSTRATEDTHEFOLLOWINGPERFORMANCECRITERIAFORROTATIONALSTABILITYSHALLBEFULFILLEDTHEROTATIONOFTHEMERIDIANDEFINEDBYTHEIOLAXISINDICATORASMEASUREDANDCOMPAREDBETWEENDAY0THEDAYOFSURGERYPOSTOPERATIVEEXAMINATIONANDTHEFORM4EXAMINATIONSHALLBELESSTHAN10IN90OFTHECASES,LESSTHAN20IN95OFTHECASES,ANDLESSTHAN30IN99OFTHECASESTHEN,IFNECESSARYDUETORISKANALYSIS,ACLINICALINVESTIGATIONSHALLBEPERFORMEDUSINGTHETORICVERSIONOFTHEMODELINTHEEVENTTHATATORICIOLCLINICALINVESTIGATIONISREQUIREDDUETORISKANALYSIS,THESUBJECTSTHATUNDERGOSECONDARYSURGERYTOCORRECTIOLAXISMARKROTATIONSHALLHAVETHEIRCLINICALRESULTSPRIORTOTHESECONDARYSURGERYCARRIEDFORWARDASTHEFINALRESULTSFORTHATSUBJECTINTHECASEOFEXAMINATIONSSCHEDULEDTOBEPERFORMEDLATERINTHECLINICALINVESTIGATION,THESPONSORSHALLCONSIDERREQUIRINGEACHOFTHESEEXAMINATIONSTOBEPERFORMEDPRIORTOTHESECONDARYSURGERY,IFPOSSIBLEADDITIONALELEMENTSFORTORICIOLSAREOUTLINEDINANNEXC623ADDITIONALREQUIREMENTSFORACCOMMODATINGIOLSACONTROLLEDCLINICALINVESTIGATIONOFANACCOMMODATINGIOLSHALLEVALUATETHEADDITIONALSAFETYANDPERFORMANCECONCERNS,SPECIFICALLYINCLUDINGTHEEVALUATIONOFACCOMMODATIVEAMPLITUDEUSINGATLEASTONEOBJECTIVEMETHODGUIDANCEONCLINICALINVESTIGATIONOFACCOMMODATINGIOLSISOUTLINEDINANNEXDITSHALLCONSISTOFTWOPHASES,WITHPHASETWOBEGINNINGONLYAFTERTHEFIRSTPHASEHASDEMONSTRATEDTHATTHEACCOMMODATINGIOLPROVIDESANAVERAGEOFATLEAST1DOFOBJECTIVEACCOMMODATIONTHEOVERALLSTUDYSHALLDEMONSTRATETHATTHEACCOMMODATINGIOLALSOPROVIDES1DOFOBJECTIVEACCOMMODATIONATTHEPOINTOFSTABILIZATION63CHARACTERISTICSTHECLINICALINVESTIGATIONALPLANSHALLPROVIDEINFORMATIONREGARDINGCHARACTERISTICSTOBESTUDIED,ANDINSTRUCTIONSREGARDINGTHEGRADINGANDDOCUMENTATIONOFTHESECHARACTERISTICSWHENEVERPOSSIBLE,OBJECTIVEMETHODSSHALLBEUSED,SUCHASPHOTOGRAPHICIMAGINGTHEFOLLOWINGCHARACTERISTICSSHALLBECONSIDEREDIFADDITIONALCLAIMSARETOBEMADE,ADDITIONALCORRESPONDINGCHARACTERISTICSSHALLBESTUDIED631GENERALCHARACTERISTICSABESTSPECTACLECORRECTEDVISUALACUITYBSCVABSUBJECTIVEREFRACTIONCINTRAOCULARPRESSUREDCORNEALSTATUS2ISO2014ALLRIGHTSRESERVEDBSENISO1197972014ISO1197972014EESIGNSOFINFLAMMATION1ANTERIORCHAMBERCELLS2ANTERIORCHAMBERFLARE3CYSTOIDMACULAROEDEMA4HYPOPYON5ENDOPHTHALMITISFPUPILLARYBLOCKGRETINALDETACHMENTHSTATUSOFANTERIORANDPOSTERIORCAPSULEIIOLDECENTRATION2JIOLTILT2KIOLDISCOLORATIONLIOLOPACITY632TORICIOLCHARACTERISTICSAUNCORRECTEDVISUALACUITYBKERATOMETRYCIOLMARKAXISROTATION633ACCOMMODATINGIOLCHARACTERISTICSAUNCORRECTEDVISUALACUITYATDISTANCE,INTERMEDIATEANDNEARBVISUALACUITYATNEARANDINTERMEDIATEWITHBESTDISTANCECORRECTIONCBESTCORRECTEDNEARVISUALACUITYDADDITIONALREFRACTIONOVERBESTDISTANCESUBJECTIVECORRECTIONREQUIREDTOACHIEVEBESTCORRECTEDNEARACUITYEOBJECTIVEACCOMMODATIVEAMPLITUDEFCONTRASTSENSITIVITYGSUBJECTQUESTIONNAIREHPUPILSIZE634ADDITIONALCHARACTERISTICSIFJUSTIFIEDBYTHERISKANALYSIS,THESEADDITIONALCHARACTERISTICSSHALLBECONSIDEREDACYCLOPLEGICREFRACTIONBSPECULARMICROSCOPYCGONIOSCOPICEXAMINATIONDPUPILSIZEISO2014ALLRIGHTSRESERVED3BSENISO1197972014ISO1197972014EEANTERIORCHAMBERDEPTHMEASUREMENT64INVESTIGATIONDURATIONTHEMINIMUMDURATIONOFTHECLINICALINVESTIGATIONSSHALLBEONEYEARSEEANNEXAFORVISITWINDOWTOLERANCEFORAPHAKICPOSTERIORCHAMBERIOLSWHICHARENOTMODIFICATIONSOFAMODELFORWHICHSAFETYANDPERFORMANCEDATAHAVEBEENESTABLISHEDTHROUGHCLINICALINVESTIGATIONTHEMINIMUMDURATIONOFTHECLINICALINVESTIGATIONSSHALLBETHREEYEARSSEEANNEXAFORVISITWINDOWTOLERANCEFORAPHAKICANTERIORCHAMBERIOLSWHICHARENOTMODIFICATIONSOFAMODELFORWHICHSAFETYANDPERFORMANCEDATAHAVEBEENESTABLISHEDTHROUGHCLINICALINVESTIGATIONFORALLTORICIOLS,ASIXMONTHSTUDYOFTHENONTORICVERSIONOFTHEIOLSHALLBEPERFORMEDTOENSUREROTATIONALSTABILITYTHENFORTORICIOLSTHATAREAMODIFICATIONOFANIOLTHATHASMETTHEREQUIREMENTSOFALLPARTSOFISO11979,RISKANALYSISMAYREQUIRETHATTHISROTATIONALSTABILITYSTUDYISFOLLOWEDBYACLINICALINVESTIGATIONOFTHEACTUALTORICIOLFORSIXMONTHSTORICIOLSTHATARENOTAMODIFICATIONOFANIOLTHATHASMETTHEREQUIREMENTSOFALLPARTSOFISO11979SHALLREQUIREAFULLCLINICALINVESTIGATIONOFONEYEARDURATIONTHEMINIMUMSTUDYDURATIONFORACCOMMODATINGIOLSTHROUGHCLINICALINVESTIGATIONSHALLBEONEYEARBUTMAYREQUIREUPTOTHREEYEARSBASEDONTHERISKANALYSISCONSULTISO/TR229791FORGUIDANCEONINVESTIGATIONDURATIONFORMODIFICATIONSOFLENSMODELSFORWHICHSAFETYANDPERFORMANCEHAVEBEENESTABLISHEDTHROUGHCLINICALINVESTIGATIONALLSUBJECTSINACLINICALINVESTIGATIONTHATHAVENOTBEENDISCONTINUEDSHALLCOMPLETEALLVISITSOFTHEINVESTIGATIONTHECLINICALINVESTIGATIONSHALLBECONSIDEREDCOMPLETEDWHENALLSUBJECTSTHATHAVEBEENENROLLEDINTHEINVESTIGATION,INCLUDINGSUBJECTSWHOSEIOLWASREMOVEDORREPLACED,HAVEREACHEDTHEFINALREPORTINGPERIOD65ENROLLMENTTOMINIMIZETHERISKSASSOCIATEDWITHTHECLINICALINVESTIGATIONOFANEWIOL,SUBJECTENROLLMENTSHALLOCCURINSTAGESTHESUBJECTDATAFROMEACHSTAGESHALLBEEVALUATEDANDFOUNDACCEPTABLEBYTHESPONSORANDTHECOORDINATINGINVESTIGATORANDBYTHEREGULATORYBODY,IFAPPLICABLEPRIORTOTHECONTINUATIONOFTHECLINICALINVESTIGATIONGUIDANCEONPHASEDENROLLMENTISINCLUDEDINANNEXAMONOFOCALIOL,ANNEXCTORICIOLANDANNEXDACCOMMODATINGIOLRISKANALYSISSHOULDBEUSEDTODETERMINEIFANEARLIERPHASETHANTHEPHASE1LISTEDINTHEANNEXESABOVEISNEEDEDTOADDRESSSAFETYISSUESASSOCIATEDWITHTHEIOLDESIGN66BILATERALIMPLANTATIONANYPLANSFORFELLOWEYEIMPLANTATIONSHALLBEDESCRIBEDINTHECLINICALINVESTIGATIONPLANBILATERALIMPLANTATIONSHALLNOTBEIMPLEMENTEDUNTILINITIALSAFETYANDPERFORMANCEDATAHAVEBEENCOLLECTED,EVALUATEDANDCONFIRMEDBYTHESPONSORANDCOORDINATINGINVESTIGATORANDBYTHERISKANALYSIS,IFAPPLICABLEONLYTHEFIRSTEYEOFEACHSUBJECTSHALLBEINCLUDEDINTHEPRIMARYSTATISTICALANALYSISWHENIMPLANTATIONOFFELLOWEYEISPERMITTED,THECLINICALINVESTIGATIONPLANSHALLSPECIFYTIMEPERIODBETWEENIMPLANTATIONOFFIRSTEYEANDOFFELLOWEYE,BASEDUPONRISKANALYSISNOTETHEREVIEWOFDATAFROMATLEAST50EYESWITHSIXMONTHSOFFOLLOWUPISRECOMMENDEDPRIORTOFELLOWEYEIMPLANTATIONRISKANALYSISMIGHTALLOWANEARLIERIMPLANTATIONINFELLOWEYESIFSUFFICIENTLYJUSTIFIEDBYPREVIOUSCLINICALEXPERIENCE67SURGICALTECHNIQUETHECLINICALINVESTIGATIONPLANSHALLCONTAINDESCRIPTIONSOFTHESURGICALTECHNIQUE,THEINTRAOPERATIVEUSEOFOPHTHALMICVISCOSURGICALDEVICES,ANDTHEUSEOFPREOPERATIVE,INTRAOPERATIVEANDPOSTOPERATIVEMEDICATIONSANYDEVIATIONSHALLBERECORDEDONTHECASEREPORTFORMS4ISO2014ALLRIGHTSRESERVEDBSENISO1197972014ISO1197972014EFORTORICIOLS,THECLINICALINVESTIGATIONPLANSHALLSPECIFYTHETYPEANDLOCATIONOFTHEINCISIONTHEESTIMATEDEFFECTOFTHEINCISIONONTHECORNEALASTIGMATISMSHALLBEUSEDINTHEPROTOCOLFORCHOOSINGTHEAPPROPRIATECYLINDRICALPOWER68EXAMINATIONANDTREATMENTOFSUBJECTSTHEREPORTINGPERIODSAREDESCRIBEDINANNEXATHECLINICALINVESTIGATIONPLANSHALLDESCRIBEHOWSUBJECTVISITSANDOPHTHALMICADVERSEEVENTSTHATOCCURBETWEENSTANDARDREPORTINGPERIODSWILLBEHANDLEDINTHEDATAANALYSES69ADVERSEEVENTSREPORTSSERIOUSADVERSEEVENTSANDALLADVERSEDEVICEEFFECTSSHALLBEREPORTEDUSINGASPECIALCASEREPORTFORMANDFORWARDEDTOTHESPONSORASREQUIREDALLOTHEROPHTHALMICADVERSEEVENTSSHALLBEREPORTEDUSINGEITHERTHESTANDARDVISITCASEREPORTFORMORSPECIFICADVERSEEVENTFORMSANDBECOLLECTEDDURINGMONITORINGNONOPHTHALMICEVENTSTHATARENONSERIOUSARENOTREQUIREDTOBEREPORTED610INCLUSIONANDEXCLUSIONCRITERIA6101GENERALTHEFOLLOWINGINCLUSION/EXCLUSIONCRITERIASHALLBECONSIDEREDADDITIONALCRITERIASHALLBEINCLUDEDDEPENDINGONTHERISKANALYSISFORTHEPARTICULARIOLMODEL61011INCLUSIONCRITERIAAADULTBCATARACTDOESNOTAPPLYFORPHAKICIOLCBESTCORRECTEDVISUALACUITYPROJECTEDTOBE0,2LOGMARORLOWERDCALCULATEDIOLPOWERISWITHINTHERANGEOFTHEINVESTIGATIONALIOLESIGNEDINFORMEDCONSENTFORM61012EXCLUSIONCRITERIAAPREVIOUSINTRAOCULARANDCORNEALSURGERYBTRAUMATICCATARACTCPREGNANCYANDLACTATIONDCONCURRENTPARTICIPATIONINANOTHERDRUGORDEVICEINVESTIGATION6102ADDITIONALCRITERIAFORTORICIOL61021INCLUSIONCRITERIAACORNEALCYLINDRICALERRORWITHINTHERANGEDEFINEDINTHECLINICALINVESTIGATIONPLANCIPBSTABILITYOFTHECORNEAHASBEENDEMONSTRATEDBYKERATOMETRYCEXPECTEDDILATEDPUPILSIZEATLEASTLARGEENOUGHTOVISUALIZETHEAXISMARKINGS610211ADDITIONALINCLUSIONCRITERIAFORPHAKICTORICIOLSISO2014ALLRIGHTSRESERVED5BSENISO1197972014ISO1197972014EATHEINCLUSIONCRITERIADESCRIBEDINISO1197910SHALLBECONSIDERED61022EXCLUSIONCRITERIA610221ADDITIONALEXCLUSIONCRITERIAFORPHAKICTORICIOLSTHEEXCLUSIONCRITERIADESCRIBEDINISO1197910SHALLBECONSIDERED6ISO2014ALLRIGHTSRESERVEDBSENISO1197972014ISO1197972014EANNEXAINFORMATIVEELEMENTSOFACLINICALINVESTIGATIONA1GENERALTHEFOLLOWINGAREELEMENTSOFACLINICALINVESTIGATIONPLANWHICHCANASSISTINCOLLECTINGDATAFORTHEPURPOSEOFDETERMININGTHESAFETYANDPERFORMANCEOFIOLSA2NUMBEROFSUBJECTSTHECLINICALINVESTIGATIONINCLUDESAMINIMUMOF300SUBJECTSWHENTHERESULTSARECOMPAREDTOTHESAFETYANDPERFORMANCEENDPOINTSINANNEXBINTHECASEOFANINVESTIGATIONWITHACONCURRENTCONTROLGROUP,CALCULATETHENUMBEROFSUBJECTSSUFFICIENTTODETECTDIFFERENCESINTHESAFETYANDPERFORMANCEENDPOINTSINANNEXBWITHSIMILARSTATISTICALPOWERTOTHEINVESTIGATIONMENTIONEDABOVEANYADDITIONALCLAIMS,BEYONDTHOSEFORSAFETYANDPERFORMANCE,REQUIRECALCULATIONOFASAMPLESIZEFORTHATPURPOSETOTAKEINTOACCOUNTTHATSOMESUBJECTSARELOSTDURINGTHECOURSEOFTHECLINICALINVESTIGATIONINCLUDINGDECEASEDSUBJECTSANDSUBJECTSWHOHAVETHEIOLEXPLANTED,ENROLABOUTA390SUBJECTSINTHEONEYEARINVESTIGATIONB500SUBJECTSINTHETHREEYEARINVESTIGATIONSIGNIFICANTLYLARGERNUMBERSOFSUBJECTSARENOTTOBEENROLLEDINORDERTOMINIMIZEEXPOSURETOTHERISKSOFANEWIOLTOASSISTINACHIEVINGABALANCEINTHENUMBEROFSUBJECTSFROMEACHINVESTIGATOR,EACHSURGEONCONTRIBUTESAMINIMUMOF20SUBJECTS,BUTNOMORETHAN25OFTHESUBJECTSINTHEINVESTIGATIONIFTHERISKANALYSISDETERMINESTHATALIMITEDCLINICALINVESTIGATIONISSUFFICIENTSEEISO/TR229791,THENENROLL125SUBJECTSA3PHASEDENROLMENTTOMINIMIZETHEPOTENTIALRISKS,THECLINICALINVESTIGATIONCONSISTSOFTWOPHASESAPHASE1AMAXIMUMOF100SUBJECTSAREINCLUDEDAFTERATLEAST50OFTHOSEHAVEREACHEDCASEREPORTFORM4,THEIRDATAAREEVALUATEDIFTHERESULTSAREACCEPTABLE,THENEXTPHASECANBEGINBPHASE2THEREMAINDEROFTHESUBJECTSAREINCLUDEDA4REPORTINGPERIODSTHETIMEFRAMESFORTHEREPORTINGPERIODSAREDEFINEDBELOWACASEREPORTFORM0PREOPERATIVE/OPERATIVEREPORTINGBCASEREPORTFORM11OR2DAYSPOSTOPERATIVELYCCASEREPORTFORM27TO14DAYSPOSTOPERATIVELYDCASEREPORTFORM330TO60DAYSPOSTOPERATIVELYISO2014ALLRIGHTSRESERVED7BSENISO1197972014ISO1197972014EECASEREPORTFORM4120TO180DAYSPOSTOPERATIVELYFCASEREPORTFORM5330TO420DAYSPOSTOPERATIVELYGCASEREPORTFORM6630TO780DAYSPOSTOPERATIVELYHCASEREPORTFORM7990TO1140DAYSPOSTOPERATIVELYTHEMINIMUMSAMPLESIZENEEDSTOBEACHIEVEDATEACHOFTHEREPORTINGPERIODSA5STANDARDIZATIONOFTHECLINICALEVALUATIONDEFINECRITERIAFOREVALUATIONOFALLSTUDIEDVARIABLESDEFINETESTINGCONDITIONSFORALLMEASUREMENTSBEFORECOMMENCINGTHEINVESTIGATIONINSTRUCTANDTRAINALLINVESTIGATORSTOUSETHESE,INORDERTOOBTAINDATATHATCANBECOMBINEDFORTHEPURPOSEOFSTATISTICALANALYSISA6DATAANALYSISCONSIDERTHEFOLL
温馨提示
- 1. 本站所有资源如无特殊说明，都需要本地电脑安装OFFICE2007和PDF阅读器。图纸软件为CAD,CAXA,PROE,UG,SolidWorks等.压缩文件请下载最新的WinRAR软件解压。
- 2. 本站的文档不包含任何第三方提供的附件图纸等，如果需要附件，请联系上传者。文件的所有权益归上传用户所有。
- 3. 本站RAR压缩包中若带图纸，网页内容里面会有图纸预览，若没有图纸预览就没有图纸。
- 4. 未经权益所有人同意不得将文件中的内容挪作商业或盈利用途。
- 5. 人人文库网仅提供信息存储空间，仅对用户上传内容的表现方式做保护处理，对用户上传分享的文档内容本身不做任何修改或编辑，并不能对任何下载内容负责。
- 6. 下载文件中如有侵权或不适当内容，请与我们联系，我们立即纠正。
- 7. 本站不保证下载资源的准确性、安全性和完整性, 同时也不承担用户因使用这些下载资源对自己和他人造成任何形式的伤害或损失。
评论
0/150
提交评论