Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 12:35 AM
Study NCT ID:
NCT00963560
Status:
COMPLETED
Last Update Posted:
2011-08-09
First Post:
2009-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Presbyopia-Correcting Intraocular Lenses (IOLs)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@alconlabs.com', 'phone': '888-451-3937; 817-568-6725', 'title': 'Director of Alcon Clinical', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'otherDetails': "All data and discoveries arising out of the study, patentable or nonpatentable, shall be the sole property of Alcon Laboratories, Inc. Alcon reserves the right of prior review of any publication or presentation of information related to the study. Alcon may use these data now and in the future for presentation or publication at Alcon's discretion or for submission to government regulatory agencies.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day of surgery until visit 6 months following surgery.', 'eventGroups': [{'id': 'EG000', 'title': 'ReSTOR +3', 'description': 'Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)', 'otherNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Crystalens HD', 'description': 'Bilateral implantation of Crystalens HD Intraocular Lens (IOL)', 'otherNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Crystalens AO', 'description': 'Bilateral implantation of Crystalens AO Intraocular Lens (IOL)', 'otherNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Best Corrected Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ReSTOR +3', 'description': 'Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)'}, {'id': 'OG001', 'title': 'Crystalens HD', 'description': 'Bilateral implantation of Crystalens HD Intraocular Lens (IOL)'}, {'id': 'OG002', 'title': 'Crystalens AO', 'description': 'Bilateral implantation of Crystalens AO Intraocular Lens (IOL)'}], 'classes': [{'title': '4m (far) Distance', 'categories': [{'measurements': [{'value': '-0.075', 'spread': '0.100', 'groupId': 'OG000'}, {'value': '-0.080', 'spread': '0.103', 'groupId': 'OG001'}, {'value': '-0.081', 'spread': '0.110', 'groupId': 'OG002'}]}]}, {'title': '60cm (intermediate) Distance', 'categories': [{'measurements': [{'value': '0.227', 'spread': '0.119', 'groupId': 'OG000'}, {'value': '0.176', 'spread': '0.139', 'groupId': 'OG001'}, {'value': '0.200', 'spread': '0.154', 'groupId': 'OG002'}]}]}, {'title': '40 cm (near) Distance', 'categories': [{'measurements': [{'value': '0.057', 'spread': '0.086', 'groupId': 'OG000'}, {'value': '0.364', 'spread': '0.183', 'groupId': 'OG001'}, {'value': '0.420', 'spread': '0.188', 'groupId': 'OG002'}]}]}, {'title': 'Preferred Distance', 'categories': [{'measurements': [{'value': '0.055', 'spread': '0.121', 'groupId': 'OG000'}, {'value': '0.223', 'spread': '0.146', 'groupId': 'OG001'}, {'value': '0.222', 'spread': '0.138', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months after surgery', 'description': 'Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '2 ReSTOR +3 subjects and 1 Crystalens HD subject missed their final visits and were not included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ReSTOR +3', 'description': 'Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)'}, {'id': 'FG001', 'title': 'Crystalens HD', 'description': 'Bilateral implantation of Crystalens HD Intraocular Lens (IOL)'}, {'id': 'FG002', 'title': 'Crystalens AO', 'description': 'Bilateral implantation of Crystalens AO Intraocular Lens (IOL)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Bilateral diagnosis of cataracts of subjects \\>21 years of age.', 'preAssignmentDetails': 'During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '132', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'ReSTOR +3', 'description': 'Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)'}, {'id': 'BG001', 'title': 'Crystalens HD', 'description': 'Bilateral implantation of Crystalens HD Intraocular Lens (IOL)'}, {'id': 'BG002', 'title': 'Crystalens AO', 'description': 'Bilateral implantation of Crystalens AO Intraocular Lens (IOL)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.4', 'spread': '9.4', 'groupId': 'BG000', 'lowerLimit': '41', 'upperLimit': '81'}, {'value': '64', 'spread': '7.8', 'groupId': 'BG001', 'lowerLimit': '50', 'upperLimit': '79'}, {'value': '65.3', 'spread': '7.5', 'groupId': 'BG002', 'lowerLimit': '50', 'upperLimit': '81'}, {'value': '64.23', 'spread': '8.23', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'lastUpdateSubmitDate': '2011-07-13', 'studyFirstSubmitDate': '2009-08-19', 'resultsFirstSubmitDate': '2011-07-13', 'studyFirstSubmitQcDate': '2009-08-20', 'lastUpdatePostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-13', 'studyFirstPostDateStruct': {'date': '2009-08-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Corrected Visual Acuity', 'timeFrame': '6 Months after surgery', 'description': 'Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ReSTOR +3'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with Presbyopia-Correcting Intraocular Lenses (IOLs).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with bilateral cataracts\n* candidate for presbyopic lens\n\nExclusion Criteria:\n\n* \\> 1 Diopter preoperative astigmatism by Keratometry readings\n* pre-existing conditions that could skew the results'}, 'identificationModule': {'nctId': 'NCT00963560', 'briefTitle': 'Presbyopia-Correcting Intraocular Lenses (IOLs)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs', 'orgStudyIdInfo': {'id': 'M09-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ReSTOR +3', 'description': 'Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)', 'interventionNames': ['Device: ReSTOR +3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Crystalens HD', 'description': 'Bilateral implantation of Crystalens HD Intraocular Lens (IOL)', 'interventionNames': ['Device: Crystalens HD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Crystalens AO', 'description': 'Bilateral implantation of Crystalens AO Intraocular Lens (IOL)', 'interventionNames': ['Device: Crystalens AO']}], 'interventions': [{'name': 'ReSTOR +3', 'type': 'DEVICE', 'description': 'Bilateral implantation of the AcrySof ReSTOR Aspheric +3 Model SN6AD1 Intraocular lens (IOL) for the treatment of cataract.', 'armGroupLabels': ['ReSTOR +3']}, {'name': 'Crystalens HD', 'type': 'DEVICE', 'description': 'Bilateral implantation of the Crystalens HD intraocular lens (IOL) for the treatment of cataract.', 'armGroupLabels': ['Crystalens HD']}, {'name': 'Crystalens AO', 'type': 'DEVICE', 'description': 'Bilateral implantation of the Crystalens AO intraocular lens (IOL) for the treatment of cataract.', 'armGroupLabels': ['Crystalens AO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Contact Alcon Call Center For Trial Locations', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Diane Houtman, Director - Global Scientific Market Affairs Dept', 'oldOrganization': 'Alcon Laboratories, Inc.'}}}}