Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-04 @ 6:57 PM
Study NCT ID:
NCT00719732
Status:
COMPLETED
Last Update Posted:
2010-03-16
First Post:
2008-07-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3
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': 'Alcon Clinical', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'otherDetails': "No paper that incorporates Sponsor Condfidential information will be submitted for publication without Sponsor's prior written agreement.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 6 months post-operative', 'description': 'Volunteered and solicited adverse events were collected from the time of surgery to the 6 month post-operative visit.', 'eventGroups': [{'id': 'EG000', 'title': 'ReSTOR Aspheric +3', 'description': 'Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).', 'otherNumAtRisk': 196, 'otherNumAffected': 0, 'seriousNumAtRisk': 196, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Chronic inflammation/iritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Uncorrected Visual Acuity (UCVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ReSTOR Aspheric +3', 'description': 'Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).'}], 'classes': [{'title': 'UCVA at 40 cm', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.10', 'groupId': 'OG000'}]}]}, {'title': 'UCVA at 50 cm', 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.15', 'groupId': 'OG000'}]}]}, {'title': 'UCVA at 60 cm', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.14', 'groupId': 'OG000'}]}]}, {'title': 'UCVA at 70 cm', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.13', 'groupId': 'OG000'}]}]}, {'title': 'UCVA at 4 m', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Uncorrected Visual Acuity (UCVA) measured by means of logMAR at various distances (40 centimeters (cm), 50 cm, 60 cm, 70 cm, and 4 meters (m)). Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ReSTOR Aspheric +3', 'description': 'Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '218'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'Unilateral (not bilateral) implantation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Illness not associated with device', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects 18 - 70 years of age, either sex and any race. Diagnosis of cataracts in one or both eyes.', 'preAssignmentDetails': "Subject's eligibility was determined at the preoperative visit. All subjects met inclusion/exclusion criteria."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ReSTOR Aspheric +3', 'description': 'Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).'}], 'measures': [{'title': 'Age Categorical', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '143', 'groupId': 'BG000'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Date of birth received for 207 of 218 subjects; therefore, age data not available for 11 subjects.', 'unitOfMeasure': 'participants'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Gender not received for 212 of 218 subjects, therefore, gender missing for 6 subjects.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-04', 'studyFirstSubmitDate': '2008-07-21', 'resultsFirstSubmitDate': '2009-09-18', 'studyFirstSubmitQcDate': '2008-07-21', 'lastUpdatePostDateStruct': {'date': '2010-03-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-03-04', 'studyFirstPostDateStruct': {'date': '2008-07-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uncorrected Visual Acuity (UCVA)', 'timeFrame': '6 months', 'description': 'Uncorrected Visual Acuity (UCVA) measured by means of logMAR at various distances (40 centimeters (cm), 50 cm, 60 cm, 70 cm, and 4 meters (m)). Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ReSTOR Aspheric +3 IOL'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'A prospective evaluation of the visual parameters in a series of patients bilaterally implanted with AcrySof ReSTOR +3 Intraocular Lens (IOL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with cataracts\n\nExclusion Criteria:\n\n* Pre-existing conditions that could skew the results or are contraindications for the ReSTOR intraocular lens;\n* \\<1 diopter astigmatism by keratometry readings.'}, 'identificationModule': {'nctId': 'NCT00719732', 'briefTitle': 'Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3', 'nctIdAliases': ['NCT00762203'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3', 'orgStudyIdInfo': {'id': 'M07-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ReSTOR Aspheric +3', 'description': 'Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).', 'interventionNames': ['Device: ReSTOR']}], 'interventions': [{'name': 'ReSTOR', 'type': 'DEVICE', 'description': 'Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).', 'armGroupLabels': ['ReSTOR Aspheric +3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Alcon Call Center for Trial Locations', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Diane Houtman', 'oldOrganization': 'Alcon Research, Ltd.'}}}}