Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT00710905
Status:
TERMINATED
Last Update Posted:
2011-11-24
First Post:
2008-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3
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': 'When a clinical study report or manuscript, in lieu of a final report, is completed, Alcon will provide the summary findings of the study to the investigator.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Surgical visit until 6 months after surgery.', 'eventGroups': [{'id': 'EG000', 'title': 'ReSTOR', 'description': 'Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.', 'otherNumAtRisk': 50, 'otherNumAffected': 8, 'seriousNumAtRisk': 50, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Posterior Capsule Opacification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Eye disorders'}, {'term': 'Visual disturbances', 'notes': 'Visual disturbances including, but not limited to: floaters and flashes, photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders'}, {'term': 'Allergic Reaction', 'notes': 'Mild allergic reaction to prednisolone eye drops', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}], 'seriousEvents': [{'term': 'Retinal Detachment', 'notes': 'non-fatal medical event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Binocular Visual Acuity at Near, Intermediate and Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ReSTOR', 'description': 'Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.'}], 'classes': [{'title': 'Uncorrected distance VA (4 m)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.08', 'groupId': 'OG000'}]}]}, {'title': 'Uncorrected intermediate VA (60 cm)', 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.11', 'groupId': 'OG000'}]}]}, {'title': 'Uncorrected best near VA (34.11 cm +/- 4.23 cm)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.10', 'groupId': 'OG000'}]}]}, {'title': 'Best corrected distance VA (4 m)', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.07', 'groupId': 'OG000'}]}]}, {'title': 'Best corrected intermediate VA (60 cm)', 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.15', 'groupId': 'OG000'}]}]}, {'title': 'Best corrected best near VA (34.17 cm +/- 4.40 cm)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months after surgery', 'description': 'Binocular uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m) (distance), 60 centimeters (cm) (intermediate), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) 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 VA.', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ReSTOR', 'description': 'Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}]}], 'recruitmentDetails': 'Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ReSTOR', 'description': 'Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Gender information was not collected for one subject.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'whyStopped': 'Postmarket study terminated as the SN6AD3 is no longer promoted.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-21', 'studyFirstSubmitDate': '2008-07-03', 'resultsFirstSubmitDate': '2011-10-04', 'studyFirstSubmitQcDate': '2008-07-07', 'lastUpdatePostDateStruct': {'date': '2011-11-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-10-04', 'studyFirstPostDateStruct': {'date': '2008-07-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Binocular Visual Acuity at Near, Intermediate and Distance', 'timeFrame': '6 months after surgery', 'description': 'Binocular uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m) (distance), 60 centimeters (cm) (intermediate), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) 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 VA.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cataract IOL ReSTOR Aspheric', 'Bilateral cataract'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to prospectively evaluate the visual parameters in a series of patients after phacoemulsification cataract surgery in a series of patients bilaterally implanted with the AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) Models SN6AD1 And SN6AD3.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.\n\nExclusion Criteria:\n\n* Subjects with pre-existing conditions that could skew the results or are contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study. Please consult the AcrySof® ReSTOR® Aspheric product inserts under "Precautions" for subject groups that should be excluded from this study.\n* All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by Keratometry (K) readings. If the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.'}, 'identificationModule': {'nctId': 'NCT00710905', 'briefTitle': 'Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3', 'orgStudyIdInfo': {'id': 'ALCONsur002.08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ReSTOR', 'description': 'Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.', 'interventionNames': ['Device: AcrySof ReSTOR Aspheric IOL models SN6AD1 and SN6AD3']}], 'interventions': [{'name': 'AcrySof ReSTOR Aspheric IOL models SN6AD1 and SN6AD3', 'type': 'DEVICE', 'description': 'Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, AcrySof ReSTOR +4 IOL in the other eye following cataract removal.', 'armGroupLabels': ['ReSTOR']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V2S 5A1', 'city': 'Abbotsford', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Dr John Blaylock', 'geoPoint': {'lat': 49.05798, 'lon': -122.25257}}, {'zip': 'G1S 1X6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Dr Dominique Meyer', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'John Blaylock', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}