Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-28 @ 7:40 PM
Study NCT ID:
NCT00758550
Status:
COMPLETED
Last Update Posted:
2010-03-16
First Post:
2008-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Visual Function After Bilateral Implantation of AcrySof® Toric
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@alconlabs.com', 'phone': '888.451.3937; 817.568.6725', 'title': 'Alcon Clinical', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'AcrySof Toric IOL', 'description': 'AcrySof Toric Intraocular Lens', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AcrySof Natural IOL', 'description': 'AcrySof Natural Intraocular Lens', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Uncorrected Visual Acuity (UCVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AcrySof Toric IOL', 'description': 'AcrySof Toric Intraocular Lens'}, {'id': 'OG001', 'title': 'AcrySof Natural IOL', 'description': 'AcrySof Natural Intraocular Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months after surgery', 'description': 'Uncorrected Visual Acuity (UCVA) from surgery 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'}, {'type': 'SECONDARY', 'title': 'Questionnaire Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AcrySof Toric IOL', 'description': 'AcrySof Toric Intraocular Lens'}, {'id': 'OG001', 'title': 'AcrySof Natural IOL', 'description': 'AcrySof Natural Intraocular Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months', 'description': 'Results of questionnaire rating the quality of distance vision without glasses or contact lenses. Measured on a scale of 0 to 6 (0 = worst, 6 = best).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AcrySof Toric IOL', 'description': 'AcrySof Toric Intraocular Lens'}, {'id': 'FG001', 'title': 'AcrySof Natural IOL', 'description': 'AcrySof Natural Intraocular Lens'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '60 cataract patients were enrolled into the study', 'preAssignmentDetails': 'Randomized'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AcrySof Toric IOL', 'description': 'AcrySof Toric Intraocular Lens'}, {'id': 'BG001', 'title': 'AcrySof Natural IOL', 'description': 'AcrySof Natural Intraocular Lens'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'lastUpdateSubmitDate': '2010-03-04', 'studyFirstSubmitDate': '2008-09-23', 'resultsFirstSubmitDate': '2009-08-13', 'studyFirstSubmitQcDate': '2008-09-24', 'lastUpdatePostDateStruct': {'date': '2010-03-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-03-04', 'studyFirstPostDateStruct': {'date': '2008-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uncorrected Visual Acuity (UCVA)', 'timeFrame': '6 Months after surgery', 'description': 'Uncorrected Visual Acuity (UCVA) from surgery measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.'}], 'secondaryOutcomes': [{'measure': 'Questionnaire Results', 'timeFrame': '6 Months', 'description': 'Results of questionnaire rating the quality of distance vision without glasses or contact lenses. Measured on a scale of 0 to 6 (0 = worst, 6 = best).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Visual function;', 'Refractive cylinder;', 'AcrySof® Toric;', 'AcrySof® Natural'], 'conditions': ['Visual Function']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to evaluate visual function of AcrySof Toric and AcrySof Natural Intraocular Lenses (IOLs) following implant for replacement of cataract.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Bilateral cataracts\n* 40\\~80 years of age\n* 4 Days - 1 Week interval between a single patient's surgery\n* dilated pupil size (in dim light) ≥ 4.0 mm\n* Anticipated correction with an IOL of +10 Diopters \\~ +25 Diopters\n* 0.75 - 2.0 Diopters of astigmatism preoperatively as measured by Keratometry readings\n\nExclusion Criteria:\n\n* Preoperative ocular pathology\n* Previous intraocular or corneal surgery\n* An increased risk for complications which could require vitreoretinal surgery\n* Corneal irregularities\n* Corneal opacities\n* Current contact lens usage(within 6 months prior to first surgery)"}, 'identificationModule': {'nctId': 'NCT00758550', 'briefTitle': 'Visual Function After Bilateral Implantation of AcrySof® Toric', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Visual Function After Bilateral Implantation of AcrySof® Toric', 'orgStudyIdInfo': {'id': 'CM-06-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AcrySof Toric IOL', 'description': 'AcrySof Toric Intraocular Lens (IOL)', 'interventionNames': ['Device: AcrySof® Toric IOL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AcrySof Natural IOL', 'description': 'AcrySof Natural Intraocular Lens (IOL)', 'interventionNames': ['Device: AcrySof Natural']}], 'interventions': [{'name': 'AcrySof® Toric IOL', 'type': 'DEVICE', 'description': 'AcrySof® Toric Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery', 'armGroupLabels': ['AcrySof Toric IOL']}, {'name': 'AcrySof Natural', 'type': 'DEVICE', 'description': 'AcrySof Natural Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery', 'armGroupLabels': ['AcrySof Natural IOL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Alcon Call Center', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Benny Li, Scientific Clinical Affairs Manager', 'oldOrganization': 'Alcon Research Ltd.'}}}}