Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT00760058
Status:
WITHDRAWN
Last Update Posted:
2015-05-12
First Post:
2008-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Enrollment not initiated for study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-08', 'studyFirstSubmitDate': '2008-09-24', 'studyFirstSubmitQcDate': '2008-09-24', 'lastUpdatePostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contrast sensitivity', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Visual acuity, contrast acuity, wavefront analysis, corneal spherical aberration, manifest refraction.', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cataract, intraocular lens'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to compare the visual outcomes of three aspheric monofocal intraocular lenses after cataract surgery - ACRYSOF® IQ, Tecnis® and Akreos® MI60.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subjects, aged 50 and over.\n* Subjects diagnosed with bilateral cataracts requiring cataract extraction and implantation of a posterior chamber intraocular lens.\n* Subjects must be willing to undertake the additional ophthalmic tests within 3 months of the second lens implantation.\n* Subjects must be assessed to be able to dilate to a minimum of 6 mm pre operatively.\n* Subjects' pupil size must be ≥ 4.5 mm in mesopic conditions.\n\nExclusion Criteria:\n\n* Subjects who have previously had corneal surgery.\n* Subjects who have potential visual acuity which is \\< 6/12 due to other ocular pathology\n* Subjects with corneal pathology.\n* Subjects with astigmatism of greater than 1D.\n* Subjects diagnosed with glaucoma.\n* Subjects diagnosed with diabetes.\n* Subjects who have previously participated in a clinical investigation within 30 days prior to enrolment\n* Subjects with a know history of poor compliance\n* Subjects with planned adjunctive surgery"}, 'identificationModule': {'nctId': 'NCT00760058', 'briefTitle': 'Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL', 'orgStudyIdInfo': {'id': 'AUS-06-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'AcrySof® IQ intraocular lens', 'interventionNames': ['Device: AcrySof® IQ IOL']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Tecnis® Aspheric intraocular lens', 'interventionNames': ['Device: Tecnis® Aspheric intraocular lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Akreos® MI60 intraocular lens', 'interventionNames': ['Device: Akreos® MI60 intraocular lens']}], 'interventions': [{'name': 'AcrySof® IQ IOL', 'type': 'DEVICE', 'description': 'Replacement of natural crystalline lens in cataract surgery', 'armGroupLabels': ['1']}, {'name': 'Tecnis® Aspheric intraocular lens', 'type': 'DEVICE', 'description': 'Replacement of natural crystalline lens in cataract surgery', 'armGroupLabels': ['2']}, {'name': 'Akreos® MI60 intraocular lens', 'type': 'DEVICE', 'description': 'Replacement of natural crystalline lens in cataract surgery', 'armGroupLabels': ['3']}]}, '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': 'Robert Kitchen, Director of Scientific Affairs', 'oldOrganization': 'Alcon Laboratories (Australia) Pty Ltd'}}}}