Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-26 @ 2:41 AM
Study NCT ID:
NCT00604305
Status:
WITHDRAWN
Last Update Posted:
2012-06-12
First Post:
2008-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comperative Trial Between an Accommodative Iol and Monofocal Iol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Company could not supply the accommodating intraocular lenses for the study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-10', 'studyFirstSubmitDate': '2008-01-17', 'studyFirstSubmitQcDate': '2008-01-29', 'lastUpdatePostDateStruct': {'date': '2012-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'distance and near visual acuity', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'centration pco', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['CATARACT SURGERY']}, 'descriptionModule': {'briefSummary': 'a comparison of two intraocular lenses in regard of accommodative power.', 'detailedDescription': "A new accommodating IOL (Acuity Ltd, Israel) will be compared with Alcon's Acrysof for 1 year for visual acuity and distance and near best corrected visual acuity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 30 and 65\n* Required cataract operation in one or both eyes\n* BCVA potetial at least 20/30\n* Clear intraoccular media\n* Willing to participate in study as evidenced by signing a written Informed Consent\n\nExclusion Criteria:Main\n\n* Prior surgery at the selected eye\n* No light perception or poor potential for improvement\n* Phacodonesis and damaged zonules\n* Pupil size at least 6 mm.\n* History of uveitis\n* Macular disease decreasing vision below 20/30\n* Amblyopia\n* Axial length shorter than 21 mm and longer than 25 mm'}, 'identificationModule': {'nctId': 'NCT00604305', 'briefTitle': 'Comperative Trial Between an Accommodative Iol and Monofocal Iol', 'organization': {'class': 'OTHER', 'fullName': 'Shaare Zedek Medical Center'}, 'officialTitle': "A Randomized Single Blind Comparative Study of the Acuity's C-Well Accommodating Intra Occular Lens (AIOL) Against Alcon's Acrysof", 'orgStudyIdInfo': {'id': '6666476CTIL'}, 'secondaryIdInfos': [{'id': 'Rozenman-CWPMS001'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acrysof', 'description': 'Routine monofocal IOL', 'interventionNames': ['Device: Acrysof']}, {'type': 'ACTIVE_COMPARATOR', 'label': "Acuity's AIOL", 'description': 'Accomodaing IOL', 'interventionNames': ["Device: Acuity's AIOL"]}], 'interventions': [{'name': 'Acrysof', 'type': 'DEVICE', 'description': 'Monofocal IOL', 'armGroupLabels': ['Acrysof']}, {'name': "Acuity's AIOL", 'type': 'DEVICE', 'description': 'Accommodating IOL', 'armGroupLabels': ["Acuity's AIOL"]}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaare Zedek Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of eye department', 'investigatorFullName': 'Dr. Yaacov Rozenman', 'investigatorAffiliation': 'Shaare Zedek Medical Center'}}}}