Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-01-01 @ 12:17 AM
Study NCT ID:
NCT00851760
Status:
COMPLETED
Last Update Posted:
2009-08-04
First Post:
2009-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epiretinal Macular Membrane and Cataract Extraction
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': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-03', 'studyFirstSubmitDate': '2009-02-25', 'studyFirstSubmitQcDate': '2009-02-25', 'lastUpdatePostDateStruct': {'date': '2009-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Combined and consecutive surgeries are effective procedures to treat idiopathic ERM. The functional and anatomical results are equivalent in both procedures.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Epiretinal Macular Membrane', 'Cataract Extraction']}, 'descriptionModule': {'briefSummary': 'The investigators proposed to assess the functional and anatomical outcomes of cataract and idiopathic epiretinal macular membrane extraction in combined and consecutive surgeries.', 'detailedDescription': 'A retrospective nonrandomized clinical case series study collected 174 consecutive eyes of 174 patients undergoing macular surgery between January 2005 and December 2006. Patients suffering from epiretinal macular membranes (ERM) secondary to uveitis, trauma, or associated with a simultaneous retinal detachment (RD) were excluded. We treated 109 eyes with a combined procedure (group 1) and 65 eyes with a consecutive surgery (membrane surgery and cataract separately)(group 2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients had symptomatic visual loss and needed vitrectomy for ERM removal.\n\nExclusion Criteria:\n\n* Patients suffering from ERM secondary to uveitis, trauma, or associated with a simultaneous RD were excluded.'}, 'identificationModule': {'nctId': 'NCT00851760', 'briefTitle': 'Epiretinal Macular Membrane and Cataract Extraction', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Idiopathic Epiretinal Macular Membrane and Cataract Extraction : Combined vs Consecutive Surgery', 'orgStudyIdInfo': {'id': 'CHU Dijon OPH 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 Combined Surgery', 'interventionNames': ['Procedure: Combined surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 consecutive surgery', 'interventionNames': ['Procedure: Consecutive surgery']}], 'interventions': [{'name': 'Consecutive surgery', 'type': 'PROCEDURE', 'description': 'Consecutive surgery for epiretinal macular membrane and cataract extraction', 'armGroupLabels': ['2 consecutive surgery']}, {'name': 'Combined surgery', 'type': 'PROCEDURE', 'description': 'Combined surgery for epiretinal macular membrane and cataract extraction', 'armGroupLabels': ['1 Combined Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'state': 'Burgundy', 'country': 'France', 'facility': 'Ophthalmology Unit CHU Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Pr Creuzot Garcher', 'oldOrganization': 'Centre Hospitalier Universitaire Dijon'}}}}