Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-01-24 @ 11:07 PM
Study NCT ID:
NCT01343134
Status:
COMPLETED
Last Update Posted:
2011-05-16
First Post:
2011-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anatomical and Functional Macular Changes in Retinal Detachment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-12', 'studyFirstSubmitDate': '2011-04-26', 'studyFirstSubmitQcDate': '2011-04-26', 'lastUpdatePostDateStruct': {'date': '2011-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Retina', 'Rhegmatogenous retinal detachment', 'Macular detachment', 'Spectral domain OCT', 'Microperimetry'], 'conditions': ['Rhegmatogenous Retinal Detachment']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the correlation between morphologic changes in the outer retina and visual function after successful repair of rhegmatogenous retinal detachment with macula off.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with successful repair of rhegmatogenous retinal detachment after macula off and minimum 6 month follow-up after surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rhegmatogenous retinal detachment\n\nExclusion Criteria:\n\n* Epiretinal membrane'}, 'identificationModule': {'nctId': 'NCT01343134', 'briefTitle': 'Anatomical and Functional Macular Changes in Retinal Detachment', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'orgStudyIdInfo': {'id': 'Marie Pierre 01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retinal detachment cohort', 'interventionNames': ['Device: Measure the outer retina by spectral domain optical coherence tomography (HRA Spectralis; Heidelberg), and microperimetry (OPKO Instruments)']}], 'interventions': [{'name': 'Measure the outer retina by spectral domain optical coherence tomography (HRA Spectralis; Heidelberg), and microperimetry (OPKO Instruments)', 'type': 'DEVICE', 'description': 'Measure the thickness of the outer retina by spectral domain optical coherence tomography (HRA Spectralis; Heidelberg)and perform central microperimetry using new OPKO Instruments OCT.', 'armGroupLabels': ['Retinal detachment cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'state': 'Burgundy', 'country': 'France', 'facility': 'Ophthalmology Department CHU Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}], 'overallOfficials': [{'name': 'Catherine Creuzot-Garcher, MD;PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ophthalmology department CHU Dijon'}, {'name': 'Marie Pierre Delolme, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmology Department CHU Dijon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Pr Catherine Creuzot-Garcher', 'oldOrganization': 'Ophthalmology department'}}}}