Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-02-20 @ 1:44 PM
Study NCT ID:
NCT05647928
Status:
COMPLETED
Last Update Posted:
2022-12-13
First Post:
2022-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retinal Redetachment After Silicone Oil Removal : a Risk Factor Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018630', 'term': 'Vitreoretinopathy, Proliferative'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 307}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-04', 'studyFirstSubmitDate': '2022-12-04', 'studyFirstSubmitQcDate': '2022-12-04', 'lastUpdatePostDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of retinal redetachment after silicone oil removal', 'timeFrame': 'a minimum period of 6 months after silicone oil removal'}, {'measure': 'pre- and intraoperative risk factors of retinal redetachment after silicone oil removal', 'timeFrame': 'a minimum period of 6 months after silicone oil removal'}], 'secondaryOutcomes': [{'measure': 'final retinal reattachment rate', 'timeFrame': 'a minimum period of 6 months after silicone oil removal'}, {'measure': 'final best corrected visual acuity', 'timeFrame': 'a minimum period of 6 months after silicone oil removal'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rhegmatogenous retinal detachment', 'silicone oil', 'proliferative vitreoretinopathy'], 'conditions': ['Retinal Redetachment After Silicone Oil Removal']}, 'referencesModule': {'references': [{'pmid': '39148018', 'type': 'DERIVED', 'citation': 'Gisquet C, Ndiaye NC, Dubroux C, Angioi-Duprez K, Berrod JP, Conart JB. Retinal redetachment after silicone oil removal: a risk factor analysis. BMC Ophthalmol. 2024 Aug 15;24(1):346. doi: 10.1186/s12886-024-03618-z.'}]}, 'descriptionModule': {'briefSummary': 'To report the rate of retinal redetachment after silicone oil removal (SOR) following rhegmatogenous retinal detachment (RRD) surgery and to determine potential risk factors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who underwent pars plana vitrectomy with silicone oil tamponade at the Nancy University Hospital from January 2015 to January 2022.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with successfully repaired rhegmatogenous retinal detachment and subsequent silicone oil removal\n* minimum follow-up period of 6 months after silicone oil removal\n\nExclusion Criteria:\n\n* Silicone oil tamponade for indications other than rhegmatogenous retinal detachment\n* Retinal redetachment during silicone oil tamponade\n* Prior history of silicone oil tamponade'}, 'identificationModule': {'nctId': 'NCT05647928', 'briefTitle': 'Retinal Redetachment After Silicone Oil Removal : a Risk Factor Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Retinal Redetachment After Silicone Oil Removal : a Risk Factor Analysis', 'orgStudyIdInfo': {'id': '2022PI084'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'retinal redetachment after silicone oil removal', 'interventionNames': ['Other: no intervention']}, {'label': 'NO retinal redetachment after silicone oil removal', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['NO retinal redetachment after silicone oil removal', 'retinal redetachment after silicone oil removal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'CHRU Nancy Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Professeur Jean-Baptiste CONART', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}