Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT01480505
Status:
COMPLETED
Last Update Posted:
2011-11-29
First Post:
2011-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Vitrectomy for the Treatment of Retinal Detachment in Highly Myopic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D012163', 'term': 'Retinal Detachment'}, {'id': 'D012167', 'term': 'Retinal Perforations'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 840}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-28', 'studyFirstSubmitDate': '2011-11-21', 'studyFirstSubmitQcDate': '2011-11-28', 'lastUpdatePostDateStruct': {'date': '2011-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessing the functional and anatomical outcome of primary vitrectomy in Rhegmatogenous retinal detachment in highly myopic eyes', 'description': 'To assess by visual acuity measurements, fundus ophthalmoscopy and OCT scans the functional and anatomical outcome in patients with higly myopic eyes whom we performed primary vitrectomy without scleral buckling for rhegmatogenous retinal detachment (RRD)in comparison to standard surgical technics wich consist on scleral buckling and pars plana vitrectomy with fluid gas exchange.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Retinal detachment', 'high myopia', 'macular hole', 'axial length', 'Scleral buckling', 'Vitrectomy', 'Visual acuity', 'fundus examination results'], 'conditions': ['Intraocular Pressure,', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'Purpose:\n\nTo assess the functional and anatomical outcome of primary vitrectomy without scleral buckling for rhegmatogenous retinal detachment (RRD) in highly myopic eyes with axial length over 30 mm.\n\nMethods Design: Retrospective single center series. Setting: University Hospital. Patients: High myopic patients treated with primary vitrectomy without scleral buckling for a rhegmatogenous retinal detachment.\n\nOutcome measures: Anatomical success rate with complete reattachment of the retina without silicone oil tamponade and postoperative best-corrected visual acuity (BCVA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'On the basis of axial length greater than 30 mm, 67 eyes of 67 patients with at least six-month follow-up in our department were selected.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* retinal detachment secondary to peripheral breaks (retinal tears, atrophic retinal hole)\n* secondary to posterior breaks (MH, PVT).\n\nExclusion Criteria: retinal detachment secondary to\n\n* severe eye injury,\n* diabetic retinopathy,\n* retinopathy of prematurity,\n* uveitis.'}, 'identificationModule': {'nctId': 'NCT01480505', 'briefTitle': 'Primary Vitrectomy for the Treatment of Retinal Detachment in Highly Myopic', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'orgStudyIdInfo': {'id': 'Brice 01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High myopic eye', 'description': 'Persons with high Myopia suffered from Rhegmatogenous Retinal detachment', 'interventionNames': ['Procedure: Pars plana vitrectomy with gas tamponade']}], 'interventions': [{'name': 'Pars plana vitrectomy with gas tamponade', 'type': 'PROCEDURE', 'description': 'A standard three-port 20 Gauge vitrectomy under a wide-angle-viewing contact lens was performed. Peripheral vitreous shaving was completed under slit-lamp illumination without contact lens by gentle scleral indentation. Posterior hyaloid detachment was checked and completed if necessary without dye. The epiretinal membrane removal or internal limiting membrane (ILM) peeling was performed if necessary. In general this latter procedure was not conducted for RD secondary to peripheral retinal tears without any sign of PVR or ERM but was done in almost all cases related to posterior break.\n\nSubretinal fluid was aspirated through the retinal tear, the MH, the PVT or through a retinotomy to obtain a complete peroperative retinal reattachment.', 'armGroupLabels': ['High myopic eye']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'state': 'Burgundy', 'country': 'France', 'facility': 'Ophthalmology Department', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Docteur', 'investigatorFullName': 'Nicot Frederic', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Dijon'}}}}