[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100480605":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":32,"locations":23,"responsibleParty":37,"collaborators":23,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":48,"minAge":49,"maxAge":23,"enrollmentInfo":50,"targetDuration":23,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":23,"overallStatus":60,"whyStopped":23,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":23},{"fullName":5,"class":6},"Central Hospital, Nancy, France","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Control group","The internal limiting membrane is not removed",[12],"Procedure: Control group",{"label":14,"type":6,"description":15,"interventionNames":16},"Intervention group","The internal limiting membrane of the posterior pole is removed",[17],"Procedure: Intervention group",[19,24],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"PROCEDURE","Vitrectomy and gas tamponade without internal limiting membrane peeling",[9],null,{"type":20,"name":14,"description":25,"armGroupLabels":26,"otherNames":23},"Vitrectomy, internal limiting membrane peeling and gas tamponade",[14],[28],{"name":29,"affiliation":30,"role":31},"Jean-Baptiste CONART, Prof","Brabois Hospital, Nancy, France","PRINCIPAL_INVESTIGATOR",[33],{"name":29,"role":34,"phone":35,"phoneExt":23,"email":36},"CONTACT","+33383155101","jbconart@hotmail.com",{"type":38,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100480605","internal-limiting-membrane-peeling-in-retinal-detachment-surgery-100480605",false,"NCT05538156","Internal Limiting Membrane Peeling in Retinal Detachment Surgery","Internal Limiting Membrane Peeling in Macula-off Retinal Detachment With Grade B Proliferative Vitreoretinopathy","IMPURITY","Inclusion Criteria:\n\n* Patients older than 18 years old\n* With macula-off retinal detachment complicated by grade B proliferative vitreoretinopathy\n\nExclusion Criteria:\n\n* Underage patients\n* History of retinal detachment\n* History of intraocular surgery (except for cataract surgery)\n* Traumatic retinal detachment\n* Macular hole-associated retinal detachment\n* Concurrent macular disease (diabetic maculopathy, age-related macular degeneration)",true,"ALL","18 Years",{"count":51,"type":52},126,"ESTIMATED","INTERVENTIONAL",[55],"NA","Despite advances in surgical techniques over the recent decades, proliferative vitreoretinopathy (PVR) remains the main obstacle to successful rhegmatogenous retinal detachment (RRD) repair, accounting for nearly 75% of all primary surgical failures. It is characterized by the growth and contraction of cellular membranes within the vitreous cavity and on both surfaces of the detached retina as well as intraretinal fibrosis.\n\nThe Retina Society classification, modified in 1991 and currently the most widely used, divided PVR into three grades. Grade A is limited to the presence of vitreous haze and pigment clumps. Grade B includes rolled or irregular edges of tear and\u002For inner retinal surface wrinkling with possible retinal stiffness and vessel tortuosity. Grade C is defined as the presence of full-thickness fixed retinal folds and is further subdivided based on the number of hours involved and the location.\n\nRecently, Foveau et al., in a retrospective comparative case series, have demonstrated that performing internal limiting membrane (ILM) peeling during RRD surgery may increase the anatomical success rate for this indication.\n\nThe aim of this multi-center, prospective, randomized controlled clinical trial study is to evaluate the effectiveness of ILM peeling on surgical outcomes in patients with primary macula-off RRD complicated by grade B PVR.",[58,59],"Retinal Detachment","Proliferative Vitreoretinopathy","NOT_YET_RECRUITING","2022-09-09",{"date":63,"type":64},"2022-09-13","ACTUAL",{"date":66,"type":52},"2022-09",{"date":68,"type":52},"2027-12",{"name":5,"class":6}]