[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563024":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":55,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":9,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":26,"overallStatus":76,"whyStopped":26,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Eye & ENT Hospital of Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"FCSB","EXPERIMENTAL","Using foldable capsular scleral buckle surgery to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity",[13],"Procedure: foldable capsular scleral buckling",{"label":15,"type":16,"description":17,"interventionNames":18},"PPV","ACTIVE_COMPARATOR","Using pars plana vitrectomy to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity",[19],"Procedure: vitrectomy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","foldable capsular scleral buckling","Using foldable capsular vitreous body as a novel scleral buckle material to treat the primary rhegmatogenous retinal detachment (RRD) of medium complexity",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"vitrectomy","Using vitrectomy to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity.",[15],[32],{"facility":33,"status":26,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"EyeEntFudan","Shanghai","Shanghai Municipality","200031","China","CN",{"type":40,"coordinates":41},"Point",[42,43],121.45806,31.22222,{"lat":43,"lon":42},[46,51,54],{"name":47,"role":48,"phone":49,"phoneExt":26,"email":50},"Zhongcui Sun, PhD","CONTACT","+8621-64377134-2501","zhongcui.sun@aliyun.com",{"name":52,"role":48,"phone":49,"phoneExt":26,"email":53},"ruiping Gu, phD","pingruigu@126.com",{"name":47,"role":48,"phone":26,"phoneExt":26,"email":26},{"type":56,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100563024","foldable-capsular-scleral-buckling-versus-vitrectomy-in-medium-complex-rhegmatogenous-retinal-detachment-treatment-100563024",false,"NCT06610786","Foldable Capsular Scleral Buckling Versus Vitrectomy in Medium-complex Rhegmatogenous Retinal Detachment Treatment","The Use of FCSB in Medium-complex RRD - a Safety and Efficacy Evaluation","Inclusion Criteria:\n\nOne or more retinal holes which cannot be treated sufficiently with a single silicon sponge or silicone band (e.g. large holes, multiple holes, multiple holes of varying anterior-posterior localisation, massive traction)\n\nExclusion Criteria\n\n1. simple rhegmatogenous retinal detachment which can be treated with a single silicon sponge or silicone band (e.g. single holes, no traction, limit retinal detachment)\n2. Complicated RRD, including macular hole within the arcade, PVR C or D, severe cataract, severe vitreous hemorrhage, unclear macular hole,\n3. Combined with other eye diseases that affect vision prognosis.\n4. History of other eye surgeries including cataract surgery.\n5. Presence of systemic diseases that may affect postoperative observation and follow-up.","ALL","18 Years","60 Years",{"count":68,"type":69},100,"ESTIMATED","INTERVENTIONAL",[72],"NA","The objective of the study is to evaluate:\n\n1. Safety and efficacy of a novel foldable capsular scleral buckle (FCSB) in scleral buckling for primary rhegmatogenous retinal detachment (RRD) of medium complexity.\n2. Comparison between FCSB and pars plana vitrectomy in therapeutic effects and complications in the treatment of primary RRD of medium complexity.",[75],"Rhegmatogenous Retinal Detachment","NOT_YET_RECRUITING","2024-09-20",{"date":79,"type":80},"2024-09-24","ACTUAL",{"date":82,"type":69},"2024-12-01",{"date":84,"type":69},"2029-12-01",{"name":5,"class":6},1]