[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599242":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":46,"collaborators":19,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":19,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":19,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":19,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Eye & ENT Hospital of Fudan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"hAM","EXPERIMENTAL","This is a single arm study using literature-reported postoperative outcomes of IRB-RRD patients as the comparator.",[13],"Device: hAM",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","The hAM stands for human amniotic membrane, which was used to seal inferior retinal breaks after complete vitrectomy.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Zhongcui Sun, PhD.","CONTACT","+8621-64377134-2501","zhongcui.sun@aliyun.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"EyeEntFudan","RECRUITING","Shanghai","Shanghai Municipality","200031","China","CN",{"type":36,"coordinates":37},"Point",[38,39],121.45806,31.22222,{"lat":39,"lon":38},[42,44],{"name":43,"role":23,"phone":24,"phoneExt":19,"email":25},"Zhongcui Sun, PhD",{"name":43,"role":45,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"type":47,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100599242","ham-for-inferior-rrd-100599242",false,"NCT07081945","hAM for Inferior RRD","Prospective Study on the Use of Human Amniotic Membrane (hAM) in the Treatment of Inferior Rhegmatogenous Retinal Detachment (RRD)","Inclusion Criteria:\n\n1. Subjects having given free and informed consent to take part in the study.\n2. Subjects between 18 and 70 years old.\n3. Subjects suffering RRD (both primary and recurrent RRDs) with at least one of these conditions:\n\n   1. inferior retinal breaks between 4- and 8-o'clock within the detached area regardless of PVR grade;\n   2. requiring retinotomy inferiorly between 4- and 8-o'clock (due to severe inferior PVR or inferior retinal shortening).\n\nExclusion Criteria:\n\n1. Subjects with RRD with only anterior retina breaks or dialysis and meet the indications for scleral buckling surgery.\n2. Subjects with RRD whose retinal breaks located between the 4- and 8-o'clock positions and are not involved in the detached area.\n3. Subjects with pre-existing serious eye diseases (corneal ulcers, glaucoma, uveitis, etc).\n4. History of epilepsy or serious psychiatric diseases.\n5. Other conditions that the researcher found improper to be included into this study.","ALL","18 Years","70 Years",{"count":59,"type":60},50,"ESTIMATED","INTERVENTIONAL",[63],"NA","The objective of the study is to evaluate the efficacy of using hAM patches over the retina to seal inferior retinal breaks. The researchers will evaluate whether hAM patch-assisted vitrectomy improves surgical success rate of retinal reattachment.",[66],"Rhegmatogenous Retinal Detachment","2025-07-23",{"date":69,"type":70},"2025-07-28","ACTUAL",{"date":72,"type":60},"2025-08-01",{"date":74,"type":60},"2026-07-31",{"name":5,"class":6},1]