[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549382":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":65,"collaborators":26,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":26,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Walailak University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Inverted flap","ACTIVE_COMPARATOR","Patients who will undergo 25-gauge pars plana vitrectomy with inverted flap technique and SF6 tamponade.",[13],"Procedure: 25-gauge pars plana vitrectomy with inverted flap technique and SF6 tamponade",{"label":15,"type":16,"description":17,"interventionNames":18},"Amniotic membrane hydrogel","EXPERIMENTAL","Patients who will undergo 25-gauge pars plana vitrectomy with complete internal limiting membrane peeling, amniotic membrane hydrogel filling and SF6 tamponade.",[19],"Procedure: 25-gauge pars plana vitrectomy with complete internal limiting membrane peeling with amniotic membrane hydrogel filling and SF6 tamponade",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","25-gauge pars plana vitrectomy with inverted flap technique and SF6 tamponade","Standard 3 port 25-gauge pars plana vitrectomy with inverted flap technique after brilliant blue dye staining and SF6 tamponade. \"Flower petal\" type of inverted flap will be performed - multiple small ILM flaps will be created around the macular hole and placed over the macular hole",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"25-gauge pars plana vitrectomy with complete internal limiting membrane peeling with amniotic membrane hydrogel filling and SF6 tamponade","Standard 3 port 25-gauge pars plana vitrectomy with complete internal limiting membrane peeling around the macular hole after brilliant blue dye staining then filling the hole with amniotic membrane hydrogel and sulfur hexafluoride (SF6) tamponade",[15],[32],{"name":33,"affiliation":34,"role":35},"Jakkrit Juhong, MD.","School of Medicine, Walailak university","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+66816773406","jakkrit.ju@wu.ac.th",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Jakkrit Juhong","RECRUITING","Nakhon Si Thammarat","Thasala","80160","Thailand","TH",{"type":51,"coordinates":52},"Point",[53,54],99.96667,8.43333,{"lat":54,"lon":53},[57,59,60,63],{"name":58,"role":38,"phone":39,"phoneExt":26,"email":40},"Jakkrit Juhong, MD",{"name":58,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":61,"role":62,"phone":26,"phoneExt":26,"email":26},"Auemphon Mormuang, PhD","SUB_INVESTIGATOR",{"name":64,"role":62,"phone":26,"phoneExt":26,"email":26},"Hathaichanok Impheng, PhD",{"type":35,"investigatorFullName":43,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Head of Vitreoretinal unit, Ophthalmology department, Walailak University","100549382","comparative-study-of-decellularized-human-amniotic-membrane-hydrogel-and-inverted-internal-limiting-membrane-flap-in-idiopathic-large-macular-holes-100549382",false,"NCT06433284","Comparative Study of Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap in Idiopathic Large Macular Holes","Comparative Study of Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap in Idiopathic Large Macular Holes (MACROHOLE): a Randomized-control Trial","MACROHOLE","Inclusion Criteria:\n\n* \\>18 years old\n* idiopathic full thickness macular hole \\> 400 micron of diameter\n* phakic or pseudophakic\n* absence of systemic adverse conditions\n\nExclusion Criteria:\n\n* idiopathic full thickness macular hole \\> 1,500 micron of diameter\n* traumatic macular holes\n* myopic macular holes,\n* concomitant retinal and other ocular disease\n* previous ocular surgery except cataract surgery","ALL","18 Years",{"count":78,"type":79},26,"ESTIMATED","INTERVENTIONAL",[82],"NA","The human amniotic membrane (hAM) patch, introduced by Rizzo et al. in 2018, showed a 100% anatomical success rate for large or failed macular holes over a 6-month follow-up. Despite its regenerative properties like promoting angiogenesis and having low immunogenicity, its clinical use is limited by challenges such as trimming to fit small holes and complications during insertion. To overcome these issues, decellularized amniotic membrane (dAM) has been processed into a hydrogel form, enhancing its applicability and allowing it to be used as an injectable hydrogel for minimally invasive therapies. While dAM hydrogels have been used in various medical fields, their application in intraocular surgery is new. This study proposes using dAM hydrogel for large macular hole closure, comparing its effectiveness to the inverted ILM flap technique in a randomized controlled trial.",[85],"Macular Holes",[87,88,89],"macular holes","decellularized amniotic membrane","human amniotic membrane hydrogel","2026-05-17",{"date":92,"type":93},"2026-05-19","ACTUAL",{"date":95,"type":93},"2024-10-01",{"date":97,"type":79},"2027-01-30",{"name":5,"class":6},1]