[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585934":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":115,"collaborators":118,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":125,"sex":131,"minAge":132,"maxAge":25,"enrollmentInfo":133,"targetDuration":25,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":143,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional surgery","ACTIVE_COMPARATOR","Patients would undergo conventional surgery to repair macular hole and be instructed to adopt a face-down posturing in the first 5 days following operation.",[13],"Procedure: Conventional surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"Internal limiting membrane (ILM) flap with no gas tamponade","EXPERIMENTAL","Patients would undergo macular hole repair by the ILM flap with no gas tamponade technique. Patients will be instructed to avoid excessive movement and adopt a sit up\u002Fsupine posture for the first 24 hours, beyond which there will be no posturing restriction.",[19],"Procedure: ILM flap with no gas tamponade",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Pars plana vitrectomy (PPV) with temporal internal limiting membrane (ILM) flap would be performed. Perfluorocarbon liquid (PFCL) or viscoelastic may be used as an adjunct. Air\u002FFluid exchange would be performed at the end of surgery, further exchange of air with 8-14% octafluoropropane (C3F8) would be performed based on operating surgeon's discretion. In cases a temporal ILM flap could not be created, an ILM flap would be created from other quadrants, for example, a nasal ILM would be created instead. Patients with visually significant cataract may undergo concomitant phacoemulsification and intraocular lens implantation or deferred to post-operative month 6-12. Patients would be instructed to adopt a face-down posturing in the first 5 days following operation.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"ILM flap with no gas tamponade","Pars plana vitrectomy with temporal internal limiting membrane (ILM) flap would be performed. The ILM flap would be stabilised over the macular hole using perfluorocarbon liquid (PFCL) followed by sub-PFCL dispersive viscoelastic injection. The PFCL would be removed towards the end of surgery. In cases a temporal ILM flap could not be created, an ILM flap would be created from other quadrants, for example, a nasal ILM would be created instead. Concomitant phacoemulsification and intraocular lens implantation would be performed in patients with visually significant cataract or deferred to post-operative month 6-12. Patients will be instructed to avoid excessive movement and adopt a face forward\u002F supine position for first 24 hours. Afterwards, there would be no restriction on post-operative posturing.",[15],[31],{"name":32,"affiliation":33,"role":34},"Simon KH Szeto, MBChB, FRCOphth","Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Simon KH Dr Szeto, MBChB, MSc, FRCOphth","CONTACT","852 39435886","simonkhszeto@cuhk.edu.hk",[42,70,91],{"facility":43,"status":44,"city":45,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Hong Kong Eye Hospital","RECRUITING","Hong Kong","HK",{"type":48,"coordinates":49},"Point",[50,51],114.17469,22.27832,{"lat":51,"lon":50},[54,56,59,61,64,66,68],{"name":55,"role":38,"phone":39,"phoneExt":25,"email":40},"Simon KH Dr Szeto, MBChB, FRCOphth",{"name":57,"role":38,"phone":25,"phoneExt":25,"email":58},"Amy HY Yu, MBChB","yu.amyy@gmail.com",{"name":60,"role":34,"phone":25,"phoneExt":25,"email":25},"Simon KH Dr Szeto, MBChB, FCOphth(HK)",{"name":62,"role":63,"phone":25,"phoneExt":25,"email":25},"Ziqi Tang, PhD","SUB_INVESTIGATOR",{"name":65,"role":63,"phone":25,"phoneExt":25,"email":25},"Amy Yu, MBChB",{"name":67,"role":63,"phone":25,"phoneExt":25,"email":25},"Chi Wai Tsang, FCOphth(HK)",{"name":69,"role":63,"phone":25,"phoneExt":25,"email":25},"Shaheeda Mohamed, FCOphth(HK)",{"facility":71,"status":72,"city":73,"state":25,"zip":25,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Poznan University of Medical Sicences, University Hospital in Poznan","NOT_YET_RECRUITING","Poznan","Poland","PL",{"type":48,"coordinates":77},[78,79],16.92993,52.40692,{"lat":79,"lon":78},[82,86,87,89],{"name":83,"role":38,"phone":84,"phoneExt":25,"email":85},"Marcin Stopa, MD, PhD, FEBO","+48 61 854 72 20","stopa@ump.edu.pl",{"name":83,"role":34,"phone":25,"phoneExt":25,"email":25},{"name":88,"role":63,"phone":25,"phoneExt":25,"email":25},"Piotr Rakowicz, PhD",{"name":90,"role":63,"phone":25,"phoneExt":25,"email":25},"Martyna Kaluzna, MD",{"facility":92,"status":72,"city":93,"state":25,"zip":25,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Chang Gung Memorial Hospital","Taoyuan","Taiwan","TW",{"type":48,"coordinates":97},[98,99],121.29696,24.99368,{"lat":99,"lon":98},[102,106,109,110,111,113],{"name":103,"role":38,"phone":104,"phoneExt":25,"email":105},"Hung Da Chou, MD","+886-975366127","hungda.chou28@gmail.com",{"name":107,"role":38,"phone":25,"phoneExt":25,"email":108},"Chi Chun Lai, MD","chichun.lai@gmail.com",{"name":103,"role":34,"phone":25,"phoneExt":25,"email":25},{"name":107,"role":63,"phone":25,"phoneExt":25,"email":25},{"name":112,"role":63,"phone":25,"phoneExt":25,"email":25},"Wei Chi Wu, PhD",{"name":114,"role":63,"phone":25,"phoneExt":25,"email":25},"Yi Shiou Hwang, PhD",{"type":34,"investigatorFullName":116,"investigatorTitle":117,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Simon KH Szeto","Clinical assistant professor",[119,121],{"name":120,"class":6},"Poznan University of Medical Sciences",{"name":122,"class":6},"Chang Gung University","100585934","no-endotamponade-for-macular-hole-repair-the-nemar-study-100585934",false,"NCT06908824","No Endotamponade for Macular Hole Repair: the NEMAR Study","The No Endotamponade for Macular Hole Repair (NEMAR) Study: An International Multi-center Randomized Controlled Trial Comparing Macular Hole Closure Using Internal Limiting Membrane Flap Without Endotamponade Versus Conventional Surgery","NEMAR","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Presence of full thickness macular hole in one eye (defined as full thickness discontinuity of neuro-sensory retina at the macula on optical coherence tomography)\n* Able to comply to post-operative posture\n* VA ≥0.05 and ≤0.8\n\nExclusion Criteria:\n\n* Fellow eye enrolled in the study\n* Eyes that underwent previous macular surgery\n* Presence of maculopathy other than macular hole, epi-retinal membrane or myopic maculopathy. For example, age-related macular degeneration, diabetic macular edema or pre-existing macular scar\n* Axial length \\>\u002F= 28mm or presence of significant myopic chorio-retinal atrophy involving the fovea\n* Minimum linear diameter \\>\u002F=800µm\n* Presence of contraindications to intraocular gas, such as advanced glaucoma or uncontrolled glaucoma\n* Significant macular puckering (Govetto staging ≥ stage 2)\n* Patients who are unable to give informed consent\n* Patients who are pregnant","ALL","18 Years",{"count":134,"type":135},180,"ESTIMATED","INTERVENTIONAL",[138],"NA","Full-thickness macular hole (MH) is a common sight threatening macular condition with a prevalence of 3.3 per 1000 individuals. Prompt surgical repair of MH is imperative in preventing irreversible vision loss from MH as the majority of patients would experience progressive loss of central vision, often resulting in visual acuity (VA) of 20\u002F200 or worse and the spontaneous closure rate is less than 10%.\n\nPars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling (with or without ILM flap) and gas tamponade, herein referred to as conventional surgery, is the current standard-of-care surgical technique in repairing MH.\n\nRecently, a novel surgical technique that omits the need of gas tamponade to repair MH has been proposed, early results from retrospective studies were encouraging.\n\nThe purpose of this prospective international multi-centre randomised controlled study is to compare the efficacy and safety of two surgical techniques in treating MH:\n\n1. Conventional surgery: PPV with ILM peeling and gas or silicone oil tamponade\n2. ILM flap with no gas tamponade surgery: PPV with ILM flap with no gas tamponade",[141,142],"Macular Hole","Macular Hole Surgery",[141,144,145,146,147],"Vitrectomy","Macular surgery","Internal limiting membrane peeling","Gas tamponade","2025-09-26",{"date":150,"type":151},"2025-09-30","ACTUAL",{"date":153,"type":151},"2025-09-16",{"date":155,"type":135},"2027-12-31",{"name":5,"class":6},3]