[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637250":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":41,"studyPopulation":30,"armGroups":42,"interventions":87,"overallOfficials":103,"centralContacts":107,"locations":117,"responsibleParty":132,"collaborators":30,"id":135,"slug":136,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":137,"sex":143,"minAge":144,"maxAge":30,"enrollmentInfo":145,"targetDuration":30,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":119,"whyStopped":30,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"fullName":5,"class":6},"Kazakh Eye Research Institute","NETWORK",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":30},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Macular Hole Closure at 7 days","Proportion of participants with OCT-confirmed anatomical macular hole closure.","7 day",{"measure":14,"description":11,"timeFrame":15},"Macular Hole Closure at 1month","1 month",{"measure":17,"description":11,"timeFrame":18},"Macular Hole Closure at 1 Year","1 year",[20,24,27],{"measure":21,"description":22,"timeFrame":23},"BCVA at Day 7","Best-corrected visual acuity (BCVA) measured at Day 7 after surgery and recorded in logMAR units.","7 days",{"measure":25,"description":26,"timeFrame":15},"BCVA at 1 Month","Best-corrected visual acuity (BCVA) measured at 1 month after surgery and recorded in logMAR units.",{"measure":28,"description":29,"timeFrame":18},"BCVA at 1 Year","Best-corrected visual acuity (BCVA) measured at 1 year after surgery and recorded in logMAR units.",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":30,"timePerspective":30,"maskingInfo":36},"RANDOMIZED","PARALLEL","Parallel-group randomized trial comparing ten PPV-based surgical techniques for full-thickness macular hole repair, with stratified randomization by macular hole size into five predefined MLD strata.","TREATMENT",{"masking":37,"maskingDescription":30,"whoMasked":38},"DOUBLE",[39,40],"PARTICIPANT","OUTCOMES_ASSESSOR","Full-thickness macular hole is a vision-threatening condition that is commonly treated with pars plana vitrectomy (PPV) and internal limiting membrane (ILM) peeling. While standard approaches achieve high closure rates in many cases, outcomes may vary depending on macular hole size and OCT morphology, and advanced surgical strategies (e.g., different ILM flap configurations, adjunctive biologic augmentation, hydrodissection, or grafting techniques) are increasingly used in clinical practice.\n\nThis single-center, randomized, parallel-group interventional study will compare ten PPV-based surgical techniques for full-thickness macular hole repair. Eligible participants will include adults with full-thickness macular hole across a broad range of minimum linear diameter (MLD), including MLD \\\u003C250 µm. After eligibility confirmation and informed consent, participants will be randomized to one of the ten procedure groups. Randomization will be stratified by macular hole size into five predefined MLD strata to ensure balanced distribution of hole sizes across all intervention groups. Postoperative care and follow-up procedures will be standardized across groups according to the study protocol.\n\nFollow-up visits are scheduled at Day 7, Month 1, and Year 1 after surgery and will include clinical examinations and OCT imaging. The primary endpoint is anatomical macular hole closure on OCT at the prespecified primary time point. Secondary endpoints include best-corrected visual acuity (BCVA), OCT-based morphologic recovery parameters, intraoperative and postoperative complication rates, reoperation rates, and adverse event information through Year 1. The study aims to generate evidence to guide selection of surgical technique based on macular hole morphometric and clinical characteristics while maintaining patient safety.",[43,49,53,57,61,65,69,74,78,83],{"label":44,"type":45,"description":46,"interventionNames":47},"PPV + PVD Induction Without ILM Peel\u002FFlap","ACTIVE_COMPARATOR","Pars plana vitrectomy (PPV) with induction of posterior vitreous detachment (PVD) performed without internal limiting membrane (ILM) peeling and without an ILM flap.",[48],"Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery",{"label":50,"type":45,"description":51,"interventionNames":52},"PPV + ERM peel + circular ILM peel (classic)","Pars plana vitrectomy (PPV) with epiretinal membrane (ERM) peeling (if present) followed by standard circular internal limiting membrane (ILM) peeling around the fovea (classic technique).",[48],{"label":54,"type":45,"description":55,"interventionNames":56},"PPV + 360° Inverted ILM Flap","Pars plana vitrectomy (PPV) with creation of a circumferential (360°) internal limiting membrane (ILM) flap that is inverted to cover the macular hole, according to the study protocol.",[48],{"label":58,"type":45,"description":59,"interventionNames":60},"PPV + Superior Hinged ILM Flap","Pars plana vitrectomy (PPV) with creation of a superior hinged internal limiting membrane (ILM) flap left attached at the superior edge and inverted to cover the macular hole, according to the study protocol.",[48],{"label":62,"type":45,"description":63,"interventionNames":64},"PPV + Temporal Hinged ILM Flap","Pars plana vitrectomy (PPV) with creation of a temporal hinged internal limiting membrane (ILM) flap, left attached at the temporal edge, and inverted to cover the macular hole, according to the study protocol.",[48],{"label":66,"type":45,"description":67,"interventionNames":68},"PPV + Multiflap ILM Flap (Cabbage Leaf\u002FStar)","Pars plana vitrectomy (PPV) with creation of multiple small internal limiting membrane (ILM) flaps (multiflap \"cabbage leaf\u002Fstar\" technique) positioned to cover the macular hole, according to the study protocol.",[48],{"label":70,"type":45,"description":71,"interventionNames":72},"PPV + ILM removal + inverted flap + PRP","Pars plana vitrectomy (PPV) with internal limiting membrane (ILM) removal and an inverted ILM flap technique. Autologous platelet-rich plasma (PRP) is applied to the macular hole area as an adjunct, according to the study protocol.",[48,73],"Biological: Autologous Platelet-Rich Plasma (PRP)",{"label":75,"type":45,"description":76,"interventionNames":77},"PPV + ILM removal + PRP","Pars plana vitrectomy (PPV) with standard internal limiting membrane (ILM) peeling (no ILM flap technique). Autologous platelet-rich plasma (PRP) is applied to the macular hole area as an adjunct, according to the study protocol.",[48,73],{"label":79,"type":45,"description":80,"interventionNames":81},"PPV + ILM Peeling + Human Amniotic Membrane (hAM) Graft","Pars plana vitrectomy (PPV) with standard internal limiting membrane (ILM) peeling followed by placement of a human amniotic membrane (hAM) graft for full-thickness macular hole repair, according to the study protocol.",[48,82],"Other: Human Amniotic Membrane (hAM) Graft",{"label":84,"type":45,"description":85,"interventionNames":86},"PPV + Macular Edge Hydrodissection","Pars plana vitrectomy (PPV) with controlled hydrodissection (hydromobilization) of the macular hole edges using balanced salt solution to gently separate and mobilize the retinal margins before macular hole closure, according to the study protocol.",[48],[88,93,98],{"type":89,"name":90,"description":91,"armGroupLabels":92,"otherNames":30},"PROCEDURE","Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery","Pars plana vitrectomy (PPV) for full-thickness macular hole repair performed according to the randomized assigned technique (e.g., ERM peel, ILM peeling, ILM flap configurations, or macular edge hydrodissection), as specified in the protocol.",[54,50,79,75,70,84,66,44,58,62],{"type":94,"name":95,"description":96,"armGroupLabels":97,"otherNames":30},"BIOLOGICAL","Autologous Platelet-Rich Plasma (PRP)","Autologous platelet-rich plasma (PRP) applied intraoperatively to the macular hole area as an adjunct to surgery, according to the study protocol.",[75,70],{"type":99,"name":100,"description":101,"armGroupLabels":102,"otherNames":30},"OTHER","Human Amniotic Membrane (hAM) Graft","Human amniotic membrane (hAM) graft placed intraoperatively for macular hole repair, according to the study protocol.",[79],[104],{"name":105,"affiliation":5,"role":106},"Sanzhar Sambet Sambet, MD","PRINCIPAL_INVESTIGATOR",[108,113],{"name":109,"role":110,"phone":111,"phoneExt":30,"email":112},"Sanzhar Sambet, MD","CONTACT","+77758719834","sanzhrs@gmail.com",{"name":114,"role":110,"phone":115,"phoneExt":30,"email":116},"Kairat Ruslanuly, MD","+77019008387","ruslanuly.kairat@gmail.com",[118],{"facility":5,"status":119,"city":120,"state":120,"zip":121,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":129,"contacts":130},"RECRUITING","Almaty","050042","Kazakhstan","KZ",{"type":125,"coordinates":126},"Point",[127,128],76.9115,43.25249,{"lat":128,"lon":127},[131],{"name":109,"role":110,"phone":111,"phoneExt":30,"email":112},{"type":106,"investigatorFullName":133,"investigatorTitle":134,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Kairat Ruslanuly","Senior Scientific Researcher","100637250","full-thickness-macular-hole-surgery-a-comparison-of-ten-techniques-100637250",false,"NCT07606404","Full-Thickness Macular Hole Surgery: A Comparison of Ten Techniques","Vitreoretinal Surgery for Full-Thickness Macular Hole: A Comparative Study of Ten Techniques","FTMH-10","Inclusion Criteria:\n\nAdults aged ≥18 years.\n\nFull-thickness macular hole (FTMH) eligible for pars plana vitrectomy (PPV).\n\nSymptom duration ≤12 months.\n\nClear ocular media sufficient for high-quality OCT imaging.\n\nNo prior pars plana vitrectomy in the study eye.\n\nNo severe foveal atrophy on OCT.\n\nAble and willing to comply with postoperative positioning and follow-up visits.\n\nWritten informed consent provided.\n\nExclusion Criteria:\n\nA. Etiology-Related \u002F Secondary Macular Holes:\n\nTraumatic macular hole.\n\nHigh myopia with posterior staphyloma (axial length \\>28 mm and\u002For spherical equivalent ≤-8.0 D).\n\nDiabetic tractional retinal detachment (TRD) or significant tractional maculopathy.\n\nRetinal vascular occlusion-related macular hole.\n\nUveitis-related macular hole.\n\nAdvanced age-related macular degeneration (AMD) with foveal atrophy.\n\nB. Prior Interventions:\n\nAny prior pars plana vitrectomy in the study eye.\n\nC. Ocular Conditions That May Affect Outcomes or Safety:\n\nActive or recent ocular infection or inflammation (e.g., uveitis, endophthalmitis, keratitis).\n\nUncontrolled glaucoma (intraocular pressure \\>28 mmHg despite treatment).\n\nMedia opacity precluding adequate OCT (e.g., dense cataract or corneal opacity).\n\nGeographic atrophy involving the fovea.","ALL","18 Years",{"count":146,"type":147},120,"ESTIMATED","INTERVENTIONAL",[150],"NA","This study compares ten modern vitreoretinal surgical techniques for full-thickness macular hole repair. Participants will be randomly assigned to one of the surgical approaches during pars plana vitrectomy, using stratified randomization based on macular hole size to ensure balanced groups. The main goal is to determine which technique provides the highest anatomical closure rate on optical coherence tomography (OCT) and the best visual outcomes. Follow-up visits are scheduled at Day 7, Month 1, and Year 1 after surgery to assess OCT findings, visual acuity, safety outcomes, and the need for reoperation.",[153],"Macular Holes",[155,156,157,158,159,160,161,162,163,164,165,166],"Full-Thickness Macular Hole","Pars Plana Vitrectomy","Internal Limiting Membrane Peeling","Inverted ILM Flap","ILM Flap","Optical Coherence Tomography","Macular Hole Closure","Best-Corrected Visual Acuity","Platelet-Rich Plasma","Amniotic Membrane Graft","Macular Hydrodissection","Surgical Technique","2026-05-29",{"date":169,"type":170},"2026-06-02","ACTUAL",{"date":172,"type":170},"2026-05-25",{"date":174,"type":147},"2028-05-27",{"name":5,"class":6},1]