[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"macular-holes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:macular-holes":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,54,81,110,144,168,189,212,235],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"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":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Macular Holes",[29,30,31,32,33,34,35,36,37,38,39,40],"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","RECRUITING","2026-05-29",{"date":44,"type":45},"2026-06-02","ACTUAL",{"date":47,"type":45},"2026-05-25",{"date":49,"type":21},"2028-05-27",{"name":51,"class":52},"Kazakh Eye Research Institute","NETWORK",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":65,"conditions":66,"keywords":67,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":53},"100549382","comparative-study-of-decellularized-human-amniotic-membrane-hydrogel-and-inverted-internal-limiting-membrane-flap-in-idiopathic-large-macular-holes-100549382","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",{"count":63,"type":21},26,[24],"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.",[27],[68,69,70],"macular holes","decellularized amniotic membrane","human amniotic membrane hydrogel","2026-05-17",{"date":73,"type":45},"2026-05-19",{"date":75,"type":45},"2024-10-01",{"date":77,"type":21},"2027-01-30",{"name":79,"class":80},"Walailak University","OTHER",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":97,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":53},"100610477","surgical-procedure-efficiency-evaluation-study-100610477","NCT07228091","Surgical Procedure Efficiency Evaluation stuDy","Surgical Procedure Efficiency Evaluation stuDy (SPEED): Combination Phaco-Vitrectomy Surgeries With UNITY VCS vs. Constellation in a Real-World Operating Room Setting","Key Inclusion Criteria:\n\n* Able to understand and sign an informed consent form (ICF) that has been approved by an ethics committee.\n* Planned combined phacovitrectomy procedure at one of the selected surgical sites.\n* Planned combined phacovitrectomy procedure with 25-gauge (G) vitrectomy tools.\n\nKey Exclusion Criteria:\n\n* Unplanned\u002Femergency phacovitrectomy.\n* Pregnant.\n* Past history of phacovitrectomy. cataract, vitrectomy in the planned operative eye.\n* Other protocol-defined exclusion criteria may apply.",{"count":89,"type":21},180,"OBSERVATIONAL","The purpose of this real-world evidence study is to compare surgical procedure times for UNITY® VCS and CONSTELLATION® Vision System.",[93,94,95,96,27],"Cataract","Vitreous Hemorrhage","Retinal Detachment","Macular Pucker",[98,99],"anterior segment ophthalmic surgery","posterior segment ophthalmic surgery","2026-02-12",{"date":102,"type":45},"2026-02-17",{"date":104,"type":45},"2026-02-09",{"date":106,"type":21},"2026-08",{"name":108,"class":109},"Alcon Research","INDUSTRY",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":118,"sex":17,"minAge":119,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":122,"conditions":123,"keywords":131,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":53},"100340496","intraoperative-oct-guidance-of-intraocular-surgery-ii-100340496","NCT03713268","Intraoperative OCT Guidance of Intraocular Surgery II","Intraoperative OCT Guidance of Intraocular Surger","MIOCT","Inclusion Criteria:\n\n1. Healthy controls: Healthy eyes without known disease: refractive error including myopia and non-significant cataract is allowed. For selected testing pseudophakia is allowed.\n2. Surgeons as research subjects: Adult (≥18 years old)\n3. Surgical patients (vitreoretinal surgery): Patients undergoing examination under anesthesia or surgery for vitreoretinal diseases\n4. Surgical patients (anterior segment surgery-glaucoma, ocular surface or strabismus requiring extraocular muscle surgery): Include both adults and children. Patient undergoing primary, elective minimally invasive glaucoma surgery, ocular surface surgery, or strabismus surgery.\n\nExclusion Criteria:\n\n1. Healthy controls: Any ocular disease that restricts the ability to perform OCT scanning. Conflict of interest with investigators\u002Fstudy personnel, e.g. a student in the lab of an investigator.\n2. Surgeons as research subjects: no specific exclusion criteria.\n3. Surgical patients (vitreoretinal surgery): Neonates (\\\u003C 4 weeks of age) and patients with any ocular disease that restricts the ability to perform OCT scanning.\n4. Surgical patients (anterior segment surgery-corneal and cataract diseases): Pediatric patients: The cornea and cataract surgery studies will be restricted to adults (≥ 18 years). Children do not have cataract surgery typically by residents and therefore would not fit our study design. Similarly pediatric corneal transplants are very rare.",true,"4 Weeks",{"count":121,"type":21},262,"The overall five-year goals of the project are to develop novel technology to provide actionable new information through provision of live volumetric imaging during surgery, improving surgical practice and outcomes. The investigators believe this technology will enable novel ophthalmic and other microsurgeries not possible due to current limitations in surgical visualization.",[27,124,125,95,126,127,93,128,129,130],"Epiretinal Membrane","Diabetic Retinopathy","Retinal Disease","Preretinal Fibrosis","Ocular Tumor","Strabismus","Healthy",[132,116,133,134],"Microscope Integrated optical coherence tomography","OCT Angiography","OCTA","2025-10-02",{"date":137,"type":45},"2025-10-06",{"date":139,"type":45},"2018-09-30",{"date":141,"type":21},"2027-05-31",{"name":143,"class":80},"Duke University",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":17,"minAge":151,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":53},"100557319","phase-4-comparison-of-efficacy-between-ilm-forceps-100557319","NCT06536569","Comparison of Efficacy Between ILM Forceps","A Comparison of the Efficacy of 25g Grieshaber Sharkskin ILM Forceps With Reflex Handle vs Standard 25g Grieshaber ILM Forceps for Internal Limiting Membrane Peeling","Inclusion Criteria:\n\n• 19y and older patients with symptomatic ERM (grade 2-3) or Macular hole (non flap-requiring) for elective ILM peeling surgery.\n\nExclusion Criteria:\n\n* Co-morbid diabetic retinopathy of any grade.\n* Neovascular AMD.\n* Previous vitrectomy.\n* Previous retinal detachment treated with scleral buckle or pneumatic retinopexy.\n* Uncontrolled glaucoma or previous glaucoma surgery.\n* Combined phacovitrectomy.\n* Macula holes with severity requiring flap.","19 Years",{"count":153,"type":21},56,[155],"PHASE4","This study is a Single center, prospective, observational, multi surgeon randomized controlled trial. Subjects will be assessed pre-operatively, operatively and at 1 month postoperatively. Clinical evaluations will include measurement of visual acuity and optical coherence tomography (OCT).",[27,124],"NOT_YET_RECRUITING","2025-03-25",{"date":161,"type":45},"2025-03-30",{"date":163,"type":21},"2025-07-01",{"date":165,"type":21},"2026-01-01",{"name":167,"class":80},"University of British Columbia",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":53},"100516099","duration-of-face-down-positioning-for-full-thickness-macular-hole-repair-100516099","NCT06000111","Duration of Face Down Positioning for Full-Thickness Macular Hole Repair","Duration of Face Down Positioning Following Full-Thickness Macular Hole Repair: a Randomized Feasibility Study","Inclusion Criteria:\n\n* Consecutive patients with an idiopathic full-thickness macular hole\n* Symptom duration of less than 6 months\n* Patient must agree to participate in this investigation\n\nExclusion Criteria:\n\n* Macular hole minimum diameter \\>1000 μm\n* A history of high myopia (\\> -6)\n* Traumatic macular hole\n* Amblyopia\n* Retinal vein occlusion\n* Inflammatory eye diseases\n* Patients found to have a retinal tear during either the pre-operative assessment or intraoperatively",{"count":176,"type":21},40,[24],"A full-thickness macular hole is when there is a small gap that opens in the center part of the retina (the light-sensitive layer of tissue in the back of the eye). Following surgical repair of these holes, patients have to lie face down for a number of days and nights. The exact amount of time necessary to position is however unknown. The goal of this randomized feasibility clinical trial is to compare 3 days and nights of face-down positioning to 7 days and nights of face-down positioning following pars plana vitrectomy surgery for full-thickness macular holes on key patient outcomes. This study will be a feasibility study to better inform a future larger clinical trial. Additionally, this investigation will be examining the rates of macular hole closure, patient visual acuity following surgery, patient quality of life, patient compliance, and complication rates.",[27],"2024-11-26",{"date":182,"type":45},"2024-11-29",{"date":184,"type":45},"2023-11-21",{"date":186,"type":21},"2025-12-31",{"name":188,"class":80},"St. Joseph's Healthcare Hamilton",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":211},"100532369","small-macular-holes-treated-with-air-100532369","NCT06211907","Small Macular Holes Treated With Air","Small Macular Holes Treated With Air: A Prospective Randomized Controlled Multicenter Trial","Inclusion Criteria:\n\n* Primary MH ≤250 μm\n* MH duration ≤12 months\n* No previous vitreoretinal surgery in study eye\n* Ability to sign informed consent\n* Signed informed consent\n* Age ˃18 years\n\nExclusion Criteria:\n\n* Previous vitreoretinal surgery in study eye\n* Secondary MH caused by other conditions than vitreomacular traction\n* Myopic MH, i.e., excessive myopia (more than -6 dioptres)\n* Traumatic MH\n* MH secondary to retinal detachment or other retinal diseases\n* Previously participation in this study",{"count":197,"type":21},132,[24],"Non-inferiority trial comparing intraocular air and gas tamponade for closure of macular holes.",[27],"2024-11-04",{"date":203,"type":45},"2024-11-06",{"date":205,"type":45},"2024-07-14",{"date":207,"type":21},"2028-06-30",{"name":209,"class":210},"Helse Stavanger HF","OTHER_GOV",7,{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":17,"minAge":219,"maxAge":220,"enrollmentInfo":221,"targetDuration":4,"studyType":22,"phases":223,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":53},"100543721","peeled-internal-limiting-membrane-reposition-100543721","NCT06359548","PEELED INTERNAL LIMITING MEMBRANE REPOSITION","PEELED INTERNAL LIMITING MEMBRANE REPOSITION FOR IDIOPATHIC MACULAR HOLES: A Single-centre, Randomized, Prospective Controlled Trial","Inclusion Criteria:\n\n1. The patients are diagnosed as MH with a diameter ≤ 600 µm by optical coherence tomography.\n2. Age ranges from 50 to 80 years.\n3. Do not participate in other clinical studies.\n4. Agree to sign an informed consent form with good compliance.\n\nExclusion Criteria:\n\n1. Traumatic macular hole.\n2. Combined with serious epiretinal membrane.\n3. Combined with diabetic retinopathy, hypertensive retinopathy.\n4. Combined with other ocular diseases, such as keratitis，uveitis，retinal vasculitis.\n5. Spherical equivalent ≥ -6.0 diopters or axial length ≥ 26 mm.\n6. History of intraocular surgery.\n7. Presence of staphyloma.\n8. Other ocular diseases that influence macular microstructure or visual function.","50 Years","90 Years",{"count":222,"type":21},90,[24],"Macular hiatus (MH) refers to a tissue defect in the photoreceptor cell layer of the inner boundary membrane of the optic disc in the macular region. Among them, idiopathic macular hiatus (IMH) is more common in people over 60 years old and is a common eye disease. With the aging of society, the number of patients increases, and it severely damages the patients' vision and life quality. Previously, the conventional surgical approach for treating MH was vitrectomy combined with inner limiting membrane (ILM) peeling. Although the closure rate of MH is high, many damages to the morphology and function of the ILM peeled area have been found. Our team firstly report a novel technique of peeled ILM reposition. Compared to traditional ILM peeling, the novel technique peeled ILM reposition maintains the integrity of internal retina by \"pull\" back the ILM flap. The previous pilot clinical study suggests that the novel technique peeled ILM reposition surgical intervention can achieve better morphology and functional prognosis. However, there is currently a lack of larger sample size prospective randomized controlled studies to further clarify the clinical efficacy of this new surgical technique in treating IMH. This study aims to conduct a single center, prospective, and randomized controlled study, combined with previous work, to analyze the efficacy of this novel technique peeled ILM peeling in the treatment of IMH. We hypothesize that this novel technique can achieved better morphological and functional prognosis compared to traditional ILM peeling.",[27],"2024-04-08",{"date":228,"type":45},"2024-04-11",{"date":230,"type":21},"2024-04-15",{"date":232,"type":21},"2026-11",{"name":234,"class":80},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":243,"enrollmentInfo":244,"targetDuration":4,"studyType":22,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":4},"100522205","gasless-macular-hole-surgery-100522205","NCT06079593","GaslEss Macular Hole Surgery","GaslEss Macular Hole Surgery (GEM): a Feasibility Study","GEM","Inclusion Criteria:\n\n* Requiring PPV to treat idiopathic (primary) FTMH.\n* 18 years or older\n* ETDRS BCVA letter score of 1 or better in the study eye\n* Able to provide written informed consent\n\nExclusion Criteria:\n\nGeneral:\n\n* Hypersensitivity to hyaluronate or other components of Healon Pro® viscoelastic\n* Any major illness or major surgical procedure within 4 weeks\n* Any other condition that, in the opinion of the investigator, would prevent the participant from granting informed consent or complying with the protocol\n\nStudy eye\n\n* Previous vitreoretinal surgery, retinopexy, open-globe injury, or endophthalmitis\n* Presence of fibrotic retinal proliferation or central epiretinal membrane (within 1 disc diameter of the fovea)\n* Aphakia\n* Current or former myopia greater than 6 dioptres\n* Current or previous posterior uveitis or choroiditis\n* Presence of other ocular co-morbidity that, in the opinion of the investigator, is likely to impair BCVA postoperatively or affect FTMH closure\n* Current ocular or periocular infection, other than mild or moderate blepharitis\n* Lens or media opacity that preclude adequate retinal assessment and imaging","100 Years",{"count":245,"type":21},60,[24],"Macular holes are a hole in the centre of the retina, the light-sensing layer in the back of the eye. They cause a central 'blind spot' in the vision, which can be very disabling for patients. Standard surgery involves injecting a large gas bubble inside the eye. This takes 4-8 weeks to leave the eye. During this time vision is greatly reduced in the eye. This limits patients' ability to drive and work. Gas causes clouding of the natural lens in the eye (cataract). The gas can also raise pressure inside the eye, causing pain and sometimes loss of vision. Patients cannot fly or have certain medicines until the gas absorbs.\n\nCritically, most patients position face down for 50 minutes out of every hour for a week after surgery. This is to float the gas bubble onto the macula. Head positioning is particularly difficult. It very often causes pain in the neck, back, arms and legs. Rarely, blood clots can form in the legs and be life-threatening if they dislodge and travel to the lungs. Head positioning also places a large burden on those caring for the patient.\n\nThe gases are 'greenhouse' gases and cause damage to the environment, for about 3,200 years.\n\nThis study looks at a new surgical technique for treating macular holes. The new technique aims to make patients' recovery from surgery easier, and safer.\n\nThe purpose of this study therefore is to compare two treatments:\n\n* Standard macular hole surgery with gas tamponade\n* Novel macular hole surgery without tamponade Gathering feasibility data to inform a future fully powered trial",[27],"2023-12-08",{"date":251,"type":45},"2023-12-14",{"date":253,"type":21},"2024-01-01",{"date":255,"type":21},"2026-10-31",{"name":257,"class":80},"King's College Hospital NHS Trust"]