[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fuchs-endothelial-dystrophy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fuchs-endothelial-dystrophy":382},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,43,68,97,128,153,181,208,232,262,288,316,341,361],{"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":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100460465","phase-3-descemet-endothelial-thickness-comparison-trial-ii-100460465",false,"NCT05275972","Descemet Endothelial Thickness Comparison Trial II","Descemet Endothelial Thickness Comparison Trials (DETECT I & II)","DETECT II","Inclusion Criteria:\n\n* Dysfunctional endothelium from FECD with few guttata extending beyond 4.5 mm\n* Peripheral endothelial cell count \\>1000 cells\u002Fmm2 in at least one quadrant\n* Good surgical candidate for either procedure as determined by the surgeon\n* Willingness to participate\n* Age greater than 18 years\n\nExclusion Criteria:\n\n* Aphakia, anterior chamber IOL or scleral fixated IOL in study eye prior to or anticipated during EK\n* Pre-operative central sub-epithelial or stromal scarring that the investigator believes is visually significant and could impact post-operative stromal clarity assessment\n* Other primary endothelial dysfunction such as PPMD\n* Visually significant optic nerve or macular pathology\n* Hypotony (Intraocular pressure \\\u003C10mmHg)\n* Any prior intraocular surgery other than cataract surgery\n* \\>3 clock hours of ANY anterior or posterior synechiae\n* \\>1 quadrant of stromal corneal vascularization\n* Inability to comply with post-operative instructions (i.e. unable to position)\n* Pregnancy","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Descemet Endothelial Thickness Comparison Trial (DETECT) II is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 60 patients with Fuchs endothelial dystrophy to DMEK versus Descemet Stripping Only (DSO) with adjunctive Ripasudil.",[27,28,29],"Fuchs","Fuchs Dystrophy","Fuchs' Endothelial Dystrophy","RECRUITING","2026-05-06",{"date":33,"type":34},"2026-05-08","ACTUAL",{"date":36,"type":34},"2023-01-23",{"date":38,"type":21},"2028-11-30",{"name":40,"class":41},"Stanford University","OTHER",8,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100536170","plasma-rich-in-growth-factors-in-corneal-endothelial-transplantation-100536170","NCT06261346","Plasma Rich in Growth Factors in Corneal Endothelial Transplantation","Safety and Efficacy of Brief Intraoperative Corneal Endothelial Graft Incubation in Plasma Rich in Growth Factors (PRGF) for Reducing Postoperative Endothelial Cell Loss","Inclusion Criteria:\n\n* undergoing endothelial keratoplasty (DSEK or DMEK) at the Bascom Palmer Eye Institute or Price Vision Group, using corneal graft tissue within 14 days of preservation\n\nExclusion Criteria:\n\n* History of corneal transplantation in the study eye, Best corrected visual acuity (BCVA) worse than 20\u002F40 in the contralateral eye, systemic immunosuppression, previous intraocular surgical procedures (other than cataract surgery) such as glaucoma tubes or silicone oil.\n\nThe following special populations will be excluded.\n\n* Adults unable to consent\n* Pregnant women\n* Prisoners","80 Years",{"count":52,"type":21},100,[54],"NA","The purpose of the study is to determine the safety and efficacy of brief intraoperative corneal endothelial graft incubation in plasma rich in growth factors (PRGF) for reducing postoperative endothelial cell loss.",[29,57],"Corneal Edema","2026-04-03",{"date":60,"type":34},"2026-04-09",{"date":62,"type":34},"2024-07-15",{"date":64,"type":21},"2027-12-31",{"name":66,"class":41},"University of Miami",2,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100472805","the-belgian-endothelial-surgical-transplant-of-the-cornea-100472805","NCT05436665","The Belgian Endothelial Surgical Transplant of the Cornea","The Belgian Endothelial Surgical Transplant of the Cornea:Clinical and Patient-reported Outcomes of Descemet Stripping Automated Endothelial Keratoplasty(DSAEK) Versus Descemet Membrane Endothelial Keratoplasty(DMEK)","BESTCornea","Inclusion Criteria:\n\n* Fuchs Endothelial Dystrophy (FED);\n* Bullous Keratopathy (BK);\n* Other miscellaneous causes of endothelial dysfunction including decompensation of a previous corneal graft;\n* Pseudophakic (post cataract surgery);\n* Patients over 18 with the capacity to read and to understand the study information and to give informed consent, as well as study quality of life questionnaires;\n* Patients willing and capable to attend the 3, 6, and 12-month follow-up appointments.\n\nExclusion Criteria:\n\n* Inability to provide informed consent;\n* Patients unable to attend the proposed follow up;\n* Inclusion of the fellow eye in the study;\n* Complex surgery combined with multiple pathologies (i.e., glaucoma surgery);\n* Other contraindications to lamellar corneas surgery;\n* Patients who elect not to participate;\n* Patients under 18 years of age;\n* Patients that are currently pregnant or breastfeeding;\n* Phakic patients with no direct plan to perform cataract surgery.",{"count":77,"type":21},220,[54],"This study is designed as a randomised multicentric parallel group pragmatic trial of Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) versus Descemet Membrane Endothelial Keratoplasty (DMEK) in corneal endothelial decompensation. the purpose is to compare the clinical and patient reported outcomes of both therapies across a broad range of indications.",[57,81,29,82,83],"Corneal Endothelial Disorder","Bullous Keratopathy","Pseudophakic Bullous Keratopathy",[85,86,87],"DMEK","DSAEK","UT-DSAEK","2026-03-30",{"date":58,"type":34},{"date":91,"type":34},"2022-08-10",{"date":93,"type":21},"2028-06-06",{"name":95,"class":41},"University Hospital, Antwerp",11,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":127},"100617936","phase-1-pvek-corneal-implant-for-treatment-of-corneal-edema-100617936","NCT07325097","PVEK Corneal Implant For Treatment of Corneal Edema","A Prospective, Single Arm Study to Assess the Safety and Tolerability of PVEK Corneal Implant for the Treatment of Corneal Edema","CIFRE","Inclusion Criteria:\n\nage 18\u002F50 years or older\n\nCorneal edema requiring endothelial keratoplasty due to Fuchs' endothelial dystrophy and\u002For pseudophakic bullous keratopathy\n\nPseudophakic study eye\n\nBest corrected visual acuity (BCVA) in the study eye between 6\u002F379 (1.8 logMAR) and 6\u002F12 (0.3 logMAR)\n\nCentral corneal thickness greater than 0.6 mm by OCT\n\nExclusion Criteria:\n\nPhakic study eye\n\nStudy eye is a \"single sight eye\" (per protocol definition) \u002F fellow eye does not meet protocol vision requirement\n\nMalpositioned intraocular lens (dislocation\u002Fsubluxation) in the study eye\n\nPrior ocular procedure in the study eye other than uncomplicated cataract surgery with a stable, centered posterior chamber IOL\n\nAxial length below 21 mm or above 26 mm\n\nOther significant corneal disease (beyond mild dry eye) or prior keratoplasty in the study eye, or visually significant corneal scarring\u002Fopacities not expected to improve with treatment\n\nActive ocular or eyelid infection\u002Finflammation; active\u002Fprior herpetic ocular infection; uveitis\n\nGlaucoma \u002F history or suspicion of elevated IOP, or screening IOP above 23 mmHg (either eye)\n\nSynechiae; abnormal anterior segment (e.g., aphakia, aniridia)\n\nCorneal endothelial cell density above 1000 cells\u002Fmm² at screening (or not reliably measurable)\n\nUncontrolled systemic conditions",{"count":106,"type":21},15,[108],"PHASE1","The goal of this clinical trial is to learn if PVEK, a corneal implant , is safe and well tolerated for people with corneal swelling caused by Fuchs' endothelial dystrophy or pseudophakic bullous keratopathy who need endothelial keratoplasty.\n\nThe main questions it aims to answer are:\n\nWhat side effects may happen after the PVEK implant?\n\nHow many participants can complete the first 6 months after surgery without needing another treatment because the implant did not help enough or was not tolerable?\n\nThis is a Phase 1 (first-in-human) study with one study group, meaning all participants receive the PVEK implant (there is no placebo or comparison group). About 15 participants will take part and will be followed for up to 12 months after surgery.\n\nParticipants will:\n\nComplete screening tests (including eye exams and routine health checks)\n\nHave the PVEK implantation surgery\n\nUse prescribed eye drops after surgery\n\nReturn for follow-up visits over the next 12 months for eye exams and tests (such as vision testing, eye pressure checks, and eye scans)",[57,29,83,111],"Corneal Endothelial Dysfunction",[113,114,115,116],"Endothelial keratoplasty","Tissue-engineered corneal implant","Corneal endothelial cells","Collagen scaffold","2026-01-08",{"date":119,"type":34},"2026-01-12",{"date":121,"type":34},"2025-09-16",{"date":123,"type":21},"2027-09",{"name":125,"class":126},"Precise Bio","INDUSTRY",3,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"100488166","phase-1-study-to-assess-safety-and-tolerability-of-multiple-doses-of-eo2002-100488166","NCT05636579","Study to Assess Safety and Tolerability of Multiple Doses of EO2002","Phase 1, Multiple Dose, Open-Label Study to Assess the Safety and Tolerability of EO2002 Intracameral Injections With or Without Topical Ripasudil in the Treatment of Corneal Edema","Inclusion Criteria:\n\nAll ocular criteria apply to the study eye unless otherwise noted.\n\n1. Age ≥ 18 years.\n2. Subject is phakic or pseudophakic with a posterior chamber intraocular lens (lens in the bag or sulcus).\n3. Symptomatic corneal edema associated with endothelial dysfunction which may be secondary to Fuchs' corneal dystrophy or pseudophakic bullous keratopathy.\n\nKey Exclusion Criteria:\n\nAll ocular criteria apply to the study eye unless otherwise noted.\n\n1. Other corneal disease\n2. Anterior chamber intraocular lens\n3. Sutured or scleral-fixated intraocular lens.\n4. Macular disease that in the investigator and\u002For sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.\n5. History of refractive surgery.\n6. History of Vitrectomy\n7. Descemet membrane detachment.\n8. History of uveitis or other ocular inflammatory disease.\n9. History of incisional glaucoma surgery (e.g.,trabeculectomy, glaucoma drainage implant).\n10. IOP \\>21 or \\\u003C7 mm Hg\n11. Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty.\n\n11\\. History of ocular neoplasm. 12. ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20\u002F200).\n\n13\\. Female who is pregnant, nursing, or planning to become pregnant, or who is of childbearing potential and not using a reliable means of contraception during the study.\n\n14\\. Subject is currently participating in or has participated within the last 3 months in any other clinical trial of an investigational drug by ocular or systemic administration.\n\n15\\. Any concomitant medical or psychological condition that could interfere with study participation or is otherwise not suitable for entry into the study in the opinion of the investigator.",{"count":136,"type":21},12,[108],"The goal of this clinical study is to assess the safety of multiple intracameral injections of EO2002 with and without topical Ripasudil.",[57,140,141,28,29,82,83,142],"Corneal Endothelial Dystrophy","Endothelial Dysfunction","Corneal Edema Pseudophakic","2025-12-02",{"date":145,"type":34},"2025-12-08",{"date":147,"type":34},"2022-11-08",{"date":149,"type":21},"2025-12-09",{"name":151,"class":41},"Asociación para Evitar la Ceguera en México",1,{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":159,"sex":17,"minAge":160,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":164,"phases":4,"briefSummary":165,"conditions":166,"keywords":170,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":152},"100218283","a-study-to-test-the-diagnostic-potential-of-brillouin-microscopy-for-corneal-ectasia-100218283","NCT02118922","A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia","Inclusion Criteria:\n\nGroup I includes healthy subjects with normal appearing corneas, normal topography and pachymetry. Group II includes patients diagnosed as having mild, moderate or advanced keratoconus by our ophthalmology expert on the basis of topography and pachymetry. Group III includes healthy subjects who have undergone LASIK surgery in the past 12 months without complications. Inclusion criteria include normal post-operative topography and pachymetry. Group IV includes patients (age 20 - 60) who have undergone LASIK surgery at least 12 months before the study imaging and have been diagnosed with post-LASIK ectasia based on topography, pachymetry and clinical evaluation.Patients diagnosed with keratoconus. Group V- Volunteers to receive PRK surgery This group includes patients who have been diagnosed with myopia and have been scheduled to undergo PRK surgery. Patients with high astigmatism \\> 2 diopter, prior ocular surgeries, and those patients taking any ocular medications except seasonal allergy medicine such as ketotifen or artificial tears will be excluded. Group VI-Volunteers to receive LASIK Surgery This group includes myopic patients who are scheduled to receive LASIK surgery. Patients with high astigmatism \\> 2 diopter, prior ocular surgeries, and those patients taking any ocular medications except seasonal allergy medicine such as ketotifen and artificial tears will be excluded. Group VII- Patients with Fuch's Endothelial Corneal Dystrophy. This group includes subjects who are diagnosed with Fuch's corneal dystrophy, at early, mild and advanced stages. The inclusion also extends to subjects with, and without keratoconus. But this exclude patients with any other corneal disorders other than keratoconus, and\u002For history of ophthalmological surgeries that may affect endothelium cell status, e.g. cataract surgeries.\n\nOverall Exclusion Criteria for all groups: Volunteers who\n\n* Have occludable narrow angles (without a patent peripheral iridotomy)\n* Monocular subjects\n* Do not or cannot understand the instructions for the imaging",true,"20 Years","75 Years",{"count":163,"type":21},168,"OBSERVATIONAL","We have developed novel Brillouin microscopy and we are testing its potential for keratoconus and ectasia diagnostics. We plan to perform axial scans of the cornea in human volunteers in order to compare biomechanical properties of Keratoconus vs. Normal corneas and compare biomechanical properties of post-LASIK ectasia vs. normal corneas.",[167,168,169,29],"Keratoconus","Ectasia","Crosslinking",[171],"LASIK","2025-11-04",{"date":174,"type":34},"2025-11-06",{"date":176,"type":34},"2013-06",{"date":178,"type":21},"2026-09",{"name":180,"class":41},"Massachusetts General Hospital",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":17,"minAge":188,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":193,"conditions":194,"keywords":196,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":42},"100494343","phase-4-the-optimise-study-100494343","NCT05716945","The OPTIMISE Study","Optimized Immunosuppression for Corneal Transplantation: A Multi-center Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n\\- Patients aged 21 years or older registered on the NOTR as candidates for DMEK corneal transplantation\n\nExclusion Criteria:\n\n* Inability to complete follow up or comply with study procedures\n* The participant is vulnerable\n* Previous corneal graft in the study eye\n* Known sensitivity or contraindication to the ingredients in the study medications\n* History of uveitis\n* History of any herpes simplex infection\n* Human Leukocyte Antigen (HLA) typed allograft\n* Pregnancy (current and planned) or lactation\n* Use of other local or systemic immunosuppressive drugs","21 Years",{"count":190,"type":21},342,[192],"PHASE4","Rationale:\n\nThe cornea is the most transplanted tissue in the Netherlands, with more than 1,500 procedures performed each year. A minimally invasive technique called Descemet Membrane Endothelial Keratoplasty (DMEK) has become the preferred method in the past decade. The main advantage of DMEK over previous techniques is a low graft rejection rate (1-2% per year). Despite this, rejection prophylaxis after DMEK follows the same high potency regimen as previous techniques in the first year, and patients are burdened with indefinite immunosuppression. The current project, OPTIMISE, aims to establish an evidence-based, cost-effective regimen that effectively prevents rejection and minimizes side effects.\n\nCorticosteroid eye drops are the mainstay of ocular immunomodulatory therapy. Their main side effect is a steroid-induced increase in intraocular pressure (IOP). It manifests in about one-fourth of patients within the first year after surgery and can lead to irreversible optic nerve damage and vision loss. Patients with IOP elevation require additional medications and hospital visits resulting in reduced quality of life and increased costs. The optimal dosing regimen in the first year after DMEK and whether patients may safely stop steroids after one year remains unknown. As a result, protocols in the Netherlands vary considerably from surgeon to surgeon. Patients are potentially over-treated in the short and long-term, resulting in undue burden for the patient and increased costs. Consequently, the Dutch Ophthalmology Society (NOG) identified the optimal short- and long-term immunosuppressive protocol for corneal transplantation as one of its Top 10 knowledge gaps, underscoring relevance for clinical practice. With this work, the investigators expect to address this knowledge gap to the benefit of our patients and society.\n\nObjective:\n\nThe OPTIMISE study aims to establish an evidence-based, cost-effective regimen that effectively prevents rejection and minimizes side effects. The hypothesis of this study is that Fluorometholone 0.1% in the first year and discontinuing medication in the second year is a cost-effective treatment strategy after DMEK.\n\nStudy design:\n\nThe design of this study is a randomized, controlled multicentre trial with a duration of 24 months.\n\nStudy population:\n\nThe study population will consist of 342 patients aged 21 years or older undergoing DMEK surgery in one eye.\n\nIntervention:\n\nAll patients will receive Descemet's Membrane Endothelial Keratoplasty. Following this procedure, patients will be randomized into the following post-operative regime in two stages:\n\nSTEP-I (Year 1):\n\nControl group: DMS 0.1% 6 times a day for 1 month tapered off to once daily within 6 months and then once a day for 6 months.\n\nIntervention group: DMS 0.1% 6 times a day for 1 month followed by FML 0.1% 4 times a day for two months tapered off to once daily within four months and then once a day for 6 months.\n\nSTEP-II (Year 2):\n\nControl Group: Half the patients in each study arm will use FML 0.1% daily. Intervention Group: Half the patients in each study arm will discontinue steroids.\n\nMain study parameters\u002Fendpoints:\n\nPrimary outcomes:\n\nStep-I: IOP elevation compared to baseline Step-II: Endothelial cell loss (ECL) in the second year\n\nSecondary outcomes are:\n\n* Rejection free graft survival.\n* Patient reported outcome measures.\n* Incremental cost-effectiveness ratios, including a short term trial-based economic evaluation (TBEE) and a life-long model-based economic evaluation (MBEE)\n* Structural outcomes including corneal, central macular and retinal nerve fibre layer thicknesses, and optic nerve head imaging.",[83,29,195],"Intraocular Pressure",[197,198],"Descemet Stripping Endothelial Keratoplasty","Cornea","2025-10-02",{"date":201,"type":34},"2025-10-06",{"date":203,"type":34},"2024-07-29",{"date":205,"type":21},"2029-03",{"name":207,"class":41},"Maastricht University Medical Center",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":17,"minAge":188,"maxAge":50,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":152},"100387062","phase-1-safety-and-efficacy-of-tissue-engineered-endothelial-keratoplasty-100387062","NCT04319848","Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty","Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty (TE-EK)","TE-EK","Inclusion Criteria:\n\nPatients who have mild to moderate corneal endothelial decompensation or bullous keratopathy, but with minimal corneal stromal scarring resulting from a variety of conditions including:\n\n* Fuchs' endothelial dystrophy\n* Post-surgical corneal decompensation (irreversible) - all forms of pseudophakic or aphakic bullous keratopathy\n\nExclusion Criteria:\n\n* Severe forms or late stage presentation of corneal decompensation with severe corneal stromal scarring, unsuitable for TE-EK surgery as opposed to penetrating keratoplasty\n* Patients with complex anterior segment complications precluding a successful TE-EK procedure\n* Patients who have other forms of endothelial dystrophy, traumatic corneal decompensation, or post-inflammatory corneal decompensation\n* Post-laser iridotomy or glaucoma related corneal decompensation\n* Patients not keen to participate in the clinical trial\n* Patients who are below 21 years of age or above 80 years of age\n* Patients who are pregnant\n* Patients who are cognitively impaired\n* Patients who are prisoners\n* Patients who are allergic to antibiotics",{"count":217,"type":21},30,[108],"Assessment of safety and efficacy of tissue-engineered corneal endothelial graft material generated using cultured human corneal endothelial cells for tissue-engineered endothelial keratoplasty (TE-EK).",[221,82,29,222],"Mild to Moderate Corneal Endothelial Decompensation","Post-surgical Corneal Decompensation (Irreversible)","2025-09-05",{"date":225,"type":34},"2025-09-12",{"date":227,"type":34},"2017-12-01",{"date":229,"type":21},"2028-06",{"name":231,"class":41},"Singapore Eye Research Institute",{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":159,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":164,"phases":4,"briefSummary":242,"conditions":243,"keywords":249,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":152},"100241590","discover-study-microscope-integrated-intraoperative-oct-study-100241590","NCT02423213","DISCOVER Study: Microscope-integrated Intraoperative OCT Study","Determination of Feasibility of Intraoperative Spectral Domain Microscope Combined\u002FIntegrated OCT Visualization During En Face Retinal and Ophthalmic Surgery: DISCOVER Study","DISCOVER","Inclusion Criteria:\n\n* The study population includes any patient requiring ophthalmic surgery\n\nExclusion Criteria:\n\n* Under the age of 18 years.\n* Cognitive\u002FMentally impaired or unable to provide consent",{"count":241,"type":21},3000,"Optical coherence tomography (OCT )provides high resolution information regarding the anatomic structure of the tissues of the eye in a cross-sectional and 3 dimensional view. Much of this information is not able to be visualized by a clinician. Utilizing this information during surgery will allow for the ophthalmic surgeons to better understand how surgical procedures impact the anatomic structure of the eye.\n\nIn this study an OCT device that has been built into the microscope (rather than mounted on the side or held in the surgeon's hand) and will be utilized to take images at various milestones during surgery to assess feasibility and potential utility of this technology. Since it is built into the microscope, there are potential significant advantages over a separate system including increased efficiency, improved working distance, and the ability to visualize tissue-instrument interactions.",[244,245,246,247,248],"Retinal Diseases","Fuchs Endothelial Dystrophy","Macular Hole","Epiretinal Membrane","Retinal Detachment",[250,251,252],"OCT","image-guided surgery","ophthalmic surgery","2025-06-23",{"date":255,"type":34},"2025-06-26",{"date":257,"type":4},"2014-01",{"date":259,"type":21},"2027-01",{"name":261,"class":41},"The Cleveland Clinic",{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":159,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":22,"phases":270,"briefSummary":271,"conditions":272,"keywords":4,"overallStatus":278,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":152},"100586395","brillouin-microscopy-used-to-evaluate-corneal-mechanical-properties-100586395","NCT06914817","Brillouin Microscopy Used to Evaluate Corneal Mechanical Properties","Brillouin Microscopy Used to Evaluate Corneal Mechanical Properties in Patients With Corneal Dystrophies and Post-Corneal Surgery: a Pilot Study","Inclusion Criteria:\n\n* Written informed consent prior to surgery\n* Patients aged 18 years and older\n* Patients who have undergone one of the following corneal surgeries or are diagnosed with one of the following dystrophies:\n\n  * Penetrating Keratoplasty (PKP) and no longer have sutures following PKP o Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)\n  * Descemet Membrane Endothelial Keratoplasty (DMEK)\n  * Fuchs' Endothelial Dystrophy (FED)\n  * Map Dot Fingerprint Dystrophy (MDFD)\n* Healthy Controls: healthy eyes without any history of corneal diseases or surgeries\n\nExclusion Criteria:\n\nAny of the following will exclude a subject from the study:\n\n* Patients with inadequate corneal imaging or corneal scarring that would impact results\n* Patients with other corneal dystrophies or corneal diseases\n* Patients with active ocular infections or inflammatory conditions\n* Patients unable to undergo Brillouin imaging adequately\n* Patients that suffered an eye trauma according to their medical history\n* Patients with fixational problems (e.g., head tremor) or with any medical condition that could interfere with the measurements\n* Pregnancy (pregnancy test will be performed in women of reproductive age)",{"count":52,"type":21},[54],"This study aims to explore the mechanical properties of the cornea using a non-invasive imaging technique called Brillouin microscopy. This innovative method measures corneal elasticity by detecting small shifts in light frequency, which occur due to interactions with acoustic waves in the tissue. These measurements can provide insights into how corneal stiffness is altered in various eye diseases or after surgery.\n\nThe study includes 100 participants, divided into different groups: patients with Fuchs' Endothelial Dystrophy (FED), Map Dot Fingerprint Dystrophy (MDFD), and those who have undergone corneal surgeries such as Penetrating Keratoplasty (PKP), Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK), and Descemet Membrane Endothelial Keratoplasty (DMEK). Healthy individuals will also be studied as a control group.\n\nParticipants will first receive a standard eye exam, including a slit-lamp examination. Then, Brillouin microscopy will be used to measure the cornea's mechanical stiffness. Additional tests include optical coherence tomography (OCT), corneal topography and tomography, pachymetry (measuring corneal thickness), endothelial cell count, and intraocular pressure (IOP) measurement.\n\nThe purpose of this study is to better understand how diseases and surgeries affect corneal biomechanics. The researchers will also examine how well the Brillouin measurements match with findings from other clinical imaging tests. The results may help improve diagnosis and treatment options for corneal disorders.",[273,274,275,276,245,277],"Map Dot Fingerprint Dystrophy","Post-penetrating Keratoplasty","Post-Descemet Membrane Endothelial Keratoplasty","Healthy Corneas","Ost-Descemet Stripping Automated Endothelial Keratoplasty","NOT_YET_RECRUITING","2025-04-02",{"date":281,"type":34},"2025-04-06",{"date":283,"type":21},"2025-04-01",{"date":285,"type":21},"2025-10-01",{"name":287,"class":41},"Vienna Institute for Research in Ocular Surgery",{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":164,"phases":4,"briefSummary":298,"conditions":299,"keywords":303,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":152},"100583856","fecd-trace-fuchs-endothelial-corneal-dystrophy-trajectory-and-correlation-with-genotype-in-the-united-kingdom-100583856","NCT06881771","FECD-TRACE: Fuchs' Endothelial Corneal Dystrophy TRAjectory and Correlation With Genotype in the United Kingdom","Investigating Genetic Causes and Molecular Mechanisms Responsible for Inherited Corneal Disease","FECD-TRACE","Inclusion Criteria:\n\n* Willing and able to provide informed consent for participation in the study\n* Willing to attend scheduled study visits and undergo a clinical examination\n* Willing to donate blood\u002Fsaliva samples\n* Fulfil the abovementioned cohort criteria\n\nExclusion Criteria:\n\n* Presence of a secondary cause for corneal endothelial dysfunction or oedema\n* Presence of clinically evident corneal oedema\n* History of concurrent corneal diseases\n* History of corneal surgeries, including corneal transplantation\n* Cognitive impairment or inability to provide informed consent for participation in the study",{"count":297,"type":21},500,"FECD-TRACE is an integral component of a large research program dedicated to Fuchs Endothelial Corneal Dystrophy (FECD) in the United Kingdom. This longitudinal, observational study aims to comprehensively characterize a cohort of younger research participants who have a genetic predisposition to developing FECD. By utilizing advanced anterior segment imaging techniques, the study will monitor these individuals over a span of several years, capturing phenotypic changes that reflect the progression of the disease. Concurrently, genetic biomarkers will be examined to establish correlations with the observed phenotypic changes. The primary objective of FECD-TRACE is to enhance our understanding of the intricate genetic mechanisms underlying FECD and establish connections between these genetic findings and clinical outcomes. Ultimately, this research strives to facilitate the development of personalized care approaches for individuals affected by FECD.",[28,29,300,301,302],"Fuchs' Endothelial Corneal Dystrophy of Bilateral Eyes","Corneal Dystrophy Fuchs","Corneal Dystrophy",[304,305,306,140],"Fuchs' Corneal Endothelial Dystrophy","FECD","Corneal Dystrophies","2025-03-11",{"date":309,"type":34},"2025-03-18",{"date":311,"type":34},"2024-02-01",{"date":313,"type":21},"2027-02-01",{"name":315,"class":41},"University College, London",{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":11,"sex":17,"minAge":323,"maxAge":324,"enrollmentInfo":325,"targetDuration":4,"studyType":22,"phases":327,"briefSummary":328,"conditions":329,"keywords":331,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":152},"100519809","phase-3-the-effects-of-ripasudil-in-patients-with-fed-undergoing-femtosecond-laser-assisted-cataract-surgery-100519809","NCT06048380","The Effects of Ripasudil in Patients With FED Undergoing Femtosecond Laser Assisted Cataract Surgery","The Effects of Ripasudil in Patients With Fuchs Endothelial Corneal Dystrophy Undergoing Femtosecond Laser Assisted Cataract Surgery","Inclusion Criteria:\n\n1. Patients with FED who will be listed for cataract surgery as part of standard clinical practice (A cataract will be defined as clouding of the lens that interferes with normal vision).\n2. Only patients older than 50 years will be included, as cataracts develops with increasing age. No gender criteria are applied.\n3. Ability to provide informed consent, and are willing and able to sign a written Informed Consent Form prior to any study-specific procedures.\n4. Patients must be willing and able to return for scheduled follow-up examinations for up to 12 months after the surgery.\n\nExclusion Criteria:\n\n1. Patients who are unable to give consent.\n2. An only-functioning eye in a patient who has lost visual potential in the contralateral eye.\n3. Diagnosis of clinically relevant eye diseases that may interfere with the aim of the study.\n4. History of ripasudil use, as well as other systemic disease such as cardiovascular or renal disease.\n5. Patients who have previous allergic reactions to the contents present in Glanatec Ophthalmic solution 0.4%","50 Years","100 Years",{"count":326,"type":21},120,[24],"The purpose of this research is to investigate the effects of ripasudil administered as an ophthalmic solution in patients with FED after femtosecond laser assisted cataract surgery. The secondary aim is to identity the characteristics of patients who will benefit the most with the use of ripasudil based on the test results obtained from this study.",[29,330],"Cataract",[332],"Ripasudil","2025-01-27",{"date":335,"type":34},"2025-01-29",{"date":337,"type":21},"2025-03-01",{"date":339,"type":21},"2025-07",{"name":231,"class":41},{"id":342,"slug":343,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":22,"phases":349,"briefSummary":350,"conditions":351,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":152},"100566218","endothelial-side-up-inverted-femtosecond-laser-assisted-dsaek-100566218","NCT06652321","Endothelial Side Up Inverted Femtosecond Laser Assisted DSAEK","Endothelial Side Up Inverted Femtosecond Laser Assisted DSAEK a Pilot Study","Inclusion Criteria:\n\nPatients with Fuchs' endothelial dystrophy Patients with bullous keratopathy secondary to intraocular surgeries, iridocorneal endothelial syndrome, or viral keratitis\n\nExclusion Criteria:\n\nBullous keratopathy secondary to glaucoma or ocular trauma Corneal stromal scarring or opacities Diseases not affecting the corneal endothelium, including corneal ectasia (e.g., keratoconus, keratoglobus, pellucid marginal degeneration) Epithelial, Bowman layer\u002Fanterior stromal, and stromal dystrophies Hypotonic eyes Retinal diseases Any type of optic atrophy",{"count":106,"type":21},[54],"To evaluate the clinical outcomes (pos toperative best corrected visual acuity, endothelial count) and anatomical results (interface smoothness) of DSAEK with Femto LDV-prepared grafts from the endothelial side.",[83,29],"2024-10-18",{"date":354,"type":34},"2024-10-22",{"date":356,"type":34},"2022-01-01",{"date":358,"type":21},"2024-11-30",{"name":360,"class":41},"Dar El Oyoun Hospital",{"id":362,"slug":363,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":368,"enrollmentInfo":369,"targetDuration":4,"studyType":22,"phases":370,"briefSummary":371,"conditions":372,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":152},"100304911","phase-4-glanatecr-for-descemet-stripping-in-fuchs-endothelial-dystrophy-100304911","NCT03249337","Glanatec(R) for Descemet Stripping in Fuch's Endothelial Dystrophy","A Pilot Study For Efficacy And Safety Of Glanatec® Opthalmic Solution 0.4% On Corneal Edema And Endothelial Cell Counts In Subjects With Fuchs Endothelial Dystrophy Undergoing Descemet Stripping Without Endothelial Keratoplasty","Inclusion Criteria:\n\n* • Ability to understand read and sign the informed consent form.\n\n  * Age between 30 and \\\u003C91 years\n  * Ability to understand and follow instructions and study procedures\n  * Willingness to comply with all study procedures and be available for the duration of the study\n  * Ability to apply eye drop medication and willing to adhere to study medication regimen\n  * Diagnosed with Fuchs dystrophy (clinically and on confocal microscopy) by the study investigator.\n  * Pseudophakic FED with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber intraocular lens.\n  * Fuchs dystrophy grades 2-4 on the Krachmer grading scale\n  * Presence of central guttae deemed by the investigator to be the chief cause of visual symptoms, rather than cataract or corneal stromal edema\n  * Clear peripheral cornea with an endothelial cell count \\>1000 cells\u002Fmm2 on specular microscopy\n  * Best corrected visual acuity in the study eye is 20\u002F40 or worse at study enrollment\n  * The patient is dissatisfied with current vision\n  * The patient is otherwise to be offered a corneal graft\n  * For females with reproductive potential, willingness to use highly effective contraception (e.g., hormonal contraception, barrier contraception, intrauterine device, or abstinence).\n  * Indication for surgery may include cataract extraction and posterior chamber intraocular lens implantation\n\nExclusion Criteria:\n\n* • Uncontrolled glaucoma (IOP \\>25 mmHg)\n\n  * Presence of secondary corneal pathology such as infective or autoimmune keratitis\n  * Advanced corneal stromal edema defined as the presence of haze, bullae, or DM folds on slit-lamp biomicroscopy\n  * History of herpes simplex virus or cytomegalovirus keratitis\n  * Prior endothelial keratoplasty\n  * Aphakic in study eye.\n  * Allergy to any component of the Ripasudil hydrochloride hydrate 0.4% that will be used in the course of the study\n  * For women of child-bearing potential: Pregnant or lactating, or planning to become pregnant within the next 6 months.\n  * Any other ocular condition that, in the opinion of the investigator, may preclude the subject from study participation.","91 Years",{"count":217,"type":21},[192],"In brief, the objective of this study is to investigate whether the drug Glanatec ® which is approved in Japan for glaucoma and ocular hypertension, can be used in patients with Fuchs endothelial dystrophy who have had a descemet stripping procedure without endothelial keratoplasty. While some limited data exists as a proof of concept in in vitro or animal studies, and Glanatec® has been successfully used in a recently published case series for this indication, there is insufficient data to show that this drug can be effectively used for corneal cell clearing while maintaining patient safety.\n\nThe goal of the study is to provide sufficient proof of concept for the use of this drug in patients with FED whose only treatment alternative is to undergo corneal transplant.",[29],"2021-08-09",{"date":375,"type":34},"2021-08-11",{"date":377,"type":34},"2017-12-06",{"date":379,"type":21},"2021-12",{"name":381,"class":41},"Marian Macsai, MD","Fuch's Endothelial Dystrophy"]