[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"corneal-edema\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:corneal-edema":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,57,83,112,145,174,199],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100621310","phase-3-aurn001-efficacy-in-participants-with-corneal-edema-secondary-to-corneal-endothelial-dysfunction-100621310",false,"NCT07368959","AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction","ASTRA: A Phase 3 Multi-center, Randomized, Double-Masked, Prospective Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-3)","Key Ocular Inclusion Criteria:\n\n(All ocular criteria apply to the study eye unless noted otherwise)\n\n* Have corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)\n* BCVA between 65 ETDRS letters (approximate 20\u002F50 Snellen equivalent) and 5 ETDRS letters (approximate 20\u002F800 Snellen equivalent)\n* Be pseudophakic with PCIOL\n\nKey Ocular Exclusion Criteria:\n\n(All ocular criteria apply to the study eye unless noted otherwise)\n\n* Have progressive corneal dystrophies or degenerations\n* Have visually significant corneal or other ocular pathologies\n\nOther inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The purpose of this study is to assess the efficacy and safety of single injection dose of AURN001 compared with placebo in adult participants with corneal edema secondary to corneal endothelial dysfunction.",[26,27,28,29],"Corneal Edema","Corneal Endothelial Dysfunction","Fuchs Endothelial Corneal Dysfunction","Pseudophakic Bullous Keratopathy (PBK)",[31,32,33,34,35,36,37,38,39,40,41,42,43],"Best Corrected Visual Acuity","Central corneal thickness","Human Corneal Endothelial Cells","Neltependocel","Postsurgical endothelial dysfunction","Keratoplasty","Pseudophakic Corneal Edema (PCE)","Corneal Endothelial Cells","Endothelial Cells","AURN001","Y-27632","Endothelial Keratoplasty","Corneal Endothelial Cell Therapy","RECRUITING","2026-05-21",{"date":47,"type":48},"2026-05-22","ACTUAL",{"date":50,"type":48},"2026-02-19",{"date":52,"type":20},"2028-01",{"name":54,"class":55},"Aurion Biotech","INDUSTRY",12,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":21,"phases":67,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"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":66,"type":20},100,[68],"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.",[71,26],"Fuchs' Endothelial Dystrophy","2026-04-03",{"date":74,"type":48},"2026-04-09",{"date":76,"type":48},"2024-07-15",{"date":78,"type":20},"2027-12-31",{"name":80,"class":81},"University of Miami","OTHER",2,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":99,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"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":92,"type":20},220,[68],"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.",[26,96,71,97,98],"Corneal Endothelial Disorder","Bullous Keratopathy","Pseudophakic Bullous Keratopathy",[100,101,102],"DMEK","DSAEK","UT-DSAEK","2026-03-30",{"date":72,"type":48},{"date":106,"type":48},"2022-08-10",{"date":108,"type":20},"2028-06-06",{"name":110,"class":81},"University Hospital, Antwerp",11,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":124,"conditions":125,"keywords":126,"overallStatus":135,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":4},"100619403","endoart-implantation-in-subjects-with-chronic-corneal-edema---us-study-100619403","NCT07344168","EndoArt® Implantation in Subjects With Chronic Corneal Edema - US Study","A Prospective, Open-label, Single Arm Study to Evaluate the Safety and Effectiveness of the EndoArt® in Subjects With Chronic Corneal Edema in Whom Multiple Prior Keratoplasty (EK\u002FPK) Have Failed, and Who Are Not Reasonable Candidates for Any Form of Corneal Transplant, Including Penetrating Keratoplasty","Inclusion Criteria:\n\n1. Male or female subjects 30-85 years of age.\n2. Have chronic corneal edema (lasting at least 3 months) and have experienced at least 3 prior keratoplasty (EK\u002FPK) failures.\n3. Is not a reasonable candidate for any form of corneal transplant, including penetrating keratoplasty.\n4. CCT of 650-1200 μm, not including DSAEK thickness.\n\n   \\* In cases where the treated eye has undergone PKP, or if the corneal thickness of the contralateral eye cannot be measured (e.g., monocular patient, or if the contralateral eye has corneal edema or a history of PKP), the CCT of the study eye must be between 700-1200 μm.\n5. Pseudophakia\n6. Cornea WTW between 10-13 mm\n7. IOP \\\u003C20 mmHg and IOP≥8 mmHg\n8. BCVA of the study eye equal or worse than 0.50 LogMAR and up to 2.40 LogMAR (Hand motion is between 2.20-2.40 LogMAR).\n9. Must have better visual acuity in the contralateral eye, which must be at least 0.20 LogMAR better than the treated eye and have a visual acuity of at least 1.00 LogMAR.\n10. Central general clarity grade ≥2 (See Table 14. Central general clarity grading)\n11. Willing and able to understand and sign informed consent prior to any study-related procedure.\n12. Willing and able to follow study instructions (e.g., to lay on one's back for at least 4 hours post op.), able to self-administer or have caregiver available to administer eyedrops as required by the protocol for the duration of the study, and able to attend study visits\u002Fassessments for the duration of the study.\n\nExclusion Criteria:\n\n1. No light perception or light perception.\n2. Opaque scar in the visual axis that is indicated for PKP.\n3. Irregular posterior cornea (e.g. post trauma) in the 6.5 mm central part of the cornea (EndoArt® diameter).\n4. Current infection of the cornea.\n5. Central Band keratopathy and\u002For limbal stem cell deficiency.\n6. Diagnosis of: Sjogren's Syndrome, GVHD.\n7. PUK (peripheral ulcerative keratitis)\n8. Phthisis bulbi or subject is at high risk of developing phthisis (Hypothony).\n9. History of corneal refractive surgery: LASIK, PRK, SMILE, Epi-keratoplasty (or any anterior lamellar keratoplasty, inlays) and Radial Keratotomy (RK).\n10. Severe corneal distortion e.g.: keratoconus, pellucid marginal degeneration or keratoglobus (not relevant post PKP).\n11. Subject with medically uncontrolled intra ocular pressure, which requires surgical intervention.\n12. Aphakia.\n13. Active inflammation, or active, recurrent, or Chronic Uveitis\n14. Dislocation or partial dislocation of the IOL.\n15. Have large iris defect (more than 90 degrees) which could compromise intraoperative air bubble formation, excluding inferior defect.\n16. Severe ptosis (middle of pupil or covering the pupil entirely).\n17. Subject receiving regular intravitreal injection.\n18. History of persistent\u002F recurrent corneal erosion or persistent epithelial defect with difficulties in epithelial re-growth (erosion more than 2 months).\n19. History of ocular herpetic keratitis\n20. Current retinal detachments\n21. Advanced optic nerve cupping (defined as a cup-disc ratio of 0.9 or greater).\n22. Posterior segment masses or other acute significant posterior segment pathology (e.g., active age-related macular degeneration or chronic cystoid macular edema).\n23. Afferent Pupillary Defect (APD)\n24. Fellow eye CCT \\\u003C 500 µm\n25. Any other acute ocular condition\n26. Bilateral implantation of the EndoArt®\n27. Posterior vitrectomy (anterior vitrectomy is allowed)\n28. Subjects with mental impairment\n29. Subject with history of spontaneous corneal perforations.\n30. Pregnant or lactating women, or with childbirth plans during the clinical trial\n31. Currently participating or have participated in an investigational study, other than this study, within the past 60 days.","35 Years","85 Years",{"count":122,"type":20},123,[68],"The EndoArt® device is intended to treat patients with chronic corneal edema due to endothelial dysfunction, in whom prior multiple keratoplasty (EK\u002FPK) have failed, and who are not reasonable candidates for any form of corneal transplant, including penetrating keratoplasty.\n\nThe EndoArt® (Corneal Artificial Endothelial layer) is a permanent synthetic implant. It is made of a clear, transparent, foldable, biologically compatible hydrophilic copolymer. The device serves as an inert physical barrier, blocking the ingress of fluid from the Anterior Chamber (AC) into the cornea.",[26],[127,128,129,130,131,132,133,134],"Corneal edema","Chronic corneal edema","Artificial Endothelial layer","EndoArt","Failed keratoplasty","Human tissue corneal transplantation failure","Failed DSEK","Failed DMEK","NOT_YET_RECRUITING","2026-03-11",{"date":138,"type":48},"2026-03-13",{"date":140,"type":20},"2026-05-01",{"date":142,"type":20},"2030-04-30",{"name":144,"class":55},"Eye-yon Medical",{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":21,"phases":155,"briefSummary":157,"conditions":158,"keywords":159,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":173},"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":154,"type":20},15,[156],"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)",[26,71,98,27],[160,161,162,163],"Endothelial keratoplasty","Tissue-engineered corneal implant","Corneal endothelial cells","Collagen scaffold","2026-01-08",{"date":166,"type":48},"2026-01-12",{"date":168,"type":48},"2025-09-16",{"date":170,"type":20},"2027-09",{"name":172,"class":55},"Precise Bio",3,{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":21,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":198},"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":56,"type":20},[156],"The goal of this clinical study is to assess the safety of multiple intracameral injections of EO2002 with and without topical Ripasudil.",[26,185,186,187,71,97,98,188],"Corneal Endothelial Dystrophy","Endothelial Dysfunction","Fuchs Dystrophy","Corneal Edema Pseudophakic","2025-12-02",{"date":191,"type":48},"2025-12-08",{"date":193,"type":48},"2022-11-08",{"date":195,"type":20},"2025-12-09",{"name":197,"class":81},"Asociación para Evitar la Ceguera en México",1,{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":206,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":209,"phases":4,"briefSummary":210,"conditions":211,"keywords":214,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":198},"100591686","validation-of-the-use-of-terahertz-scanning-system-on-corneal-scars-and-corneal-edema-100591686","NCT06983652","Validation of the Use of Terahertz Scanning System on Corneal Scars and Corneal Edema","Validation of the Use of Terahertz Scanning System on Corneal Scars and Corneal Edema: Phase II Clinical Trial","Inclusion Criteria:\n\n* Be at least 21 years of age.\n* Regardless of gender (Male\u002FFemale).\n* Regardless of race (Chinese\u002FMalay\u002FIndian\u002FEurasian\u002FOthers).\n* Willingness and ability to follow all instructions and comply with study schedule for study visit.\n* Patients with corneal endothelial dysfunction (Fuchs' endothelial dystrophy or other causes of bullous keratopathy) at any disease stage OR Patients with corneal scars from any cause, with the absence of corneal edema.\n* Ability to hold face sufficiently stable to undergo necessary scans.\n\nExclusion Criteria:\n\n* Eyes with active inflammation or infection, or chronic ocular surface inflammation\n* Unable to give consent\n* Physically immobile\u002Fpoor instructional compliance\n* PI determined\n* Pregnant\u002F breast feeding women","21 Years",{"count":208,"type":20},150,"OBSERVATIONAL","This observational study aims to validate the use of THz scanning system in corneal edema and corneal scars, and to investigate the accuracy and performance on the use of THz scanning system in the evaluation of the progression of corneal edema and corneal scars. Participants corneal scars and corneal edema will undergo THz scanning, followed by a series of conventional clinical examinations for detailed characterization of the corneal lesion. The performance of the use of THz system on corneal scars and edema will be evaluated by correlating measurements from the THz scans with those obtained from standard clinical methods. The investigators hypothesize that the THz scanning system has the capacity to evaluate the hydration level on human corneas.",[212,213,26],"Corneal Diseases","Corneal Scars and Opacities",[215,216,217,218,219],"cornea","corneal scar","corneal edema","Terahertz","hydration","2025-05-14",{"date":222,"type":48},"2025-05-21",{"date":224,"type":48},"2024-07-01",{"date":226,"type":20},"2026-08-31",{"name":228,"class":81},"Singapore Eye Research Institute"]