[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pseudophakic-bullous-keratopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pseudophakic-bullous-keratopathy":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,45,76,107,132,160,184],{"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":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100582138","prognosis-of-posterior-lamellar-keratoplasty-100582138",false,"NCT06859411","Prognosis of Posterior Lamellar Keratoplasty","Prognosis of Posterior Lamellar Keratoplasty: an Observational Cohort Study","CORNEACOHORT","Inclusion Criteria:\n\n* patients who received a posterior lamellar keratoplasty in Metz-Thionville Regional Hospital between 2012 and 2030\n\nExclusion Criteria:\n\n* patients refusing to take part in the study","ALL","18 Years",{"count":20,"type":21},1000,"ESTIMATED","OBSERVATIONAL","Over the past decade, the management of Fuchs' endothelial corneal dystrophy (FECD) and pseudophakic bullous keratopathy (PBK) has been revolutionized by the development of posterior lamellar keratoplasty techniques: DSAEK and DMEK.\n\nDSAEK (Descemet Stripping Automated Endothelial Keratoplasty) involves replacing the patient's endothelium and pathological descemetum with a descemetic endothelial graft combined with a thin stromal lamella. The endothelial density of the grafts is generally greater than 2,400 cells\u002Fmm². Depending on the grafting center and tissue bank, grafts may be either pre-cut in the tissue bank or cut on the operating table by the surgeon himself.\n\nThe donor graft is placed on an artificial anterior chamber, and automated microkeratome cutting produces grafts with an average thickness of 100 to 200µm, sometimes less than 100um (known as UT-DSAEK or ultra-thin DSAEK).\n\nDMEK (Descemet Membrane Endothelial Keratoplasty) is a strictly endothelium and Descemet's membrane graft, as close as possible to the original anatomy of the cornea. The graft is dissected manually either in a tissue bank (pre-cut grafts) or on the operating table by the surgeon. The thickness of the graft is between 15 and 18 microns.\n\nThe primary objective of this observational cohort is to compare the evolution of visual acuity after DMEK, DSAEK or UT-DSAEK transplantation.\n\nSecondary objectives are to compare the evolution of endothelial cell density, corneal thickness and early and late post-operative complications, and to identify factors predictive of these different endpoints.",[25,26],"Fuchs' Endothelial Corneal Dystrophy","Pseudophakic Bullous Keratopathy",[28,29,30,31],"posterior lamellar keratoplasty","cornea","DMEK","DSAEK","RECRUITING","2026-06-20",{"date":35,"type":36},"2026-06-24","ACTUAL",{"date":38,"type":36},"2024-06-01",{"date":40,"type":21},"2040-01-01",{"name":42,"class":43},"Centre Hospitalier Régional Metz-Thionville","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"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":54,"type":21},220,"INTERVENTIONAL",[57],"NA","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.",[60,61,62,63,26],"Corneal Edema","Corneal Endothelial Disorder","Fuchs' Endothelial Dystrophy","Bullous Keratopathy",[30,31,65],"UT-DSAEK","2026-03-30",{"date":68,"type":36},"2026-04-03",{"date":70,"type":36},"2022-08-10",{"date":72,"type":21},"2028-06-06",{"name":74,"class":43},"University Hospital, Antwerp",11,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":55,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":106},"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":85,"type":21},15,[87],"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)",[60,62,26,90],"Corneal Endothelial Dysfunction",[92,93,94,95],"Endothelial keratoplasty","Tissue-engineered corneal implant","Corneal endothelial cells","Collagen scaffold","2026-01-08",{"date":98,"type":36},"2026-01-12",{"date":100,"type":36},"2025-09-16",{"date":102,"type":21},"2027-09",{"name":104,"class":105},"Precise Bio","INDUSTRY",3,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":55,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":44},"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":115,"type":21},12,[87],"The goal of this clinical study is to assess the safety of multiple intracameral injections of EO2002 with and without topical Ripasudil.",[60,119,120,121,62,63,26,122],"Corneal Endothelial Dystrophy","Endothelial Dysfunction","Fuchs Dystrophy","Corneal Edema Pseudophakic","2025-12-02",{"date":125,"type":36},"2025-12-08",{"date":127,"type":36},"2022-11-08",{"date":129,"type":21},"2025-12-09",{"name":131,"class":43},"Asociación para Evitar la Ceguera en México",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":139,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":55,"phases":142,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":159},"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":141,"type":21},342,[143],"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.",[26,62,146],"Intraocular Pressure",[148,149],"Descemet Stripping Endothelial Keratoplasty","Cornea","2025-10-02",{"date":152,"type":36},"2025-10-06",{"date":154,"type":36},"2024-07-29",{"date":156,"type":21},"2029-03",{"name":158,"class":43},"Maastricht University Medical Center",8,{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":169,"conditions":170,"keywords":171,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":44},"100382373","oct-in-fuchs-dystrophy-100382373","NCT04258787","OCT in Fuchs' Dystrophy","Evaluating Corneal Edema in Fuchs' Endothelial Dystrophy Using Optical Coherence Tomography","Inclusion Criteria:\n\n* Damaged or diseased corneal endothelium from Fuchs' or PBK\n* Willingness to commit to required study visits\n\nExclusion Criteria:\n\n* Prior Endothelial Keratoplasty (EK) or any other surgery except uncomplicated cataract surgery\n* Presence of a condition that increases the probability for treatment failure (e.g., heavily vascularized cornea, uncontrolled uveitis)\n* Other primary endothelial dysfunction conditions (e.g., posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy, iridocorneal endothelial syndrome)\n* Central sub-epithelial or stromal scarring that could impact post-operative clarity assessment\n* Peripheral anterior synechiae in the angle greater than 3 clock hours\n* Hypotony\n* Uncontrolled glaucoma\n* Visually significant optic nerve or macular pathology",{"count":168,"type":21},60,"This is an observational study using optical coherence tomography (OCT) technology to quantify corneal edema in Fuchs' endothelial dystrophy and predict refractive shift from resolving corneal edema after surgical treatments.",[121,26],[172,26,173,174],"Fuchs","Optical Coherence Tomography (OCT)","PBK","2025-09-05",{"date":177,"type":36},"2025-09-09",{"date":179,"type":36},"2020-06-26",{"date":181,"type":21},"2028-06",{"name":183,"class":43},"Oregon Health and Science University",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":55,"phases":192,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":44},"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":85,"type":21},[57],"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.",[26,62],"2024-10-18",{"date":197,"type":36},"2024-10-22",{"date":199,"type":36},"2022-01-01",{"date":201,"type":21},"2024-11-30",{"name":203,"class":43},"Dar El Oyoun Hospital"]