[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"corneal-endothelial-cell-loss\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:corneal-endothelial-cell-loss":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,86],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100646069","phase-2-a-study-of-ca201a-eye-drops-to-prevent-corneal-endothelial-cell-loss-in-patients-undergoing-cataract-surgery-100646069",false,"NCT07694375","A Study of CA201A Eye Drops to Prevent Corneal Endothelial Cell Loss in Patients Undergoing Cataract Surgery","A Multicentre, Randomised, Double-masked, Vehicle-controlled, Parallel-arm, Phase 2 Study of the Safety and Efficacy of CA201A for the Prevention of Corneal Endothelial Cell Loss in Subjects Undergoing Cataract Surgery","Inclusion Criteria:\n\n* The subject must voluntarily sign and date a Human Research Ethics Committee (HREC) approved informed consent form (ICF) prior to the initiation of any screening or study-specific procedures.\n* In the Investigator's opinion, the subject is willing and able to comply with study instructions and complete all scheduled study visits.\n* Male or female aged ≥18 and ≤85 years.\n* Scheduled to undergo cataract extraction by phacoemulsification with implantation of a posterior chamber intraocular lens.\n* Has the potential to improve best-corrected visual acuity (BCVA) in the study eye following surgery, as judged by the Investigator.\n* Has a nuclear cataract exhibiting a nuclear opalescence of Grade 3, 4, or 5 in the study eye according to the Lens Opacities Classification System III (LOCS III) classification. This includes pure nuclear cataracts as well as mixed-type cataracts (ie, nuclear opalescence grade 3 to 5 with or without co-existing cortical and\u002For posterior subcapsular opacities).\n* Has corneal endothelium in the study eye that can be adequately assessed using specular microscopy, with sufficient image quality for endothelial cell density analysis.\n* Has a central corneal ECD ≥1000 cells\u002Fmm² in the study eye at the Screening visit, as measured by specular microscopy.\n* Has a pinhole visual acuity of ≥35 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (approximately equivalent to 6\u002F60 Snellen) in the study eye at the Screening visit, measured using an ETDRS chart at 4 meters. The fellow eye must have visual acuity sufficient, in the opinion of the Investigator, to allow safe postoperative function.\n* Female subjects must be of nonchildbearing potential or have a negative pregnancy test at Screening and agree to use appropriate contraception throughout the study.\n* Male subjects with female partners of childbearing potential must agree to use appropriate contraception and refrain from sperm donation during the study.\n\nExclusion Criteria:\n\n* Ocular Exclusions (Study Eye):\n* Active immunosuppressive or autoimmune disease that, in the opinion of the Investigator, could affect ocular surface integrity.\n* Active or chronic\u002Frecurrent ocular or systemic disease that is uncontrolled and likely to impair wound healing.\n* Intraocular pressure (IOP) ≤6 mmHg in either eye at screening.\n* Clinically significant Fuchs' endothelial corneal dystrophy (Grade 4 or higher on clinical examination).\n* History of corneal transplantation or other corneal surgery.\n* History of intraocular surgery in the study eye within 6 months of screening (except YAG laser capsulotomy \\>3 months prior to screening).\n* Planned combined cataract surgery with other intraocular procedures (eg, glaucoma surgery, vitrectomy).\n* Active ocular infection or inflammation in either eye.\n* Uncontrolled glaucoma (intraocular pressure \\>25 mmHg on maximum tolerated medical therapy) in the study eye.\n* Significant corneal opacity, scarring, or irregularity that would interfere with accurate specular microscopy assessment (including cases where image acquisition or analysis is not feasible).\n* History of uveitis or other chronic inflammatory eye disease in the study eye.\n* Proliferative diabetic retinopathy or active retinal disease in the study eye, that in the Investigator's opinion, may increase surgical risk or confound postoperative assessments.\n* Any other ocular condition that, in the opinion of the Investigator, may interfere with study assessments or subject safety.\n* History of corneal or retinal surgery (laser or incisional) in the study eye within 6 months, or planned ocular surgery during the study period.\n* Presence of severe corneal guttae or other abnormalities in the study eye that, in the opinion of the Investigator, preclude reliable endothelial cell assessment by specular microscopy.\n* Anticipated complex cataract surgery in the study eye that, in the opinion of the Investigator, is likely to substantially increase endothelial injury risk or require nonstandard surgical techniques (eg, brunescent or hypermature cataract, significant zonular instability requiring planned capsular support devices, or other features expected to materially prolong phacoemulsification).\n* Specular microscopy images that are not gradable at Screening despite repeat acquisition attempts.\n* Systemic Exclusions:\n* Known hypersensitivity to ascorbic acid or any component of the study drug or vehicle.\n* Current use of systemic ascorbic acid supplementation (oral or intravenous) \\>500 mg\u002Fday (Subjects taking ≤500 mg\u002Fday may continue their current regimen).\n* History of calcium oxalate nephrolithiasis (kidney stones) within the past 5 years.\n* Severe renal impairment (estimated glomerular filtration rate \\\u003C30mL\u002Fmin\u002F1.73 m²).\n* Known glucose-6-phosphate dehydrogenase (G6PD) deficiency associated with clinically significant hemolytic risk.\n* Pregnant or breastfeeding women.\n* Females of childbearing potential unwilling to use acceptable contraception.\n* Participation in another interventional clinical study or use of an investigational product within 6 weeks or 5 half-lives (whichever is longer) prior to study treatment. Observational studies and the use of over-the-counter vitamins or supplements are not exclusionary.\n* Medical or psychiatric conditions that, in the opinion of the Investigator, would make consistent follow-up unlikely or pose an unacceptable medical risk.\n* Clinically significant abnormalities in screening laboratory assessments (hematology, serum chemistry, or urinalysis), that, in the opinion of the Investigator, render the subject unsuitable for participation.\n\nIn general, subjects will be excluded if any of the following are present at screening:\n\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2.5 × upper limit of normal (ULN)\n* Total bilirubin \\>1.5 × ULN (unless consistent with Gilbert's syndrome)\n* Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m² Laboratory abnormalities not meeting the above thresholds may still be considered exclusionary if deemed clinically significant by the Investigator.","ALL","18 Years","85 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is designed to assess whether an investigational eye drop called CA201A can help protect the cornea (the outer covering of the eye) and reduce damage to corneal endothelial cells following cataract surgery, without causing significant side effects. Cataract surgery is one of the common surgical procedures, however, it can sometimes lead to a loss of corneal endothelial cells, which are essential for maintaining the corneal clarity and long-term eye health.\n\nAbout 200 adults in Australia who are scheduled to have cataract surgery will be enrolled in this study following eligibility check. All eligible participants will be randomly assigned (by chance) to receive either the CA201A eye drops or a similar eye drop without the active ingredient. Neither the participant nor the study doctor will know the treatment each participant is receiving until the study is completed.\n\nAll enrolled participants will place 1 drop of CA201A four times daily, starting 7 days prior to the surgery, continue on the day of surgery, and then keep using them for 4 weeks following surgery. After treatment, participants will be followed for up to 12 weeks after surgery in order to monitor safety and assess how well the treatment works.\n\nAll participants will undergo standard cataract surgery and receive usual care; the study eye drops will be given in addition to this routine treatment. Throughout the study, doctors will measure changes in corneal endothelial cell density and perform other eye examinations to evaluate the treatment effect.",[27,28],"Corneal Endothelial Cell Loss","Corneal Endothelial Damage Following the Hard Nuclear Cataract Surgery",[30,31],"cataract surgery","corneal endothelial cell loss","RECRUITING","2026-08-05",{"date":35,"type":36},"2026-08-06","ACTUAL",{"date":38,"type":36},"2026-07-28",{"date":40,"type":21},"2027-02",{"name":42,"class":43},"Caravel Oculus Pty Ltd","INDUSTRY",8,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":70,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100649041","phase-2-study-of-eo2002-in-subjects-with-corneal-edema-secondary-to-corneal-endothelial-dysfunction-100649041","NCT07729137","Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction","A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 2 Study of EO2002 in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction (EMERALD)","EMERALD","Key Inclusion Criteria:\n\n1. Symptomatic central corneal edema that is primarily responsible for loss of vision associated with endothelial dysfunction which may be secondary to Fuchs corneal dystrophy or pseudophakic bullous keratopathy.\n2. Early Treatment Diabetic Retinopathy Study (ETDRS)-best-corrected distance visual acuity between 20 and 65 letters inclusive (≥ 20 and ≤ 65 letters)\n3. Central corneal thickness ≥ 600 μm and ≤ 1,000 μm, OR Medical Monitor review and approval based on either:\n\n   1. Historical CCT increased by ≥ 50 μm OR\n   2. Findings of edema by corneal tomography or Anterior Segment Optical Coherence Tomography (AS-OCT).\n4. Participant is considered a surgical candidate for full-thickness corneal transplantation or endothelial (partial thickness) keratoplasty (EK) consistent with standard-of-care indications.\n\nKey Exclusion Criteria:\n\n1. Corneal disease in either eye (other than corneal endothelial dysfunction secondary to Fuchs dystrophy or pseudophakic bullous keratopathy) including active or prior herpetic ocular infection, severe dry eye disease (e.g., Sjogren's), or active inflammation.\n2. Central corneal scarring from trauma, burns, or infection, or band keratopathy\n3. History of keratoconus or other corneal ectasia (e.g., keratoglobus and pellucid marginal degeneration).\n4. Visually significant cataract, that may limit the participant's ability to demonstrate treatment-related improvement in BCVA.\n5. Presence of an anterior chamber, sutured, or scleral-fixated intraocular lens.\n6. Presence of a multifocal or diffractive intraocular lens.\n7. Prior vitrectomy.\n8. Corneal refractive surgery.\n9. Descemet dettachment\n10. Minimally invasive glaucoma surgery (MIGS), intraocular pressure (IOP)- lowering implant (e.g., Durysta® or iDose®), or any incisional glaucoma surgery (e.g., trabeculectomy, glaucoma drainage implant).","21 Years",{"count":55,"type":21},121,[24],"This study will evaluate the safety and effectiveness of a single injection of EO2002 at one of two dose levels (150,000 or 500,000 magnetic human corneal endothelial cells \\[mHCECs\\]), compared with a placebo injection, in participants with corneal edema caused by corneal endothelial dysfunction.",[59,60,61,62,63,64,27,65,66,67,68,69],"Corneal Edema","Fuchs","Fuchs Dystrophy","Fuchs' Endothelial Dystrophy","Endothelial Corneal Dystrophy","Corneal Endothelial Decompensation","Corneal Endothelial Disorder","Corneal Endothelial Dystrophy 1","Endothelial Cell Loss, Corneal","Pseudophakic Bullous Keratopathy","Pseudophakic Bullous Keratopathy (PBK)",[71,72,73,61,60,74],"FECD","PBK","Corneal endothelial dysfunction","Corneal edema","NOT_YET_RECRUITING","2026-07-27",{"date":78,"type":36},"2026-07-29",{"date":80,"type":21},"2026-09",{"date":82,"type":21},"2028-02",{"name":84,"class":43},"Emmecell",1,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":96,"phases":4,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":114},"100504367","the-viability-control-of-human-endothelial-cells-before-keratoplasty-v-check-study-100504367","NCT05847387","The Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study","Preoperative Surgeon Evaluation of Corneal Endothelial Status: the Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study","V-CHECK","Inclusion Criteria:\n\n* Age older than 18 years old\n* Planned corneal transplantation: perforating keratoplasty (PK), Descemet stripping automated endothelial keratoplasty (DSAEK), ultra-thin DSAEK (UT-DSAEK) or Descemet membrane endothelial keratoplasty (DMEK)\n* Indication for corneal transplantation (low-moderate risk of rejection): keratoconus, Fuchs endothelial dystrophy\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Prior corneal transplantation\n* Planned preloaded DSAEK or preloaded DMEK\n* Planned keratoplasty not involving corneal endothelium transplantation (i.e., superficial\u002Fdeep anterior lamellar keratoplasty)\n* Evidence of concurrent microbial keratitis\n* Evidence of non-infectious or autoimmune keratitis\n* Impending or frank corneal perforation\n* Uncontrolled, elevated intraocular pressure (IOP)- Previous glaucoma surgery\n* Acute or chronic inflammatory\u002Finfectious anterior segment uveitis\n* Presence of an anterior chamber intraocular lens (IOL) for phakic or aphakic purposes",{"count":95,"type":21},135,"OBSERVATIONAL","The purpose of this international cohort study is to validate a new method for preoperative assessment of endothelial viability in donor corneal tissues for transplantation, and to correlate endothelial health as assessed by the surgical team to functional and structural long-term outcomes in the cohort of patients receiving them.",[99,27],"Corneal Transplant Failure",[101,102,103],"Keratoplasty","Corneal endothelium","Eye Banking","2025-09-29",{"date":106,"type":36},"2025-10-02",{"date":108,"type":36},"2023-12-01",{"date":110,"type":21},"2026-09-30",{"name":112,"class":113},"Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia","OTHER",12]