[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"corneal-transplant-failure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:corneal-transplant-failure":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100574025","phase-2-excrossv-multi-site-trial-for-vascularized-high-risk-keratoplasty-100574025",false,"NCT06753916","ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty","Multicenter Clinical Trial to Evaluate the Safety and Efficacy of Ex Vivo Corneal Cross-linking of Donor Corneal Tissue Used for Vascularized High-risk Keratoplasty","ExCrossV","Inclusion Criteria:\n\n* Age 18 and older\n* Willing and able to provide written informed consent\n* Willing and able to comply with study assessments for the full duration of the study\n* Patients undergoing high-risk penetrating keratoplasty, defined as corneal neovascularization (NV) in 1 or more quadrants ≥2 mm from the limbus or extension of corneal NV to the graft-host junction in a previously failed graft\n* Superficial vessels are defined as those within the anterior one-third of the cornea and deep vessels within the posterior two-thirds of the cornea (i.e., deep stroma).\n\nSuperficial CNV involving ≤2 quadrants (equivalent to ≤6 clock hours) without deep CNV are classified as mild. CNV with \\>2 quadrants of superficial vessels (\\>6 clock hours) or 1 quadrant of deep vessels (\\>3 clock hours) as severe (36).\n\nExclusion Criteria:\n\n* History of Stevens-Johnson syndrome or ocular pemphigoid\n* Ocular or periocular malignancy\n* Non-healing epithelial defect of at least 0.5x0.5 mm in host corneal bed lasting ≥6 weeks preoperatively\n* Uncontrolled glaucoma\n* Change in topical corticosteroid regimen within 14 days of transplantation\n* Use of systemic immunosuppressive for indication other than corneal graft rejection\n* Participation in another simultaneous medical investigation or trial\n* Pregnancy (positive pregnancy test) or lactating\n* Pre-menopausal women not using adequate contraception (Reliable intrauterine devices, hormonal contraception or a spermicide in combination with a barrier method)\n* Ocular infection within 30 days prior to study entry.\n* Presence of anterior chamber intraocular lens\n* Active uveitis within 90 days prior to the study entry.\n* No ocular surgery or procedure within 90 days prior to the study entry or concomitant to the study procedure.","ALL","18 Years",{"count":20,"type":21},96,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The main objective of this study is to determine the safety of Ex Vivo Cross Linking (CXL) of donor corneal tissue in participants who have undergone high-risk penetrating keratoplasty.",[27],"Corneal Transplant Failure",[29,30],"Keratoplasty","Cross Linking","RECRUITING","2026-04-17",{"date":34,"type":35},"2026-04-21","ACTUAL",{"date":37,"type":35},"2025-04-01",{"date":39,"type":21},"2031-01-01",{"name":41,"class":42},"Massachusetts Eye and Ear Infirmary","OTHER",12,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":43},"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":53,"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.",[27,57],"Corneal Endothelial Cell Loss",[29,59,60],"Corneal endothelium","Eye Banking","2025-09-29",{"date":63,"type":35},"2025-10-02",{"date":65,"type":35},"2023-12-01",{"date":67,"type":21},"2026-09-30",{"name":69,"class":42},"Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia"]