[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574025":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":48,"responsibleParty":258,"collaborators":44,"id":261,"slug":262,"hasResults":263,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":263,"sex":269,"minAge":270,"maxAge":44,"enrollmentInfo":271,"targetDuration":44,"studyType":274,"phases":275,"briefSummary":277,"conditions":278,"keywords":280,"overallStatus":95,"whyStopped":44,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":292},{"fullName":5,"class":6},"Massachusetts Eye and Ear Infirmary","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants Receiving Treated Cross Linked Corneal Tissue","EXPERIMENTAL","Participants in this group will receive tissue that has been treated with 0.1% riboflavin (Vitamin B2) and 20% dextran (Photrexa® viscous and Photrexa®) with UV light treatment. Participants will be monitored over a period of 24 months.",[13],"Procedure: Corneal Donor Tissue with Cross Linking",{"label":15,"type":16,"description":17,"interventionNames":18},"Participants Receiving Untreated Cross Linked Corneal Tissue","PLACEBO_COMPARATOR","Participants in this group will receive tissue that has has not been treated with 0.1% riboflavin (Vitamin B2) and 20% dextran (Photrexa® viscous and Photrexa®) without UV light treatment. Participants will be monitored over a period of 24 months.",[19],"Procedure: Corneal Donor Tissue without Cross Linking",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Corneal Donor Tissue with Cross Linking","Participants are transplanted with corneal donor tissue that has been treated with 0.1% riboflavin (Vitamin B2) and 20% dextran (Photrexa® Viscous \\& Photrexa®) with UV light treatment.",[9],[27],"Treatment",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Corneal Donor Tissue without Cross Linking","Participants are transplanted with corneal donor tissue that has not been treated with the UV light and the 0.1% riboflavin (Vitamin B2) and 20% dextran (Photrexa® Viscous \\& Photrexa®) without UV light treatment, this is the control group.",[15],[33],"Control",[35],{"name":36,"affiliation":37,"role":38},"Joseph Ciolino, MD","Massachusetts Eye and Ear","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Michael Cheung, MSc, CCRP","CONTACT","6175736060",null,"mcheung0@meei.harvard.edu",{"name":47,"role":42,"phone":44,"phoneExt":44,"email":44},"Nikolay Boychev, OD, PhD",[49,66,78,93,113,134,154,173,188,205,222,241],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"University of California Irvine - Gavin Herbert Eye Institute","NOT_YET_RECRUITING","Irvine","California","92617","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-117.82311,33.66946,{"lat":61,"lon":60},[64],{"name":65,"role":38,"phone":44,"phoneExt":44,"email":44},"Marjan Farid, MD",{"facility":67,"status":51,"city":68,"state":53,"zip":69,"country":55,"countryCode":56,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"The University of California Los Angeles - Doris Stein Eye Research Center","Los Angeles","90095",{"type":58,"coordinates":71},[72,73],-118.24368,34.05223,{"lat":73,"lon":72},[76],{"name":77,"role":38,"phone":44,"phoneExt":44,"email":44},"Anthony Aldave, MD",{"facility":79,"status":51,"city":80,"state":53,"zip":81,"country":55,"countryCode":56,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"University of California San Francisco - Wayne and Gladys Valley Center for Vision","San Francisco","94158",{"type":58,"coordinates":83},[84,85],-122.41942,37.77493,{"lat":85,"lon":84},[88,91],{"name":89,"role":42,"phone":44,"phoneExt":44,"email":90},"Beth Cutrer","Beth.Cutrer@ucsf.edu",{"name":92,"role":38,"phone":44,"phoneExt":44,"email":44},"Julie Schallhorn, MD",{"facility":94,"status":95,"city":96,"state":97,"zip":98,"country":55,"countryCode":56,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"University of Miami - Bascom Palmer Eye Institute","RECRUITING","Miami","Florida","33136",{"type":58,"coordinates":100},[101,102],-80.19366,25.77427,{"lat":102,"lon":101},[105,108,111],{"name":106,"role":42,"phone":44,"phoneExt":44,"email":107},"Jeremy Sandoval","jxs7997@med.miami.edu",{"name":109,"role":42,"phone":44,"phoneExt":44,"email":110},"Javier Parades, MBA, CCRP","jxp2537@med.miami.edu",{"name":112,"role":38,"phone":44,"phoneExt":44,"email":44},"Guillermo Amescua, MD",{"facility":114,"status":95,"city":115,"state":116,"zip":117,"country":55,"countryCode":56,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Price Vision Group","Indianapolis","Indiana","46260",{"type":58,"coordinates":119},[120,121],-86.15804,39.76838,{"lat":121,"lon":120},[124,128,132],{"name":125,"role":42,"phone":126,"phoneExt":44,"email":127},"Marianne Price, PhD","317-844-5530","mprice@cornea.org",{"name":129,"role":42,"phone":130,"phoneExt":44,"email":131},"Lauren Blisset","(317) 814-2996","lauren@cornea.org",{"name":133,"role":38,"phone":44,"phoneExt":44,"email":44},"David Price, MD",{"facility":135,"status":95,"city":136,"state":137,"zip":138,"country":55,"countryCode":56,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Kansas City Eye Clinic","Overland Park","Kansas","66204",{"type":58,"coordinates":140},[141,142],-94.67079,38.98223,{"lat":142,"lon":141},[145,149,151],{"name":146,"role":42,"phone":147,"phoneExt":44,"email":148},"Megan Hefer, CCRP","913-341-3100","mhefter@kceyeclinic.com",{"name":150,"role":38,"phone":44,"phoneExt":44,"email":44},"Christopher Ketcherside, MD",{"name":152,"role":153,"phone":44,"phoneExt":44,"email":44},"Megan Haghnegahdar, MD","SUB_INVESTIGATOR",{"facility":155,"status":51,"city":156,"state":157,"zip":158,"country":55,"countryCode":56,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Mid-Atlantic Cornea Consultant","Towson","Maryland","21204",{"type":58,"coordinates":160},[161,162],-76.60191,39.4015,{"lat":162,"lon":161},[165,169,171],{"name":166,"role":42,"phone":167,"phoneExt":44,"email":168},"Brittany Daman","410-616-9952","brittanyd@midatlanticcornea.com",{"name":170,"role":38,"phone":44,"phoneExt":44,"email":44},"Sudeep Pramanik, MD",{"name":172,"role":38,"phone":44,"phoneExt":44,"email":44},"Alexander Altman, MD",{"facility":37,"status":95,"city":174,"state":175,"zip":176,"country":55,"countryCode":56,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Boston","Massachusetts","02114",{"type":58,"coordinates":178},[179,180],-71.05977,42.35843,{"lat":180,"lon":179},[183,185,187],{"name":41,"role":42,"phone":184,"phoneExt":44,"email":45},"617-573-6060",{"name":47,"role":42,"phone":44,"phoneExt":44,"email":186},"nboychev@meei.harvard.edu",{"name":36,"role":38,"phone":44,"phoneExt":44,"email":44},{"facility":189,"status":95,"city":190,"state":191,"zip":192,"country":55,"countryCode":56,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"University of Michigan - Kellogg Eye Center","Ann Arbor","Michigan","48015",{"type":58,"coordinates":194},[195,196],-83.74088,42.27756,{"lat":196,"lon":195},[199,203],{"name":200,"role":42,"phone":201,"phoneExt":44,"email":202},"Lianne Shami, BS","734-647-8397","liannes@med.umich.edu",{"name":204,"role":38,"phone":44,"phoneExt":44,"email":44},"Shahzad Mian, MD",{"facility":206,"status":51,"city":207,"state":208,"zip":209,"country":55,"countryCode":56,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"Wake Forest Baptist Eye Center","Bermuda Run","North Carolina","27006",{"type":58,"coordinates":211},[212,213],-80.422,36.00375,{"lat":213,"lon":212},[216,220],{"name":217,"role":42,"phone":218,"phoneExt":44,"email":219},"Christina Robbins","336-716-3859","Christina.Robbins@Advocatehealth.org",{"name":221,"role":38,"phone":44,"phoneExt":44,"email":44},"Matthew Giegengack, MD",{"facility":223,"status":95,"city":224,"state":208,"zip":225,"country":55,"countryCode":56,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"Duke University - Duke Eye Center","Durham","27705",{"type":58,"coordinates":227},[228,229],-78.89862,35.99403,{"lat":229,"lon":228},[232,236,239],{"name":233,"role":42,"phone":234,"phoneExt":44,"email":235},"Nathan Hamilton","919-668-0230","nathan.hamilton@duke.edu",{"name":237,"role":42,"phone":44,"phoneExt":44,"email":238},"Kyle Munar","kyle.munar@duke.edu",{"name":240,"role":38,"phone":44,"phoneExt":44,"email":44},"Esen Akpek, MD",{"facility":242,"status":95,"city":243,"state":244,"zip":245,"country":55,"countryCode":56,"cosmosGeoPoint":246,"geoPoint":250,"contacts":251},"Cincinnati Eye Institute","Cincinnati","Ohio","45242",{"type":58,"coordinates":247},[248,249],-84.51439,39.12711,{"lat":249,"lon":248},[252,256],{"name":253,"role":42,"phone":254,"phoneExt":44,"email":255},"Lee Stokes","513-569-3213","lstokes@cvphealth.com",{"name":257,"role":38,"phone":44,"phoneExt":44,"email":44},"Kavitha Sivaraman, MD",{"type":38,"investigatorFullName":259,"investigatorTitle":260,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Joseph B. Ciolino, MD","Associate Professor of Ophthalmology","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":272,"type":273},96,"ESTIMATED","INTERVENTIONAL",[276],"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.",[279],"Corneal Transplant Failure",[281,282],"Keratoplasty","Cross Linking","2026-04-17",{"date":285,"type":286},"2026-04-21","ACTUAL",{"date":288,"type":286},"2025-04-01",{"date":290,"type":273},"2031-01-01",{"name":5,"class":6},12]