[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536170":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":46,"responsibleParty":77,"collaborators":80,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":26,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":26,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":26,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"University of Miami","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"PRGF group","EXPERIMENTAL","Participants tissue will be incubated in plasma rich in growth factors prior to endothelial keratoplasty procedure. Participants will be followed up for up to 1 year.",[13,14],"Procedure: Endothelial keratoplasty","Biological: PRGF",{"label":16,"type":17,"description":18,"interventionNames":19},"Control group","ACTIVE_COMPARATOR","Participants will undergo endothelial keratoplasty procedure. Participants will be followed up for up to 1 year.",[13],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Endothelial keratoplasty","Surgical replacement of the corneal endothelial cell layer (the cell layer lining the inner surface of the cornea) with brief incubation of the donor tissue in PRGF prior to graft implantation. This incubation will be a one time procedure done to the tissue in the operating room.\n\nThe endothelial keratoplasty is 30-45 minutes.",[16,9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"BIOLOGICAL","PRGF","Plasma Rich in Growth Factors (PRGF) is a mixture of proteins and growth factors obtained from the blood of the patient.\n\nPRGF incubation lasts 15 minutes. It is a one-time procedure performed on the tissue that will be done in the operating room prior to endothelial keratoplasty.",[9],[33],{"name":34,"affiliation":35,"role":36},"Alfonso L Sabater, MD","Bascom Palmer Eye Institute","PRINCIPAL_INVESTIGATOR",[38,42],{"name":34,"role":39,"phone":40,"phoneExt":26,"email":41},"CONTACT","3053266326","asabater@med.miami.edu",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Marianne Price, PhD","317-814-2990","mprice@cornea.org",[47,64],{"facility":35,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Miami","Florida","33136","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-80.19366,25.77427,{"lat":58,"lon":57},[61,63],{"name":34,"role":39,"phone":62,"phoneExt":26,"email":41},"305-326-6326",{"name":34,"role":36,"phone":26,"phoneExt":26,"email":26},{"facility":65,"status":48,"city":66,"state":67,"zip":68,"country":52,"countryCode":53,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Price Vision Group","Indianapolis","Indiana","46260",{"type":55,"coordinates":70},[71,72],-86.15804,39.76838,{"lat":72,"lon":71},[75,76],{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},{"name":43,"role":36,"phone":26,"phoneExt":26,"email":26},{"type":36,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Alfonso Sabater","Associate Professor of Clinical Ophthalmology",[81],{"name":82,"class":83},"Beauty of Sight","UNKNOWN","100536170","plasma-rich-in-growth-factors-in-corneal-endothelial-transplantation-100536170",false,"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","ALL","18 Years","80 Years",{"count":95,"type":96},100,"ESTIMATED","INTERVENTIONAL",[99],"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.",[102,103],"Fuchs' Endothelial Dystrophy","Corneal Edema","2026-04-03",{"date":106,"type":107},"2026-04-09","ACTUAL",{"date":109,"type":107},"2024-07-15",{"date":111,"type":96},"2027-12-31",{"name":5,"class":6},2]