[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07217249":3,"trial-entities:NCT07217249":173,"trial-summary:NCT07217249":178},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":37,"secondary_outcomes":42,"sex":43,"minimum_age":44,"maximum_age":45,"healthy_volunteers":46,"eligibility_criteria":47,"std_ages":56,"locations":59,"central_contacts":166,"overall_officials":167,"references":171,"see_also_links":172},"NCT07217249","DEKS 5-year Extension Study","Effect of Donor Diabetes and Other Factors on Corneal Transplant Endothelial Cell Loss and Success at 5 Years","Diabetes Endothelial Keratoplasty Study (DEKS): Impact of Diabetes and Other Predictors on Corneal Transplant Endothelial Cell Loss and Success","ENROLLING_BY_INVITATION","2030-04-30","2026-02","2026-02-27","2025-12-03","Case Western Reserve University","OTHER",true,"This multi-center clinical trial is designed to assess the association of diabetes in a cornea donor with transplant success and loss of endothelial cells 5 years following Descemet membrane endothelial keratoplasty (DMEK). Study eyes are assigned to receive either a cornea from a donor without diabetes or a cornea from a donor with diabetes in a masked fashion.",null,[19,20],"Fuchs Endothelial Corneal Dystrophy","Corneal Endothelial Decompensation",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},570,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"PROCEDURE","Descemet membrane endothelial keratoplasty","Replacement of the recipient corneal endothelial and Descemet membrane with healthy tissue from a donor cornea.",[35,36],"Assigned cornea from a donor with diabetes","Assigned cornea from a donor without diabetes",[38],{"measure":39,"description":40,"timeFrame":41},"Change in central corneal endothelial cell density 5 years after Descemet membrane endothelial keratoplasty.","Central corneal endothelial cell density will be assessed by specular microscopy at 3 and 5 years after Descemet membrane endothelial keratoplasty and the results will be compared with the baseline donor endothelial cell density assessed at the eye bank that provided the donor tissue.","Subjects are followed for 5 years after corneal transplantation.",[],"ALL","30 Years","93 Years",false,{"inclusion":48,"exclusion":53,"raw_text":55},[49,50,51,52],"Willing to return to the study site for follow up at 3 and 5 years after a Descemet membrane endothelial keratoplasty procedure","Fluent in English or Spanish","Willing to have fingerstick blood sample collected to determine HbA1c level","Participated and completed 12-month follow-up in the DEKS study for one or both eyes or a DEKS participant that had a study eye regraft prior to the 12-month visit.",[54],"Lack cognitive capacity such that consent could not be provided.","Inclusion Criteria:\n\n* Willing to return to the study site for follow up at 3 and 5 years after a Descemet membrane endothelial keratoplasty procedure\n* Fluent in English or Spanish\n* Willing to have fingerstick blood sample collected to determine HbA1c level\n* Participated and completed 12-month follow-up in the DEKS study for one or both eyes or a DEKS participant that had a study eye regraft prior to the 12-month visit.\n\nExclusion Criteria:\n\n* Lack cognitive capacity such that consent could not be provided.",[57,58],"ADULT","OLDER_ADULT",[60,69,77,85,93,101,105,113,120,128,135,142,150,158],{"facility":61,"city":62,"state":63,"zip":64,"country":65,"geoPoint":66},"Georgia Eye Partners","Atlanta","Georgia","30189","United States",{"lat":67,"lon":68},33.749,-84.38798,{"facility":70,"city":71,"state":72,"zip":73,"country":65,"geoPoint":74},"Price Vision Group","Indianapolis","Indiana","46260",{"lat":75,"lon":76},39.76838,-86.15804,{"facility":78,"city":79,"state":80,"zip":81,"country":65,"geoPoint":82},"University of Iowa Hospitals and Clinics","Iowa City","Iowa","52242",{"lat":83,"lon":84},41.66113,-91.53017,{"facility":86,"city":87,"state":88,"zip":89,"country":65,"geoPoint":90},"Kansas City Eye Clinic","Overland Park","Kansas","66204",{"lat":91,"lon":92},38.98223,-94.67079,{"facility":94,"city":95,"state":96,"zip":97,"country":65,"geoPoint":98},"Mid-Atlantic Cornea Consultants","Baltimore","Maryland","21204",{"lat":99,"lon":100},39.29038,-76.61219,{"facility":102,"city":95,"state":96,"zip":103,"country":65,"geoPoint":104},"The Wilmer Eye Institute\u002FJohns Hopkins","21287",{"lat":99,"lon":100},{"facility":106,"city":107,"state":108,"zip":109,"country":65,"geoPoint":110},"University of Michigan\u002FKellogg Eye Center","Ann Arbor","Michigan","48105",{"lat":111,"lon":112},42.27756,-83.74088,{"facility":114,"city":115,"state":108,"zip":116,"country":65,"geoPoint":117},"Verdier Eye Center","Grand Rapids","49546",{"lat":118,"lon":119},42.96336,-85.66809,{"facility":121,"city":122,"state":123,"zip":124,"country":65,"geoPoint":125},"Minnesota Eye Consultants","Bloomington","Minnesota","55431",{"lat":126,"lon":127},44.8408,-93.29828,{"facility":129,"city":130,"state":123,"zip":131,"country":65,"geoPoint":132},"Mayo Clinic","Rochester","55905",{"lat":133,"lon":134},44.02163,-92.4699,{"facility":136,"city":137,"state":123,"zip":138,"country":65,"geoPoint":139},"Associated Eye Care","Stillwater","55082",{"lat":140,"lon":141},45.05636,-92.80604,{"facility":143,"city":144,"state":145,"zip":146,"country":65,"geoPoint":147},"Moyes Eye Center","Kansas City","Missouri","64154",{"lat":148,"lon":149},39.09973,-94.57857,{"facility":151,"city":152,"state":153,"zip":154,"country":65,"geoPoint":155},"Legacy Devers Eye Institute","Portland","Oregon","97210",{"lat":156,"lon":157},45.52345,-122.67621,{"facility":159,"city":160,"state":161,"zip":162,"country":65,"geoPoint":163},"Ophthalmic Partners","Bala-Cynwyd","Pennsylvania","19004",{"lat":164,"lon":165},40.00761,-75.23407,[],[168],{"name":169,"affiliation":13,"role":170},"Jonathan Lass, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":174,"biomarkers":177},[175,176],"Corneal Decompensation","Fuchs Endothelial Dystrophy",[],{"nct_id":4,"found":46,"summary":17,"prompt_version":17}]