Effect of Donor Diabetes and Other Factors on Corneal Transplant Endothelial Cell Loss and Success at 5 Years

Not Applicable

Not yet recruiting

• Conditions: Fuchs Endothelial Corneal Dystrophy; Corneal Endothelial Decompensation

• Registration Number: NCT07217249
• Lead Sponsor: Case Western Reserve University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-13
• Study First Submitted QC: 2025-10-13
• Last Update Submitted: 2025-10-13
• Study First Posted: 2025-10-15
• Last Update Posted: 2025-10-15
• Study Start: 2025-12-30
• Primary Completion: 2029-12-30
• Study Completion: 2030-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 570

Inclusion Criteria

• 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.

Exclusion Criteria

• Lack cognitive capacity such that consent could not be provided.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in central corneal endothelial cell density 5 years after Descemet membrane endothelial keratoplasty.	Subjects are followed for 5 years after corneal transplantation.	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.

Trial Locations

Locations (5)

Price Vision Group; 🇺🇸 Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

University of Michigan/Kellogg Eye Center; 🇺🇸 Ann Arbor, Michigan, United States

Verdier Eye Center; 🇺🇸 Grand Rapids, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States