NCT07217249

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 570 (estimated)
• Sponsor: Case Western Reserve University · Academic / Other
• Sex: All
• Age: 30 Years – 93 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fuchs Endothelial Corneal Dystrophy
• Corneal Endothelial Decompensation

Interventions

Type	Name	Description
PROCEDURE	Descemet membrane endothelial keratoplasty	Replacement of the recipient corneal endothelial and Descemet membrane with healthy tissue from a donor cornea.

Timeline

• Start date: 2025-12-03
• Primary completion: 2029-12-30
• Completion: 2030-04-30
• First posted: 2025-10-15
• Last updated: 2026-02-27

Locations

14 sites across 1 country: United States