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

Enrolling by invitation · Not applicable

Conditions studied: Fuchs Endothelial Corneal Dystrophy, Corneal Endothelial Decompensation

In brief

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.

Key facts

Study ID

NCT07217249

Run by

Case Western Reserve University

People needed

570

Starts

2025-12-03

Expected to finish

2030-04-30

Last updated by the study team

2026-02-27

Who can join

Age: 30 and older, up to 93. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Georgia Eye Partners — Atlanta, Georgia, United States
• Price Vision Group — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Kansas City Eye Clinic — Overland Park, Kansas, United States
• Mid-Atlantic Cornea Consultants — Baltimore, Maryland, United States
• The Wilmer Eye Institute/Johns Hopkins — Baltimore, Maryland, United States
• University of Michigan/Kellogg Eye Center — Ann Arbor, Michigan, United States
• Verdier Eye Center — Grand Rapids, Michigan, United States
• Minnesota Eye Consultants — Bloomington, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Associated Eye Care — Stillwater, Minnesota, United States
• Moyes Eye Center — Kansas City, Missouri, United States
• Legacy Devers Eye Institute — Portland, Oregon, United States
• Ophthalmic Partners — Bala-Cynwyd, Pennsylvania, United States

Full record on ClinicalTrials.gov

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