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

NCT07217249 — Not applicable, Enrolling by invitation, 570 participants, Case Western Reserve University

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Diabetes Endothelial Keratoplasty Study (DEKS): Impact of Diabetes and Other Predictors on Corneal Transplant Endothelial Cell Loss and Success

Registry	NCT07217249, acronym DEKS
Status	Enrolling by invitation
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	570 (Estimated)
Sponsor	Case Western Reserve University (Other); collaborators: National Eye Institute (NEI)
Conditions	Fuchs Endothelial Corneal Dystrophy, Corneal Endothelial Decompensation
Interventions	Descemet membrane endothelial keratoplasty (Procedure)
Dates	start 2025-12-03, primary completion 2029-12-30 (estimated), completion 2030-04-30 (estimated), first posted 2025-10-15, last updated 2026-02-27
Locations	14 sites in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Assigned cornea from a donor without diabetes	Active comparator	Procedure: Descemet membrane endothelial keratoplasty	Eyes assigned to this arm receive a cornea from a donor without diabetes and undergo Descemet membrane endothelial keratoplasty.
Assigned cornea from a donor with diabetes	Active comparator	Procedure: Descemet membrane endothelial keratoplasty	Eyes assigned to this arm receive a cornea from a donor with diabetes for Descemet membrane endothelial keratoplasty.

Descemet membrane endothelial keratoplasty (Procedure): Replacement of the recipient corneal endothelial and Descemet membrane with healthy tissue from a donor cornea.

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 30 Years to 93 Years

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.

+Locations (14)

Facility	City	Country
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

+Investigators

Jonathan Lass, MD, Principal investigator, Case Western Reserve University

+Funding

NIH grants: 1UG1EY037206-01, 5UG1EY030030-05

My Notes

Public

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