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

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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Key information

Conditions

Fuchs Endothelial Corneal Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Corneal Endothelial Decompensation Eye Diseases Eye Diseases, Hereditary Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn

Age range

30 year–93 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgia Eye Partners, Atlanta, Georgia, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Descemet Membrane Endothelial Keratoplasty

Procedure

Replacement of the recipient corneal endothelial and Descemet membrane with healthy tissue from a donor cornea.

Primary outcomes

Change in central corneal endothelial cell density 5 years after Descemet membrane endothelial keratoplasty.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

National Eye Institute (NEI)

Registry information

Official study title

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

Acronym: DEKS

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2030
First posted: Oct 15, 2025
Registry last updated: Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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