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ENROLLING_BY_INVITATIONNA

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

NCT07217249•Case Western Reserve University

View on ClinicalTrials.gov

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.

Eligibility

Age

30 - 93 years

Sex

ALL

Healthy Volunteers

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)

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

Key Dates

Start Date

December 3, 2025

Primary Completion Date

December 30, 2029

Completion Date

April 30, 2030

Last Updated

February 27, 2026

Enrollment

570

ESTIMATED participants

Conditions

Fuchs Endothelial Corneal DystrophyCorneal Endothelial Decompensation

Interventions

Descemet membrane endothelial keratoplasty

PROCEDURE

DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy

NCT07024693

Fuchs Endothelial Corneal DystrophyFuchs

View study

RECRUITINGPHASE2

Targeting Reactive Oxygen Species Production as a Novel Therapeutic in Fuch's Endothelial Corneal Dystrophy

NCT04440280

Fuchs Endothelial Corneal Dystrophy

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy

Targeting Reactive Oxygen Species Production as a Novel Therapeutic in Fuch's Endothelial Corneal Dystrophy

Comparison of Outcomes Between Femtosecond Laser-Assisted and Conventional Phacoemulsification in Fuchs Endothelial Corneal Dystrophy Patients With Cataracts

A Study to Evaluate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)

The Postoperative Head Position as a Predictor of the Surgical Outcome After DMEK