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

NCT07217249 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 570

Last updated 2026-02-27

No results posted yet for this study

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

PROCEDURE

Descemet membrane endothelial keratoplasty

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

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Case Western Reserve University

    lead OTHER

Principal Investigators

  • Jonathan Lass, MD · Case Western Reserve University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
93 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-03
Primary Completion
2029-12-30
Completion
2030-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07217249 on ClinicalTrials.gov