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Impact of Donor Diabetes on DMEK Success and Endothelial Cell Loss

NCT05134480 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1097

Last updated 2026-04-16

Study results available
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Summary

This double-masked multi-center trial will evaluate the association of diabetes in the cornea donor with transplant success and loss of endothelial cells through 1 year 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.

Conditions

  • Corneal Endothelial Decompensation
  • Fuchs' Endothelial Dystrophy

Interventions

PROCEDURE

Descemet membrane endothelial keratoplasty

cornea transplant procedure to replace dysfunctional endothelial cell layer

Sponsors & Collaborators

  • Jaeb Center for Health Research

    collaborator OTHER

  • 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
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-21
Primary Completion
2025-07-15
Completion
2025-09-15

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 NCT05134480 on ClinicalTrials.gov