N/A
N=1,274
Impact of Donor Diabetes on DMEK Success and Endothelial Cell Loss
Corneal Endothelial Decompensation · Fuchs' Endothelial Dystrophy
Bottom Line
View on ClinicalTrials.gov: NCT05134480 ↗Enrolled (actual)
1,274
Serious AEs
0.4%
Results posted
Apr 2026
Primary outcome: Primary: Graft Failure — 32; 15 eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Descemet membrane endothelial keratoplasty (Procedure)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Case Western Reserve University
- Primary completion
- Jul 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Graft Failure |
32; 15 | — |
| SECONDARY Endothelial Cell Density |
1927; 1920 | — |
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.
Eligibility Criteria
Participant Inclusion Criteria:
- Age range 30- 25mm Hg.
- Controlled glaucoma with prior tube shunt placement for glaucoma (controlled glaucoma with minimally invasive glaucoma surgery (MIGS) or trabeculectomy is allowed)
- Fellow eye visual acuity < 20/200 due to an ocular condition other than a cornea disease that would be a candidate for DMEK
- Intraocular pressure <8 mmHg
- Topical Rho kinase inhibitor, including netarsudil, used within 1 month prior to study entry and anticipated during the course of the study
- Fellow eye enrolled in the DEKS that has met study-criteria for graft failure.
Data sourced from ClinicalTrials.gov (NCT05134480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.