Impact of Donor Diabetes on DMEK Success and Endothelial Cell Loss
CompletedNAResults postedLast updated 16 April 2026
What this trial tests
NA trial testing Descemet membrane endothelial keratoplasty in Corneal Endothelial Decompensation in 1,097 participants. Completed in 15 September 2025.
Adults 30 to 90, any sex, with Corneal Endothelial Decompensation or Fuchs' Endothelial Dystrophy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Graft FailurePrimary· 1 year
Graft failure is defined as the occurrence of one of the following: a graft which requires replacement for any reason or the recipient cornea remains cloudy after surgery without clearing for 8 weeks or longer
Group
Value
95% CI
Cornea From Donor Without Diabetes
32
Cornea From Donor With Diabetes
15
Endothelial Cell DensitySecondary· 1 year
Central corneal endothelial cell density assessed with specular microscopy
Group
Value
95% CI
Cornea From Donor Without Diabetes
1927
± 498
Cornea From Donor With Diabetes
1920
± 496
Adverse events — posted to ClinicalTrials.gov
Time frame: from enrollment until end of follow-up, up to 15 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
Other trials of Descemet membrane endothelial keratoplasty
Trials testing the same drug.
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· NA
· enrolling by invitation
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Case Western Reserve University
Last refreshed: 16 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05134480.