By InvitationNot Applicable

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

United States570 participantsStarted 2025-12-03

Plain-language 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.

Who can participate

Age range30 Years – 93 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in central corneal endothelial cell density 5 years after Descemet membrane endothelial keratoplasty.

Timeframe: Subjects are followed for 5 years after corneal transplantation.

Trial details

NCT IDNCT07217249

SponsorCase Western Reserve University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12-30

View on ClinicalTrials.gov More Fuchs Endothelial Corneal Dystrophy trials