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

RECRUITINGN/ASponsored by Case Western Reserve University
Actively Recruiting
PhaseN/A
SponsorCase Western Reserve University
Started2025-12-03
Est. completion2029-12-30
Eligibility
Age30 Years – 93 Years
Healthy vol.Accepted
Locations14 sites
View on ClinicalTrials.gov →

NCT07217249

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.

Eligibility

Age: 30 Years – 93 YearsHealthy volunteers accepted
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.

Conditions3

Corneal Endothelial DecompensationDiabetesFuchs Endothelial Corneal Dystrophy

Locations14 sites

Georgia Eye Partners
Atlanta, Georgia, 30189
Breshae Hill404-953-4059breshae.hill@gaeyepartners.com
Price Vision Group
Indianapolis, Indiana, 46260
Marianne Price, PhD317-814-2990mprice@cornea.org
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Constance Mullinix319-356-2861constance-mullinnix@uiowa.edu
Kansas City Eye Clinic
Overland Park, Kansas, 66204
Megan Hefter913-341-3100mhefter@KCeyeclinic.com
Huffman and Huffman, PSC
Lexington, Kentucky, 40509
Melinda Sears859-263-4631Melinda@huffmanandhuffman.com

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