Diabetes Endothelial Keratoplasty Study (DEKS): Impact of Diabetes and Other Predictors on Corneal Transplant Endothelial Cell Loss and Success

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 93
Healthy Volunteers: f
View:

• 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.

Locations
United States
Iowa
University of Iowa Hospitals and Clinics
NOT_YET_RECRUITING
Iowa City
Indiana
Price Vision Group
RECRUITING
Indianapolis
Michigan
University of Michigan/Kellogg Eye Center
NOT_YET_RECRUITING
Ann Arbor
Verdier Eye Center
RECRUITING
Grand Rapids
Minnesota
Mayo Clinic
NOT_YET_RECRUITING
Rochester
Contact Information
Primary
Jonathan Lass, MD
jonathan.lass@case.edu
216-844-8608
Time Frame
Start Date: 2025-12-03
Estimated Completion Date: 2030-04-30
Participants
Target number of participants: 570
Treatments
Active_comparator: Assigned cornea from a donor without diabetes
Eyes assigned to this arm receive a cornea from a donor without diabetes and undergo Descemet membrane endothelial keratoplasty.
Active_comparator: Assigned cornea from a donor with diabetes
Eyes assigned to this arm receive a cornea from a donor with diabetes for Descemet membrane endothelial keratoplasty.
Related Therapeutic Areas
Sponsors
Collaborators: National Eye Institute (NEI)
Leads: Case Western Reserve University

This content was sourced from clinicaltrials.gov