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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Case Western Reserve University
Study ID
NCT07217249
Status
Enrolling By Invitation

Conditions

  • Corneal Endothelial Decompensation
  • Fuchs Endothelial Corneal Dystrophy

Eligibility Criteria

Sex
ALL
Age
30 Years - 93 Years
Healthy Volunteers
Not accepted

Interventions

  • Descemet membrane endothelial keratoplasty — PROCEDURE
    Replacement of the recipient corneal endothelial and Descemet membrane with healthy tissue from a donor cornea.

Study Details

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.

Key Dates

Start date
Dec 3, 2025
Status verified
Feb 2026
Primary completion
Dec 30, 2029
Completion
Apr 30, 2030

Study Design

Enrollment
570 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in central corneal endothelial cell density 5 years after Descemet membrane endothelial keratoplasty. [ Time Frame: Subjects are followed for 5 years after corneal transplantation. ]

Locations (14)

FacilityCityStateZIPSite coordinators
Georgia Eye PartnersAtlantaGeorgia30189-
Price Vision GroupIndianapolisIndiana46260-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
Kansas City Eye ClinicOverland ParkKansas66204-
Mid-Atlantic Cornea ConsultantsBaltimoreMaryland21204-
The Wilmer Eye Institute/Johns HopkinsBaltimoreMaryland21287-
University of Michigan/Kellogg Eye CenterAnn ArborMichigan48105-
Verdier Eye CenterGrand RapidsMichigan49546-
Minnesota Eye ConsultantsBloomingtonMinnesota55431-
Mayo ClinicRochesterMinnesota55905-
Associated Eye CareStillwaterMinnesota55082-
Moyes Eye CenterKansas CityMissouri64154-
Legacy Devers Eye InstitutePortlandOregon97210-
Ophthalmic PartnersBala-CynwydPennsylvania19004-

Find similar trials in Atlanta, GA

By research site
Georgia Eye Partners· Atlanta, GAPrice Vision Group· Indianapolis, INUniversity of Iowa Hospitals and Clinics· Iowa City, IAKansas City Eye Clinic· Overland Park, KSMid-Atlantic Cornea Consultants· Baltimore, MDThe Wilmer Eye Institute/Johns Hopkins· Baltimore, MD

Related Studies