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

Purpose

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.

Conditions

  • Fuchs Endothelial Corneal Dystrophy
  • Corneal Endothelial Decompensation

Eligibility

Eligible Ages
Between 30 Years and 93 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Procedure: Descemet membrane endothelial keratoplasty
    Replacement of the recipient corneal endothelial and Descemet membrane with healthy tissue from a donor cornea.
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.
  • Procedure: Descemet membrane endothelial keratoplasty
    Replacement of the recipient corneal endothelial and Descemet membrane with healthy tissue from a donor cornea.

Recruiting Locations

Price Vision Group
Indianapolis 4259418, Indiana 4921868 46260
Contact:
Marianne Price, PhD
317-814-2990
mprice@cornea.org

Verdier Eye Center
Grand Rapids 4994358, Michigan 5001836 49546
Contact:
Paula Johnson
616-949-2001
pjohnson@verdiereyecenter.com

More Details

Status
Recruiting
Sponsor
Case Western Reserve University

Study Contact

Jonathan Lass, MD
216-844-8608
jonathan.lass@case.edu