Print

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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.