Effect of Donor Diabetes and Other Factors on Corneal Transplant Endothelial Cell Loss and Success at 5 Years
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Descemet membrane endothelial keratoplasty.
- Who it may be relevant to
- Registry conditions: Fuchs Endothelial Corneal Dystrophy, Corneal Endothelial Decompensation. Basic parameters: 30 years — 93 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Diabetes Endothelial Keratoplasty Study (DEKS): Impact of Diabetes and Other Predictors on Corneal Transplant Endothelial Cell Loss and Success
Overview
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.
Interventions
- Procedure Descemet membrane endothelial keratoplasty
Replacement of the recipient corneal endothelial and Descemet membrane with healthy tissue from a donor cornea.
Primary outcome measures
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 14 centers
- Georgia Eye Partners — Atlanta
- Price Vision Group — Indianapolis
- University of Iowa Hospitals and Clinics — Iowa City
- Kansas City Eye Clinic — Overland Park
- Mid-Atlantic Cornea Consultants — Baltimore
- The Wilmer Eye Institute/Johns Hopkins — Baltimore
- University of Michigan/Kellogg Eye Center — Ann Arbor
- Verdier Eye Center — Grand Rapids
- … and 6 more centers
Identifiers
NCT: NCT07217249 · DEKS 5-year Extension Study · 1UG1EY037206-01 · 5UG1EY030030-05