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

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07217249

Acronym

DEKS

Enrollment

570

Registered

2025-10-15

Start date

2025-12-03

Completion date

2030-04-30

Last updated

2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Endothelial Decompensation, Fuchs Endothelial Corneal Dystrophy

Brief 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.

Interventions

PROCEDUREDescemet membrane endothelial keratoplasty

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 93 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in central corneal endothelial cell density 5 years after Descemet membrane endothelial keratoplasty.	Subjects are followed for 5 years after corneal transplantation.	Central corneal endothelial cell density will be assessed by specular microscopy at 3 and 5 years after Descemet membrane endothelial keratoplasty and the results will be compared with the baseline donor endothelial cell density assessed at the eye bank that provided the donor tissue.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJonathan Lass, MD

Case Western Reserve University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026