NCT07217249

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
570

participants targeted

Target at P75+ for not_applicable

Timeline
49mo left

Started Dec 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Dec 2025Apr 2030

First Submitted

Initial submission to the registry

October 13, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 15, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

December 3, 2025

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2029

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2030

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

4.1 years

First QC Date

October 13, 2025

Last Update Submit

February 26, 2026

Conditions

Fuchs Endothelial Corneal DystrophyCorneal Endothelial Decompensation

Outcome Measures

Primary Outcomes (1)

  • Change in central corneal endothelial cell density 5 years after Descemet membrane endothelial keratoplasty.

    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.

    Subjects are followed for 5 years after corneal transplantation.

Study Arms (2)

Assigned cornea from a donor without diabetes

ACTIVE COMPARATOR

Eyes assigned to this arm receive a cornea from a donor without diabetes and undergo Descemet membrane endothelial keratoplasty.

Procedure: Descemet membrane endothelial keratoplasty

Assigned cornea from a donor with diabetes

ACTIVE COMPARATOR

Eyes assigned to this arm receive a cornea from a donor with diabetes for Descemet membrane endothelial keratoplasty.

Procedure: Descemet membrane endothelial keratoplasty

Interventions

Descemet membrane endothelial keratoplastyPROCEDURE

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

Assigned cornea from a donor with diabetesAssigned cornea from a donor without diabetes

Eligibility Criteria

Age30 Years - 93 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Lack cognitive capacity such that consent could not be provided.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Georgia Eye Partners

Atlanta, Georgia, 30189, United States

Location

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Kansas City Eye Clinic

Overland Park, Kansas, 66204, United States

Location

Mid-Atlantic Cornea Consultants

Baltimore, Maryland, 21204, United States

Location

The Wilmer Eye Institute/Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

University of Michigan/Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Location

Verdier Eye Center

Grand Rapids, Michigan, 49546, United States

Location

Minnesota Eye Consultants

Bloomington, Minnesota, 55431, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Associated Eye Care

Stillwater, Minnesota, 55082, United States

Location

Moyes Eye Center

Kansas City, Missouri, 64154, United States

Location

Legacy Devers Eye Institute

Portland, Oregon, 97210, United States

Location

Ophthalmic Partners

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, HereditaryCorneal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jonathan Lass, MD

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2025

First Posted

October 15, 2025

Study Start

December 3, 2025

Primary Completion (Estimated)

December 30, 2029

Study Completion (Estimated)

April 30, 2030

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

US(14)