Impact of Donor Diabetes on DMEK Success and Endothelial Cell Loss

NCT05134480 | Completed Results DMC

• 3 other identifiers: DEKS1UG1EY030039-01A11UG1EY030030-01A1
• Study Type: interventional
• Target: 1,097
• Locations: 1 country
• Sites: 2

Brief Summary

This double-masked multi-center trial will evaluate the association of diabetes in the cornea donor with transplant success and loss of endothelial cells through 1 year 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.

Conditions

Corneal Endothelial Decompensation; Fuchs' Endothelial Dystrophy

Outcome Measures

Primary Outcomes (1)

• Graft Failure

  Graft failure is defined as the occurrence of one of the following: a graft which requires replacement for any reason or the recipient cornea remains cloudy after surgery without clearing for 8 weeks or longer

  1 year

Secondary Outcomes (1)

• Endothelial Cell Density

  1 year

Study Arms (2)

Cornea from donor with diabetes

ACTIVE COMPARATOR

Participant eye will be assigned a cornea recovered from a donor with diabetes.

Procedure: Descemet membrane endothelial keratoplasty

Cornea from donor without diabetes

ACTIVE COMPARATOR

Participant eye will be assigned a cornea recovered from a donor without diabetes.

Procedure: Descemet membrane endothelial keratoplasty

Interventions

Descemet membrane endothelial keratoplasty PROCEDURE

cornea transplant procedure to replace dysfunctional endothelial cell layer

Cornea from donor with diabetes; Cornea from donor without diabetes

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range 30- \< 91 years with minimum life expectancy of at least 1 year
• Willingness to return to study site for follow up at 1 month and 1 year
• Fluent in English or Spanish
• Willingness to have fingerstick blood sample collected to determine HbA1c level at entry and at 1 year. The participant must agree to have their primary care provider contacted (or an appropriate referral provided) if they were not known to have diabetes and the HbA1c suggests they may have diabetes. Similarly, if already known to have diabetes and the HbA1c is high, the participant must agree to have their primary care provider contacted or an appropriate referral provided.
• Has at least one eye clinically recommended for Descemet membrane endothelial keratoplasty (DMEK) that is able to be scheduled for DMEK between 5 to 90 days after enrollment. If second eye is enrolled, it must be scheduled for DMEK between 7 days and 6 months after DMEK on the first eye.
• Has a condition related to endothelial dysfunction which will be treated by DMEK. Eligible indications for DMEK include:
• Presence of Fuchs endothelial corneal dystrophy (FECD) meeting at least one of the following: phakic FECD with or without cataract (triple procedure including DMEK for FECD, cataract extraction and posterior chamber intraocular lens implantation (IOL) is allowed)
• pseudophakic FECD with posterior capsule supported, sulcus supported, or scleral-fixated posterior chamber IOL
• pseudophakic corneal edema with posterior capsule supported, sulcus supported, or scleral-fixated posterior chamber IOL without FECD

You may not qualify if:

• Pregnant or planning to become pregnant prior to the DMEK study surgery, based on verbal report.
• Lack cognitive capacity such that consent could not be provided.
• Presence of a condition that has a high probability for failure (e.g., failed penetrating keratoplasty, uncontrolled uveitis)
• Stromal vascularization that will impede assessment of recipient stroma clarity
• Other primary endothelial dysfunction conditions including posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy.
• Indication for surgery that is not suitable for DMEK (e.g, keratoconus, stromal dystrophies and scars)
• Aphakic corneal edema with or without FECD
• Anterior chamber IOL in study eye prior to DMEK or planned placement of anterior chamber IOL during DMEK
• Presence of vitreous in the anterior chamber
• Planned IOL exchange of an anterior chamber IOL with a posterior chamber IOL in study eye at time of study DMEK
• Pre-operative central sub-epithelial or stromal scarring that could impact post-operative recipient stromal clarity assessment
• Presence of anterior synechiae
• Peripheral anterior synechiae in the angle greater than a total of three clock hours
• Uncontrolled glaucoma with or without prior filtering surgery, tube shunt placement, or MIGS. Uncontrolled glaucoma is defined as intraocular pressure \> 25mm Hg.
• Controlled glaucoma with prior tube shunt placement for glaucoma (controlled glaucoma with minimally invasive glaucoma surgery (MIGS) or trabeculectomy is allowed)

Sponsors & Collaborators

• Case Western Reserve University: lead
• Jaeb Center for Health Research: collaborator
• National Eye Institute (NEI): collaborator

Study Sites (2)

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

Verdier Eye Center

Grand Rapids, Michigan, 49546, United States

Location

Related Publications (3)

• Price MO, Szczotka-Flynn LB, Bauza CE, Reed ZW, Benetz BA, Greiner MA, Verdier DD, Soper MC, Titus MS, Monnier VM, Arafah BM, Kollman C, Beck RW, Lass JH; Writing Committee for the Diabetes Endothelial Keratoplasty Study Group. Diabetes Endothelial Keratoplasty Study: Methods and Impact on the Use of Corneas From Donors With Diabetes for Descemet Membrane Endothelial Keratoplasty. Cornea. 2026 Mar 1;45(3):312-321. doi: 10.1097/ICO.0000000000003776. Epub 2025 Jan 9.

  PMID: 39808526 RESULT

• Price FW Jr, Szczotka-Flynn LB, Price MO, Bauza CE, Reed ZW, Arafah BM, Greiner MA, Johnson PJ, Keeler DB, Mian SI, Patel SV, Pramanik S, Soper MC, Terry MA, Titus MS, Verdier DD, Kollman C, Beck RW, Lass JH; Diabetes Endothelial Keratoplasty Study Group. Donor Diabetes and 1-Year Descemet Membrane Endothelial Keratoplasty Success Rate: A Randomized Clinical Trial. JAMA Ophthalmol. 2025 Dec 1;143(12):1043-1051. doi: 10.1001/jamaophthalmol.2025.4253.

  PMID: 41105094 RESULT

• Lass JH, Benetz BA, Verdier DD, Szczotka-Flynn LB, Bauza CE, Reed ZW, Greiner MA, Mian SI, Patel SV, Pramanik S, Price FW Jr, Soper MC, Terry MA, Titus MS, Kollman C, Beck RW, Price MO; Diabetes Endothelial Keratoplasty Study Group. Endothelial Cell Loss 1 Year After Successful DMEK in the Diabetes Endothelial Keratoplasty Study: A Randomized Clinical Trial. JAMA Ophthalmol. 2025 Dec 1;143(12):1053-1060. doi: 10.1001/jamaophthalmol.2025.4261.

  PMID: 41105099 RESULT

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Jonathan Lass, MD
• Organization: University Hospitals Cleveland Medical Center

deks@case.edu

216-952-2000

Study Officials

• Jonathan Lass, MD

  Case Western Reserve University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants and the clinical site staff, including the investigators and outcomes assessor will be masked to all donor tissue parameters except storage solution.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Chair

Model Details: Prospective, randomized, double-masked (participant and clinical site) clinical trial

Study Record Dates

• First Submitted: November 13, 2021
• First Posted: November 26, 2021
• Study Start: January 21, 2022
• Primary Completion: July 15, 2025
• Study Completion: September 15, 2025
• Last Updated: April 16, 2026
• Results First Posted: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be made available indefinitely after publication of the study results, which is anticipated by July, 2030.

Locations

US (2)