Impact of Donor Diabetes on DMEK Success and Endothelial Cell Loss

Completed · Not applicable

Conditions studied: Corneal Endothelial Decompensation, Fuchs' Endothelial Dystrophy

In brief

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.

Key facts

Study ID

NCT05134480

Run by

Case Western Reserve University

People needed

1097

Starts

2022-01-21

Expected to finish

2025-09-15

Last updated by the study team

2026-04-16

Who can join

Age: 30 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

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)
• Fellow eye visual acuity < 20/200 due to an ocular condition other than a cornea disease that would be a candidate for DMEK
• Intraocular pressure <8 mmHg
• Topical Rho kinase inhibitor, including netarsudil, used within 1 month prior to study entry and anticipated during the course of the study
• Fellow eye enrolled in the DEKS that has met study-criteria for graft failure.

Where it is running

• Price Vision Group — Indianapolis, Indiana, United States
• Verdier Eye Center — Grand Rapids, Michigan, United States

Full record on ClinicalTrials.gov

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