Impact of Donor Diabetes on DMEK Success and Endothelial Cell Loss (NCT05134480) | Clinical Trial Compass
CompletedNot Applicable
Impact of Donor Diabetes on DMEK Success and Endothelial Cell Loss
United States1,097 participantsStarted 2022-01-21
Plain-language 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.
Who can participate
Age range30 Years – 90 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Pregnant or planning to become pregnant prior to the DMEK study surgery, based on verbal report.