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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
570
Replacement of the recipient corneal endothelial and Descemet membrane with healthy tissue from a donor cornea.
Georgia Eye Partners
Atlanta, Georgia, United States
Price Vision Group
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
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.
Time frame: Subjects are followed for 5 years after corneal transplantation.
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Kansas City Eye Clinic
Overland Park, Kansas, United States
Mid-Atlantic Cornea Consultants
Baltimore, Maryland, United States
The Wilmer Eye Institute/Johns Hopkins
Baltimore, Maryland, United States
University of Michigan/Kellogg Eye Center
Ann Arbor, Michigan, United States
Verdier Eye Center
Grand Rapids, Michigan, United States
Minnesota Eye Consultants
Bloomington, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
...and 4 more locations