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(for at least one location)
Describes the nature of a clinical study. Types include:
The objectives of this study are to determine if the 1-year graft success rate following DMEK performed with corneas from donors without diabetes is superior to the graft success rate with cornea donors with diabetes, to determine if the 1-year central endothelial cell loss (ECL) following DMEK performed with corneas from donors without diabetes is superior to the central ECL when corneas from donors with diabetes are used, nd to explore the relationship of severity of diabetes in the donor, as measured by eye bank-determined diabetes risk categorization scores, post-mortem hemoglobin A1c (HbA1c), and skin advanced glycation endproducts (AGE) and oxidation markers, with 1-year graft outcomes (i.e., graft success and ECL) following DMEK in corneas from donors with diabetes.
The association of diabetes in the cornea donor with transplant success and loss of endothelial cells one year following Descemet membrane endothelial keratoplasty (DMEK) will be evaluated in a double-masked multi-center trial in which study eyes will be assigned to receive either a cornea from a donor without diabetes or a cornea from a donor with diabetes.
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