An interventional study of Descemet membrane endothelial keratoplasty in Fuchs Endothelial Corneal Dystrophy and Corneal Endothelial Decompensation, sponsored by Case Western Reserve University. Enrolling by invitation at 14 sites in United States. Open to participants aged 30 Years to 93 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Case Western Reserve University · Not applicable, Interventional, and Treatment
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.
92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 27 are open to participants now.
This study's planned enrollment of 570 is above the median of 50 across 62 interventional studies indexed under Fuchs' Endothelial Dystrophy.
Browse Fuchs' Endothelial Dystrophy studies →Case Western Reserve University is the lead sponsor of 160 studies on the registry; 28 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eyes assigned to this arm receive a cornea from a donor without diabetes and undergo Descemet membrane endothelial keratoplasty.
Procedure: Descemet membrane endothelial keratoplasty
Eyes assigned to this arm receive a cornea from a donor with diabetes for Descemet membrane endothelial keratoplasty.
Procedure: Descemet membrane endothelial keratoplasty
Replacement of the recipient corneal endothelial and Descemet membrane with healthy tissue from a donor cornea.
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.
Started Dec 2025 (actual). Primary completion is estimated for Dec 2029, 48 months after the start.
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Fuchs' Endothelial Dystrophy →
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