Effect of Donor Diabetes and Other Factors on Corneal Transplant Endothelial Cell Loss and Success at 5 Years
NCT ID: NCT07217249
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
570 participants
INTERVENTIONAL
2025-12-03
2030-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Assigned cornea from a donor without diabetes
Eyes assigned to this arm receive a cornea from a donor without diabetes and undergo Descemet membrane endothelial keratoplasty.
Descemet membrane endothelial keratoplasty
Replacement of the recipient corneal endothelial and Descemet membrane with healthy tissue from a donor cornea.
Assigned cornea from a donor with diabetes
Eyes assigned to this arm receive a cornea from a donor with diabetes for Descemet membrane endothelial keratoplasty.
Descemet membrane endothelial keratoplasty
Replacement of the recipient corneal endothelial and Descemet membrane with healthy tissue from a donor cornea.
Interventions
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Descemet membrane endothelial keratoplasty
Replacement of the recipient corneal endothelial and Descemet membrane with healthy tissue from a donor cornea.
Eligibility Criteria
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Inclusion Criteria
* Fluent in English or Spanish
* Willing to have fingerstick blood sample collected to determine HbA1c level
* Participated and completed 12-month follow-up in the DEKS study for one or both eyes or a DEKS participant that had a study eye regraft prior to the 12-month visit.
Exclusion Criteria
30 Years
93 Years
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
Case Western Reserve University
OTHER
Responsible Party
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Principal Investigators
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Jonathan Lass, MD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University
Locations
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Price Vision Group
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Michigan/Kellogg Eye Center
Ann Arbor, Michigan, United States
Verdier Eye Center
Grand Rapids, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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