Journal article
Diabetes Endothelial Keratoplasty Study: Methods and Impact on the Use of Corneas From Donors With Diabetes for Descemet Membrane Endothelial Keratoplasty
Cornea, Vol.45(3), pp.312-321
03/2026
DOI: 10.1097/ICO.0000000000003776
PMCID: PMC12238323
PMID: 39808526
Abstract
Describe aims, methods, characteristics of donors, donor corneas and recipients, and potential impact of the Diabetes Endothelial Keratoplasty Study (DEKS).
The DEKS is a randomized, clinical trial to assess graft success and endothelial cell density (ECD) 1 year after Descemet membrane endothelial keratoplasty (DMEK) using corneas from donors with versus without diabetes in a 1:2 minimization assignment. Diabetes severity in the donor is assessed by medical history, postmortem HbA1c, and donor skin advanced glycation end-products and oxidation markers. A central image analysis reading center assesses baseline donor, 1-month and 1-year postoperative ECD.
The DEKS used corneas from 1154 donors for 1421 DMEK procedures on 1097 participants (324 bilateral) at 28 clinical sites. Forty-eight tissue preparations failed (3%). Mean donor age was 65 years; mean eye bank-determined screening ECD was 2709 cells/mm2. Ultimately, 106 (9%) of 1154 donors without diabetes history were classified as diabetic based on postmortem HbA1c ≥6.5%, and 509 (36%) of 1421 donor lenticules were classified as coming from diabetic donors. Recipients were 58% female, 96% White, and 53% phakic. Study eyes were treated for Fuchs endothelial corneal dystrophy (96%), pseudophakic corneal edema (2%), and failed endothelial keratoplasty (2%). Mean recipient age was 70 years; 21% had diabetes history and 26 (2%) had central laboratory determined HbA1c ≥6.5% without diabetes history.
The DEKS will increase understanding of factors related to DMEK success while determining whether diabetes and/or diabetes severity in the donor and/or recipient adversely affects graft success and endothelial cell loss.
Details
- Title: Subtitle
- Diabetes Endothelial Keratoplasty Study: Methods and Impact on the Use of Corneas From Donors With Diabetes for Descemet Membrane Endothelial Keratoplasty
- Creators
- Marianne O Price - Cornea Research Foundation of AmericaLoretta B Szczotka-Flynn - Case Western Reserve UniversityColleen E Bauza - Jaeb Center for Health ResearchZachariah W Reed - Jaeb Center for Health ResearchBeth Ann Benetz - Case Western Reserve UniversityMark A Greiner - University of IowaDavid D Verdier - Verdier Eye Center, Grand Rapids, MIMark C Soper - VisionFirst, Indianapolis, INMichael S Titus - Eversight, Ann Arbor, MIVincent M Monnier - Case Western Reserve UniversityBaha M Arafah - University Hospitals of ClevelandCraig Kollman - Jaeb Center for Health ResearchRoy W Beck - Jaeb Center for Health ResearchJonathan H Lass - Case Western Reserve UniversityWriting Committee for the Diabetes Endothelial Keratoplasty Study Group
- Resource Type
- Journal article
- Publication Details
- Cornea, Vol.45(3), pp.312-321
- DOI
- 10.1097/ICO.0000000000003776
- PMID
- 39808526
- PMCID
- PMC12238323
- NLM abbreviation
- Cornea
- ISSN
- 0277-3740
- eISSN
- 1536-4798
- Grant note
- EY030030 and EY030039 / National Eye Institute, Eye Bank Association of America, The Cornea Society, Cleveland Eye Bank Foundation, Beauty of Sight: A Lions Eye Bank, CorneaGen, Eversight, Eye Bank for Sight Restoration, Eye Bank of Kentucky, Lions Gift of Sight, Iowa Lions Eye Bank, Lions Eye Bank of Wisconsin, Kenneth Maverick, MD, Mayo Clinic, San Antonio Eye , San Diego Eye , Utah Lions Eye , VisionFirst, VisionGift
- Language
- English
- Electronic publication date
- 01/09/2025
- Date published
- 03/2026
- Academic Unit
- Pharmaceutical Sciences and Experimental Therapeutics; Ophthalmology and Visual Sciences
- Record Identifier
- 9984773417302771
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