Diabetes Severity in Cornea Donors and 1-Year Outcomes in Recipients in the Diabetes Endothelial Keratoplasty Study

Importance The effect of cornea donor diabetes severity on graft success, endothelial cell density (ECD), and morphometry after Descemet membrane endothelial keratoplasty (DMEK) is not known. Objective To determine whether graft success, corneal endothelial cell loss (ECL), and morphometric changes 1 year after DMEK are associated with cornea donor diabetes severity measured by severity score, donor’s postmortem level of hemoglobin A 1c (HbA 1c ), and postmortem advanced glycation end products (AGEs) or advanced oxidation end products (AOPs). Design, Setting, and Participants This was a secondary analysis of a multicenter, double-masked, randomized clinical trial at 28 clinical sites (46 surgeons) and 13 eye banks in the US among individuals undergoing low- to moderate-risk DMEK. AGE and AOP measurements were collected from a subset of donors. Data analysis was conducted from September 1, 2025, through April 30, 2026. Intervention DMEK performed with a cornea from a donor without or with diabetes, assigned using a minimization procedure (comparable to randomization) to achieve an approximate 2:1 distribution, respectively. Main Outcomes and Measures Graft success, ECL, coefficient of variation (CV) of cell area, and percentage of hexagonal cells (HEX) at 1 year from eye bank and postoperative specular central endothelial images. Results A total of 1097 individuals (1421 study eyes; median [IQR] age, 71 [66-76] years; 631 [57.5%] female) undergoing low- to moderate-risk DMEK (1044 [95.2%] for Fuchs endothelial corneal dystrophy) were included. AGE and AOP measurements were collected from a subset of 472 donors (542 study donor corneas). Among 968 eyes with a postmortem donor HbA 1c level lower than 6.5%, the 1-year graft success rate was 97.1% (95% CI, 95.4%-98.4%), compared with 97.4% (95% CI, 93.9%-100.0%), 93.0% (95% CI, 83.3%-98.8%), and 95.8% (95% CI, 87.3%-100.0%) among eyes with a donor HbA 1c level of 6.5% to less than 7.5% (n = 194), 7.5% to less than 9.0% (n = 86), and 9.0% or higher (n = 48), respectively ( P = .72). There was no significant difference in mean ECD across donor HbA 1c groups. Donor diabetes severity measured with severity score, donor HbA 1c level, and AGE and AOP metrics was not associated with 1-year graft failure, ECD, CV in cell area, or HEX percentage. Conclusions and Relevance This secondary analysis of a randomized clinical trial found that ECL and morphometry 1 year after DMEK were not affected by cornea donor diabetes severity. Comparable 1-year graft success, ECL, and cell morphometrics with tissue from donors with and without diabetes, regardless of the diabetes severity biomarker values observed, support the use of corneas from donors with diabetes for endothelial keratoplasty procedures without additional preoperative testing or risk stratification based on the diabetes status of the cornea donor. Trial Registration ClinicalTrials.gov Identifier: NCT05134480

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Journal
JAMA Ophthalmology
Published
2026-10-08
DOI
https://doi.org/10.1001/jamaophthalmol.2026.4253
Primary Topic
Corneal surgery and disorders
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article
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article

Diabetes Severity in Cornea Donors and 1-Year Outcomes in Recipients in the Diabetes Endothelial Keratoplasty Study

Nambi Nallasamy, Charlene M. Maloney, James M. Huffman, Brandon D. Ayres et al.
JAMA Ophthalmology
Corneal surgery and disorders
article

Diabetes Severity in Cornea Donors and 1-Year Outcomes in Recipients in the Diabetes Endothelial Keratoplasty Study

Nambi Nallasamy, Charlene M. Maloney, James M. Huffman, Brandon D. Ayres, Evan D. Schoenberg, Gregory A. Schmidt, Parag A. Majmudar, Torres Nidia, Michael D. Greenwood, Beth Ann Benetz, Jeremy N. Shapiro, Yassine J. Daoud, Ula V. Jurkunas, Ahmed F. Omar, David R. Sell, Angela J. Verkade, Keith H. Baratz, Baha M. Arafah, Allen Omid Eghrari, Lawrence R. Tenkman, Mark C. Soper, Jesse M. Vislisel, Vincent M. Monnier, Robin L. Gal, Emily J. Treichel, Christopher S. Sáles, S.R. Cole, Marianne O. Price, Michelle R. Boyce, Francis W. Price, David D. Verdier, Loretta B. Szczotka‐Flynn, Sherman W. Reeves, Nandini Venkateswaran, Yong W. Kam, Mark A. Greiner, Yogi Sharma, David R. Hardten, John E. Bokosky, Divya S. Srikumaran, Ryan J. Bailey, Anjulie Gang, Neal Vaidya, Jessica Chen, Paul M Phillips, Christina Maria, M. Bowes Hamill, Christopher R. Croasdale, Luke B. Potts, Craig Kollman, Kristin A. Jones, Rachel H. Epstein, Roy W. Beck, Peter B. Veldman, Michael D. Straiko, Jonathan H. Lass, Jamie Alexander, Alex J. Bauer, Elainey Hardtke, Lisa Leavy, Kristy Coonfield, Vicki Crosser, Que Evans, Jim Nykaza, Drew Monteleone Haught, Jim Wier, Ryan Stanfield, Nick Risbrudt, Chris Sinkey, Gwen Toti, Allison Dreyer, Jennifer Rinn, Deepitha Nelson, Christopher Hood, Albert Jun, Elizabeth Prasad, Ilina Cardenas, Angela Young, Lindsay Ernst, Megan Mack, Michael Cheung, Jessica Nguyen, DJ Gordon, Taylor Hall, Melinda Sears, Diabetes Endothelial Keratoplasty Study Group, Muhammad Ali, Merisa Stone, Derek Phelps, Denise Pape, Alyson Saville, Christopher S. Ketcherside, Jenni Fox, Mark Hansen, Ari Brandsdorfer, Leslie Castaneda, Ashlyn Lynn, Ellen Koo, Sharra Kelly, Gayle Waldheim Brown
article en

Abstract

Importance The effect of cornea donor diabetes severity on graft success, endothelial cell density (ECD), and morphometry after Descemet membrane endothelial keratoplasty (DMEK) is not known. Objective To determine whether graft success, corneal endothelial cell loss (ECL), and morphometric changes 1 year after DMEK are associated with cornea donor diabetes severity measured by severity score, donor’s postmortem level of hemoglobin A 1c (HbA 1c ), and postmortem advanced glycation end products (AGEs) or advanced oxidation end products (AOPs). Design, Setting, and Participants This was a secondary analysis of a multicenter, double-masked, randomized clinical trial at 28 clinical sites (46 surgeons) and 13 eye banks in the US among individuals undergoing low- to moderate-risk DMEK. AGE and AOP measurements were collected from a subset of donors. Data analysis was conducted from September 1, 2025, through April 30, 2026. Intervention DMEK performed with a cornea from a donor without or with diabetes, assigned using a minimization procedure (comparable to randomization) to achieve an approximate 2:1 distribution, respectively. Main Outcomes and Measures Graft success, ECL, coefficient of variation (CV) of cell area, and percentage of hexagonal cells (HEX) at 1 year from eye bank and postoperative specular central endothelial images. Results A total of 1097 individuals (1421 study eyes; median [IQR] age, 71 [66-76] years; 631 [57.5%] female) undergoing low- to moderate-risk DMEK (1044 [95.2%] for Fuchs endothelial corneal dystrophy) were included. AGE and AOP measurements were collected from a subset of 472 donors (542 study donor corneas). Among 968 eyes with a postmortem donor HbA 1c level lower than 6.5%, the 1-year graft success rate was 97.1% (95% CI, 95.4%-98.4%), compared with 97.4% (95% CI, 93.9%-100.0%), 93.0% (95% CI, 83.3%-98.8%), and 95.8% (95% CI, 87.3%-100.0%) among eyes with a donor HbA 1c level of 6.5% to less than 7.5% (n = 194), 7.5% to less than 9.0% (n = 86), and 9.0% or higher (n = 48), respectively ( P = .72). There was no significant difference in mean ECD across donor HbA 1c groups. Donor diabetes severity measured with severity score, donor HbA 1c level, and AGE and AOP metrics was not associated with 1-year graft failure, ECD, CV in cell area, or HEX percentage. Conclusions and Relevance This secondary analysis of a randomized clinical trial found that ECL and morphometry 1 year after DMEK were not affected by cornea donor diabetes severity. Comparable 1-year graft success, ECL, and cell morphometrics with tissue from donors with and without diabetes, regardless of the diabetes severity biomarker values observed, support the use of corneas from donors with diabetes for endothelial keratoplasty procedures without additional preoperative testing or risk stratification based on the diabetes status of the cornea donor. Trial Registration ClinicalTrials.gov Identifier: NCT05134480

JAMA Ophthalmology
University of Iowa (US), Massachusetts Eye and Ear Infirmary (US), Mayo Clinic (US), University Hospitals of Cleveland (US), University of Iowa Hospitals and Clinics (US), Cornea Research Foundation of America (US), Emory Eye Center (US), Price Vision Group (US), Lions Eye Bank at Albany (US), Jaeb Center for Health Research (US), Minnesota Lions Eye Bank (US), Stiles Eyecare Excellence (US), Case Western Reserve University (US)
Openalex Percentile: Top 13%
Corneal surgery and disorders
DOISourceOpenAlex
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