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. 2025 Oct 17:e254261.
doi: 10.1001/jamaophthalmol.2025.4261. Online ahead of print.

Endothelial Cell Loss 1 Year After Successful DMEK in the Diabetes Endothelial Keratoplasty Study: A Randomized Clinical Trial

Jonathan H Lass  1   2   3 , Beth Ann Benetz  1   2   3 , David D Verdier  4 , Loretta B Szczotka-Flynn  1   2 , Colleen E Bauza  5 , Zachariah W Reed  5 , Mark A Greiner  6 , Shahzad I Mian  7 , Sanjay V Patel  8 , Sudeep Pramanik  9 , Francis W Price Jr  10 , Mark C Soper  11   12 , Mark A Terry  13 , Michael S Titus  14 , Craig Kollman  5 , Roy W Beck  5 , Marianne O Price  15 ; Diabetes Endothelial Keratoplasty Study Group
Collaborators, Affiliations

Endothelial Cell Loss 1 Year After Successful DMEK in the Diabetes Endothelial Keratoplasty Study: A Randomized Clinical Trial

Jonathan H Lass et al. JAMA Ophthalmol. .

Abstract

Importance: The effect of cornea donor diabetes on endothelial cell density (ECD) and morphometry after Descemet membrane endothelial keratoplasty (DMEK) is not known.

Objective: To determine whether endothelial cell loss (ECL) and morphometric changes 1 year after successful DMEK are related to cornea donor's diabetes status.

Design, setting, and participants: This was a multicenter, double-masked, randomized clinical trial conducted from February 2022 to July 2024 at 28 US clinical sites (46 surgeons) and 13 eye banks. Included in the trial were the eyes of recipients (some of whom received tissue from donors without diabetes and others who received tissue from donors with diabetes) who underwent successful DMEK, primarily for Fuchs endothelial corneal dystrophy, and had at least 1 analyzable postoperative endothelial image.

Intervention: DMEK performed with a cornea from a donor without or with diabetes, assigned using a minimization procedure to achieve an approximate 2:1 distribution.

Main outcomes and measures: ECD, ECL, coefficient of variation in cell area (CV), and percentage of hexagonal cells (HEX) at 1 year from eye bank and postoperative specular central endothelial images.

Results: A total 1274 eyes of 982 recipients (mean [SD] age, 70 [8] years; 569 female [57.9%]; 816 [64.1%] with tissue from donors without diabetes and 458 [35.9%] with tissue from donors with diabetes) were included in the study. Preoperatively, mean (SD) central ECD in tissue from donors without diabetes and with diabetes were 2676 (290) cells/mm2 and 2671 (286) cells/mm2, respectively. At 1 year, mean (SD) ECL was 28.3% (16.1%) and 28.0% (17.0%), in the donor groups without and with diabetes, respectively (adjusted mean difference = -0.4%; 95% CI, -2.3% to 1.4%), resulting in a mean (SD) 1-year ECD of 1927 (498) cells/mm2 and 1920 (496) cells/mm2, respectively (adjusted mean difference = 10 cells/mm2; 95% CI, -36 to 56; P = .95). No difference in ECD at 1 year associated with diabetes severity was noted (P = .97). Mean (SD) CV did not differ at 1 year between the 2 groups of eyes (31.5% [4.1%] vs 31.4% [4.1%]; adjusted mean difference = -0.4%; 95% CI, -0.9% to 0.1%; P = .51), and mean (SD) HEX did not differ at 1 year between the 2 groups of eyes (57.7% [5.8%] vs 57.2% [5.8%]; adjusted mean difference = 0.1%, 95% CI, -0.8% to 0.9%; P = .33).

Conclusions and relevance: This randomized clinical trial found that ECL and morphometry 1 year after DMEK were not affected by cornea donor diabetes status. With comparable 1-year graft success with tissue from donors with and without diabetes demonstrated in this trial, these findings support the use of corneas from donors with diabetes for endothelial keratoplasty procedures.

Trial registration: ClinicalTrials.gov Identifier: NCT05134480.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Lass reported receiving grants from National Eye Institute (NEI); a donation to Case Western Reserve University from Eye Bank Association of America, The Cornea Society, Cleveland Eye Bank Foundation, Beauty of Sight, CorneaGen, Eversight, Eye Bank for Sight Restoration, Eye Bank for Kentucky, Gift of Sight, Iowa Lions Eye Bank, Kenneth Maverick MD, Lions Eye Bank of Wisconsin, San Antonio Eye Bank, San Diego Eye Bank, Utah Lions Eye Bank, VisionFirst, VisionGift to support additional expenses beyond National Institutes of Health (NIH) funding during the conduct of the study; and nonfinancial support as board member from Eversight and Cleveland Eye Bank Foundation outside the submitted work. Dr Verdier reported receiving personal fees from NIH Verdier Eye Center PLC to cover usual and customary expenses for patients receiving care in the DEKS study. Dr Szczotka-Flynn reported receiving grants from the NIH and LenTechs and personal fees from Epion outside the submitted work. Dr Bauza reported receiving grants from the NEI during the conduct of the study. Dr Reed reported receiving grants from the NIH during the conduct of the study. Dr Mian reported receiving grants from the NEI and Kowa outside the submitted work. Dr Patel reported receiving personal fees from Santen Inc, Design Therapeutics Inc, Emmecell, Thea, Iris Medicine Inc (ended in 2024), and Invirsa Inc (ended in 2024) and being the developer of V-FUCHS, which is licensed by Mayo Clinic to Santen Inc, Design Therapeutics Inc, Iris Medicine Inc, and Kowa Research Institute. Dr F. Price reported receiving grants from the NEI during the conduct of the study; personal fees from EyeYon and Alcon; and stock ownership in RxSight. Mr Soper reported receiving grants from the NEI and being an employee of VisionFirst Eye Bank (retired in 2023) outside the submitted work. Dr Terry reported receiving grants from the NEI during the conduct of the study. Mr Titus reported receiving grants from Jaeb Center for Health Research Foundation Inc and personal fees from Eversight outside the submitted work. Dr Kollman reported receiving grants from the NIH during the conduct of the study. Dr Beck reported receiving grants from Jaeb Center for Health Research during the conduct of the study. Dr M. Price reported receiving grants from the NEI during the conduct of the study; personal fees from EyeYon; and stock ownership in RxSight. No other disclosures were reported.

Comment in

  • doi: 10.1001/jamaophthalmol.2025.4254

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