Study finds diabetic donor tissue effective in corneal transplant surgeries

Study finds diabetic donor tissue effective in corneal transplant surgeries

ONLINE EXCLUSIVE

Cornea
November 2025

by Liz Hillman
Editorial Co-Director

With the need for quality donor corneal tissue outstripping supply, especially outside the U.S., there is an interest in expanding the donor pool. While the EBBA doesn’t explicitly exclude donors with diabetes,1 this disease status has called into question the quality of the tissue and endothelial health for more advanced procedures like DMEK.

A pair of recent studies from the Diabetes Endothelial Keratoplasty Study Group published in JAMA Ophthalmology, however, found that diabetes status did not affect success of DMEK outcomes overall, nor did it result in greater endothelial cell loss when compared to tissue from a donor without diabetes.

“Knowing that diabetes can impact healing, cornea surgeons and eye bank staff have always wondered whether a diabetic donor could delay healing of a DMEK graft,” said W. Barry Lee, MD, President of the Cornea Society, and Bennie Jeng, MD, Past President of the Cornea Society, in an email to EyeWorld. “The Diabetes Endothelial Keratoplasty Study confirms that the success rate of DMEK is the same for diabetic donor tissue and non-diabetic donor tissue. Surgeons and eye bankers can now feel comfortable using diabetic donor tissue for DMEK without additional concerns about the outcomes in patients with Fuchs endothelial dystrophy.”

Source: iStock.com/Drew Beynon #DBPic

One paper published on the randomized clinical trial by Price et al. looked at whether DMEK outcomes—the 1-year DMEK success rate—was affected by diabetes status of the donor.2 The trial was conducted between February 2022 and July 2025 at 28 clinical sites by 46 surgeons with donor corneas from 13 U.S. eye banks. Most of the participants in the study (95%) were undergoing DMEK for Fuchs.

The 1-year graft success was 96.3% in the 912 eyes that received tissue from donors without diabetes and 97.1% in the 509 eyes that received tissue from donors with diabetes. The authors also looked at diabetes severity, finding that the probability of graft success was 96.5% when the donors had mild diabetes and 97.3% when the donors had moderate to severe diabetes. The authors reported rates of primary donor failure, surgical complications, and subsequent failure: 2.5%, 0.7%, 0.3%, respectively, in the donor tissue without diabetes and 2.6%, 0.4%, and 0%, respectively, in the donor tissue with diabetes.

The other randomized trial by Lass et al. reviewed more specifically whether there was a difference in endothelial cell loss and morphometry after DMEK with tissue from donors with or without diabetes.3 The authors recorded mean central endothelial cell density from tissue of donors with and without diabetes, finding 2,671 cells/mm2 and 2,676 cells/mm2, respectively. Endothelial cell loss at 1 year was 28.0% from tissue of donors with diabetes and 28.3% in the population without diabetes. The authors wrote that there was no difference in endothelial cell density based on diabetes severity at 1-year postop. The mean percentage of hexagonal cells also did not differ after 1 year between the two groups.

The authors of both studies concluded that corneal tissue from donors with diabetes could be successfully used in endothelial keratoplasty.

In an invited commentary about the studies, Kathryn Colby, MD, PhD, and Andrea Blitzer, MD, praised the design of the studies, noting that the Diabetes Endothelial Keratoplasty Study, which was funded by the National Eye Institute, “provides the strongest evidence to date, to our knowledge, for addressing this question”—whether diabetes status of the donor can affect outcomes of endothelial procedures like DMEK.4 They did note, as did the authors, limitations within the study, namely 1 year being a short follow-up for graft survival and that most of the patients receiving donor tissue had Fuchs, “making it unclear whether these results generalize to other EK indications or to penetrating keratoplasty.”

Regardless, Dr. Colby and Dr. Blitzer’s opinion is that these studies “should reassure eye banks and surgeons that a donor having diabetes does not compromise DMEK success through at least 1 year among patients with FECD.”

“With this study, we can put to rest the common misconception that diabetic donors provide lower quality grafts,” said Julie Schallhorn, MD, EyeWorld Cornea Editor and Rose B. Williams Endowed Chair in Corneal Research at the University of California, San Francisco. “Each corneal donor provides a true gift to our patients, and this study gives surgeons the confidence to place DMEK grafts from diabetics and utilize this gift to its fullest extent.”

References

  1. Eye Bank Association of America Medical Standards. June 2024. https://restoresight.org/wp-content/uploads/2024/07/EBAA_MedicalStandardsBook_June2024.pdf
  2. Price FW, et al. Donor diabetes and 1-year Descemet membrane endothelial keratoplasty success rate: a randomized clinical trial. JAMA Ophthalmol. 2025. Online ahead of print.
  3. Lass JH, et al. Endothelial cell loss 1 year after successful DMEK in the Diabetes Endothelial Keratoplasty Study: a randomized clinical trial. JAMA Ophthalmol. 2025. Online ahead of print.
  4. Colby KA, Blitzer AL. Impact of the Diabetes Endothelial Keratoplasty Study. JAMA Ophthalmol. 2025. Online ahead of print.
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