Donor diabetes severity did not affect DMEK success at one year

Design

Secondary analysis of a multicentre double-masked randomised trial

Population

1,097 recipients, 1,421 eyes having low- to moderate-risk DMEK

Primary outcome

One-year graft success and endothelial cell loss by donor diabetes severity

Effect

Graft success 97.1% (HbA1c <6.5%) vs 93.0% to 97.4% in higher bands, p = 0.72

This secondary analysis of the Diabetes Endothelial Keratoplasty Study, a multicentre double-masked trial at 28 US sites and 13 eye banks, included 1,097 people and 1,421 eyes having low- to moderate-risk DMEK, almost all for Fuchs dystrophy. Donor corneas from people with and without diabetes were allocated about 1:2 by minimisation. Diabetes severity was measured by a clinical score, postmortem HbA1c and, in a subset, glycation and oxidation end products.

One-year graft success was 97.1% (95% CI 95.4 to 98.4) with donor HbA1c below 6.5%, and 97.4%, 93.0% and 95.8% in the higher HbA1c bands, up to 9.0% or above (p = 0.72). Endothelial cell density, cell area variation and hexagonality did not differ. No measure of donor diabetes severity was associated with graft failure or cell loss.

Corneas from diabetic donors are often deprioritised or subjected to extra assessment. These data support using them for routine DMEK without additional screening by diabetes status, which matters for supply. In India, where diabetes is common among older donors and waiting lists are long, that could widen the usable donor pool, though the result applies to low- to moderate-risk DMEK and one-year outcomes.

• Do not exclude donor corneas from routine DMEK on the basis of donor diabetes alone.
• Continue standard eye bank assessment of endothelial cell density and morphology.
• Apply the finding to low- to moderate-risk DMEK; high-risk grafts were not studied.
• Discuss with eye banks whether diabetes-based deprioritisation can be relaxed.
• Watch for longer-term follow-up, since these are one-year results.

Why it matters

Diabetes in the donor has been a reason to set tissue aside, and this evidence says it need not be.

Don't overread it

The result covers one-year outcomes in low- to moderate-risk DMEK, not high-risk grafts or long-term survival.

The statistics, in plain English

Graft success ranged from 93% to 97% across HbA1c bands with p = 0.72, so the small differences are compatible with chance. The highest HbA1c groups were small (48 and 86 eyes), giving wide intervals, so a modest effect in very poorly controlled donors cannot be fully excluded.

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