Donor diabetes severity did not affect one-year DMEK outcomes

Design

Secondary analysis of a multicentre, double-masked randomised clinical trial

Population

1,097 individuals (1,421 eyes) having DMEK, 95.2% for Fuchs endothelial corneal dystrophy

Primary outcome

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

Effect

Graft success 97.1% (donor HbA1c below 6.5%) versus 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, included 1,097 patients (1,421 eyes, 95.2% with Fuchs dystrophy) having low- to moderate-risk Descemet membrane endothelial keratoplasty. Donor corneas, with or without diabetes, were allocated about 2 to 1 by minimisation.

One-year graft success was 97.1% (95% CI 95.4% to 98.4%) with donors whose postmortem HbA1c was below 6.5%, 97.4% for 6.5% to below 7.5%, 93.0% for 7.5% to below 9.0%, and 95.8% for 9.0% or higher (P = 0.72). Endothelial cell density, cell-size variability and hexagonality did not differ. Donor diabetes severity score and measures of advanced glycation and oxidation end products were also not associated with outcomes.

The authors conclude the results support using corneas from donors with diabetes for endothelial keratoplasty without extra testing or risk stratification. The one-year horizon is short for graft survival, and the highest HbA1c groups were small, with wide intervals.

• One-year graft success was 93.0% to 97.4% across donor HbA1c bands (P = 0.72).
• Endothelial cell density and morphology did not differ by donor diabetes severity.
• Most recipients had Fuchs dystrophy with low- to moderate-risk surgery.
• The highest-HbA1c donor groups were small (86 and 48 eyes).
• Longer follow-up is needed to confirm graft survival.

Why it matters

Donor diabetes is common and could shrink an already limited cornea supply if it were an unnecessary exclusion.

Don't overread it

One-year outcomes in low- to moderate-risk recipients do not show long-term graft survival or safety in high-risk eyes.

The statistics, in plain English

A P value of 0.72 means no detectable difference, not proof of none. With only 48 eyes in the highest HbA1c group and 93.0% in one band, the data cannot exclude a modest difference in those subgroups.

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