Longitudinal Trends in Tissue-Related Adverse Events After Corneal Transplantation.

PURPOSE: The longitudinal trend of tissue-related adverse events (AEs) from corneal transplant procedures is not well characterized. By identifying corneal transplantation-related AEs over time, eye banks and clinicians can better understand changes and assess the risks associated with tissue transplantation.

DESIGN

Trend study.

SUBJECTS: Corneal tissues obtained from individuals who donated to Eversight Eye Bank.

METHODS

This study investigated the rates of reported AEs at a large eye bank in the United States. Data was extracted from the eye bank database between May 2007 and December 2024. A longitudinal analysis of AEs in corneal tissue was conducted across AE types and procedural types.

MAIN OUTCOME MEASURES: The main outcome measures were surgeon-reported AEs to the eye bank and AEs determined to be tissue-related causes. AE types for tissue-related AEs were assessed.

RESULTS

A total of 126,072 donor tissues were included between May 2007 and December 2024. 176 AEs were determined to be tissue-related, representing an estimated prevalence of 0.14% (95% CI: 0.12%-0.16%). For every year, there was an associated 6.7% (95% CI: 3.8%-9.5%) reduction in the odds of AEs (P < .001), an estimated 69.2% reduction over 17 years. Adjusted for year, Descemet stripping automated endothelial keratoplasty (EK) (DSAEK) had 2.3 times (95% CI: 1.6-3.2, P < .001) and Descemet membrane EK (DMEK) had a 2.8 (95% CI: 1.8-4.5, P < .001) odds of AE compared to PKP, but no significant difference in the rate of improvement for PKP to DSAEK (P = .6) or PKP to DMEK (P = .4). Rates of infectious keratitis (OR: 0.91, 95% CI: 0.83-0.99, P = .024) and primary graft failure (OR: 0.90, 95% CI: 0.86-0.94, P < .001) significantly improved year-over-year, while endophthalmitis (P = .13) and early regraft (P = .3) did not significantly improve.

CONCLUSIONS

AE rates in corneal transplantation procedures continue to decline year-over-year, highlighting the improving safety and quality in eye banking and corneal transplantation. Rates improved across procedure types (PKP, DMEK, and DSAEK) and AEs (infectious keratitis and graft failure).