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P1 Investigating unexpectedly high primary graft failure rates with imported corneal tissue: comparison across three tissue providers

bmjophth · 2026-04-29 · canonical JSON source

5 visible annotations · policy: published · automated confidence ≥ 75.00%

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Aims Primary graft failure (PGF) is a recognised complication of corneal transplantation. National audit data reports rates between 0.3–12%. This study identified factors to investigate and processes to institute when graft failure rates rise above those expected. Background With increasing national graft tissue shortages (Provider A), overseas tissue was imported. Due to concerns with tissue from Provider B, Provider C was then used.Methods Clinical outcomes were compared over three six-month periods relating to the different providers. For provider B, a pathway for investigation and reporting was developed.Results 106 eyes were analysed (31 Provider A, 43 Provider B, 32 Provider C). PGF occurred in 32.6% of Provider B grafts versus 9.7% of A, and 6.3% of C (p<0.01). Regrafts were required in 30.2% of B cases (versus 16.1% and 3.1%, p<0.01). Rebubbling occurred in 34.2% of endothelial B cases (versus 10.0% and 18.8%, p<0.10). Mean final visual acuity was 0.60 logMAR (versus 0.48, and 0.23, p<0.05,). Concerns with Provider B grafts led to incident reporting, suspension of transplantation, local investigation of graft supply-chain, handling and storage and liaison with the provider initiated an international review. Provider C was subsequently introduced under strengthened assurance processes.Conclusions Provider B tissue was associated with higher PGF compared with A and C. Concerns led to suspension of grafting, reporting to the Human Tissue Authority and a change of supplier. This audit highlights the importance of vigilance, local quality assurance, and national reporting when introducing new donor tissue sources.