Topical 0.02% tacrolimus as adjunctive immunoprophylaxis in high-risk penetrating keratoplasty: a four-year...

To describe the incidence and clinical profile of graft rejection in high-risk penetrating keratoplasty (PK) recipients treated with a compounded topical formulation of 0.02% tacrolimus combined with 1% prednisolone.

This retrospective observational study included 41 eyes from 41 high-risk PK patients operated between 2019 and 2023 at the Oftalmosalud Eye Institute (Lima, Peru), with a minimum follow-up of 12 months. All patients received adjunctive immunoprophylaxis with topical 0.02% tacrolimus and 1% prednisolone, initiated on the first postoperative day and maintained throughout follow-up. High-risk PK refers to corneal transplantation in eyes with predisposing factors for immune-mediated graft rejection. Graft rejection episodes were classified as reversible or irreversible based on clinical course and treatment response.

Graft rejection occurred in 15 of 41 eyes (36.6%), with 60% of these episodes being reversible and 40% irreversible. The remaining 26 eyes (63.4%) maintained clear grafts without signs of rejection. The most frequent high-risk clinical features were corneal neovascularization in 21 eyes (51.2%), ocular surface disease in 9 eyes (21.9%), and persistent inflammation in 7 eyes (17.0%). No serious adverse events related to topical tacrolimus were observed.

Topical 0.02% tacrolimus in combination with prednisolone may represent a safe adjunctive strategy in high-risk PK. These findings support the incorporation of topical tacrolimus into immunosuppressive regimens for high-risk corneal transplantation. Prospective controlled trials are warranted to confirm its long-term efficacy and safety.