Observational studyInternational ophthalmology2026
Topical 0.02% tacrolimus as adjunctive immunoprophylaxis in high-risk penetrating keratoplasty: a four-year retrospective study.
Observational study in International ophthalmology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
7 authors.
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Abstract
purposeTo 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.
methodsThis 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.
resultsGraft 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.
conclusionsTopical 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.
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