Background/aims The present study aims to identify the rate of rejection and safety of 0.03% tacrolimus eye drops associated with 1% prednisolone in a topical formulation, comparing them with the use of 1% prednisolone eye drops alone in patients with high-risk corneal transplantation.

Methods Retrospective cohort study with 72 patients (72 eyes) who underwent more than one penetrating keratoplasty (PK) in the same eye or had severe chemical burn between 2004 and 2011 in the department of cornea and external disease of the Clinical Hospital of Porto Alegre, Brazil. We compared the records of 36 patients that performed unilateral PK and received only 1% prednisolone eye drops between May 2004 and July 2008, with 36 patients that received 0.03% tacrolimus eye drops in addition to 1% prednisolone between August 2008 and August 2011.

Results The mean follow-up of the group exposed to tacrolimus was 23.1 months and 24.0 in the prednisolone alone group. The demographics, intraoperative and initial indications for first PK were similar between groups, as well as the number of regrafts performed. Intraocular pressure (IOP) was not statistically different among groups. Regarding irreversible rejections, topical tacrolimus showed greater protection: only seven grafts (19.4%) lost transparency against 16 (44.4%) in the 1% prednisolone alone group (p <0.05).

Conclusions Topical 0.03% tacrolimus was effective in preventing irreversible rejection in patients with high-risk corneal transplantation without increasing IOP.