Tacrolimus (FK506) in the management of high-risk corneal and limbal grafts.

OBJECTIVE: To assess the efficacy and side effects of tacrolimus in the management of patients with high-risk corneal and limbal grafts.

DESIGN: Noncomparative case series.

PARTICIPANTS: Seventeen patients (23 grafts) were treated with tacrolimus; 15 patients (20 host corneas) had two or more quadrants of stromal vascularization, 6 patients had stem cell deficiency, and 6 patients had glaucoma. Seven patients had received one previous graft, six patients had two previous grafts, and four patients had three previous grafts.

INTERVENTION: Patients with high-risk corneal and limbal grafts were treated with systemic tacrolimus at a mean optimum dosage of 4.4 mg daily (range, 2-12 mg daily).

MAIN OUTCOME MEASURES: Graft survival, visual acuity.

RESULTS: No patient has had irreversible graft rejection while receiving tacrolimus. The follow-up period ranges from 12 to 46 months, with a mean of 24 months. Three patients have had reversible graft rejection associated with low tacrolimus levels. Nine patients have stopped treatment; two had reversible rejection within 2 months of stopping, and five grafts remain clear. The other four patients stopped treatment because of graft failure, which was not considered to be rejection related. Eight patients remain on treatment, and all have clear grafts.

CONCLUSIONS: Tacrolimus (FK506) is effective in prevention of rejection in patients with high-risk corneal and limbal grafts.