This double-blinded randomised controlled trial tested the use of adjuvant topical Tacrolimus drops in cases of acute endothelial rejection in penetrating keratoplasty (PK). Patients with typical signs of endothelial rejection were randomised to receive either steroid therapy with topical Tacrolimus 0.05% four times a day (group 1) or steroid therapy with artificial tears four times a day as a placebo (group 2). Steroid therapy comprised of oral prednisolone (1mg/kg) and topical prednisolone acetate 1%, applied hourly for three days, followed by gradual taper of drop frequency. Seventeen patients in group 1 and 14 in group 2 completed the study. Rejection reversal was achieved in 88.2% in group 1 and 85.7 % in group 2, with no significant difference between groups. Group 1 showed significantly shorter mean time to rejection resolution compared to group 2; by mean of 16 days. This, however, did not translate into significant differences in best-corrected visual acuity or central corneal thickness after treatment discontinuation. However, rejection recurrence rates were significantly lower in group 1 than group 2. This is the first study to examine adjuvant use of topical Tacrolimus in acute graft rejection. Results point to shorter times to rejection resolution and lower rejection recurrence rates after treatment discontinuation, suggesting there might be a role for topical Tacrolimus in acute treatment of endothelial graft rejection.
Tacrolimus for endothelial rejection
Reviewed by Magdalena Popiela
Topical tacrolimus as adjuvant therapy to corticosteroids in acute endothelial graft rejection after penetrating keratoplasty: a randomized controlled trial.
