Abstract

Background: Immunosuppressive therapy is the main postoperative treatment for keratoplasty, as immune mediated graft rejection is now-a-days the most common cause of graft failure after penetrating keratoplasty accounting for at least one-third of failure cases.^(1-2) So, the proportion of people who can derive the long term benefit from corneal grafting depends on graft survival rate which is mainly related to post-operative immunosuppressant therapy.

Aim: This study was done to observe the combined Effect of steroid sparing topical drug with routine topical steroid post Penetrating Keratoplasty on graft Rejection, corneal transparency, corneal Vascularization and Visual outcome compared to topical steroid alone.

Method: It was a single-center prospective randomized comparative treatment study completed in the duration of two years. 60 eyes of 60 patients were assigned into three different groups in a randomized manner. All patients underwent therapeutic penetrating keratoplasty by a similar method that involved a donor button that was oversized by 0.5 mm and 16 bites of interrupted sutures. Along with 1% prednisolone acetate Group A received 0.03% Tacrolimus ointment and group-B received 0.1% cyclosporine in topical form. While group-C received 1% prednisolone acetate only. Intergroup analysis was done using chi-square test, one way ANOVA test and Kruskal-Wallis test (p value <0.05 was considered significant). Patients whose Keratoplasty was done for fungal corneal ulcer were excluded.

Result: There were no differences among three groups for mean age of donor and recepient, gender predilection, mean graft size, death enucleation interval and enucleation transplantation interval. However variation was noted in recepient’s corneal pathology for which keratoplasty was done but it was found to be statistically insignificant. The study revealed that after a mean follow-up of 6 months for each group, addition of Topical Tacrolimus had beneficial effect in getting clear graft (70%) and hence good visual acuity post operatively, prevention of vascularisation (60% of cases showed no vascularsation), less graft rejection 60%, reversal of graft rejection 75% and preventing complication like suture infiltrate (50%), secondary glaucoma (30%), cataract (25%), as compared to topical cyclosporine. Although it was found to be statistically insignificant.

Conclusion: Although statistically insignificant, combination of topical tacrolimus with topical prednisolone acetate was found to be better as compared to topical prednisolone alone and combination of topical cyclosporine with topical prednisolone acetate. Hence it can be safely said that post-keratoplasty conventional Immunosuppressant therapy which is Topical Prednisolone Acetate 1% can be used in conjunction with topical tacrolimus for better graft outcomes. However standard immunosuppressant therapy which is topical steroid could not be replaced by topical cyclosporine or tacrolimus alone in our setup.

Keywords: Penetrating keratoplasty, Tacrolimus, cyclosporine, Graft rejection, Graft failure.