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N. Gupta, A. Sloan, B. Ambati; FK–506 Ointment Improves Early Postoperative Outcomes in High–Risk Penetrating Keratoplasty Following Graft Failure . Invest. Ophthalmol. Vis. Sci. 2006;47(13):2379.
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© ARVO (1962-2015); The Authors (2016-present)
Tacrolimus (FK–506) is an immunosuppressant that inhibits T–cell receptor–mediated signal transduction. This pathway plays a major role in graft rejection and failure. The purpose of this study is to evaluate the effects of post–operative FK–506 ointment in high–risk eyes with graft failure undergoing repeat penetrating keratoplasty (PK).
We identified eight eyes of eight patients with failed corneal grafts. All eyes were scheduled for repeat penetrating keratoplasty with FK–506 ointment 0.03% QID added to the routine postoperative regimen. Patients were followed for a minimum of four months. Postoperative BCVA following repeat PK with FK–506 was compared to BCVA following first PK. LogMar scale + SD was used to record all BCVA. Statistical significance (p<0.01) was assessed with Mann–Whitney analysis. In addition, grafts were evaluated for evidence of graft rejection and failure as well as clarity. Patients were also asked to report any side effects of treatment with FK–506 at each postoperative visit.
The average patient age was 46 years (range 11 to 77) and 50% were female. No difference (p=0.5) in preoperative BCVA was found between the first PK (–2.67 + 0.83) and repeat PK with FK–506 (–2.36 + 0.95). Postoperative BCVA (–0.76 + 0.17, 20/115) following repeat PK with FK–506 was statistically significant (p<0.01) when compared to preoperative BCVA (–2.36 + 0.95, 20/2000). Also, there was a statistically significant difference (p<0.01) between the postoperative BCVA following repeat PK with FK–506 (20/115) and postoperative BCVA (–1.8 + 0.76, 20/800) from the first PK. After four months, all eight grafts were clear and without evidence of graft rejection or failure. Two of eight patients (25%) complained of minor irritation due to FK–506 ointment but continued treatment.
The results of this study demonstrate that FK–506 ointment is an effective adjunct in the postoperative management of high–risk penetrating keratoplasty. Postoperative BCVA was significantly improved (p<0.01) following the use of FK–506 ointment, and the treatment was well tolerated. Furthermore, all eight grafts remained clear and healthy during the follow–up period. These results suggest the need for further randomized clinical trials evaluating the role of topical FK–506 in the management of penetrating keratoplasty.
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