A Novel Cyclosporine A Drug-Delivery System for Prevention of Human Corneal Rejection after High-risk Keratoplasty: A Clinical Study

Abstract

To evaluate the efficacy of a novel cyclosporine A (CsA) drug-delivery system (DDS) in the anterior chamber for suppressing the occurrence of rejection and improving the survival of corneal allografts after high-risk keratoplasty. Single-center, noncomparative case series. Ninety-two eyes of 92 patients with corneal blindness who required corneal transplantation at Shandong Eye Institute from May 2003 to June 2011. The CsA DDS was implanted into the anterior chamber during high-risk keratoplasty, and subsequent therapeutic effects were evaluated. Occurrence and reversal of graft rejection within 12 months after surgery, long-term survival of corneal grafts (>12 months), biodegradation of the CsA DDS, endothelial cell density by noncontact specular microscopy, and iris status by ultrasound biomicroscopy (UBM). At 6 months, the transplantation was scored as success in 81 eyes (88.0%), partial success in 7 eyes (7.6%), and failure in 4 eyes (4.3%). The mean graft survival time was 36.1 ± 17.7 months (range, 12.3-61.6 months). The carrier of the CsA DDS, polylactide-co-glycolide-co-caprolactone, biodegraded completely at 7.6 ± 4.3 months (range, 5-13 months). The density of endothelial cells was 2154 ± 230 cells/mm(2) (range, 2067-2319 cells/mm(2)) immediately after surgery and 2079 ± 156 cells/mm(2) (range, 1950-2254 cells/mm(2); P > 0.05) at 6 months. No edema of corneal stroma and iris was observed by UBM. The CsA DDS implanted in the anterior chamber seems to be effective for the prophylaxis of immune rejection after high-risk keratoplasty without toxicity to the cornea and the iris of patients. It can decrease the rejection episode and prolong the survival time of allografts. The anterior chamber may be a promising drug-delivery target for treatment or prevention of endothelial graft rejection after corneal transplantation.