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

Purpose: 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. Design: Single-center, noncomparative case series. Participants: Ninety-two eyes of 92 patients with corneal blindness who required corneal transplantation at Shandong Eye Institute from May 2003 to June 2011. Methods: The CsA DDS was implanted into the anterior chamber during high-risk keratoplasty, and subsequent therapeutic effects were evaluated. Main Outcome Measures: 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). Results: 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. Conclusions: 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. Financial Disclosure(s): The authors have no proprietary or commercial interest in any of the materials discussed in this article. Ophthalmology 2013;120:695-702 (C) 2013 by the American Academy of Ophthalmology.