Abstract
PURPOSE: To evaluate the surgical technique, clinical performance, and biocompatibility of a novel keratoprosthesis (KPro) named KPro of Brazil (KoBra) in an alkali-burned rabbit model. METHODS: Two-piece three-dimensional-printed titanium powder and polymethyl methacrylate KPros were implanted into 14 alkali-burned corneas of 14 rabbits using an autologous full-thickness corneal graft as the KPro carrier. Rabbits were examined weekly for 12 months to evaluate retention and postoperative complications. Anterior segment optical coherence tomography (AS-OCT) and scanning electron microscopy (SEM) were performed at the end of the experiment to evaluate the relationship between the KoBra and the carrier graft. RESULTS: All surgeries were performed without intraoperative complications, and the immediate postoperative period was uneventful. In 12 eyes (85.7%), the implanted KPros integrated into the operated eyes and maintained clear optics without extrusion or further complications over 12 months. Two eyes presented late postoperative complications that progressed to KPro extrusion: one had a presumed infectious keratitis, and the other had sterile stromal necrosis. AS-OCT demonstrated the correct relationship of the device and carrier graft in all remaining animals at the final follow-up. SEM findings indicate the integration of the porous structure of the back plate into the surrounding tissue. CONCLUSIONS: Clinical evaluations, AS-OCT, and SEM findings indicate good biointegr-ation of the implanted device into the corneal carrier graft. KoBra has the advantage of using recipients' own corneas as the prosthesis supporter, and its surgical procedure is relatively simple and safe. TRANSLATIONAL RELEVANCE: Titanium three-dimensional-printed technology used in an animal limbal stem-cell deficiency model holds great promise for the treatment of corneal blindness in humans.