CorNeat KPro: Ocular Implantation Study in Rabbits.

PURPOSE

The purpose of this study was to evaluate surgical feasibility and long-term integration of the CorNeat Keratoprosthesis (KPro), a novel synthetic cornea, in rabbits.

METHODS

The CorNeat KPro is a synthetic corneal implant designed to treat corneal blindness by using a polymeric scaffold for biointegration, consequently assimilating synthetic optics within ocular tissues. Eight New Zealand White rabbits were implanted unilaterally with the CorNeat KPro and observed for 6 months. Animals were regularly monitored by a certified ophthalmologist using slit-lamp biomicroscopy. One animal developed postoperative endophthalmitis and was removed from the study 7 weeks postsurgery. At termination, eyes were enucleated and evaluated histologically to assess local tissue integration and inflammatory response.

RESULTS

The surgical procedure was found feasible. The CorNeat KPro integrated into all operated eyes, resulting in a retention rate of 87.5% at the conclusion of the 6-month follow-up period. We observed minimal-to-mild conjunctival and iridial congestion and did not find additional inflammatory indicators, such as anterior chamber fibrin, flare, or cells. The optical element of the device remained clear with zero incidence of retroprosthetic membrane formation. Histopathological evaluation revealed comparable tissue and cellular reaction in all eyes, consisting of the presence of fibroblasts and associated collagen fibrils within the device's skirt component. Some eyes showed a mild foreign body reaction surrounding the skirt.

CONCLUSIONS

Clinical and histological findings indicate the integration of the implanted device into the surrounding tissue, evident by the retention rate and the diffuse infiltration of fibroblasts with collagen deposition among the device's fibrils. These data hold promise for clinical application in humans.