Results of an in vitro Experimental Study of a New Eye Corneal Prosthesis Model for Penetrating Single-stage Keratoprosthetics

Objective: To study the cellular and tissue response to the integration and fixation of a new keratoprosthesis design for penetrating keratoprosthetics using the method of organotypic cultivation of human cadaveric cornea in comparison with one-stage implantation of the Fedorov-Zuev keratoprosthesis.
Material and methods. Together with the engineers of the company “Reper-NN” and researchers of the S. Fyodorov Eye Microsurgery Federal State Institution, a new model of keratoprosthesis for one-stage keratoprosthesis has been developed. It consists of two main parts: an outer plate with an optical cylinder and an inner plate with a central threaded sleeve for subsequent tightening of the optical cylinder. In this study, a series of experimental and morphological studies were conducted, including in vitro experiment, immunohistochemical and histological studies, and electron microscopy, in which two experimental groups were compared: Group 1 (n = 5) — corneas with an implanted new penetrating keratoprosthesis; and Group 2 (n = 5) — corneas with an implanted Fedorov-Zuev keratoprosthesis together with an optical cylinder.
Results. During a series of experimental studies, the biointactness of the new keratoprosthesis model was confirmed, the biocompatibility of the material and the admissibility of using this model for single-stage keratoprosthetics in clinical practice were proven, in contrast to the Fedorov-Zuev keratoprosthesis, which is intended primarily for staged implantation.
Conclusion. Finding an optimal keratoprosthesis model for patients with degenerative leukomas, with the aim of conserving donor material and accelerating visual rehabilitation, is an important and relevant area of research. The developed model of penetrating keratoprosthesis for single-stage keratoprosthetics demonstrated its effectiveness, biocompatibility and safety of the design during the experimental study, which is a safer and more predictable in terms of postoperative stability and the likelihood of complications, compared to the existing Fedorov-Zuev model.

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