Preclinical safety and stability study of a next generation telescope prosthesis for end-stage macular degeneration

To assess the surgical procedure, safety and stability of a next generation injectable telescope prosthesis in a rabbit model. Methods: After removal of the crystalline lenses of eight New Zealand White rabbits, the next generation device was randomly implanted in one eye, and the available telescope prosthesis (Normal device) was implanted in the fellow eye. Operative parameters (incision, capsulorrhexis size and operative time), intraoperative and postoperative complications rates, endothelial cell density changes and the distance between the corneal endothelium and the telescope (central clearance distance) were measured and compared between the groups. Results: Incision size and capsulorrhexis size were smaller, and operative time was shorter in the next generation group in comparison with the Normal group. No difference was found in the intraoperative and postoperative complication rates between the groups. Endothelial cell density loss observed in the next generation group was less than the loss in the Normal group, but the difference was not significant statistically. The central clearance distance was significantly larger in the next generation group in comparison with the Normal group (P=0.001). Conclusions: The next generation telescope was implanted through a smaller incision, with a shorter surgical time and a larger central clearance distance in the rabbit eyes, in comparison with the Normal group. The next generation device may allow reduced trauma to the corneal endothelium, better control during surgery and induce less astigmatism while preserving the optical advantages of the Food and Drug Administration-approved telescope prosthesis.