Long-Term Observations of the First Human Implantation of an Artificial Endothelial Layer for Endothelial Dysfunction: A Pilot Study.

Abstract

Purpose: To describe the long-term observations of the first human implantation of EndoArt, a synthetic endothelial implant, in a small cohort of patients with corneal edema secondary to endothelial dysfunction.

Methods: This retrospective case series analyzed 5 eyes from 5 patients who underwent EndoArt implantation, with a minimum follow-up of 12 months. Clinical outcomes, including corrected distance visual acuity and central corneal thickness, were evaluated pre- and postoperatively. Rebubbling procedures and any complications were recorded. Histological analysis was performed on 1 explanted corneal button.

Results: The mean follow-up was 38.4 ± 20 months (range: 19-72 months). A reduction in mean central corneal thickness was observed, from 741.2 ± 88.3 μm preoperatively to 558.4 ± 72.7 μm postoperatively (P < 0.001). Corrected distance visual acuity improved in 4 of 5 eyes, although not significantly overall (P = 0.19). The mean number of rebubbling procedures was 2.8 ± 1.3 per eye. No serious implant-related complications were observed during the follow-up period. Histological findings showed fibrocellular tissue partially integrating the implant, which may contribute to graft adherence. Two patients with Fuchs dystrophy received the device as a primary procedure because of ethical or religious constraints regarding donor tissue.

Conclusions: This small pilot series of the first human EndoArt implantation observed a significant reduction of corneal edema over time and a favorable safety profile in select patients. Although these findings are encouraging, they should be interpreted with caution given the limited sample size. Larger, controlled studies are needed to better understand the safety, efficacy, and long-term outcomes of this synthetic implant.