Long-term Corneal Rejuvenation after Transplantation of Cultured Human Corneal Endothelial Cells.

Abstract

To investigate the long-term efficacy of cultured human corneal endothelial cell (CEC) transplantation with ρ-associated protein kinase (ROCK) inhibitor for the treatment of corneal endothelial failure. Prospective observational study. Sixty-five patients with corneal endothelial failure were treated via cell therapy using cultured allogeneic human CECs (0.2 - 1.0 × 10⁶ cells) supplemented with a ROCK inhibitor injected into the anterior chamber of the eye who were followed up for up to 10 years after surgery. At 24 weeks and 1 to 10 years after surgery, corneal transparency, CEC density, central corneal thickness, and best-corrected visual acuity on a Landolt C eye chart were recorded. The Kaplan-Meier method was used to estimate the postoperative probability for restoration and persistence of corneal transparency. The primary outcome was corneal restoration and transparency after surgery. Secondary outcomes were CEC density exceeding 500 and 1000 cells/mm², corneal thickness < 630 μm, and an improvement in best-corrected visual acuity (BCVA) equivalent to a decrease of at least 0.2 in logarithm of the minimal angle of resolution at 24 weeks and 5 years after surgery. For the primary outcome, the overall success in maintaining corneal transparency at 24 weeks, 5 years, and 10 years after surgery was 98.5% (95% confidence interval [CI], 89.6%-99.8%), 93.0% (95% CI, 82.4%-97.3%), and 83.7% (95% CI, 54.4%-95.0%), respectively. A CEC density of more than 1000 cells/mm² was achieved in 79.6% (95% CI, 65.7%-89.8%), corneal thickness < 630 μm was achieved in 85.4% (95% CI, 72.2%-93.9%), and BCVA improvement was achieved in 85.7% (95% CI, 72.8%-94.1%) at 5 years after surgery. No severe adverse reactions occurred. Cultured human CEC transplantation provided sustained clinical improvement and demonstrated a favorable long-term safety profile in patients with corneal endothelial failure. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.