Central Cornea Changes on Anterior Segment OCT and In Vivo Confocal Microscopy After Autologous Limbal Epithelial Cell Transplantation.

Abstract

Purpose: To describe 1-year changes in the cornea as assessed by anterior segment optical coherence tomography (AS-OCT) and in vivo confocal microscopy (IVCM) for participants receiving a tissue graft generated from a new manufacturing process using cultivated autologous limbal epithelial cells.

Methods: Cultivated autologous limbal epithelial cell grafts were produced in a 2-stage manufacturing process following a good manufacturing process-compliant protocol. AS-OCT and IVCM were completed at baseline and 12 months after the treatment in subsets of these participants. Secondary efficacy outcomes were determined based on improvement of central corneal epithelial morphology and thickness [corneal epithelial thickness (CET)] and presence of conjunctival or corneal cells in central cornea.

Results: Among 14 participants, 13 (93%) were male, 12 (86%) were white, the mean age was 46 ± 16 years. At baseline, CET was 53 (range: 34, 64) microns, and epithelial basal cell density was 3964 (range: 822-5788) cells/mm2; the ratio of the cells at central cornea was 20% corneal and 90% conjunctival epithelial cells. At 12 months, the mean changes were 3 μm in CET (P = 0.67), and 1967 cells/mm2 in epithelial basal cell density (P = 0.02); the proportion of the central cells improved to 75% corneal and 38% conjunctival epithelial cells.

Conclusions: The AS-OCT and IVCM findings are consistent with the clinical improvement, indicating the reconstitution of the corneal phenotype and clearing of the optical axis. Nevertheless, IVCM is notably more effective for in-depth analysis of the epithelial phenotype and thickness than AS-OCT.