Regenerative Surgery of the Corneal Stroma for Advanced Keratoconus: One Year Outcomes.

PURPOSE: To evaluate the one-year safety and efficacy of the cellular therapy of the corneal stroma by implanting autologous adipose derived adult stem cells (ADASc) with or without sheets of decellularized donor human corneal stroma within the stroma of patients with advanced keratoconus.

METHODS: Prospective interventional non-randomized series of cases. Fourteen consecutive patients were selected and distributed into 3 experimental groups: A) Implantation of autologous ADASc alone (3x 106 /1mL ) (n:5); B) Decellularized donor 120 μm thick corneal stroma lamina alone (n:5); C) Recellularized donor lamina with 1x106 autologous ADASc+ another 1x106 /1mL cells at the time of the surgery (n:4). Autologous ADASc were obtained by elective liposuction. Implantation was performed into the corneal stroma through a femtosecond-assisted 9.5mm diameter lamellar dissection under topical anesthesia. Twelve months follow-up data are presented.

RESULTS: No complications were observed along the one year follow up and full corneal transparency recovered within 3 months in all patients. No patient lost lines of visual acuity. Corrected distance visual acuity improved 0.231, 0.264 and 0.094 Snellen-lines in G1-2-3 respectively. In G1, refractive parameters showed an overall stability, while in G2-3 sphere improved 2.35D and 0.625D respectively. Anterior keratometry remained stable(G1) and improved in G2-3 (mean improvement of 2D). Corneal aberrometry significantly improved. Corneal thickness showed in the OCT a mean improvement of 14.5μm (G1) and 116.4μm (G2-3) in the central thickness, and new collagen production was observed at the surgical plane(G1). Confocal biomicroscopy confirmed the host recellularization of the implanted laminas.

CONCLUSIONS: Intrastromal implantation of autologous ADASc and/or decellularized human corneal stroma did not show complications at one year of follow up and it was moderately effective for the treatment of advanced keratoconus.