Intrastromal Keratoplasty Using Biosynthetic Corneas Versus Human Donor Corneas in Advanced Keratoconus.

Abstract

Purpose: The objective of this study was to compare the clinical outcomes of intrastromal keratoplasty using biosynthetic corneas with human donor corneas in cases of advanced keratoconus.

Methods: A prospective nonblinded randomized controlled study was conducted at a tertiary eye center in India. Treatment-naïve patients with advanced keratoconus aged 18 years or older were included. Twenty eyes were randomized into 2 groups-group 1 (human donor corneal lenticule, n = 10) and group 2 (biosynthetic corneal lenticule, n = 10). Efficacy analyses included an increase in the thinnest pachymetry and a decrease in the maximum keratometry (Kmax). Safety analyses included any adverse events in the postoperative period.

Results: At 6 months postoperatively, the rise in the thinnest pachymetry in group 1 was 346.8 ± 40.82 to 486.7 ± 15.7 μm (P < 0.001) and in group 2 was 366.2 ± 31.3 to 548.3 ± 59.1 μm (P < 0.001). The biosynthetic group exhibited a significant increase in the thinnest pachymetry (P = 0.005). However, both groups showed a similar decrease in Kmax (71.06 ± 7.95 to 63.3 ± 3.74 D in group 1 and 69.13 ± 8.54 to 61.5 ± 6.2 D in group 2; P = 0.44). No adverse events were seen at 6 months of follow-up.

Conclusion: Femtosecond-assisted intrastromal implantation of biosynthetic corneas is a safe and effective alternative to human donor corneas in cases of advanced keratoconus.