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

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.

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.

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.

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