Femtosecond Intrastromal Lenticular Implantation Combined With Accelerated Collagen Cross-Linking for the Treatment of Keratoconus--Initial Clinical Result in 6 Eyes.

PURPOSE: To evaluate the initial outcomes of femtosecond intrastromal lenticular implantation (FILI) combined with accelerated collagen cross-linking in patients with progressive keratoconus.

METHODS

In this interventional, prospective, exploratory case series, patients with progressive keratoconus and contact lens intolerance were included. All eyes underwent femtosecond laser-enabled placement of stromal donor tissue and simultaneous accelerated collagen cross-linking. Follow-up of patients was conducted for a mean period of 190 ± 13 days (range, 177-193 days).

RESULTS

Six eyes from 6 patients were included in the study. Based on values before and 6 months after the procedure, clinical improvement was noted in uncorrected distance visual acuity (1.06 ± 0.48 logMAR vs. 0.38 ± 0.27 logMAR), corrected distance visual acuity (0.51 ± 0.20 logMAR vs. 0.20 ± 0.24 logMAR), and manifest spherical equivalent (-3.47 ± 1.15 D vs. -1.77 ± 1.7 D). There was flattening of mean keratometry in 3-mm and 5-mm zones by 3.42 ± 2.09 D and 1.70 ± 1.31 D, respectively. Mean pachymetry in the central and midperipheral zones increased by 18.3 ± 7.3 μm and 33.0 ± 8.8 μm, respectively. All eyes had reduction in higher-order aberrations, specifically coma. No eye lost lines of corrected distance visual acuity. No adverse events such as haze, infection, or allogeneic graft rejection were observed.

CONCLUSIONS

Initial experience with this small number of eyes suggests that the combination of tissue addition and accelerated collagen cross-linking may be a feasible option for low to moderate keratoconus. A larger cohort and longer follow-up are required to validate our results and establish long-term safety and efficacy of the procedure.