Comparison of 1-Year Outcomes Between Small Incision Lenticule Extraction With Prophylactic Cross-Linking and Femtosecond Laser-Assisted In Situ Keratomileusis With Prophylactic Cross-Linking.

Purpose: To compare small incision lenticule extraction with prophylactic cross-linking (SMILE Xtra) and femtosecond laser-assisted in situ keratomileusis with prophylactic cross-linking (FS-LASIK Xtra) in their safety, efficacy, predictability, and stability.

Methods: This is a prospective cohort study. Forty-eight eyes subjected to SMILE Xtra and 90 eyes subjected to FS-LASIK Xtra were enrolled. The enrolled eyes exhibited either borderline corneal topography or high myopia with thin cornea. The following parameters were evaluated before surgery and at 1 day; 1 week; and 1, 3, 6, and 12 months after surgery: corrected distance visual acuity, uncorrected distance visual acuity, manifest refractive spherical equivalent (MRSE), keratometry values, and thinnest corneal thickness.

Results: After 1 month, no eye showed loss of 1 or more lines of corrected distance visual acuity. At 12 months, uncorrected distance visual acuity was 20/20 or better for 98% and 99% eyes in the SMILE Xtra and FS-LASIK Xtra groups, respectively (P = 0.657). For 93.8% eyes in the SMILE Xtra group and 90% eyes in the FS-LASIK Xtra group, the achieved MRSE was within ±0.50 diopter of the intended MRSE (P = 0.669). The correlation coefficients for predictability of MRSE correction by SMILE Xtra and FS-LASIK Xtra were 0.987 and 0.983, respectively. The mean MRSE values, keratometry values, and thinnest corneal thickness measured at the different time points showed no significant intra- or intergroup differences.

Conclusions: Our evaluations of 1-year outcomes suggest that the safety, efficacy, predictability, and stability of SMILE Xtra are comparable with those of FS-LASIK Xtra.