Prospective, Randomized Contralateral Eye Comparison of Wavefront-Guided Laser In Situ Keratomileusis and Small Incision Lenticule Extraction Refractive Surgeries

Abstract

Purpose: Wavefront-guided laser in situ keratomileusis (WFG-LASIK) and small incision lenticule extraction (SMILE) are keratorefractive surgeries that can improve uncorrected visual acuity in myopic patients. Comparison of visual outcomes in myopic patients treated with LASIK and SMILE is needed.

Design: Prospective, randomized contralateral eye-controlled trial.

Methods: We performed a single-center prospective, randomized contralateral eye comparison of WFG-LASIK and SMILE (NCT03067077). Myopic patients with low levels of astigmatism were treated with WFG-LASIK in one eye and SMILE in the fellow eye from March 2017 to March 2021. Treatments were randomized by ocular dominance. WFG-LASIK and SMILE were performed. Postoperative evaluation at 1 day consisted of uncorrected distance visual acuity (UDVA), wavefront aberrometry, and a slit-lamp examination. On subsequent postoperative visits at 1 month, 3 months, 6 months, and 12 months, UDVA, manifest refraction, 5% and 25% low-contrast visual acuity, wavefront aberrometry, and slit-lamp examination were performed.

Main outcome measure: The primary outcome measure was UDVA at 12 months.

Results: Eighty-eight eyes of 44 patients with myopia were enrolled in the study. Seventy-four eyes of 37 patients had successful treatments and completed 12 months of follow-up. At postoperative month 12, there were a significantly higher proportion of WFG-LASIK eyes that had ≥20/20 UDVA compared with SMILE eyes (94% vs 83%, P < .05). There was no difference between spherical equivalent between WFG-LASIK eyes and SMILE eyes (-0.17 ± 0.25 vs -0.29 ± 0.38, P > .05); there was no difference in higher order aberrations, including coma, trefoil, and spherical aberrations (P > 0.05); and there were a significantly higher proportion of WFG-LASIK eyes that had improved 5% and 25% low-contrast visual acuity compared with SMILE eyes (P < 0.05).

Conclusions: WFG-LASIK and SMILE both offered marked improvements in corrected distance visual acuity and excellent predictability in both eyes. Compared with SMILE, WFG-LASIK resulted in faster visual recovery, better low-contrast visual acuity, and greater gains in uncorrected visual acuity.