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Randomised controlled trial comparing small incision lenticule extraction vs laser in-situ keratomileusis: one year refractive outcomes

Poster Details

First Author: M.Ang SINGAPORE

Co Author(s):    M. Farook   H. Htoon   J. Mehta              

Abstract Details


To compare visual and refractive outcomes between Small Incision Lenticule Extraction (SMILE) and laser in situ keratomileusis (LASIK).


Single tertiary center, parallel group, single-masked, paired-eye design, non-inferiority, randomized controlled trial.


Each participant was randomized to receive SMILE or LASIK using the VisuMax (Carl Zeiss Meditec, Germany) 500kHz femtosecond laser system; with LASIK excimer ablation using Wavelight Allegretto 400Hz laser system (Alcon Laboratories Inc., USA). The study was powered for a non-inferiority analysis comparing SMILE and LASIK using one-year postoperative refractive predictability i.e. percentage eyes with postoperative spherical equivalent (SE) within ±0.50 D of the intended target. Secondary outcome measures included standard reported visual and refractive outcomes at one-year.


We analyzed our results in 70 subjects (mean age 29 ±5 years, % female) who randomly underwent LASIK and SMILE in each eye (SE: -5.3±1.8D vs. -5.2±1.7D; P=0.865). Predictability results suggested that SMILE was not inferior to LASIK (90% vs. 89% within ±0.5D SE; P=0.740). Postoperative efficacy index was 1.0±0.2 vs. 1.0±0.2 (P=0.540), with 83% vs 86% of eyes (P=0.625) achieving unaided distance visual acuity in LASIK and SMILE respectively. Safety (1.15±0.2 vs. 1.15±0.2; P=0.93) was not significantly different between LASIK and SMILE eyes.


One-year visual and refractive outcomes from our randomized fellow-eye trial suggests that SMILE was not inferior to LASIK.

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