Posters

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

Purpose:

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

Setting:

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

Methods:

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.

Results:

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.

Conclusions:

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

Financial Disclosure:

None