Randomized Clinical Trial Comparing Femtosecond LASIK and Small-Incision Lenticule Extraction

Purpose To compare femtosecond LASIK with small-incision lenticule extraction (SMILE) for the treatment of myopia and myopic astigmatism. Design Prospective, randomized, paired-eye, single-masked clinical trial. Participants Consecutive eligible patients were randomized to undergo SMILE and LASIK in either eye at a single tertiary referral eye center. Methods Patients were treated in each eye using the VisuMax (Carl Zeiss Meditec, Jena, Germany) 500-kHz femtosecond laser system. Excimer ablation was subsequently performed using the WaveLight EX500 excimer laser (Alcon Laboratories, Inc, Fort Worth, TX) in the eye for LASIK. Main Outcome Measure Refractive predictability at 3 months. Secondary outcomes were refractive outcomes, that is, efficacy and safety at 3 and 12 months. Results We recruited 70 consecutive patients (mean age, 28±5 years; 64% women; all Asian) with no difference in preoperative spherical equivalent (SE) between eyes (–5.3±1.8 diopters [D] vs. –5.2±1.7 D; P = 0.87). At 3 months, 99% of SMILE eyes and 97% of LASIK eyes achieved SE within ±1.0 D of attempted correction (P = 1.0). Small-incision lenticule extraction achieved similar results as LASIK in terms of efficacy index (0.97±0.20 vs. 0.99±0.20; P = 0.56), uncorrected distance visual acuity (UDVA) of 20/40 or better (100% vs. 100%; P = 1.0), and UDVA of 20/20 or better (84% vs. 87%; P = 0.63). Safety index (1.1±0.2 vs. 1.1±0.2; P = 0.57) was similar between SMILE and LASIK eyes at 3 months. At 12 months, SMILE was similar to LASIK in terms of efficacy (85% vs. 83% UDVA ≥20/20; P = 0.81), predictability (99% vs. 99% ±1.0 D of attempted correction SE; P = 1.0), and safety (1.15±0.20 vs. 1.15±0.20; P = 0.93). Conclusions The results from this randomized trial suggest that SMILE produced promising refractive outcomes in terms of predictability, efficacy, and safety at 3 and 12 months of follow-up. To compare femtosecond LASIK with small-incision lenticule extraction (SMILE) for the treatment of myopia and myopic astigmatism. Prospective, randomized, paired-eye, single-masked clinical trial. Consecutive eligible patients were randomized to undergo SMILE and LASIK in either eye at a single tertiary referral eye center. Patients were treated in each eye using the VisuMax (Carl Zeiss Meditec, Jena, Germany) 500-kHz femtosecond laser system. Excimer ablation was subsequently performed using the WaveLight EX500 excimer laser (Alcon Laboratories, Inc, Fort Worth, TX) in the eye for LASIK. Refractive predictability at 3 months. Secondary outcomes were refractive outcomes, that is, efficacy and safety at 3 and 12 months. We recruited 70 consecutive patients (mean age, 28±5 years; 64% women; all Asian) with no difference in preoperative spherical equivalent (SE) between eyes (–5.3±1.8 diopters [D] vs. –5.2±1.7 D; P = 0.87). At 3 months, 99% of SMILE eyes and 97% of LASIK eyes achieved SE within ±1.0 D of attempted correction (P = 1.0). Small-incision lenticule extraction achieved similar results as LASIK in terms of efficacy index (0.97±0.20 vs. 0.99±0.20; P = 0.56), uncorrected distance visual acuity (UDVA) of 20/40 or better (100% vs. 100%; P = 1.0), and UDVA of 20/20 or better (84% vs. 87%; P = 0.63). Safety index (1.1±0.2 vs. 1.1±0.2; P = 0.57) was similar between SMILE and LASIK eyes at 3 months. At 12 months, SMILE was similar to LASIK in terms of efficacy (85% vs. 83% UDVA ≥20/20; P = 0.81), predictability (99% vs. 99% ±1.0 D of attempted correction SE; P = 1.0), and safety (1.15±0.20 vs. 1.15±0.20; P = 0.93). The results from this randomized trial suggest that SMILE produced promising refractive outcomes in terms of predictability, efficacy, and safety at 3 and 12 months of follow-up.