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

Area of Science:

• Ophthalmology
• Refractive Surgery
• Corneal Surgery

Background:

• Myopia and myopic astigmatism are common refractive errors impacting visual acuity.
• Surgical interventions like LASIK and SMILE aim to correct these conditions.
• Comparing the efficacy and safety of different refractive surgery techniques is crucial for patient outcomes.

Purpose of the Study:

• To compare the outcomes of femtosecond laser-assisted in situ keratomileusis (LASIK) with small-incision lenticule extraction (SMILE).
• To evaluate refractive predictability, efficacy, and safety of SMILE versus LASIK for myopia and myopic astigmatism.
• To assess visual outcomes at 3 and 12 months post-operatively.

Main Methods:

• A prospective, randomized, paired-eye, single-masked clinical trial was conducted.
• Seventy consecutive patients with myopia/myopic astigmatism were randomized to undergo either SMILE or LASIK.
• Both procedures utilized a 500-kHz femtosecond laser system, with excimer ablation for LASIK.

Main Results:

• At 3 months, 99% of SMILE eyes and 97% of LASIK eyes achieved spherical equivalent within ±1.0 D of attempted correction.
• Efficacy (e.g., uncorrected distance visual acuity ≥20/20) and safety indices were similar between SMILE and LASIK at both 3 and 12 months.
• Refractive predictability remained high for both groups at 12 months (99% within ±1.0 D).

Conclusions:

• Small-incision lenticule extraction (SMILE) demonstrates promising refractive outcomes comparable to LASIK.
• Both SMILE and LASIK are effective and safe surgical options for correcting myopia and myopic astigmatism.
• The study supports SMILE as a viable alternative to LASIK with similar long-term results.