Small-incision lenticule extraction for moderate to high myopia: Predictability, safety, and patient satisfaction.

Purpose: To present our initial clinical experience with ReLEx® smile for treatment of moderate to high myopia.
Setting: Department of Ophthalmology, Aarhus University Hospital.
Design: Prospective clinical study.
Methods: In ReLEx smile an intrastromal lenticule is cut by a femtosecond laser and manually extracted without creation of a flap. In this study, 144 patients were treated with ReLEx smile and followed for 3 months. Only one randomly chosen eye of each subject was used in the statistical analyses.
Results: Preoperative SE averaged -7.18 D ±1.57 D. In total, 127 patients (= eyes) completed the 3 month follow-up. Of eyes with emmetropia as target refraction, 40% had an uncorrected distance visual acuity ≤0.1 (logMAR) at day 1 after surgery, increasing to 72% at 3 months. Mean corrected distance visual acuity (CDVA) improved significantly from -0.01 (logMAR) before surgery to -0.03 after 3 months. Of the 127 eyes, none lost ≥2 lines of CDVA, and 6 eyes lost 1 line of CDVA after 3 months. In contrast, 1 eye gained 2 lines, and 24 eyes gained 1 line of CDVA. Achieved refraction was -0.09 ±0.45 D from attempted refraction. The proportion of eyes within ±0.50 D was 77%, and 95% was within ±1.00 D. Ninety-five percent of the patients would recommend ReLEx smile to others.
Conclusion: ReLEx smile is a minimal invasive femtosecond laser refractive procedure. In this study, refractive predictability, safety, and patient satisfaction at 3 months seemed high and comparable to previous studies of ReLEx smile, ReLEx flex, and FS-LASIK.