Five-Year Follow-Up of Visual Outcomes and Optical Quality After Small Incision Lenticule Extraction for Moderate and High Myopia.

INTRODUCTION: This study investigated the long-term visual and optical quality changes after small incision lenticule extraction (SMILE) for the correction of moderate to high myopia. METHODS: Forty-one eyes of 41 patients with a mean spherical equivalent (SE) of - 6.74 ± 1.45 D undergoing SMILE were enrolled. Preoperative and 1-month, 3-month, 1-year and 5-year postoperative follow-up examinations were performed including visual acuity, manifest refraction, corneal aberrations and contrast sensitivity. An optical quality analysis system was used to measure objective scatter index (OSI), Strehl ratio (SR) and modulation transfer function cutoff frequency (MTFcutoff). RESULTS: The safety and efficacy indices were 1.09 ± 0.12 and 1.03 ± 0.17, respectively, at the 5-year follow-up. No significant changes in SE from 1 month to 5 years postoperatively were found. The OSI significantly increased at 1 and 3 months postoperatively (p < 0.01 and p < 0.01) and declined at 1 and 5 years (p = 0.81 and p = 0.87). MTFcutoff and SR showed similar trends. Coma, spherical aberration and total higher-order aberration significantly increased after SMILE (p < 0.01) and remained stable from 1 month to 5 years after surgery (p > 0.05). Contrast sensitivity in the photopic and mesopic condition showed no significant changes during 5-year follow-up (p > 0.05). CONCLUSION: The SMILE procedure is satisfactory in terms of optical quality for correcting moderate and high myopia in the long-term period. TRIAL REGISTRATION: ChiCTR-ONRC-13003114.