Clinical relevance: More than 6 million small-incision lenticule extraction (SMILE) procedures have been performed worldwide since 2011. Therefore, its long-term safety and efficacy should be investigated.
Background: This study aimed to evaluate 10-year refractive outcomes, corneal stability, axial length, and wavefront aberrations in patients who underwent SMILE to correct myopia.
Methods: Thirty two patients (32 eyes) who underwent SMILE-based myopic correction. Corrected distance visual acuity, uncorrected distance visual acuity, corneal stability, axial length, and wavefront aberrations were evaluated preoperatively and at 1 month and 1, 5, and 10 years postoperatively.
Results: At 10 years postoperatively, the safety and efficacy indices for the patients included in this study were 1.19 ± 0.21 and 1.04 ± 0.27, respectively. For 26 (81%) and 30 eyes (94%), correction to within ±0.50 D and ±1.00 D of the target was achieved, respectively. Over the 10-year follow-up duration, a mean -0.32 ± 0.56 D regression was observed (-0.03 ± 0.06 D/year). Relative to baseline, horizontal and vertical comas significantly increased, as did the incidence of higher-order aberrations (all P < 0.001), whereas axial length and corneal elevation remained stable during follow-up.
Conclusion: These results indicate that the SMILE-based correction for myopia of up to -10 Dioptres is safe, effective, and stable, with relatively constant wavefront aberrations and corneal stability over time after treatment.
Keywords: Myopia; small incision lenticule extraction; ten-year outcomes.