Predictors for the Outcome of Small-incision Lenticule Extraction for Myopia

PURPOSE: To study the influence of patient- and surgery-related parameters on the predictability, efficacy, and safety of small-incision lenticule extraction (SMILE) for treatment of myopia. METHODS: This prospective, clinical quality, control study comprised 670 eyes from 335 patients with myopia up to -10.00 diopters (D) (spherical equivalent refraction) and astigmatism up to 2.00 D treated with SMILE in both eyes and followed for 3 months. RESULTS: Preoperative mean spherical equivalent refraction was -7.19 +/- 1.30 D. In eyes with emmetropia as the target refraction, 84% obtained uncorrected distance visual acuity <= 0.10 logMAR (20/25 or better Snellen equivalent) at 3 months. Mean corrected distance visual acuity (CDVA) improved from -0.03 to -0.05 logMAR (P<.01). Two or more lines of CDVA were lost in 2.4% (16 eyes). The achieved refraction was 0.25 +/- 0.44 D less than attempted after 3 months, and 80% (537 eyes) and 94% (631 eyes) were within +/- 0.50 and +/- 1.00 D of attempted correction, respectively. Multiple linear regression analyses revealed that spherical equivalent refraction undercorrection was predicted by increasing patient age (0.10 D per decade; P<.01) and steeper corneal curvature (0.04 D per D; P<.01). Safety and efficacy of the procedure were minimally affected by age, gender, and simultaneous cylinder correction. CONCLUSIONS: Undercorrection of 0.25 D and small effects of patient age and corneal curvature suggest that the standard nomogram for SMILE need only minor adjustments. This study suggests that safety and efficacy are not influenced to any clinically significant degree by easily discernible patient factors. [J Refract Surg. 2012;28(12):865-871.] doi:10.3928/1081597X-20121115-01