Early Clinical Outcome of Hyperopic Small Incision Lenticule Extraction (SMILE) Using the VisuMax 800 in South Korea: A Pilot Study
Abstract
Purpose This study evaluated the early outcomes of hyperopic small incision lenticule extraction (SMILE) using the VisuMax 800 femtosecond laser in a South Korean cohort, focusing on safety, efficacy, refractive predictability, and centration accuracy. Methods This retrospective study included 11 eyes from seven patients who underwent hyperopic SMILE using the VisuMax 800 between December 1, 2024, and October 31, 2025, at Onnuri Eye Hospital in Jeonju, South Korea. All eyes completed at least 3 months of postoperative follow-up. Preoperative and postoperative evaluations included uncorrected and corrected distance visual acuity (CDVA), manifest refraction, tomography, and wavefront aberrometry. Outcomes were analyzed using the standard nine graphs for refractive surgery. Astigmatic changes were assessed using the Alpins vector method. Optical zone decentration was calculated using postoperative Placido-Scheimpflug topography. Results The median preoperative spherical equivalent (SEQ) was +2.50 diopters (D) (interquartile range [IQR], 1.94–4.12 D). At 3 months, eight eyes (72.7%) were within ±0.50 D and all eyes (100%) were within ±1.00 D of the residual SEQ. The median efficacy index was 0.90 (IQR, 0.80–0.95). CDVA was unchanged in 63.6% of eyes and decreased by one line in 36.4%; no eye lost two or more lines. The median safety index was 0.86 (IQR, 0.80–1.00). Root mean square higher-order aberrations (RMS HOA) increased by +0.38 μm (IQR, 0.09–0.52 μm). The median…
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Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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