PURPOSE To evaluate the 7-year visual, refractive, and optical outcomes following small incision lenticule extraction (SMILE) for high myopia and myopic astigmatism. METHODS Sixty-nine eyes (69 patients) undergoing SMILE between March 2011 and January 2012 at Aarhus University Hospital were included. Preoperative, 3-month, 3-year, and 7-year evaluation included: manifest refraction and uncorrected (UDVA) and corrected (CDVA) distance visual acuities, total corneal refractive power (TCRP), average keratometry (Km), aberrations, and central corneal thickness (CCT). RESULTS Preoperative spherical equivalent averaged -7.53 ± 1.18 diopters (D). Twenty-seven eyes were targeted emmetropia. In the emmetropic eyes, the postoperative logMAR UDVA remained stable (P = .11). When including all eyes, UDVA became worse from 3 to 7 years (3 months: 0.050 ± 0.16 logMAR; 3 years: 0.044 ± 0.21 logMAR; 7 years: 0.131 ± 0.29 logMAR; P < .027), whereas CDVA remained stable (3 months: -0.07 ± 0.09 logMAR; 3 years: -0.09 ± 0.08 logMAR; 7 years: -0.09 ± 0.08 logMAR, P > .99). At 7 years, 59.4% and 81.2% were within ±0.50 and ±1.00 D of target refraction, respectively. Average refractive regression was significant from 3 months to 7 years (-0.34 ± 0.69 D) and from 3 to 7 years (-0.25 ± 0.41 D, P < .05). After exclusion of three outliers with high myopic correction (< 9.63 D) and considerable regression (<-1.50 D), the average regression over 7 years was -0.25 ± 0.49 D (P = .004) with no significant change from 3 to 7 years (P = .069). Average CCT, TCRP, and anterior Km significantly increased (P < .001), whereas the posterior Km and total corneal aberrations remained stable (P > .092). CONCLUSIONS The long-term visual outcome remained stable after SMILE, but with an average regression of -0.34 D over 7 years. A minor group with high myopic correction exhibited considerable refractive regression years after SMILE. [J Refract Surg. 2021;37(10):654-661.].

中文翻译：

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SMILE 治疗高度近视的 7 年结果：视觉和屈光结果以及像差。

目的 评估高度近视和近视散光的小切口微透镜提取 (SMILE) 后 7 年的视觉、屈光和光学结果。方法 纳入 2011 年 3 月至 2012 年 1 月在奥胡斯大学医院接受 SMILE 治疗的 69 只眼（69 名患者）。术前、3 个月、3 年和 7 年评估包括：明显屈光和未矫正 (UDVA) 和矫正 (CDVA) 远视力、总角膜屈光力 (TCRP)、平均角膜曲率 (Km)、像差和中央角膜厚度（CCT）。结果术前等效球镜平均屈光度为 -7.53 ± 1.18 (D)。二十七只眼睛是有针对性的正视眼。在正视眼中，术后 logMAR UDVA 保持稳定（P = .11）。当包括所有眼睛时，UDVA 从 3 到 7 年（3 个月：0.050 ± 0. 16 logMAR；3 年：0.044 ± 0.21 logMAR；7 年：0.131 ± 0.29 logMAR；P < .027），而 CDVA 保持稳定（3 个月：-0.07 ± 0.09 logMAR；3 年：-0.09 ± 0.08 logMAR；7 年：-0.09 ± 0.08 logMAR，P > .99）。7 年时，59.4% 和 81.2% 分别在目标屈光度的 ±0.50 和 ±1.00 D 范围内。从 3 个月到 7 年（-0.34 ± 0.69 D）和从 3 到 7 年（-0.25 ± 0.41 D，P < .05），平均屈光回归是显着的。在排除三个高度近视矫正 (< 9.63 D) 和显着回归 (<-1.50 D) 的异常值后，7 年的平均回归为 -0.25 ± 0.49 D (P = .004)，从 3 到 7 没有显着变化年（P = .069）。平均 CCT、TCRP 和前 Km 显着增加 (P < .001)，而后 Km 和总角膜像差保持稳定 (P > .092)。结论 SMILE 术后长期视力结果保持稳定，但 7 年平均回归为 -0.34 D。在 SMILE 后数年，高度近视矫正的小群体表现出相当大的屈光退化。[J 屈光手术。2021;37(10):654-661.]。