J Refract Surg. 2022 May;38(5):262-271. doi: 10.3928/1081597X-20220314-01. Epub 2022 May 1.
To report the outcomes of small incision lenticule extraction (SMILE) for high myopia between -9.00 and -14.00 diopters (D).
This was a prospective study of SMILE for high myopia using the VisuMax femtosecond laser (Carl Zeiss Meditec). Inclusion criteria were attempted spherical equivalent refraction (SEQ) between -9.00 and -14.00 D, cylinder up to 7.00 D, corrected distance visual acuity (CDVA) of 20/40 or better, age 21 years or older, and suitable for SMILE. The sub-lenticule thickness was 220 µm or greater, and the total uncut stromal thickness was 300 µm or greater. Patients were to be followed up for 1 year. Standard outcomes analysis was performed using 12-month data where available or 3-month data otherwise.
Of 187 eyes treated, data were available at 12 months for 181 eyes (96.8%) and 3 months for 4 eyes (2.1%), and 2 eyes (1.1%) were lost to follow-up. Mean attempted SEQ was -10.55 ± 1.00 D (range: -9.00 to -12.99 D). Mean cylinder was -1.19 ± 0.83 D (range: 0.00 to -4.00 D). Preoperative CDVA was 20/20 or better in 73% of eyes. Postoperative uncorrected distance visual acuity was 20/20 or better in 57% and 20/25 or better in 82% of eyes. Mean SEQ relative to target was -0.22 ± 0.48 D (range: -1.63 to +1.38 D), 66% ± 0.50 D and 93% ±1.00 D. Mean SEQ 12-month change was -0.08 ± 0.34 D (range: -1.75 to +0.88 D). There was loss of one line of CDVA in 4% of eyes, and no eyes lost two or more lines. Contrast sensitivity was unchanged. Patient satisfaction was 8 or more out of 10 in 94% and 6 or more in 99% of patients.
Outcomes of SMILE for myopia greater than -9.00 D at 3 to 12 months showed excellent efficacy, safety, stability, and predictability, with high patient satisfaction. .
报告 10.00 至 14.00 屈光度（D）高度近视患者行小切口微透镜取出术（SMILE）的结果。
本研究为前瞻性研究，采用卡尔蔡司公司的 VisuMax 飞秒激光行 SMILE 治疗高度近视。纳入标准为：等效球镜（SEQ）-9.00 至-14.00 D，柱镜不超过 7.00 D，最佳矫正远视力（CDVA）20/40 或更佳，年龄 21 岁或以上，适合行 SMILE。亚透镜厚度 220 µm 或以上，总未切割基质厚度 300 µm 或以上。患者随访 1 年。如有 12 个月数据，则采用标准结果分析；否则采用 3 个月数据。
187 只眼中，181 只眼（96.8%）在 12 个月时可获得数据，4 只眼（2.1%）在 3 个月时可获得数据，2 只眼（1.1%）失访。平均尝试 SEQ 为-10.55 ± 1.00 D（范围：-9.00 至-12.99 D）。平均柱镜为-1.19 ± 0.83 D（范围：0.00 至-4.00 D）。术前 CDVA 为 20/20 或更佳的眼占 73%。术后未矫正远视力 20/20 或更佳的眼占 57%，20/25 或更佳的眼占 82%。与目标相比，平均 SEQ 为-0.22 ± 0.48 D（范围：-1.63 至+1.38 D），66%±0.50 D，93%±1.00 D。平均 SEQ 12 个月变化为-0.08 ± 0.34 D（范围：-1.75 至+0.88 D）。4%的眼视力下降一行，无一眼视力下降两行或更多。对比敏感度无变化。94%的患者对手术结果满意度为 8 分或更高，99%的患者满意度为 6 分或更高。
3 至 12 个月时，SMILE 治疗大于-9.00 D 的近视的结果显示出极好的疗效、安全性、稳定性和可预测性，患者满意度高。
