Burazovitch J, Naguzeswski D, Beuste T, Guillard M
Ophthalmology service, Argentan medical center, 47, rue Aristide-Briand, 61200 Argentan, France.
rue Quadrant, 14123 Fleury-sur-Orne, France.
J Fr Ophtalmol. 2017 Jun;40(6):e201-e209. doi: 10.1016/j.jfo.2017.05.001. Epub 2017 Jun 7.
To determine whether the visual outcomes of the refractive surgery technique small incision lenticule extraction (SMILE), are stable, effective, and predictable for high myopia over a four-year period.
This is a retrospective study. The data were collected between March 2012 and July 2016.
Two hundred and forty-eight patients participated in the study; that is, 496 eyes: 140 eyes of 70 patients (52 women/18 men) were classified into the highly myopic group (refraction measured in spherical equivalent (RMSE)>-6 D), and 356 eyes of 178 patients (98 women/80 men) into the control group (RMSE<-6 D). Follow-up tests were conducted immediately following the procedure (D+1), after three months, after one year, and after four years. Refraction, uncorrected visual acuity (UCVA), and best visual corrected acuity (BCVA) were measured. The highly myopic group (HMG) contained more women, and astigmatism was higher for this group than for the control group (CG).
These were BCVA, refractive stability, the index of safety (SI: BCVA preoperatively D+1/BCVA postoperatively), and predictability (the percentage of eyes within±0.5 D of the target).
In both groups, UCVA was better after the fourth year than it was immediately after the procedure (HMG: P=0.001; CG: P=0.001). Although it differed at one year (P=0.01), the groups' refractive stability tended to converge over four years (P=0.138). The groups' SI was found to be identical in the four follow-up tests (P=0.734 at D+1; P=0.07 at M+1; P=0.160 at M3 and Y1; and P=0.274 at Y4). For the HMG, SI stability was attained after three months (1.00±0.1); whereas it was attained after one month (0.91±0.11) for the CG. Four years after the surgery, we observed that 87% of the operated-upon eyes in the HMG were within 0.5 D of the target.
SMILE is a good refractive surgery technique for treating high myopia. It yields stable, safe, effective, and predictable results over four years.
确定屈光手术技术小切口基质透镜切除术（SMILE）在四年期间对高度近视的视觉效果是否稳定、有效且可预测。
这是一项回顾性研究。数据收集于2012年3月至2016年7月之间。
248名患者参与了该研究，即496只眼：70名患者（52名女性/18名男性）的140只眼被分类为高度近视组（等效球镜度测量的屈光不正（RMSE）>-6D），178名患者（98名女性/80名男性）的356只眼被分类为对照组（RMSE<-6D）。术后立即（D+1）、三个月后、一年后和四年后进行随访测试。测量屈光不正、未矫正视力（UCVA）和最佳矫正视力（BCVA）。高度近视组（HMG）女性更多，且该组的散光高于对照组（CG）。
这些标准为BCVA、屈光稳定性、安全指数（SI：术前D+1时的BCVA/术后的BCVA）和可预测性（目标±0.5D范围内的眼的百分比）。
两组中，第四年后的UCVA均优于术后即刻（HMG：P=0.001；CG：P=0.001）。尽管两组在一年时存在差异（P=0.01），但在四年期间屈光稳定性趋于一致（P=0.138）。在四次随访测试中发现两组的SI相同（D+1时P=0.734；M+1时P=0.07；M3和Y1时P=0.160；Y4时P=0.274）。对于HMG，三个月后达到SI稳定性（1.00±0.1）；而对于CG，一个月后达到（0.91±0.11）。手术四年后，我们观察到HMG中87%的手术眼在目标±0.5D范围内。
SMILE是一种治疗高度近视的良好屈光手术技术。它在四年期间产生稳定、安全、有效且可预测的结果。
