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[616只球柱面近视眼睛行小切口透镜切除术(SMILE)术后5年的视觉效果]

[Visual outcomes 5 years after small incision lenticule extraction (SMILE), surgery on spherocylindrical myopia eyes, from 616 eyes].

作者信息

Burazovitch J, Ferguene H, Naguszewski D

机构信息

CHR Argentan, service ophtalmologie, 47, rue Aristide-Briand, 61200 Paris, France.

CHR Argentan, service ophtalmologie, 47, rue Aristide-Briand, 61200 Paris, France.

出版信息

J Fr Ophtalmol. 2018 May;41(5):433-440. doi: 10.1016/j.jfo.2018.01.003.

Abstract

OBJECTIVE

Determine if the visual criteria of the technique of surgery refractive by Femtosecond Laser-assisted duckweed Extraction - Small Lenticule Extraction (FLEx-Smile), realized in the laser femtosecond VisuMax (Carl Zeiss Meditec, Jena, Germany), are stable, secure, effective and predictable in the long term, to the nearsighted and astigmatic.

MODEL OF THE STUDY

Retrospective study, monocentric with data collected between March 2012 and March 2017.

PARTICIPANTS

The study included 616 eyes of 309 nearsighted and astigmatic patients (spherical equivalent from 1 to 11 D). They were followed in postoperative immediate (D+1), in 3 months, in 1 year and in 5 years. The taken measures include the refraction, the uncorrected visual acuteness (UVAC) and the best visual corrected acuteness (BVAC).

THE PRIMARY AND SECONDARY ASSESSMENT CRITERIA

The criteria of evaluation were based on the BVAC, the refractive stability, the index of security (IS: MAVC to preoperative D+1/BVAC before operation) and the predictability (percentage of eyes in±1 D of SE target).

RESULTS

UVAC was better 5th year than after the intervention (P=0.001) and 88% of the operated eyes had an UVAC in 8/10 (logMAR=0.1). For the stability refractive, the patients became nearsighted between the intervention and 5th year (P=0.001), with a regression of 0.240 D. The indication of safety was better 5th year than the day after the intervention (P=0.001), 92% of eyes operated in 5 years were 0.5 D of SE target and 77% of eyes had lost no line.

CONCLUSION

SMILE is a good technique of surgery refractive stable, secure, effective and predictable on the long term.

摘要

目的

确定在德国耶拿卡尔蔡司医疗技术公司的飞秒激光VisuMax中实现的飞秒激光辅助浮萍提取-小透镜提取(FLEx-Smile)手术屈光技术的视觉标准,对于近视和散光患者而言,从长期来看是否稳定、安全、有效且可预测。

研究模型

回顾性研究,单中心研究,收集了2012年3月至2017年3月之间的数据。

参与者

该研究纳入了309例近视和散光患者的616只眼睛(球镜等效度数为1至11D)。对他们进行了术后即刻(D+1)、3个月、1年和5年的随访。所采取的测量包括验光、未矫正视力(UVAC)和最佳矫正视力(BVAC)。

主要和次要评估标准

评估标准基于BVAC、屈光稳定性、安全指数(IS:术前D+1时的平均绝对视力变化/术前BVAC)和可预测性(SE目标±1D范围内的眼睛百分比)。

结果

第5年的UVAC比干预后更好(P=0.001),88%的手术眼UVAC为8/10(logMAR=0.1)。对于屈光稳定性,患者在干预后至第5年之间出现近视(P=0.001),屈光度回退0.240D。安全性指标在第5年比干预后一天更好(P=0.001),5年手术的眼睛中有92%在SE目标的0.5D范围内,77%的眼睛视力未下降。

结论

SMILE是一种长期稳定、安全、有效且可预测的屈光手术良好技术。

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