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高度近视眼中小切口透镜切除术(SMILE)手术的一年视觉效果:回顾性队列研究

One-year visual outcome of small incision lenticule extraction (SMILE) surgery in high myopic eyes: retrospective cohort study.

作者信息

Wu Wenjing, Wang Yan, Zhang Hui, Zhang Jiamei, Li Hua, Dou Rui

机构信息

Tianjin Ophthalmology and Visual Science Key Laboratory, Tianjin Eye Hospital & Eye Institute, Clinical College of Ophthalmology, Tianjin Medical University, Tianjin, China.

出版信息

BMJ Open. 2016 Sep 21;6(9):e010993. doi: 10.1136/bmjopen-2015-010993.

DOI:10.1136/bmjopen-2015-010993
PMID:27655258
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5051337/
Abstract

OBJECTIVE

To determine whether the long-term visual outcome of small incision lenticule extraction (SMILE) surgery is consistent with the short-term results in high myopic eyes.

DESIGN

Retrospective cohort study; data collected from 8 August 2011 to 31 August 2015.

SETTING

Single refractive surgery centre.

PARTICIPANTS

A total of 156 eyes were studied: 65 eyes of 39 subjects (22 female/17 male) in the high myopic group (manifest refraction spherical equivalent (MRSE) ≥-6.0 D), and 91 eyes of 54 subjects (29 female/25 male) in the control group (MRSE <-6.0 D). The inclusion criteria were subjects who had follow-ups after 1 day, 1 week, 1 month, 3, 6 months and 1 year with the manifest refraction, uncorrected and corrected distance visual acuity (UDVA/CDVA). There were no statistically significant differences between the two groups in the subjects' gender, age, or cylindrical dioptre, preoperatively (p=0.835, p=0.055, p=0.341, respectively).

PRIMARY AND SECONDARY OUTCOME MEASURES

UDVA, refractive stability, safety index (postoperative CDVA/preoperative CDVA), and predictability (the percentage of eyes within ±0.50 D).

RESULTS

In both groups, the 1-year UDVA and safety index were significantly better than results at 1 day (high myopic group: p=0.035, p<0.001; control group: p<0.016, p<0.001); the 1-year predictability showed no significant difference with the short-term results (p=1.00 in both groups). In the high myopic eyes, the 1-year MRSE was significantly worse than the short-term result (p=0.048). To correct it, the added magnitude (D) for the high myopic eyes may equal 0.13×Attempted SE (D)-0.66 D. However, the postoperative MRSE showed no differences from 1 day to 1 year (p=0.612) in the control group.

CONCLUSIONS

The 1-year visual outcomes were better than the short-term results after the SMILE surgery on the visual acuity and safety. However, the high myopic eyes suffered a significant regression at 1 year, which may be corrected by adding additional magnitude to the SE for high myopic eyes.

摘要

目的

确定小切口透镜切除术(SMILE)治疗高度近视的长期视觉效果是否与短期结果一致。

设计

回顾性队列研究;数据收集时间为2011年8月8日至2015年8月31日。

地点

单一屈光手术中心。

参与者

共研究156只眼:高度近视组(明显屈光球镜等效度(MRSE)≥-6.0 D)39例受试者的65只眼(22例女性/17例男性),对照组(MRSE<-6.0 D)54例受试者的91只眼(29例女性/25例男性)。纳入标准为术后1天、1周、1个月、3个月、6个月和1年进行明显屈光、未矫正和矫正远视力(UDVA/CDVA)随访的受试者。两组受试者术前的性别、年龄或柱镜度数差异均无统计学意义(分别为p=0.835、p=0.055、p=0.341)。

主要和次要观察指标

UDVA、屈光稳定性、安全指数(术后CDVA/术前CDVA)和可预测性(±0.50 D范围内的眼数百分比)。

结果

两组1年时的UDVA和安全指数均显著优于术后1天(高度近视组:p=0.035,p<0.001;对照组:p<0.016,p<0.001);1年时的可预测性与短期结果无显著差异(两组p均=1.00)。高度近视眼中,1年时的MRSE显著差于短期结果(p=0.048)。为矫正此情况,高度近视眼的增加量(D)可能等于0.13×预期SE(D)-0.66 D。然而,对照组术后1天至1年的MRSE无差异(p=0.612)。

结论

SMILE手术后1年的视力和安全性视觉效果优于短期结果。然而,高度近视眼在1年时出现显著回退,可通过增加高度近视眼的SE量来矫正。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0dd4/5051337/79ac2b6f0d8c/bmjopen2015010993f05.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0dd4/5051337/20012ab46619/bmjopen2015010993f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0dd4/5051337/7e88f20044dd/bmjopen2015010993f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0dd4/5051337/dfb1f5fc3676/bmjopen2015010993f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0dd4/5051337/33525734a491/bmjopen2015010993f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0dd4/5051337/79ac2b6f0d8c/bmjopen2015010993f05.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0dd4/5051337/20012ab46619/bmjopen2015010993f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0dd4/5051337/7e88f20044dd/bmjopen2015010993f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0dd4/5051337/dfb1f5fc3676/bmjopen2015010993f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0dd4/5051337/33525734a491/bmjopen2015010993f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0dd4/5051337/79ac2b6f0d8c/bmjopen2015010993f05.jpg

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