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ENGLISH ABSTRACT
准分子激光上皮下角膜磨镶术与飞秒激光辅助原位角膜磨镶术矫治高度近视的效果及安全性比较
刘明娜
高华
李娜
史伟云
作者及单位信息
·
DOI： 10.3760/cma.j.cn115989-20200818-00597
A comparison of postoperative efficacy and safety between laser-assisted subepithelial keratomileusis versus femtosecond laser assisted in situ keratomileusis for high myopic eyes
Liu Mingna
Gao Hua
Li Na
Shi Weiyun
Authors Info & Affiliations
Liu Mingna
Eye Hospital of Shandong First Medical University, State Key Laboratory Cultivation Base Eye Institute, Shandong Provincial Key Laboratory of Ophthalmology, Shandong Eye Institute, Shandong First Medical University & Shandong Academy of Medical Sciences, Jinan 250021, China
Gao Hua
Eye Hospital of Shandong First Medical University, State Key Laboratory Cultivation Base Eye Institute, Shandong Provincial Key Laboratory of Ophthalmology, Shandong Eye Institute, Shandong First Medical University & Shandong Academy of Medical Sciences, Jinan 250021, China
Li Na
Eye Hospital of Shandong First Medical University, State Key Laboratory Cultivation Base Eye Institute, Shandong Provincial Key Laboratory of Ophthalmology, Shandong Eye Institute, Shandong First Medical University & Shandong Academy of Medical Sciences, Jinan 250021, China
Shi Weiyun
Eye Hospital of Shandong First Medical University, State Key Laboratory Cultivation Base Eye Institute, Shandong Provincial Key Laboratory of Ophthalmology, Shandong Eye Institute, Shandong First Medical University & Shandong Academy of Medical Sciences, Jinan 250021, China
·
DOI： 10.3760/cma.j.cn115989-20200818-00597
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摘要

目的对准分子激光上皮下角膜磨镶术(LASEK)和飞秒激光辅助原位角膜磨镶术(FS-LASIK)治疗高度近视的有效性、安全性以及稳定性进行比较。

方法采用队列研究方法，纳入2013年1月至2016年12月在山东省眼科医院接受LASEK或FS-LASIK且1年随访期资料完整的高度近视患者75例141眼病历资料，其中接受LASEK者28例56眼作为LASEK组，术前等效球镜度为(-8.29±1.64)D；接受FS-LASIK者47例85眼作为FS-LASIK组，术前等效球镜度为(-7.97±1.38)D。采用小数视力法记录术眼术前和术后最佳矫正视力(BCVA)和术后裸眼视力(UCVA)；采用主觉验光法测定术眼等效球镜度。评估2个组术眼术后有效性指数、安全性指数、稳定性和可预测性以及术后并发症，其中有效性指数为术眼术后UCVA与术前BCVA比值，安全性指数为术眼术后BCVA与术前BCVA比值，稳定性为术后6个月与12个月间等效球镜度差异，可预测性为术后6个月和12个月屈光度在±0.50 D以内的眼数比例。

结果术后6个月和术后12个月，LASEK组和FS-LASIK组术眼有效性指数和安全性指数比较差异均无统计学意义(均 P>0.05)。术后6个月和12个月LASEK组术眼等效球镜度分别为(0.08±0.30)D和(0.10±0.38)D，差异无统计学意义( t＝0.376， P>0.05)；FS-LASIK组术后6个月和12个月术眼等效球镜度分别为(0.00±0.32)D和(0.01±0.35)D，差异无统计学意义( t＝0.227， P>0.05)，2个组术后屈光稳定性较好。术后12个月，LASEK组和FS-LASIK组等效球镜度在±0.50 D以内者分别占91.1%(51/56)和96.4%(82/85)，2个组间差异无统计学意义( χ 2＝1.838， P>0.05)。术后12个月LASEK组4眼出现角膜上皮下混浊，术后BCVA小于术前。

结论LASEK和FS-LASIK矫治高度近视均安全、有效。角膜上皮下混浊是引起LASEK术后BCVA下降的主要原因。

准分子激光上皮下角膜磨镶术;飞秒激光辅助原位角膜磨镶术;高度近视
ABSTRACT

ObjectiveTo evaluate and compare the safety, efficacy, stability and predictability of laser-assisted subepithelial keratomileusis (LASEK) with femtosecond laser assisted in situ keratomileusis (FS-LASIK) for high myopic eyes.

MethodsA non-randomized controlled clinical study was performed.The clinical data of 141 eyes of 75 patients who received LASEK or FS-LASIK for high myopia in Shandong Eye Hospital from January 2013 to December 2016 with complete medical data during 1-year following-up.The 56 eyes with the preoperative diopter of (-8.29±1.64)D received LASEK (LASEK group), and the 85 eyes with the preoperative diopter (-7.97±1.38)D underwent FS-LASIK (FS-LASIK group). Pre- and post-operative best corrected visual acuity (BCVA) and post-operative uncorrected visual acuity (UCVA) were recorded, and the spherical equivalent was examined by subjective optometry.The efficacy index, safety index, refractive stability, predictability and complications were assessed 6 months and 12 months after surgery.Efficacy index was defined as postoperative UCVA/preoperative BCVA; safety index was postoperative BCVA/preoperative BCVA; refractive stability was the difference of spherical equivalent between postoperative 6 months and 12 months, and predictability was the percentage of the eyes with the diopter ≤±0.50 D after surgery.This study protocol was approved by the Ethic Committee of Shandong Eye Hospital (No.SDSYKYY20180130).

ResultsThere were no significant differences in efficacy index and safety index in both LASEK group and FS-LASIK group at 6 months and 12 months after surgery (all at P>0.05). The spherical equivalent was (0.08±0.30)D and (0.10±0.38)D in the LASEK group and (0.00±0.32)D and (0.01±0.35)D in the FS-LASIK group at 6 months and 12 months after surgery, and there were no significant differences between different time points in both LASEK group and FS-LASIK group ( t=0.376, P>0.05; t=0.227, P>0.05), showing a good refractive stability.At 12 months after surgery, the percentage of the eyes with spherical equivalent within ±0.50 D was 91.1% in the LASEK group and 96.4% in the FS-LASIK group, there was no significant difference between the two groups ( χ 2=1.838, P>0.05). Four eyes in the LASEK group developed corneal haze at 12 months after the operation, and the postoperative BCVA was less than the preoperative BCVA.

ConclusionsBoth LASEK and FS-LASIK are safe, effective, stable and predictable for the correction of high myopic eyes.Corneal haze after LASEK is the main reason for the loss of BCVA.

Laser-assisted subepithelial keratomileusis;Femtosecond laser assisted in situ keratomileusis;High myopia
Shi Weiyun, Email: mocdef.3ab61ihsnuyiew
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引用本文

刘明娜,高华,李娜,等. 准分子激光上皮下角膜磨镶术与飞秒激光辅助原位角膜磨镶术矫治高度近视的效果及安全性比较[J]. 中华实验眼科杂志,2020,38(10)：851-857.

DOI:10.3760/cma.j.cn115989-20200818-00597

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近视是当前我国青少年面临的主要健康问题之一。据北京大学中国健康发展研究中心发布的《国民视觉健康报告》数据，我国6～15岁人群近视患病率为46.64%，16～24岁人群近视患病率为54.9%～79.0% [ 1 ]。成年近视人群中有20%～24%是高度近视 [ 2 ]，据估计，到2050年全球将有49.8%的人口患近视，9.8%的人口患高度近视 [ 3 ]。由于眼镜给人们的工作生活带来各种不便，越来越多的成年人有矫治视力的需求。目前常用的激光矫治近视手术方式主要分为表层激光手术和基质激光手术。表层手术由于术后糖皮质激素应用时间长和部分患者出现角膜上皮下雾状混浊(haze)使其适应证受到限制，多主张用于中低度近视的矫治 [ 4 ]。有研究发现，基质手术矫治近视的有效性和安全性高于表层手术 [ 5 ]，但是基质手术存在角膜瓣相关的风险，而且对于眼部容易受伤工种或者不适合基质手术的高度近视患者，表层手术仍可以优先考虑 [ 4 ]。本研究拟对准分子激光上皮下角膜磨镶术(laser-assisted subepithelial keratomileusis，LASEK)和飞秒激光辅助原位角膜磨镶术(femosecond laser in situ keratomileusis，FS-LASIK)治疗高度近视的安全性、有效性、稳定性和可预测性进行比较。
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备注信息
A
史伟云，Email： mocdef.3ab61ihsnuyiew
B
所有作者均声明不存在任何利益冲突
C
国家自然科学基金项目 (81530027、81870639)
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