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准分子激光屈光手术与有晶状体眼人工晶状体矫正中高度近视的比较。

Excimer laser refractive surgery versus phakic intraocular lenses for the correction of moderate to high myopia.

作者信息

Barsam Allon, Allan Bruce D S

机构信息

Moorfields Eye Hospital NHS Foundation Trust, London, UK.

出版信息

Cochrane Database Syst Rev. 2012 Jan 18;1:CD007679. doi: 10.1002/14651858.CD007679.pub3.

Abstract

BACKGROUND

Myopia is a condition in which the focusing power (refraction) of the eye is greater than that required for clear distance vision. There are two main types of surgical correction for moderate to high myopia; excimer laser and phakic intraocular lenses (IOLs). Excimer laser refractive surgery for myopia works by removing corneal stroma to lessen the refractive power of the cornea and to bring the image of a viewed object into focus onto the retina rather than in front of it. Phakic IOLs for the treatment of myopia work by diverging light rays so that the image of a viewed object is brought into focus onto the retina rather than in front of the retina. They can be placed either in the anterior chamber of the eye in front of the iris or in the posterior chamber of the eye between the iris and the natural lens.

OBJECTIVES

The aim of this review is to compare the effect of excimer laser refractive surgery versus phakic IOLs for the correction of moderate to high myopia.

SEARCH METHODS

We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2011, Issue 11), MEDLINE (January 1950 to November 2011), EMBASE (January 1980 to November 2011), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to November 2011), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). There were no date or language restrictions in the electronic searches for trials. The electronic databases were last searched on 28 November 2011.

SELECTION CRITERIA

We included randomised controlled trials (RCTs) comparing excimer laser refractive surgery and phakic IOLs for the correction of myopia greater than 6.0 diopters (D) spherical equivalent.

DATA COLLECTION AND ANALYSIS

Two authors independently assessed trial quality and extracted data. We performed data analysis. We summarised data for outcomes using odds ratios. We used a fixed-effect model as only three trials were included in the review.

MAIN RESULTS

This review included three RCTs with a total of 228 eyes. The range of myopia of included patients was -6.0 D to -20.0 D of myopia with up to 4.0 D of myopic astigmatism. The percentage of eyes with uncorrected visual acuity (UCVA) of 20/20 or better at 12 months postoperative was not significantly different between the two groups. Phakic IOL surgery was safer than excimer laser surgical correction for moderate to high myopia as it results in significantly less loss of best spectacle corrected visual acuity (BSCVA) at 12 months postoperatively. However there is a low risk of developing early cataract with phakic IOLs. Phakic IOL surgery appears to result in better contrast sensitivity than excimer laser correction for moderate to high myopia. Phakic IOL surgery also scored more highly on patient satisfaction/preference questionnaires.

AUTHORS' CONCLUSIONS: The results of this review suggest that phakic IOLs are safer than excimer laser surgical correction for moderate to high myopia in the range of -6.0 to -20.0 D and phakic IOLs are preferred by patients. While phakic IOLs might be accepted clinical practice for higher levels of myopia (greater than or equal to 7.0 D of myopic spherical equivalent with or without astigmatism), it may be worth considering phakic IOL treatment over excimer laser correction for more moderate levels of myopia (less than or equal to 7.0 D of myopic spherical equivalent with or without astigmatism). Further RCTs adequately powered for subgroup analysis are necessary to further elucidate the ideal range of myopia for phakic IOLs.

摘要

背景

近视是一种眼睛的聚焦能力(屈光)大于清晰远视力所需聚焦能力的病症。中高度近视的手术矫正主要有两种类型:准分子激光手术和有晶体眼人工晶状体(IOL)植入术。近视的准分子激光屈光手术通过去除角膜基质来降低角膜的屈光力,使所观察物体的图像聚焦在视网膜上而非视网膜前方。用于治疗近视的有晶体眼人工晶状体通过使光线发散来起作用,从而使所观察物体的图像聚焦在视网膜上而非视网膜前方。它们可置于虹膜前方的眼前房或虹膜与自然晶状体之间的眼后房。

目的

本综述的目的是比较准分子激光屈光手术与有晶体眼人工晶状体植入术矫正中高度近视的效果。

检索方法

我们检索了Cochrane中心对照试验注册库(CENTRAL)(其中包含Cochrane眼科和视力组试验注册库)(《Cochrane图书馆》2011年第11期)、MEDLINE(1950年1月至2011年11月)、EMBASE(1980年1月至2011年11月)、拉丁美洲和加勒比地区卫生科学文献数据库(LILACS)(1982年1月至2011年11月)、对照试验元注册库(mRCT)(www.controlled-trials.com)、ClinicalTrials.gov(www.clinicaltrials.gov)以及世界卫生组织国际临床试验注册平台(ICTRP)(www.who.int/ictrp/search/en)。电子检索试验时没有日期或语言限制。电子数据库的最后检索时间为2011年11月28日。

入选标准

我们纳入了比较准分子激光屈光手术和有晶体眼人工晶状体植入术矫正等效球镜度数大于6.0屈光度(D)近视的随机对照试验(RCT)。

数据收集与分析

两位作者独立评估试验质量并提取数据。我们进行了数据分析。我们使用比值比总结结局数据。由于本综述仅纳入了三项试验,我们采用了固定效应模型。

主要结果

本综述纳入了三项RCT,共228只眼。纳入患者的近视范围为-6.0 D至-20.0 D近视,伴有高达4.0 D的近视散光。术后12个月时,两组间未矫正视力(UCVA)达到20/20或更好的眼的百分比无显著差异。对于中高度近视,有晶体眼人工晶状体手术比准分子激光手术矫正更安全,因为术后12个月时其导致的最佳矫正视力(BSCVA)损失显著更少。然而,有晶体眼人工晶状体植入术后发生早期白内障的风险较低。对于中高度近视,有晶体眼人工晶状体手术似乎比准分子激光矫正能带来更好的对比敏感度。有晶体眼人工晶状体手术在患者满意度/偏好问卷上的得分也更高。

作者结论

本综述结果表明,对于-6.0至-20.0 D范围内的中高度近视,有晶体眼人工晶状体比准分子激光手术矫正更安全,且患者更倾向于选择有晶体眼人工晶状体。虽然有晶体眼人工晶状体可能是较高程度近视(等效球镜度数大于或等于7.0 D近视,伴有或不伴有散光)的可接受临床治疗方法,但对于较中度近视(等效球镜度数小于或等于7.0 D近视,伴有或不伴有散光),考虑有晶体眼人工晶状体治疗而非准分子激光矫正可能是值得的。需要进一步开展有足够样本量进行亚组分析的RCT,以进一步阐明有晶体眼人工晶状体的理想近视范围。

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