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白内障摘除术后多焦点与单焦点人工晶状体的比较

Multifocal versus monofocal intraocular lenses after cataract extraction.

作者信息

de Silva Samantha R, Evans Jennifer R, Kirthi Varo, Ziaei Mohammed, Leyland Martin

机构信息

Oxford Eye Hospital, Oxford, UK.

Cochrane Eyes and Vision, ICEH, London School of Hygiene & Tropical Medicine, Keppel Street, London, UK, WC1E 7HT.

出版信息

Cochrane Database Syst Rev. 2016 Dec 12;12(12):CD003169. doi: 10.1002/14651858.CD003169.pub4.

Abstract

BACKGROUND

Good unaided distance visual acuity (VA) is now a realistic expectation following cataract surgery and intraocular lens (IOL) implantation. Near vision, however, still requires additional refractive power, usually in the form of reading glasses. Multiple optic (multifocal) IOLs are available which claim to allow good vision at a range of distances. It is unclear whether this benefit outweighs the optical compromises inherent in multifocal IOLs.

OBJECTIVES

To assess the visual effects of multifocal IOLs in comparison with the current standard treatment of monofocal lens implantation.

SEARCH METHODS

We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 5), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to June 2016), Embase (January 1980 to June 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 13 June 2016.

SELECTION CRITERIA

All randomised controlled trials comparing a multifocal IOL of any type with a monofocal IOL as control were included. Both unilateral and bilateral implantation trials were included. We also considered trials comparing multifocal IOLs with "monovision" whereby one eye is corrected for distance vision and one eye corrected for near vision.

DATA COLLECTION AND ANALYSIS

We used standard methodological procedures expected by Cochrane. We assessed the 'certainty' of the evidence using GRADE.

MAIN RESULTS

We found 20 eligible trials that enrolled 2230 people with data available on 2061 people (3194 eyes). These trials were conducted in Europe (13), China (three), USA (one), Middle East (one), India (one) and one multicentre study in Europe and the USA. Most of these trials compared multifocal with monofocal lenses; two trials compared multifocal lenses with monovision. There was considerable variety in the make and model of lenses implanted. Overall we considered the trials at risk of performance and detection bias because it was difficult to mask participants and outcome assessors. It was also difficult to assess the role of reporting bias.There was moderate-certainty evidence that the distance acuity achieved with multifocal lenses was not different to that achieved with monofocal lenses (unaided VA worse than 6/6: pooled RR 0.96, 95% confidence interval (CI) 0.89 to 1.03; eyes = 682; studies = 8). People receiving multifocal lenses may achieve better near vision (RR for unaided near VA worse than J3/J4 was 0.20, 95% CI 0.07 to 0.58; eyes = 782; studies = 8). We judged this to be low-certainty evidence because of risk of bias in the included studies and high heterogeneity (I = 93%) although all included studies favoured multifocal lenses with respect to this outcome.People receiving multifocal lenses may be less spectacle dependent (RR 0.63, 95% CI 0.55 to 0.73; eyes = 1000; studies = 10). We judged this to be low-certainty evidence because of risk of bias and evidence of publication bias (skewed funnel plot). There was also high heterogeneity (I = 67%) but all studies favoured multifocal lenses. We did not additionally downgrade for this.Adverse subjective visual phenomena were more prevalent and more troublesome in participants with a multifocal IOL compared with monofocals (RR for glare 1.41, 95% CI 1.03 to 1.93; eyes = 544; studies = 7, low-certainty evidence and RR for haloes 3.58, 95% CI 1.99 to 6.46; eyes = 662; studies = 7; moderate-certainty evidence).Two studies compared multifocal lenses with monovision. There was no evidence for any important differences in distance VA between the groups (mean difference (MD) 0.02 logMAR, 95% CI -0.02 to 0.06; eyes = 186; studies = 1), unaided intermediate VA (MD 0.07 logMAR, 95% CI 0.04 to 0.10; eyes = 181; studies = 1) and unaided near VA (MD -0.04, 95% CI -0.08 to 0.00; eyes = 186; studies = 1) compared with people receiving monovision. People receiving multifocal lenses were less likely to be spectacle dependent (RR 0.40, 95% CI 0.30 to 0.53; eyes = 262; studies = 2) but more likely to report problems with glare (RR 1.41, 95% CI 1.14 to 1.73; eyes = 187; studies = 1) compared with people receiving monovision. In one study, the investigators noted that more people in the multifocal group underwent IOL exchange in the first year after surgery (6 participants with multifocal vs 0 participants with monovision).

AUTHORS' CONCLUSIONS: Multifocal IOLs are effective at improving near vision relative to monofocal IOLs although there is uncertainty as to the size of the effect. Whether that improvement outweighs the adverse effects of multifocal IOLs, such as glare and haloes, will vary between people. Motivation to achieve spectacle independence is likely to be the deciding factor.

摘要

背景

白内障手术及人工晶状体(IOL)植入术后获得良好的裸眼远视力如今已成为现实的期望。然而,近视力仍需要额外的屈光力,通常以佩戴阅读眼镜的形式。有多种光学(多焦点)人工晶状体可供选择,宣称能在一系列距离下提供良好视力。目前尚不清楚这种益处是否超过多焦点人工晶状体固有的光学折衷。

目的

评估多焦点人工晶状体与当前单焦点晶状体植入的标准治疗相比的视觉效果。

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眼科和视力试验注册库)(2016年第5期)、Ovid MEDLINE、Ovid MEDLINE在研及其他非索引引文、Ovid MEDLINE每日更新、Ovid OLDMEDLINE(1946年1月至2016年6月)、Embase(1980年1月至2016年6月)、ISRCTN注册库(www.isrctn.com/editAdvancedSearch)、ClinicalTrials.gov(www.clinicaltrials.gov)以及世界卫生组织(WHO)国际临床试验注册平台(ICTRP)(www.who.int/ictrp/search/en)。我们在电子检索试验时未设置任何日期或语言限制。我们最后一次检索电子数据库是在2016年6月13日。

入选标准

纳入所有比较任何类型的多焦点人工晶状体与作为对照的单焦点人工晶状体的随机对照试验。包括单侧和双侧植入试验。我们还考虑了比较多焦点人工晶状体与“单眼视”的试验,即一只眼睛矫正远视力,另一只眼睛矫正近视力。

数据收集与分析

我们采用了Cochrane期望的标准方法程序。我们使用GRADE评估证据的“确定性”。

主要结果

我们发现20项符合条件的试验,共纳入2230人,其中2061人(3194只眼)有可用数据。这些试验在欧洲进行了13项、中国3项、美国1项、中东1项、印度1项,以及一项欧洲和美国的多中心研究。这些试验中大多数比较了多焦点与单焦点晶状体;两项试验比较了多焦点晶状体与单眼视。植入的晶状体品牌和型号差异很大。总体而言,我们认为这些试验存在执行和检测偏倚风险,因为很难对参与者和结果评估者进行遮蔽。评估报告偏倚的作用也很困难。有中等确定性证据表明,多焦点晶状体获得的远视力与单焦点晶状体获得的远视力无差异(裸眼视力差于6/6:合并RR 0.96,95%置信区间(CI)0.89至1.03;眼数 = 682;研究 = 8)。接受多焦点晶状体的人可能获得更好的近视力(裸眼近视力差于J3/J4的RR为0.20,95% CI 0.07至0.58;眼数 = 782;研究 = 8)。由于纳入研究存在偏倚风险且异质性高(I² = 93%),尽管所有纳入研究在此结果上都支持多焦点晶状体,我们将此判定为低确定性证据。接受多焦点晶状体的人可能对眼镜的依赖程度较低(RR 0.63,95% CI 0.55至0.73;眼数 = 1000;研究 = 10)。由于存在偏倚风险和发表偏倚证据(漏斗图不对称),我们将此判定为低确定性证据。此外,异质性也很高(I² = 67%),但所有研究都支持多焦点晶状体。我们未因此进一步降低证据等级。与单焦点人工晶状体相比,多焦点人工晶状体佩戴者的不良主观视觉现象更普遍且更麻烦(眩光的RR为1.41,95% CI 1.03至1.93;眼数 = 544;研究 = 7,低确定性证据;光晕的RR为3.58,95% CI 1.99至6.46;眼数 = 662;研究 = 7;中等确定性证据)。两项研究比较了多焦点晶状体与单眼视。与接受单眼视的人相比,两组在远视力(平均差(MD)0.02 logMAR,95% CI -0.02至0.06;眼数 = 186;研究 = 1)、裸眼中视力(MD 0.07 logMAR,95% CI 0.04至0.10;眼数 = 181;研究 = 1)和裸眼近视力(MD -0.04,95% CI -0.08至0.00;眼数 = 186;研究 = 1)方面均未发现任何重要差异。与接受单眼视的人相比,接受多焦点晶状体的人对眼镜的依赖可能性较小(RR 0.40,95% CI 0.30至0.53;眼数 = 262;研究 = 2),但报告眩光问题的可能性更大(RR 1.41,95% CI 1.14至1.73;眼数 = 187;研究 = 1)。在一项研究中,研究人员指出,多焦点组中更多人在术后第一年进行了人工晶状体置换(多焦点组6例参与者,单眼视组0例参与者)。

作者结论

相对于单焦点人工晶状体,多焦点人工晶状体在改善近视力方面是有效的,尽管效果大小尚不确定。这种改善是否超过多焦点人工晶状体的不良反应,如眩光和光晕,因人而异。实现摆脱眼镜依赖的动机可能是决定因素。

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