NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.
Experimental Psychology, University College London, London, UK.
Cochrane Database Syst Rev. 2022 Feb 7;2(2):CD011347. doi: 10.1002/14651858.CD011347.pub3.
BACKGROUND: Current treatments for amblyopia, typically patching or pharmacological blurring, have limited success. Less than two-thirds of children achieve good acuity of 0.20 logMAR in the amblyopic eye, with limited improvement of stereopsis, and poor adherence to treatment. A new approach, based on presentation of movies or computer games separately to each eye, may yield better results and improve adherence. These treatments aim to balance the input of visual information from each eye to the brain. OBJECTIVES: To determine whether binocular treatments in children, aged three to eight years, with unilateral amblyopia result in better visual outcomes than conventional patching or pharmacological blurring treatment. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register), MEDLINE, Embase, ISRCTN, ClinicalTrials.gov, and the WHO ICTRP to 19 November 2020, with no language restrictions. SELECTION CRITERIA: Two review authors independently screened the results of the search for relevant studies. We included randomised controlled trials (RCTs) that enrolled children between the ages of three and eight years old with unilateral amblyopia. Amblyopia was classed as present when the best-corrected visual acuity (BCVA) was worse than 0.200 logMAR in the amblyopic eye, with BCVA 0.200 logMAR or better in the fellow eye, in the presence of an amblyogenic risk factor, such as anisometropia, strabismus, or both. To be eligible, children needed to have undergone cycloplegic refraction and ophthalmic examination, including fundal examination and optical treatment, if indicated, with stable BCVA in the amblyopic eye despite good adherence with wearing glasses. We included any type of binocular viewing intervention, on any device (e.g. computer monitors viewed with liquid-crystal display shutter glasses; hand-held screens, including mobile phones with lenticular prism overlay; or virtual reality displays). Control groups received standard amblyopia treatment, which could include patching or pharmacological blurring of the better-seeing eye. We included full-time (all waking hours) and part-time (between 1 and 12 hours a day) patching regimens. We excluded children who had received any treatment other than optical treatment; and studies with less than 8-week follow-up. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. The primary outcome of the review was the change from baseline of distance BCVA in the amblyopic eye after 16 (± 2) weeks of treatment, measured in logMAR units on an age-appropriate acuity test. MAIN RESULTS: We identified one eligible RCT of conventional patching treatment versus novel binocular treatment, and analysed a subset of 68 children who fulfilled the age criterion of this review. We obtained data for the mean change in amblyopic eye visual acuity, adverse events (diplopia), and adherence to prescribed treatment at 8- and 16-week follow-up intervals, though no data were available for change in BCVA after 52 weeks. Risk of bias for the included study was considered to be low. The certainty of evidence for the visual acuity outcomes at 8 and 16 weeks of treatment and adherence to the study intervention was rated moderate using the GRADE criteria, downgrading by one level due to imprecision. The certainty of evidence was downgraded by two levels and rated low for the proportion of participants reporting adverse events due to the sample size. Acuity improved in the amblyopic eye in both the binocular and patching groups following 16 weeks of treatment (improvement of -0.21 logMAR in the binocular group and -0.24 logMAR in the patching group, mean difference (MD) 0.03 logMAR (95% confidence interval (CI) -0.10 to 0.04; 63 children). This difference was non-significant and the improvements in both the binocular and patching groups are also considered clinically similar. Following 8 weeks of treatment, acuity improved in both the binocular and patching groups (improvement of -0.18 logMAR in the patching group compared to -0.16 logMAR improvement in the binocular-treatment group) (MD 0.02, 95% CI -0.04 to 0.08). Again this difference was statistically non-significant, and the differences observed between the patching and binocular groups are also clinically non-significant. No adverse event of permanent diplopia was reported. Adherence was higher in the patching group (47% of participants in the iPad group achieved over 75% compliance compared with 90% of the patching group). Data were not available for changes in stereopsis nor for contrast sensitivity following treatment. AUTHORS' CONCLUSIONS: Currently, there is only one RCT that offers evidence of the safety and effectiveness of binocular treatment. The authors are moderately confident that after 16 weeks of treatment, the gain in amblyopic eye acuity with binocular treatment is likely comparable to that of conventional patching treatment. However, due to the limited sample size and lack of long term (52 week) follow-up data, it is not yet possible to draw robust conclusions regarding the overall safety and sustained effectiveness of binocular treatment. Further research, using acknowledged methods of visual acuity and stereoacuity assessment with known reproducibility, is required to inform decisions about the implementation of binocular treatments for amblyopia in clinical practice, and should incorporate longer term follow-up to establish the effectiveness of binocular treatment. Randomised controlled trials should also include outcomes reported by users, adherence to prescribed treatment, and recurrence of amblyopia after cessation of treatment.
背景:目前,治疗弱视的方法主要是遮盖或药物性模糊,疗效有限。不到三分之二的儿童在弱视眼中获得 0.20 对数视力的良好视力,立体视锐度改善有限,治疗依从性差。一种新的方法,基于向每只眼睛呈现电影或电脑游戏,可能会产生更好的结果并提高依从性。这些治疗方法旨在平衡大脑从每只眼睛接收的视觉信息。
目的:确定对于 3 至 8 岁患有单侧弱视的儿童,双眼治疗是否比传统的遮盖或药物性模糊治疗能产生更好的视力结果。
检索方法:我们检索了 CENTRAL(包含 Cochrane 眼部和视觉试验注册库)、MEDLINE、Embase、ISRCTN、ClinicalTrials.gov 和 WHO ICTRP,截至 2020 年 11 月 19 日,无语言限制。
选择标准:两位综述作者独立筛选搜索结果,以确定相关研究。我们纳入了随机对照试验(RCT),纳入了年龄在 3 至 8 岁之间、患有单侧弱视的儿童。弱视的定义是,在未矫正的最佳视力(BCVA)在弱视眼中差于 0.200 对数视力,而在对侧眼的 BCVA 为 0.200 对数视力或更好,且存在致弱视风险因素,如屈光不正、斜视或两者兼有。要符合纳入标准,儿童需要进行睫状肌麻痹验光和眼科检查,包括眼底检查和光学治疗,如果在弱视眼尽管对戴眼镜有良好的依从性,但 BCVA 稳定的情况下需要进行光学治疗。我们纳入了任何类型的双眼观察干预措施,任何设备上都可以进行(例如,使用液晶显示器快门眼镜观看的电脑显示器;手持屏幕,包括带有透镜棱镜覆盖物的移动电话;或虚拟现实显示器)。对照组接受标准弱视治疗,包括遮盖或药物性模糊对侧视力较好的眼睛。我们纳入了全天(所有清醒时间)和部分时间(每天 1 至 12 小时)的遮盖方案。我们排除了仅接受光学治疗以外的任何治疗的儿童;以及随访时间少于 8 周的研究。
数据收集和分析:我们使用了 Cochrane 预期的标准方法学程序。本综述的主要结果是治疗 16(±2)周后,在年龄适宜的视力测试上,弱视眼的距离 BCVA 从基线的变化,以对数视力单位(logMAR)表示。
主要结果:我们确定了一项关于传统遮盖治疗与新的双眼治疗的 RCT,并对符合本综述年龄标准的 68 名儿童进行了分析。我们获得了弱视眼视力变化、不良事件(复视)和治疗期间依从性的平均数据,在 8 周和 16 周的随访间隔,但没有 52 周时的 BCVA 变化数据。纳入研究的偏倚风险被认为是低的。使用 GRADE 标准,由于精度不足,将视力结果在 8 周和 16 周治疗以及对研究干预措施的依从性的证据确定性等级降低一级。由于样本量小,报告不良事件的参与者比例降低两级,将证据确定性等级评定为低。在 16 周的治疗后,双眼组和遮盖组的弱视眼视力均有所提高(双眼组提高-0.21 logMAR,遮盖组提高-0.24 logMAR,平均差异(MD)0.03 logMAR(95%置信区间(CI)-0.10 至 0.04;63 名儿童)。这种差异无统计学意义,且双眼组和遮盖组的改善程度也被认为是临床相似的。在 8 周的治疗后,双眼组和遮盖组的视力均有所提高(遮盖组提高-0.18 logMAR,双眼治疗组提高-0.16 logMAR)(MD 0.02,95%CI -0.04 至 0.08)。同样,这种差异无统计学意义,且遮盖组和双眼组之间的差异在临床上也无统计学意义。未报告永久性复视的不良事件。在遮盖组中,47%的 iPad 组参与者达到了超过 75%的依从性,而遮盖组的这一比例为 90%。
作者结论:目前,只有一项 RCT 提供了关于双眼治疗的安全性和有效性的证据。作者有中度信心,在治疗 16 周后,双眼治疗对弱视眼视力的提高可能与传统遮盖治疗相当。然而,由于样本量有限且缺乏长期(52 周)随访数据,目前尚无法得出关于双眼治疗总体安全性和持续有效性的可靠结论。需要进一步的研究,使用公认的视力和立体视锐度评估方法,并具有已知的可重复性,为临床实践中弱视的双眼治疗提供信息,并应纳入更长时间的随访,以确定双眼治疗的有效性。随机对照试验还应包括使用者报告的结果、对规定治疗的依从性以及治疗停止后弱视的复发情况。
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