Jones-Jordan Lisa, Wang Xue, Scherer Roberta W, Mutti Donald O
The Ohio State University, College of Optometry, 338 West 10th Avenue, 649 Fry Hall, Columbus, Ohio, USA, 43210.
Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology, 615 N. Wolfe Street, Baltimore, Maryland, USA, 21205.
Cochrane Database Syst Rev. 2020 Apr 2;4(4):CD007738. doi: 10.1002/14651858.CD007738.pub3.
Hyperopia in infancy requires accommodative effort to bring images into focus. Prolonged accommodative effort has been associated with an increased risk of strabismus. Strabismus may result in asthenopia and intermittent diplopia, and makes near work tasks difficult to complete. Spectacles to correct hyperopic refractive error is believed to prevent the development of strabismus.
To assess the effectiveness of prescription spectacles compared with no intervention for the prevention of strabismus in infants and children with hyperopia.
We searched CENTRAL (2018, Issue 12; which contains the Cochrane Eyes and Vision Trials Register); Ovid MEDLINE; Embase.com; three other databases; and two trial registries. We used no date or language restrictions in the electronic search for trials. We last searched the electronic databases on 4 December 2018.
We included randomized controlled trials and quasi-randomized trials investigating spectacle intervention or no treatment for children with hyperopia. We required hyperopia to be at least greater than +2.00 diopters (D).
We used standard Cochrane methodological procedures. The primary outcome was the proportion of children with manifest strabismus, as defined by study investigators. Other outcomes included the amblyopia, stereoacuity, and the effect of spectacle use of strabismus and visual acuity. We also collected information on change in refractive error as a measurement of the interference of emmetropization.
We identified four randomized controlled trials (985 children enrolled who were aged six months to less than 36 months) in this review. Three trials were in the UK with follow-up periods ranging from one to 3.5 years and one in the US with three years' follow-up. Investigators reported both incidence and final status regarding strabismus. Evidence of the incidence of strabismus, measured in 804 children over three to four years in four trials was uncertain although suggestive of a benefit with spectacle use (risk ratio (RR) 0.65, 95% confidence interval (CI) 0.41 to 1.02). We have very low confidence in these results due to high risk of bias, inconsistency, and imprecision. When assessed as the proportion of children with strabismus at the end of three years' follow-up, we found a similar level of evidence for an effect of spectacles on strabismus as reported in one study (RR 1.00, 95% CI 0.31 to 3.25; 106 children). We have very low confidence in these results because of low sample size and risk of bias. One trial reported on the risk for developing amblyopia and inadequate stereoacuity after three years in 106 children. There was unclear evidence for a decreased risk of developing amblyopia (RR 0.78, 95% CI 0.31 to 1.93), and limited evidence for a benefit of spectacles for prevention of inadequate stereoacuity (RR 0.38, 95% CI 0.16 to 0.88). We have very low confidence in these findings due to imprecision and risk of bias. The risk of not developing emmetropization is unclear. One trial reported on the proportion of children not achieving emmetropization at three years' follow-up (RR 0.75, 95% CI 0.18 to 3.19). One trial suggested spectacles impede emmetropization, and one trial reported no difference. These two trials could not be combined because the methods for assessing emmetropization were different. With the high risk of bias and inconsistency, the certainty of evidence for a risk for impeding or benefiting emmetropization is very low. Based on a meta-analysis of four trials (770 children), the risk of having visual acuity worse than 20/30 measured up to three years of age or at the end of three years of follow-up was uncertain for children with spectacle correction compared with those without correction (RR 0.87, 95% CI 0.64 to 1.18; very low confidence due to risk of bias and imprecision).
AUTHORS' CONCLUSIONS: The effect of spectacle correction for prevention of strabismus is still unclear. In addition, the use of spectacle on the risk of visual acuity worse than 20/30, amblyopia, and inadequate emmetropization is also unclear. There may be a benefit on prevention of inadequate stereoacuity. However, these effects may have been chance findings or due to bias.
婴儿期远视需要调节努力才能使图像清晰聚焦。长时间的调节努力与斜视风险增加有关。斜视可能导致视疲劳和间歇性复视，并使近距离工作任务难以完成。矫正远视屈光不正的眼镜被认为可以预防斜视的发生。
评估与不干预相比，佩戴处方眼镜对预防远视婴幼儿和儿童斜视的有效性。
我们检索了Cochrane中心对照试验注册库（CENTRAL，2018年第12期，其中包含Cochrane眼科和视力试验注册库）、Ovid MEDLINE、Embase.com以及其他三个数据库和两个试验注册库。我们在电子检索试验时没有设置日期或语言限制。我们最近一次检索电子数据库的时间是2018年12月4日。
我们纳入了调查眼镜干预或对远视儿童不进行治疗的随机对照试验和半随机试验。我们要求远视度数至少大于+2.00屈光度（D）。
我们采用标准的Cochrane方法学程序。主要结局是研究调查人员定义的显斜视儿童比例。其他结局包括弱视、立体视锐度以及佩戴眼镜对斜视和视力的影响。我们还收集了屈光不正变化的信息，作为衡量正视化干扰的指标。
我们在本综述中确定了四项随机对照试验（共纳入985名年龄在6个月至36个月以下的儿童）。三项试验在英国进行，随访期为1至3.5年，一项试验在美国进行，随访期为三年。研究人员报告了斜视的发病率和最终状态。四项试验中对804名儿童在三到四年内测量的斜视发病率证据尚不确定，尽管提示佩戴眼镜可能有益（风险比（RR）0.65，95%置信区间（CI）0.41至1.02）。由于存在高偏倚风险、不一致性和不精确性，我们对这些结果的信心非常低。当以三年随访结束时斜视儿童的比例进行评估时，我们发现一项研究报告的眼镜对斜视影响的证据水平相似（RR 1.00，95%CI 0.31至3.25；106名儿童）。由于样本量小和偏倚风险，我们对这些结果的信心非常低。一项试验报告了106名儿童三年后患弱视和立体视锐度不足的风险。弱视发病风险降低的证据不明确（RR 0.78，95%CI 0.31至1.93），眼镜预防立体视锐度不足有益的证据有限（RR 0.38，95%CI 0.16至0.88）。由于不精确性和偏倚风险，我们对这些发现的信心非常低。未发生正视化的风险尚不清楚。一项试验报告了三年随访时未实现正视化的儿童比例（RR 0.75，95%CI 0.18至3.19）。一项试验表明眼镜会阻碍正视化，另一项试验报告无差异。这两项试验无法合并，因为评估正视化的方法不同。由于存在高偏倚风险和不一致性，关于阻碍或促进正视化风险的证据确定性非常低。基于四项试验（770名儿童）的荟萃分析，与未矫正的儿童相比，矫正眼镜的儿童在三岁时或三年随访结束时视力低于20/30的风险尚不确定（RR 0.87，95%CI 0.64至1.18；由于偏倚风险和不精确性，信心非常低）。
眼镜矫正预防斜视的效果仍不明确。此外，佩戴眼镜对视力低于20/30、弱视和正视化不足风险的影响也不明确。在预防立体视锐度不足方面可能有益。然而，这些影响可能是偶然发现或由于偏倚导致的。
