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一项针对 3 至 5 岁中度远视儿童立即配镜与延迟配镜的随机临床试验。

A Randomized Clinical Trial of Immediate Versus Delayed Glasses for Moderate Hyperopia in Children 3 to 5 Years of Age.

机构信息

Mayo Clinic, Rochester, Minnesota, USA.

College of Optometry, The Ohio State University, Columbus, Ohio, USA.

出版信息

Am J Ophthalmol. 2019 Dec;208:145-159. doi: 10.1016/j.ajo.2019.06.021. Epub 2019 Jun 28.

DOI:10.1016/j.ajo.2019.06.021
PMID:31255587
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6889016/
Abstract

PURPOSE

To compare visual acuity (VA) and binocularity outcomes in moderately hyperopic children with normal VA and binocularity assigned to glasses versus observation.

DESIGN

Prospective randomized clinical trial (RCT).

METHODS

One hundred nineteen 3- to 5-year-old children with hyperopia between +3.00D and +6.00D spherical equivalent were randomly assigned to glasses versus observation (with glasses prescribed if deteriorated for subnormal distance VA or near stereoacuity, or manifest strabismus). Follow-up occurred every 6 months. At 3 years, the treatment strategy was classified as "failed" if any of the following were met, both with and without correction: subnormal distance VA or stereoacuity; manifest strabismus; or strabismus surgery during follow-up.

RESULTS

Of 84 (71%) children who completed the primary outcome examination, failure occurred in five (12%; 95% confidence interval [CI]: 4%-26%) of 41 assigned to glasses and four (9%; 95% CI: 3%-22%) of 43 assigned to observation (difference = 3%; 95% CI: -12%-18%; P = .72). Deterioration prior to 3 years (requiring glasses per protocol) occurred in 29% (95% CI: 19%-43%) assigned to glasses and 27% (95% CI: 17%-42%) assigned to observation.

CONCLUSIONS

In an RCT comparing glasses to observation for moderately hyperopic 3- to 5-year-old children with normal VA and binocularity, failure for VA or binocularity was not common. With insufficient enrollment and retention, our study was unable to determine whether immediate glasses prescription reduces failure rate, but low failure rates suggest that immediate glasses prescription for these children may not be needed to prevent failure for VA and/or binocularity.

摘要

目的

比较远视程度适中(远视球镜度数在+3.00D 到+6.00D 之间)、远视力和双眼视功能正常的儿童,给予眼镜矫正与观察相比,其视力和双眼视功能的结果。

设计

前瞻性随机临床试验(RCT)。

方法

将 119 名 3 至 5 岁远视球镜度数在+3.00D 到+6.00D 之间的儿童随机分为眼镜组和观察组(如果远距视力或近立体视锐度低于正常值,或出现斜视,则给予眼镜矫正;如果远距视力或近立体视锐度低于正常值或出现斜视,且需要进行斜视手术,在随访期间则给予眼镜矫正)。每 6 个月进行一次随访。如果出现以下任何一种情况(包括矫正和未矫正),则在 3 年时将治疗策略定义为“失败”:远视力或立体视锐度低于正常值;出现斜视;或在随访期间接受斜视手术。

结果

84 名(71%)完成主要结局检查的儿童中,5 名(12%;95%置信区间[CI]:4%-26%)接受眼镜矫正的儿童和 4 名(9%;95% CI:3%-22%)接受观察组的儿童失败(差异为 3%;95% CI:-12%-18%;P=.72)。在 3 年前(根据方案需要眼镜),29%(95% CI:19%-43%)接受眼镜矫正的儿童和 27%(95% CI:17%-42%)接受观察组的儿童视力下降。

结论

在一项比较远视程度适中(远视球镜度数在+3.00D 到+6.00D 之间)、远视力和双眼视功能正常的 3 至 5 岁儿童给予眼镜矫正与观察的 RCT 中,远视力和双眼视功能失败并不常见。由于入组和保留率不足,本研究无法确定立即给予眼镜处方是否会降低失败率,但低失败率表明,对于这些儿童,立即给予眼镜处方可能不是预防远视力和/或双眼视功能失败所必需的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d2f/6889016/8fb771cbdfa7/nihms-1533071-f0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d2f/6889016/d13e1710e430/nihms-1533071-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d2f/6889016/24a4f4321d6e/nihms-1533071-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d2f/6889016/af3050707a0d/nihms-1533071-f0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d2f/6889016/8fb771cbdfa7/nihms-1533071-f0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d2f/6889016/d13e1710e430/nihms-1533071-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d2f/6889016/24a4f4321d6e/nihms-1533071-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d2f/6889016/af3050707a0d/nihms-1533071-f0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d2f/6889016/8fb771cbdfa7/nihms-1533071-f0004.jpg

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