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西澳大利亚阿托品治疗近视(WA-ATOM)研究:原理、方法和参与者基线特征。

Western Australia Atropine for the Treatment of Myopia (WA-ATOM) study: Rationale, methodology and participant baseline characteristics.

机构信息

Centre for Ophthalmology and Visual Sciences (incorporating Lions Eye Institute), University of Western Australia, Perth, Western Australia, Australia.

Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, Victoria, Australia.

出版信息

Clin Exp Ophthalmol. 2020 Jul;48(5):569-579. doi: 10.1111/ceo.13736. Epub 2020 Apr 1.

DOI:10.1111/ceo.13736
PMID:32100917
Abstract

IMPORTANCE

Atropine eyedrops are a promising treatment for slowing myopia progression in East Asian children. However, its effects on children in Australia, including those of non-Asian background, have not been well-studied.

BACKGROUND

The Western Australia Atropine for the Treatment of Myopia (WA-ATOM) study aims to determine the efficacy and long-term effects of low-dose atropine eyedrops in myopia control. This paper describes the study rationale, methodology and participant baseline characteristics.

DESIGN

Single-centre, double-masked, randomized controlled trial.

PARTICIPANTS

Children (6-16 years) with spherical equivalent ≤-1.50 D in each eye, astigmatism ≤1.50 D and myopia progression by ≥0.50 D/year.

METHODS

Enrolled children were randomly assigned 2:1 to receive 0.01% atropine or placebo eyedrops. Participants are examined every 6 months during first 3 years of the study (2-year treatment phase followed by a 1-year washout phase), and then at a 5-year follow-up (2 years after the end of the washout phase).

MAIN OUTCOME MEASURES

Annual progression rate of myopia and axial length, tolerability to eyedrops and incidence and severity of unwanted effects.

RESULTS

Out of 311 children who were referred, 242 were suitable for study participation, and 153 were subsequently enrolled. The baseline characteristics of enrolled participants are presented.

CONCLUSIONS AND RELEVANCE

Outcomes of the WA-ATOM study will inform on the efficacy, tolerability, safety and long-term effects of low-dose atropine eyedrops in myopia control in Australian children. The impact of ocular sun exposure, iris colour and parental myopia on the efficacy of low-dose atropine will also be assessed.

摘要

重要性

阿托品滴眼液是一种有前途的治疗东亚儿童近视进展的方法。然而,其在澳大利亚儿童中的效果,包括非亚洲背景的儿童,尚未得到充分研究。

背景

西澳大利亚阿托品治疗近视(WA-ATOM)研究旨在确定低剂量阿托品滴眼液在近视控制中的疗效和长期效果。本文描述了研究的原理、方法和参与者的基线特征。

设计

单中心、双盲、随机对照试验。

参与者

每只眼等效球镜度≤-1.50D、散光≤1.50D且近视进展≥0.50D/年的儿童(6-16 岁)。

方法

入组儿童随机分为 2:1 接受 0.01%阿托品或安慰剂滴眼液。参与者在前 3 年的研究中每 6 个月接受一次检查(2 年治疗期后进行 1 年洗脱期),然后在 5 年随访时(洗脱期结束后 2 年)进行随访。

主要观察指标

近视和眼轴的年进展率、滴眼液的耐受性以及不良事件的发生率和严重程度。

结果

在 311 名被转介的儿童中,242 名适合参加研究,其中 153 名随后被纳入。介绍了入组参与者的基线特征。

结论和相关性

WA-ATOM 研究的结果将为澳大利亚儿童使用低剂量阿托品滴眼液控制近视的疗效、耐受性、安全性和长期效果提供信息。还将评估眼部阳光暴露、虹膜颜色和父母近视对低剂量阿托品疗效的影响。

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