Purpose

Low-concentration atropine is an emerging therapy for myopia progression, but its efficacy and optimal concentration remain uncertain. Our study aimed to evaluate the efficacy and safety of low-concentration atropine eye drops at 0.05%, 0.025%, and 0.01% compared with placebo over a 1-year period.

Design

Randomized, placebo-controlled, double-masked trial.

Participants

A total of 438 children aged 4 to 12 years with myopia of at least −1.0 diopter (D) and astigmatism of −2.5 D or less.

Methods

Participants were randomly assigned in a 1:1:1:1 ratio to receive 0.05%, 0.025%, and 0.01% atropine eye drops, or placebo eye drop, respectively, once nightly to both eyes for 1 year. Cycloplegic refraction, axial length (AL), accommodation amplitude, pupil diameter, and best-corrected visual acuity were measured at baseline, 2 weeks, 4 months, 8 months, and 12 months. Visual Function Questionnaire was administered at the 1-year visit.

Main Outcome Measures

Changes in spherical equivalent (SE) and AL were measured, and their differences among groups were compared using generalized estimating equation.

Results

After 1 year, the mean SE change was −0.27±0.61 D, −0.46±0.45 D, −0.59±0.61 D, and −0.81±0.53 D in the 0.05%, 0.025%, and 0.01% atropine groups, and placebo groups, respectively (P < 0.001), with a respective mean increase in AL of 0.20±0.25 mm, 0.29±0.20 mm, 0.36±0.29 mm, and 0.41±0.22 mm (P < 0.001). The accommodation amplitude was reduced by 1.98±2.82 D, 1.61±2.61 D, 0.26±3.04 D, and 0.32±2.91 D, respectively (P < 0.001). The pupil sizes under photopic and mesopic conditions were increased respectively by 1.03±1.02 mm and 0.58±0.63 mm in the 0.05% atropine group, 0.76±0.90 mm and 0.43±0.61 mm in the 0.025% atropine group, 0.49±0.80 mm and 0.23±0.46 mm in the 0.01% atropine group, and 0.13±1.07 mm and 0.02±0.55 mm in the placebo group (P < 0.001). Visual acuity and vision-related quality of life were not affected in each group.

Conclusions

The 0.05%, 0.025%, and 0.01% atropine eye drops reduced myopia progression along a concentration-dependent response. All concentrations were well tolerated without an adverse effect on vision-related quality of life. Of the 3 concentrations used, 0.05% atropine was most effective in controlling SE progression and AL elongation over a period of 1 year.

中文翻译：

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低浓度阿托品用于近视进展（LAMP）研究

目的

低浓度阿托品是近视发展的新兴疗法，但其疗效和最佳浓度仍不确定。我们的研究旨在评估低浓度阿托品滴眼剂与安慰剂相比在1年期间的功效和安全性，分别为0.05％，0.025％和0.01％。

设计

随机，安慰剂对照，双掩蔽试验。

参加者

共有438名4至12岁的儿童，其近视度数至少为-1.0屈光度（D），且散光度为-2.5 D或更小。

方法

参与者以1：1：1：1的比例随机分配，每晚每只眼一次接受0.05％，0.025％和0.01％的阿托品滴眼液或安慰剂滴眼液，持续1年。在基线，2周，4个月，8个月和12个月时，测量了屈光不正，眼轴长度（AL），调节幅度，瞳孔直径和最佳矫正视力。在1年的随访中进行了视觉功能问卷调查。

主要观察指标

测量球形当量（SE）和AL的变化，并使用广义估计方程比较两组之间的差异。

结果

1年后，在0.05％，0.025％和0.01％的阿托品组和安慰剂组中，平均SE变化为-0.27±0.61 D，-0.46±0.45 D，-0.59±0.61 D和-0.81±0.53 D分别为（P <  0.001），AL的平均增加分别为0.20±0.25 mm，0.29±0.20 mm，0.36±0.29 mm和0.41±0.22 mm（P < 0.001）。调节幅度分别降低了1.98±2.82 D，1.61±2.61 D，0.26±3.04 D和0.32±2.91 D（P < 0.001）。在0.05％阿托品组中，在明视和中视条件下的瞳孔大小分别增加了1.03±1.02 mm和0.58±0.63 mm;在0.025％阿托品组中，分别为0.76±0.90 mm和0.43±0.61 mm，0.49±0.80 mm和0.23 0.01％阿托品组为±0.46 mm，安慰剂组为0.13±1.07 mm和0.02±0.55 mm（P <0.001）。视敏度和与视觉有关的生活质量在每个组中均未受到影响。

结论

0.05％，0.025％和0.01％的阿托品滴眼剂会降低近视的发展，并引起浓度依赖性反应。所有浓度均耐受良好，对视力相关的生活质量无不利影响。在使用的3种浓度中，0.05％的阿托品在1年内最有效地控制了SE的进展和AL的延长。