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用于快速进展性儿童近视的阿托品(0.05%)(近视进展研究)

Atropine (0.05%) for rapid progressive childhood myopia (ARM study).

作者信息

Saxena Rohit, Gupta Vinay, Thakur Himani, Dhiman Rebika, Velpandian Thirumurthy, Phuljhele Swati, Sharma Namrata

机构信息

Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.

出版信息

Indian J Ophthalmol. 2025 Mar 1;73(3):358-361. doi: 10.4103/IJO.IJO_1526_24. Epub 2024 Dec 27.

Abstract

PURPOSE

This study aims to assess the effectiveness of atropine 0.05% for myopia control among children exhibiting (documented) rapid myopia progression (>0.75D/year).

METHODS

This prospective interventional single-arm clinical trial included children aged between 6-12 years, spherical equivalent refractive (SER) error between - 2 and - 6D, and having documented myopia progression of >0.75D in the preceding year. All participants were administered atropine 0.05% in both eyes once at bedtime for 1 year. The primary outcome measure was a change in the rate of myopia progression (D/year) and change in SER and axial length (AL) at 1 year and documentation of any adverse effects related to therapy.

RESULTS

Forty children were enrolled with a mean age of 8.5 ± 2.2 years. (45% male) The mean SER 1 year before starting atropine treatment was -3.53 ± 0.78D. At baseline, the mean SER was -4.58 ± 1.03D, which increased to -4.98 ± 0.97D after 1-year follow-up. The study reported a 62% reduction in the rate of myopia progression after 1 year of atropine 0.05% treatment (-1.05 ± 0.21D/year [baseline] to - 0.4 ± 0.14D/year[1-year follow-up] [ P < 0.001]). The mean AL increased from 24.98 ± 2.43 mm (baseline) to 25.21 ± 2.32 mm (1 year). There was no significant correlation between changes in AL and SER ( r : 0.57; P : 0.063). The study observed the response to treatment was independent of the age at baseline, baseline refractive error, baseline rate of progression, gender, and family history of myopia. No adverse effects from atropine 0.05% were reported.

CONCLUSIONS

Atropine 0.05% could be an effective treatment for children with rapidly progressing myopia with no significant side effects.

摘要

目的

本研究旨在评估0.05%阿托品对近视进展迅速(记录显示>0.75D/年)的儿童控制近视的有效性。

方法

这项前瞻性干预单臂临床试验纳入了6至12岁的儿童,等效球镜屈光(SER)误差在-2至-6D之间,且前一年有记录显示近视进展>0.75D。所有参与者均在睡前双眼各滴一次0.05%阿托品,持续1年。主要结局指标为近视进展速率(D/年)的变化、1年后SER和眼轴长度(AL)的变化以及与治疗相关的任何不良反应记录。

结果

招募了40名儿童,平均年龄为8.5±2.2岁(45%为男性)。开始阿托品治疗前1年的平均SER为-3.53±0.78D。基线时,平均SER为-4.58±1.03D,1年随访后增至-4.98±0.97D。该研究报告称,0.05%阿托品治疗1年后近视进展速率降低了62%(从-1.05±0.21D/年[基线]降至-0.4±0.14D/年[1年随访][P<0.001])。平均AL从24.98±2.43mm(基线)增加到25.21±2.32mm(1年)。AL和SER的变化之间无显著相关性(r:0.57;P:0.063)。该研究观察到治疗反应与基线年龄、基线屈光不正、基线进展速率、性别和近视家族史无关。未报告0.05%阿托品有不良反应。

结论

0.05%阿托品可能是治疗近视进展迅速儿童的有效方法,且无明显副作用。

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