Low concentration atropine eye drops and progression of myopia in children: multicentre placebo controlled, double masked, randomised trial in the UK (CHAMP-UK).

Methods

Multicentre, double masked, superiority, placebo controlled, randomised trial.

多中心、双盲、优效性、安慰剂对照、随机试验。

National Health Service hospital eye services and academic institutions at five UK centres.

英国国家卫生服务（NHS）的五家医院眼科服务和学术机构。

289 children aged 6-12 years with myopia between -0.50 and -10.0 dioptres (D).

289名年龄在6-12岁之间、近视度数在-0.50至-10.0屈光度（D）的儿童。

Participants were allocated in ratio of 2:1 to atropine or placebo.

参与者按照2:1的比例分配到阿托品组或安慰剂组。

One eye drop of preserved atropine 0.01% or placebo daily for two years.

每天使用一滴含有防腐剂的0.01%阿托品或安慰剂，持续两年。

The primary outcome was spherical equivalent refractive error of both eyes measured by autorefractor under cycloplegia after two years.

主要结果是在睫状肌麻痹后使用自动验光仪测量的双眼球镜等效屈光误差，测量时间为两年后。

Secondary outcomes included change in axial length, best corrected distance and near visual acuity, reading speed, pupil diameter, spectacle correction, adverse eventrates, quality of life, and tolerability.

次要结果包括眼轴长度的变化、最佳矫正远视力和近视力、阅读速度、瞳孔直径、眼镜矫正、不良事件发生率、生活质量以及耐受性。

Outcomes were collected every six months.

每六个月收集一次结果。

An electronic monitoring system was used to assess adherence.

使用电子监测系统评估依从性。

Results

192 participants were included in the atropine group and 97 in the placebo group, with an average age of 9.3 years (standard deviation (SD) 1.7 years). 207 (72%) reported white ethnicity, 161 (56%) were girls, and the mean level of myopia was -2.87 D (SD 1.71 D).

192名参与者被纳入阿托品组，97名被纳入安慰剂组，平均年龄为9.3岁（标准差（SD）1.7岁）。207名（72%）报告为白人，161名（56%）为女孩，平均近视度数为-2.87 D（标准差（SD）1.71 D）。

A total of 235 (81%) participants completed the study, with primary outcome data available for 230 (80%) participants: 151 (79%) in the atropine group and 79 (81%) in the placebo group.

共有235名（81%）参与者完成了研究，有230名（80%）参与者的首要结果数据可用：阿托品组有151名（79%），安慰剂组有79名（81%）。

Atropine eye drops were more effective than placebo in reducing myopia progression (mean difference 0.33 D, 95% confidence interval(CI) 0.17 to 0.49 D, P<0.001).

阿托品眼药水在减缓近视进展方面比安慰剂更有效（平均差异0.33屈光度，95%置信区间（CI）0.17至0.49屈光度，P<0.001）。

Prespecified subgroup analyses did not show differences according to age, ethnicity, sex, or severity of myopia.

预先设定的亚组分析显示，根据年龄、种族、性别或近视严重程度，并未显示出差异。

Changes in central axial length were significantly less in the atropine group versus placebo group: mean difference 0.14 mm (95% CI 0.07 to 0.21, P<0.001).

与安慰剂组相比，阿托品组的中央轴向长度变化显著较小：平均差异为0.14毫米（95%置信区间0.07至0.21，P<0.001）。

There were no differences in other secondary outcomes, except pupil diameter, which was greater in the atropine group (0.36 mm, 95% CI 0.17, 0.55, P<0.001), and no differences in frequency of adverse events or in tolerability measures.

其他次要结果没有差异，除了瞳孔直径在阿托品组中更大（0.36毫米，95%置信区间0.17至0.55，P<0.001），并且在不良事件的频率或耐受性测量方面没有差异。

No serious adverse events were related to the trial drugs.

未发现与试验药物相关的严重不良事件。

Conclusions

Low concentration atropine (0.01%) eye drops significantly reduced progression of myopia and were well tolerated compared with placebo in children in the UK.

低浓度阿托品（0.01%）眼药水显著减缓了英国儿童近视的进展，并且与安慰剂相比耐受性良好。

trial_registration

ISRCTN registry ISRCTN99883695, ClinicalTrials.gov NCT03690089.

ISRCTN注册号ISRCTN99883695，ClinicalTrials.gov注册号NCT03690089。