Centre for Eye Research Ireland, School of Physics, Environmental Sustainability and Health Institute, Technological University Dublin, Dublin, Ireland.
Centre for Ophthalmology and Visual Science (incorporating Lions Eye Institute), The University of Western Australia, Perth, Western Australia, Australia.
Acta Ophthalmol. 2024 May;102(3):e245-e256. doi: 10.1111/aos.15761. Epub 2023 Sep 11.
The Myopia Outcome Study of Atropine in Children (MOSAIC) is an investigator-led, double-masked, randomized controlled trial investigating the efficacy and safety of 0.01% atropine eye drops for managing myopia progression in a predominantly White, European population.
Children aged 6-16 years with myopia were randomly allocated 2:1 to nightly 0.01% atropine or placebo eye drops in both eyes for 2 years. The primary outcome was cycloplegic spherical equivalent (SE) progression at 24 months. Secondary outcomes included axial length (AL) change, safety and acceptability. Linear mixed models with random intercepts were used for statistical analyses.
Of 250 participants enrolled, 204 (81.6%) completed the 24-month visit (136 (81.4%) treatment, 68 (81.9%) placebo). Baseline characteristics, drop-out and adverse event rates were similar between treatment and control groups. At 24 months, SE change was not significantly different between 0.01% atropine and placebo groups (effect = 0.10 D, p = 0.07), but AL growth was lower in the 0.01% atropine group, compared to the placebo group (-0.07 mm, p = 0.007). Significant treatment effects on SE (0.14 D, p = 0.049) and AL (-0.11 mm, p = 0.002) were observed in children of White, but not non-White (SE = 0.05 D, p = 0.89; AL = 0.008 mm, p = 0.93), ethnicity at 24 months. A larger treatment effect was observed in subjects least affected by COVID-19 restrictions (SE difference = 0.37 D, p = 0.005; AL difference = -0.17 mm, p = 0.001).
Atropine 0.01% was safe, well-tolerated and effective in slowing axial elongation in this European population. Treatment efficacy varied by ethnicity and eye colour, and potentially by degree of COVID-19 public health restriction exposure during trial participation.
阿托品防治儿童近视进展的研究（MOSAIC）是一项由研究者主导、双盲、随机对照临床试验，旨在研究 0.01%阿托品滴眼液在以白种人为主的欧洲人群中管理近视进展的疗效和安全性。
6-16 岁近视儿童随机分为 2:1 组，每晚双眼滴用 0.01%阿托品或安慰剂，持续 2 年。主要结局为 24 个月时的睫状肌麻痹球镜等效（SE）进展。次要结局包括眼轴（AL）变化、安全性和可接受性。采用具有随机截距的线性混合模型进行统计分析。
250 名入组患者中，204 名（81.6%）完成了 24 个月的随访（治疗组 136 名，81.4%；安慰剂组 68 名，81.9%）。治疗组和对照组之间的基线特征、失访率和不良事件发生率相似。24 个月时，0.01%阿托品组与安慰剂组的 SE 变化无显著差异（效应值=0.10D，p=0.07），但 0.01%阿托品组的 AL 增长低于安慰剂组（-0.07mm，p=0.007）。在白人儿童中观察到 SE（0.14D，p=0.049）和 AL（-0.11mm，p=0.002）有显著的治疗效果，但在非白人儿童中则无（SE=0.05D，p=0.89；AL=0.008mm，p=0.93）。在受 COVID-19 限制影响最小的受试者中，观察到更大的治疗效果（SE 差异=0.37D，p=0.005；AL 差异=-0.17mm，p=0.001）。
0.01%阿托品滴眼液在该欧洲人群中安全、耐受良好，并能有效减缓眼轴伸长。治疗效果因种族和眼颜色而异，并且可能因试验参与期间 COVID-19 公共卫生限制暴露程度而异。
