Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Kyoto, Japan.
Department of Ophthalmology, Faculty of Medicine, University of Tsukuba, Tusukuba, Ibaraki, Japan.
Jpn J Ophthalmol. 2021 May;65(3):315-325. doi: 10.1007/s10384-021-00822-y. Epub 2021 Feb 14.
Atropine eye drops prevent the progression of myopia, but their use has not been tested in the Japanese schoolchildren population. Here, we evaluate the efficacy and safety of 0.01% atropine eye drops for myopia control in Japanese children.
Multicenter (7 university hospitals), randomized, double-masked, placebo-controlled trial.
Participants were 171 Japanese schoolchildren aged 6 to 12 years, with progressive myopia, spherical equivalence (SE) of -1.00 to -6.00 diopters (D), and astigmatism of ≤1.5 D. They were randomized to receive either 0.01% atropine (n=85) or placebo (n=86) eye drops once nightly OU for 24 months. Primary and secondary efficacy endpoints were changes in SE and axial length (AL), respectively, from baseline to month 24.
Data from 168 subjects were analyzed. At month 24, compliance was similar in both groups (atropine: 83.3%; placebo: 85.7%). The least squares mean change in SE and AL from baseline were, respectively, -1.26 D (95% confidence interval [CI]: -1.35, -1.17) and 0.63 mm (0.59, 0.67) for atropine and -1.48 D (- 1.57, -1.39) and 0.77 mm (0.73, 0.81) for placebo. Inter-group differences were 0.22 D (95% CI: 0.09, 0.35; P < 0.001) for SE and - 0.14 mm (-0.20, -0.08; P < 0.001) for AL. Three patients experienced mild allergic conjunctivitis side effects, with no inter-group difference in incidence (atropine: 2.4%; 2/84 patients; placebo: 1.4%; 1/84 patients).
With good compliance, 0.01% atropine is effective and safe for preventing the progression of childhood myopia.
阿托品滴眼液可阻止近视进展，但尚未在日本学龄儿童人群中进行过相关疗效验证。本研究旨在评估 0.01%阿托品滴眼液在日本儿童近视防控中的疗效和安全性。
多中心（7 所大学医院）、随机、双盲、安慰剂对照试验。
研究对象为 171 名年龄在 6 至 12 岁、近视进展、等效球镜（SE）为−1.00 至−6.00 屈光度（D）且散光≤1.5 D 的日本学龄儿童。他们被随机分配至每晚接受 0.01%阿托品（n=85）或安慰剂（n=86）滴眼治疗，连续 24 个月。主要和次要疗效终点分别为从基线到 24 个月时 SE 和眼轴长度（AL）的变化。
共分析了 168 名受试者的数据。两组的依从性相似（阿托品组：83.3%；安慰剂组：85.7%）。从基线到 24 个月，SE 和 AL 的最小二乘均数变化分别为−1.26 D（95%置信区间[CI]：−1.35，−1.17）和 0.63 mm（0.59，0.67）（阿托品组）和−1.48 D（−1.57，−1.39）和 0.77 mm（0.73，0.81）（安慰剂组）。组间差异为 SE 差值 0.22 D（95% CI：0.09，0.35；P<0.001）和 AL 差值−0.14 mm（−0.20，−0.08；P<0.001）。3 名患者出现轻度过敏性结膜炎副作用，但两组间发生率无差异（阿托品组：2.4%；2/84 例；安慰剂组：1.4%；1/84 例）。
0.01%阿托品滴眼液疗效确切，安全性良好，可有效阻止儿童近视进展。
