Department of Ophthalmology, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.
School of Medical Technology, Jiangsu College of Nursing, Huai'an, China.
JAMA Ophthalmol. 2024 Aug 1;142(8):722-730. doi: 10.1001/jamaophthalmol.2024.2295.
Exotropia and myopia are commonly coexistent. However, evidence is limited regarding atropine interventions for myopia control in children with myopia and intermittent exotropia (IXT).
To evaluate the efficacy and safety of 0.01% atropine eye drops on myopia progression, exotropia conditions, and binocular vision in individuals with myopia and IXT.
DESIGN, SETTING, AND PARTICIPANTS: This placebo-controlled, double-masked, randomized clinical trial was conducted from December 2020 to September 2023. Children aged 6 to 12 years with basic-type IXT and myopia of -0.50 to -6.00 diopters (D) after cycloplegic refraction in both eyes were enrolled.
Participants were randomly assigned in a 2:1 ratio to 0.01% atropine or placebo eye drops administered in both eyes once at night for 12 months.
The primary outcome was change in cycloplegic spherical equivalent from baseline at 1 year. Secondary outcomes included change in axial length (AL), accommodative amplitude (AA), exotropia conditions, and binocular vision at 1 year.
Among 323 screened participants, 300 children (mean [SD] age, 9.1 [1.6] years; 152 male [50.7%]) were included in this study. A total of 200 children (66.7%) were in the atropine group, and 100 (33.3%) were in the placebo group. At 1 year, the 0.01% atropine group had slower spherical equivalent progression (-0.51 D vs -0.75 D; difference = 0.24 D; 95% CI, 0.11-0.37 D; P < .001) and AL elongation (0.31 mm vs 0.42 mm; difference = -0.11 mm; 95% CI, -0.17 to -0.06 mm; P < .001) than the placebo group. The mean AA change was -3.06 D vs 0.12 D (difference = -3.18 D; 95% CI, -3.92 to -2.44 D; P < .001) in the atropine and placebo groups, respectively. The 0.01% atropine group had a decrease in near magnitude of exodeviation whereas the placebo group had an increase (-1.25 prism diopters [PD] vs 0.74 PD; difference = -1.99 PD; 95% CI, -3.79 to -0.19 PD; P = .03). In the atropine vs placebo group, respectively, the incidence of study drug-related photophobia was 6.0% (12 of 200 participants) vs 8.0% (8 of 100 participants; difference = -2.0%; 95% CI, -9.4% to 3.7%; P = .51) and for blurred near vision was 6.0% (12 of 200 participants) vs 7.0% (7 of 100 participants) (difference = -1.0%; 95% CI, -8.2% to 4.5%; P = .74).
The findings of this randomized clinical trial support use of 0.01% atropine eye drops, although compromising AA to some extent, for slowing myopia progression without interfering with exotropia conditions or binocular vision in children with myopia and IXT.
Chinese Clinical Trial Registry Identifier: ChiCTR2000039827.
外斜视和近视通常同时存在。然而，关于阿托品干预对近视性间歇性外斜视（IXT）儿童近视控制的证据有限。
评估 0.01%阿托品滴眼液对近视性间歇性外斜视儿童近视进展、外斜视状况和双眼视觉的疗效和安全性。
设计、设置和参与者：这是一项安慰剂对照、双盲、随机临床试验，于 2020 年 12 月至 2023 年 9 月进行。招募了双眼屈光性睫状肌麻痹后屈光度为-0.50 至-6.00 屈光度（D）的基本型 IXT 和近视的 6 至 12 岁儿童。
参与者被随机分配按 2:1 的比例接受 0.01%阿托品或安慰剂滴眼液，每晚一次，持续 12 个月。
主要结局是 1 年时的睫状肌麻痹球镜等效变化。次要结局包括 1 年时的眼轴长度（AL）、调节幅度（AA）、外斜视状况和双眼视觉的变化。
在 323 名筛选参与者中，有 300 名儿童（平均[标准差]年龄，9.1[1.6]岁；男性 152 名[50.7%]）被纳入本研究。共有 200 名儿童（66.7%）被纳入阿托品组，100 名（33.3%）被纳入安慰剂组。1 年后，0.01%阿托品组的球镜等效进展速度较慢（-0.51 D 与-0.75 D；差值=0.24 D；95%置信区间，0.11-0.37 D；P<0.001），眼轴伸长速度较慢（0.31 mm 与 0.42 mm；差值=-0.11 mm；95%置信区间，-0.17 至-0.06 mm；P<0.001）。与安慰剂组相比，0.01%阿托品组的平均 AA 变化分别为-3.06 D 与 0.12 D（差值=-3.18 D；95%置信区间，-3.92 至-2.44 D；P<0.001）。0.01%阿托品组的近距外斜视量减少，而安慰剂组则增加（-1.25 棱镜度数[PD]与 0.74 PD；差值=-1.99 PD；95%置信区间，-3.79 至-0.19 PD；P=0.03）。与安慰剂组相比，0.01%阿托品组中与研究药物相关的畏光发生率分别为 6.0%（200 名参与者中的 12 名）和 8.0%（100 名参与者中的 8 名）（差异=-2.0%；95%置信区间，-9.4%至 3.7%；P=0.51），而近距视力模糊的发生率分别为 6.0%（200 名参与者中的 12 名）和 7.0%（100 名参与者中的 7 名）（差异=1.0%；95%置信区间，-8.2%至 4.5%；P=0.74）。
这项随机临床试验的结果支持使用 0.01%阿托品滴眼液，尽管在一定程度上影响 AA，但可减缓近视进展，而不会干扰近视性间歇性外斜视儿童的外斜视状况或双眼视觉。
中国临床试验注册中心标识符：ChiCTR2000039827。
