■外斜视和近视通常共存。然而,关于阿托品干预对近视和间歇性外斜视(IXT)儿童的近视控制的证据有限.
■为了评估0.01%阿托品滴眼液对近视进展的疗效和安全性,外斜视情况,近视和IXT患者的双眼视觉。
■这种安慰剂对照,双面蒙面,随机临床试验于2020年12月至2023年9月进行.纳入6至12岁的儿童,患有基础型IXT和双眼睫状肌麻痹屈光后-0.50至-6.00屈光度(D)的近视。
■参与者以2:1的比例被随机分配到0.01%的阿托品或安慰剂滴眼液中,在夜间对双眼进行一次,持续12个月。
■主要结果是1年时睫状肌麻痹球当量相对于基线的变化。次要结果包括轴向长度(AL)的变化,调节振幅(AA),外斜视情况,和1年时的双眼视力。
■在323名接受筛查的参与者中,300名儿童(平均[SD]年龄,9.1[1.6]岁;152名男性[50.7%])被纳入本研究。阿托品组共200名儿童(66.7%),安慰剂组100例(33.3%).在1年,与安慰剂组相比,0.01%阿托品组的球形等效进展较慢(-0.51Dvs-0.75D;差异=0.24D;95%CI,0.11~0.37D;P<.001)和AL伸长率(0.31mmvs0.42mm;差异=-0.11mm;95%CI,-0.17~-0.06mm;P<.001).阿托品组和安慰剂组的平均AA变化为-3.06D和0.12D(差异=-3.18D;95%CI,-3.92至-2.44D;P<.001),分别。0.01%阿托品组的离差幅度降低,而安慰剂组则增加(-1.25棱镜屈光度[PD]与0.74PD;差异=-1.99PD;95%CI,-3.79至-0.19PD;P=0.03)。在阿托品和安慰剂组,分别,研究药物相关畏光的发生率为6.0%(200名参与者中的12名)vs8.0%(100名参与者中的8名;差异=-2.0%;95%CI,-9.4%~3.7%;P=0.51),近视力模糊的发生率为6.0%(200名参与者中的12名)vs7.0%(100名参与者中的7名)(差异=-1.0%;95%CI,-8.2%~4.5%;P=
■这项随机临床试验的结果支持使用0.01%阿托品滴眼液,虽然在某种程度上损害了AA,用于减缓近视进展,而不干扰近视和IXT儿童的外斜视状况或双眼视力。
■中国临床试验注册管理机构:ChiCTR2000039827。
UNASSIGNED: Exotropia and myopia are commonly coexistent. However, evidence is limited regarding
atropine interventions for myopia control in children with myopia and intermittent exotropia (IXT).
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: Chinese Clinical Trial Registry Identifier: ChiCTR2000039827.