Centre for Public Health, Queen's University Belfast School of Medicine Dentistry and Biomedical Sciences, Belfast, UK
School of Life & Health Sciences, Aston University, Birmingham, UK.
Br J Ophthalmol. 2020 Jul;104(7):950-955. doi: 10.1136/bjophthalmol-2019-314819. Epub 2019 Oct 25.
BACKGROUND/AIMS: To report the protocol of a trial designed to evaluate the efficacy, safety and mechanism of action of low-dose atropine (0.01%) eye-drops for reducing progression of myopia in UK children. METHODS: Multicentre, double-masked, superiority, placebo-controlled, randomised trial. We will enrol children aged 6-12 years with myopia of -0.50 dioptres or worse in both eyes.We will recruit 289 participants with an allocation ratio of 2:1 (193 atropine; 96 placebo) from five centres. Participants will instil one drop in each eye every day for 2 years and attend a research centre every 6 months. The vehicle and preservative will be the same in both study arms.The primary outcome is SER of both eyes measured by autorefractor under cycloplegia at 2 years (adjusted for baseline). Secondary outcomes include axial length, best corrected distance visual acuity, near visual acuity, reading speed, pupil diameter, accommodation, adverse event rates and allergic reactions, quality of life (EQ-5D-Y) and tolerability at 2 years. Mechanistic evaluations will include: peripheral axial length, peripheral retinal defocus, anterior chamber depth, iris colour, height and weight, activities questionnaire, ciliary body biometry and chorioretinal thickness. Endpoints from both eyes will be pooled in combined analysis using generalised estimating equations to allow for the correlation between eyes within participant. Three years after cessation of treatment, we will also evaluate refractive error and adverse events. CONCLUSIONS: The Childhood Atropine for Myopia Progression in the UK study will be the first randomised trial reporting outcomes of low-dose atropine eye-drops for children with myopia in a UK population. TRIAL REGISTRATION NUMBER: ISRCTN99883695, NCT03690089.
背景/目的:报告一项旨在评估低浓度阿托品(0.01%)滴眼剂在英国儿童近视进展中的疗效、安全性和作用机制的试验方案。 方法:多中心、双盲、优效性、安慰剂对照、随机试验。我们将招募年龄在 6-12 岁、双眼近视>-0.50 屈光度的儿童。我们将从五个中心招募 289 名参与者,分配比例为 2:1(193 名阿托品;96 名安慰剂)。参与者将每天在每只眼睛滴一滴,持续 2 年,并每 6 个月到研究中心就诊。两种研究药物的载体和防腐剂将相同。主要结局是 2 年时双眼经睫状肌麻痹下自动折射仪测量的 SER(调整基线)。次要结局包括眼轴长度、最佳矫正远视力、近视力、阅读速度、瞳孔直径、调节、不良事件发生率和过敏反应、生活质量(EQ-5D-Y)和 2 年时的耐受性。机制评估将包括:周边眼轴长度、周边视网膜离焦、前房深度、虹膜颜色、身高和体重、活动问卷、睫状体生物测量和脉络膜视网膜厚度。使用广义估计方程对双眼终点进行汇总分析,以允许参与者内双眼之间的相关性。治疗停止后 3 年,我们还将评估屈光度误差和不良事件。 结论:英国儿童近视进展中的阿托品治疗研究将是第一项报告低浓度阿托品滴眼剂在英国人群中治疗儿童近视的随机试验结果。 试验注册号:ISRCTN99883695,NCT03690089。
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