Low Concentrations of Atropine for Controlling Myopia Progression in School Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cycloplegic spherical refraction change
研究概览
简要总结
Myopia is the leading cause of blindness in Taiwan. The younger children with myopia, the higher risk of high myopia in later life and complications such as retinal detachment and maculopathy will occur. We have reported the low concentration of atropine (0.05%) with the effect on retarding the myopia progression. Recently the 0.01% atropine was also reported effective and with less visual side effects such as mydriasis. The aim of this study is to compare the efficacy in controlling myopia progression and visual side effects of 2 low concentration of atropine(0.05% vs 0.01%) in children aged 6-12 years with myopia of at least -0.5 diopters (D) and astigmatism of -1.50 D or less.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Myopia of at least -0.5 diopters (D) and astigmatism of -1.50 D or less.
排除标准
- •strabismus, amblyopia. cataract, glaucoma or any ocular diseases ocular surgery history systemic diseases (ex. asthma, heart disease...)
研究组 & 干预措施
0.01% Atropine
干预措施: Atropine (Drug)
0.05% Atropine
干预措施: Atropine (Drug)
结局指标
主要结局
Cycloplegic spherical refraction change
时间窗: 1 year
Cycloplegic spherical refraction change is the main indicator of the myopia progression.
次要结局
- Axial length change(1 year)