NCT03140358进行中（未招募）3 期
The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Spherical Equivalent
研究概览
简要总结
Study of low dose atropine in preventing the onset and progression of myopia in high risk children with pre-myopia or low-myopia.
详细描述
High risk children (with family history of myopia) with low hyperopia or low myopia will be randomized to atropine or placebo, with 2 -2.5 year treatment and 1 year washout.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Any eye or systemic disease that affect vision or refractive error
- •Conditions where topical atropine contraindicated
- •Previous use of atropine or pirenzepine
- •Known past/current amblyopia or strabismus
研究组 & 干预措施
Low myopia atropine
Active Comparator
On Atropine 0.01% daily or every other day
干预措施: Atropine sulfate 0.01% (Drug)
Premyopia atropine
Active Comparator
On Atropine 0.01%
干预措施: Atropine sulfate 0.01% (Drug)
Premyopia placebo
Placebo Comparator
On placebo
干预措施: Placebo (Drug)
Low myopia placebo
Placebo Comparator
On placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Spherical Equivalent
时间窗: 3.5 years
SE
次要结局
- Axial Length(3.5 years)
研究者
Audrey Chia Wei-Lin
Adjuct Associate Professor
Singapore National Eye Centre
研究点 (1)
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