NCT00457717已完成1 期
Myopia Control by Combining Auricular Acupoint and Atropine Eyedrops
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- the progression of myopia degree, axial length elongation of eye
研究概览
简要总结
This study was designed to compare the difference of using atropine eyedrops alone from atropine combined with the stimulation of auricular acupoints therapy in reducing myopia progression.
详细描述
A total of 64 school-aged children with myopia, fulfilling eligibility criteria, were recruited. They were randomly assigned to three arms:
- 21 treated with the 0.25 % atropine each night (0.25A).
- 20 treated with the 0.5 % atropine each night (0.5A).
- 23 treated with 0.25 % atropine each night together with stimulation of auricular acupoints(0.25A+E).
This protocol was proceeded for at least 6 months.The differences in post-treatment effects of these three groups were statistically accessed.
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
- Single
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all included patients, age from 6 to 15 years, had myopia (spherical equivalent > -0.5 D) after cycloplegic refraction,
- •The astigmatism and anisometropia were less than 2.0 D,
- •IOP was less than 21 mmHg.
排除标准
- •the presence of related disease such as infection, ulceration, eyelid disease, ocular and auricular disorders,
- •individuals with amblyopia or strabismus,
- •individuals received any other therapies in the period of study,
- •individuals suffering some sort of haemostasis disorder,
- •individuals did not follow the treatment (eyedrops and/or stimulation of auricular acupoints) over seven days
结局指标
主要结局
the progression of myopia degree, axial length elongation of eye
次要结局
未报告次要终点
研究者
研究点 (2)
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