A Double-blind, Randomized Controlled Study of Low Concentration Atropine in the Prevention of Myopia in Pre-myopia Children.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 428
- 试验地点
- 1
- 主要终点
- Cumulative Incidence of Myopia
研究概览
简要总结
This double-blind, randomized controlled clinical study is to evaluate the effectiveness and safety of low concentration atropine in preventing myopia in pre-myopia children, and to explore whether there is a dose effect relationship between different concentrations of atropine in preventing myopia.
详细描述
The main questions this double-blind, randomized controlled clinical study aims to answer are:
- To evaluate the effect of low concentration atropine on the incidence of myopia in pre myopia children.
- To evaluate the effectiveness of low concentration atropine in controlling refractive and axial progression.
Patients are randomly divided into three treatment groups with different atropine concentrations(0.01%, 0.02%, 0.04%) and one control group with atropine dissolvant. Patients are required to use the eye drops every night for one year and record after daily usage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age of the screening stage is 6-9 years, both sexes;
- •One eye met the diagnosis of pre-myopia, the spherical equivalent was between -0.50D and +0.75D, the astigmatism was ≥-1.50D, and the best corrected far vision was at least 1.0;
- •At least one of parents suffers from myopia (SE of at least one eye <=-3.00D);
- •Parents have signed informed consent and agree to participate in screening and follow-up.
排除标准
- •Parents disagree to sign the informed consent;
- •Presence of strabismus, amblyopia, or other ocular abnormalities, or have a history of eye surgery;
- •Presence of other eye or systemic diseases;
- •Allergies to low concentration atropine or sulfuric acid drugs;
- •Histories of using other preventive measures, such as using red light within 6 months or atropine within 1 month;
- •Presence of other situations that the researchers think is not appropriate for patients to be included in the project.
研究组 & 干预措施
placebo
placebo eye drop
干预措施: Placebo (Drug)
0.04% atropine
0.04% atropine eye drop
干预措施: low concentration atropine (0.04%) (Drug)
0.01% atropine
0.01% atropine eye drop
干预措施: low concentration atropine (0.01%) (Drug)
0.02% atropine
0.02% atropine eye drop
干预措施: low concentration atropine (0.02%) (Drug)
结局指标
主要结局
Cumulative Incidence of Myopia
时间窗: 1 year
Effectiveness Evaluation
次要结局
- Changes in visual acuity(1 year)
- Changes in Choroidal Thickness(1 year)
- Changes in SE (after cycloplegia)(1 year)
- Changes in AL(1 year)