NCT05597163
尚未招募
不适用
A Multicenter, Double-blind, Randomized, Controlled Clinical Study of the Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents
概览
- 阶段
- 不适用
- 干预措施
- low concentration atropine (0.01%)
- 疾病 / 适应症
- Myopia, Progressive
- 发起方
- Shanghai Eye Disease Prevention and Treatment Center
- 入组人数
- 588
- 主要终点
- Proportion of SE changes over -0.75D
- 状态
- 尚未招募
- 最后更新
- 3年前
概览
简要总结
To investigate the efficacy and safety of three low-concentration atropine sulfate eye drops (0.01%, 0.025% and 0.05%) in controlling the progression of myopia in Chinese children and adolescents through a two-year clinical trial.
研究者
入排标准
入选标准
- •The age of the screening stage is 3-15 years, both sexes;
- •One eye met the diagnosis of myopic refractive error, the spherical equivalent was between -0.50D and -8.00D, the astigmatism was ≥-3.00D, and the best corrected far vision was at least 0.8;
- •Have normal thinking and language communication ability, and can actively cooperate with treatment and follow-up as required;
- •Informed consent from the guardian and the child.
排除标准
- •strabismus, amblyopia or other ocular abnormalities;
- •The presence of systemic disease abnormalities;
- •have taken myopia control treatment in the past month;
- •Allergic to low concentration atropine or sulfuric acid drugs.
研究组 & 干预措施
0.01% atropine
0.01% atropine eye drop
干预措施: low concentration atropine (0.01%)
0.025% atropine
0.025% atropine eye drop
干预措施: low concentration atropine (0.025%)
0.05% atropine
0.05% atropine eye drop
干预措施: low concentration atropine (0.05%)
cross-over
first year: placebo second year: 0.05% atropine eye drop
干预措施: low concentration atropine (0.05%)
cross-over
first year: placebo second year: 0.05% atropine eye drop
干预措施: Placebo
结局指标
主要结局
Proportion of SE changes over -0.75D
时间窗: 2 years
次要结局
- AL change(2 years)
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