Topical 0.01% Atropine for the Control of Fast Progressing Myopia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Myopia in spherical diopters
研究概览
简要总结
Myopia prevalence has dramatically increased worldwide in recent years in the general population and among children. Progressive myopia increases gradually with growth until the age of 20-25 years. At the same time, there is a remarkable increase in the prevalence of severe myopia (more than -6 diopters). Severe myopia is associated with many complications, which can lead to blindness. There is thus an increase in the number of myopic patients in general, and severe myopic patients in particular.
The management of myopia and its complications is therefore a major public health issue.
All the means likely to slow the evolution of myopia (thus to limit the prevalence of strong myopia) must be developed to limit the consequences. 0.01% Atropine seems to be a drug with a great interest to slow down the progression of myopia.
The aim of the present study is to evaluate the efficacy at 1 year of 0.01% atropine (1 drop per day administered for 1 year) on the reduction of fast progressing myopia in children aged 4 to 12, compared to a control group (instillation of a placebo).
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
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children from 4 to 12 years
- •Myopia from -1 to -6
- •Fast progressing myopia (>0.75 diopter / year)
- •Informed consent obtained
排除标准
- •Astigmatism > 1.5 diopters
- •Anisometropia > 2 diopters
- •Concomitant pathology of anterior or posterior segments
- •Other ocular diseases (Ocular inflammation, strabismus ...)
- •Atropine hypersensitivity or allergy
研究组 & 干预措施
Atropine 0.01%
干预措施: Atropine 0.01% (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Myopia in spherical diopters
时间窗: 3 months
Automatic measurement of myopia in spherical diopters under cycloplegia
次要结局
- Axial length(9 months)
- Adverse events(3 months)
- Quality of life questionnaire(3 months)