Treatment Effect of Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate as Classified by Electro-retinal Responses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Annualized Changes in Refractive Error (SER)
研究概览
简要总结
Our project is a 24-month longitudinal randomized controlled trial that aims to investigate the myopia development after topical application of 0.01% atropine in children with either fast or slow myopia progression classified according to their initial electro-retinal responses. This will help elucidate the effectiveness of using low concentration atropine for myopia control in children with different myopia progression rates.
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, Investigator)
盲法说明
Double-blinded
入排标准
- 年龄范围
- 7 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 7 and 10 years
- •Good general health and no family history of ocular diseases
- •No current or history of epilepsy or asthma
- •Myopia : -0.50 to -1.00 D (inclusive, both eyes)
- •Astigmatism : ≤ 0.50 D
- •No hyperopia, amblyopia or strabismus
- •No reported ocular eye diseases or disorders
- •No drug allergy
排除标准
- 未提供
研究组 & 干预措施
Atropine 0.01%
Group receiving atropine treatment for 18 months
干预措施: Atropine (0.01%) (Drug)
Artifical tear
Group receiving placebo for 18 months
干预措施: Artificial tear (Drug)
结局指标
主要结局
Annualized Changes in Refractive Error (SER)
时间窗: 18 months
Annualized changes in refractive error (SER) after receiving the 0.01 atropine or artificial tears up to 18 months
次要结局
- Annualized Change in Axial Length(18 months)
研究者
Henry HL Chan, PhD
Association Professor
The Hong Kong Polytechnic University