Efficacy Comparison of 2 Low-dose Atropine Eye Drops in Vietnamese Children Myopia Management
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Efficacy (SE) of Atropine drops
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy of 2 low-dose atropine drops (0,01%; 0,05%) in Vietnamese children. The main questions it aims to answer are:
- How is the difference in efficacy among 3 groups: atropine 0,01% vs 0,05% vs spectacles?
- How is the difference in side effects among 3 groups: atropine 0,01% vs 0,05% vs spectacles?
- How is the difference in rebound phenomena between 2 atropine groups?
详细描述
The study is prospective, comparative, open label. Participants are Vietnamese children. Prescribing drops : 1 drops/eye/night/ 12 months Wash-out: 12 months The atropine drops in this study are commercially available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •myopic 2 eyes (SE above from -0.75 D, astigmatism below -1.50D)
- •8 - 13 years old
- •Vietnamese, speaking Vietnamese
- •BCVA from 8/10 each eye
排除标准
- •Using any contact lens in less than 3 months
- •Other eye diseases than myopia
- •History of eye trauma, surgeries
- •Having chronic systemic diseases or having medications affecting eye.
- •Having contraindications of atropine drops
- •Pre-known allergies to atropine drops
- •Undergoing another myopia control treatments
研究组 & 干预措施
Myatro
Prescribing one 0,01% Myatro (Atropine) drop/eye/night , in 12 months Then wash-out in next 12 months
干预措施: Myatro (Drug)
Myatro XL
Prescribing one 0,05% Myatro XL (Atropine) drop/eye/night , in 12 months Then wash-out in next 12 months
干预措施: Myatro XL (Drug)
结局指标
主要结局
Efficacy (SE) of Atropine drops
时间窗: 12 months
measured by change in spherical equivalent (D) (Objective cycloplegic refraction)
Efficacy (AL) of Atropine drops
时间窗: 12 months
axial length (mm)
次要结局
- adverse symptoms 1(12 months)
- adverse symptoms 2(12 months)
- rebound effect (AL)(12 months)
- amplitude of accommodation(12 months)
- pupil size(12 months)
- rebound effect (SE)(12 months)
研究者
Thi Mong Dung Nguyen
Principal Investigator
University of Medicine and Pharmacy at Ho Chi Minh City