Randomized Controlled Trial of Different Lens Treatments on Chinese Adolescent Myopia
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change of Ocular Axial Length
研究概览
简要总结
The purpose of this study is to determine the efficacy of different lens treatments (normal spectacle lens, ortho-K, & Myovision) on myopia control in Chinese adolescent patients.
详细描述
Different lens treatments include normal spectacle lens, orthokeratology, and Myovision (a specially designed spectacle lens commercially available with peripheral defocus controlled as relative myopia).
This study is to evaluate the efficacy of these three methods in controlling myopia progression. Until now, there is no sufficient clinical evidences to compare different lens treatments.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent myopia patients
- •Myopic refraction between -1.00D and -4.50D
- •Astigmatism equal or less than -1.50D
- •Normal break up time of tear film (BUT > 10s)
排除标准
- •Existence of any ocular diseases except ametropia
- •Hyperopia
- •Severe dry eye
结局指标
主要结局
Change of Ocular Axial Length
时间窗: Baseline, 6 months, 12 months
Ocular axial length (AL), which increases with age, will be measured 3 times by an IOLMaster. The first AL examination was considered as the baseline data, and will be repeated 6 and 12 months later.
次要结局
- Change of Spherical Equivalent Refraction(Baseline, 6 months, 12 months)