Muti-center Clinical Trial to Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Changes in ocular axial length in a year
研究概览
简要总结
Clinical trial to evaluate the safety and effectiveness of two kinds of ring band cylindrical lens in delaying the progression of myopia
详细描述
Two-hundered and forty children aged 6-13 will be recruited and allocated to three groups. Subjects that were randomized to receive Circular cylindrical mirror modulated frame glasses (compact), Circular cylindrical mirror modulated frame glasses (strong defocus) or single vision frame glasses, respectively.
Primary outcome measure ocular axial length and the secondary indicator is spherical equivalent after cycloplegia.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •6-13 years old;
- •SER: -0.75 to -5.00 dioptres (D). Astigmatism and anisometropia of 1.50 D or less;
- •Monocular best corrected visual acuity (VA) of 1.0 or better;
- •Acceptance of random group allocation and the masked study design
- •Voluntarily participate in the clinical trial and sign the informed consent;
排除标准
- •Strabismus.
- •Ocular and systemic abnormalities.
- •Prior experience of myopia control.
- •Only one eye meets the inclusion criteria.
研究组 & 干预措施
Circular cylindrical mirror modulated frame glasses (compact)
Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (compact) throughout the entire course of the study.
干预措施: Circular cylindrical mirror modulated frame glasses (compact) (Device)
Circular cylindrical mirror modulated frame glasses (strong defocus)
Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (strong defocus) throughout the entire course of the study.
干预措施: Circular cylindrical mirror modulated frame glasses (strong defocus) (Device)
single vision frame glasses
Subjects that were randomized to receive the single vision frame glasses throughout the entire course of the study.
干预措施: single vision frame glasses (Device)
结局指标
主要结局
Changes in ocular axial length in a year
时间窗: baseline, 12 months
The ocular axial length was measured by AL-scan
次要结局
- Changes in cycloplegic objective spherical equivalent in a year(baseline, 12 months)