Efficacy and Safety Study of Novel Spectacle Lens Designs to Control of Myopia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 266
- 试验地点
- 28
- 主要终点
- Spherical equivalent refraction
研究概览
简要总结
Randomized, controlled, multisite, subject-and observer-masked, 3-arm parallel group clinical trial of 36-month duration to evaluate the safety and efficacy of a novel spectacle lens design in reducing the progression of juvenile myopia.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and parents of participants will be masked. Investigational site staff tasked with measuring key primary variables (i.e., axial length and SER) will be masked.
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children 6-10 years of age (day prior to 10th birthday) at time of informed consent/assent
- •SER error between -0.75 and -4.50 D
- •SER power between the two eyes must be less than or equal to 1.50 D
- •Willingness to participate in the trial for 3 years without content lens wear
排除标准
- •Previous or current use of contact lenses
- •Previous or current use of bifocals, progressive addition spectacles lenses
- •Previous or current use of myopia control treatment
- •Astigmatism worse then -1.25 DC in either eye
研究组 & 干预措施
Test Arm 2
Single vision, impact-resistant spectacle lenses
干预措施: Novel spectacle lens design (Device)
Test Arm 3
Single vision, impact-resistant spectacle lenses
干预措施: Spectacle lenses (Device)
Test Arm 1
Single vision, impact-resistant spectacle lenses
干预措施: Novel spectacle lens design (Device)
结局指标
主要结局
Spherical equivalent refraction
时间窗: 36 Months
Change in spherical equivalent refraction from baseline
Axial length
时间窗: 36 Months
Change in axial length from baseline
次要结局
未报告次要终点