Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Axial Length
研究概览
简要总结
The goal of this exploratory clinical trial is to evaluate the efficacy and safety of a test spectacle lens (standard single vision lens (SVL) during first year, and standard myopia control lens (MCL) in second year), designed with passive red-light emission, for the control of myopia progression in myopic children age 6 to 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is:
Does the test spectacle lens designed with passive red-light emission provide significant myopia control effect to children?
Researchers will compare the standard SVL designed with passive red-light emission to SVL (first year) and MCL designed with passive red-light emission to MCL (second year) to see if the test spectacle lens work to slow down myopia progression.
Participants will:
- Wear the study spectacles
- Visit Essilor R&D Centre for follow-up sessions
详细描述
The clinical trial aims to assess the efficacy and safety of a test lens, designed to emit red-light when exposed to natural daylight that can produce a cumulative red-light exposure equivalent to the sham device (Dong et. al, 2023) when children spend about 30 minutes in a day. The primary goal of this clinical trial is to evaluate the effectiveness of the test lens in slowing down the increase of axial length and controlling myopia progression compared to the reference lens design.
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, Investigator)
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children equal to or greater than 6 years old and less than 11 years at the time of signing informed consent.
- •Corrected spherical equivalent refraction (SER) between -0.75 D and -5.00 D with astigmatism not more than 2.50 D.
- •Difference in SER (Anisometropia) between two eyes should not exceed 1.00 D.
- •Best corrected visual acuity better than or equal to +0.10 log MAR (20/25 or better with Snellen).
- •Be in good general health, based on his/her and parent's/guardian's knowledge.
- •Agree to wear spectacles for >12 hours/day and at least 6 days/week.
- •Willingness and ability to participate in investigation for 2 years and attend scheduled visits.
排除标准
- •Any ocular or systemic pathologies known to affect refractive status (e.g. keratoconus, diabetes, Down's syndrome etc.)
- •Any binocular vision anomalies
- •Amblyopia
- •Use of prior myopia control treatment like specialized myopia control spectacles and contact lenses at least in the previous one month.
- •Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
- •Participation in any clinical investigation within 30 days of the baseline visit.
研究组 & 干预措施
Group B
(Year 1) OD: SVL; OS: SVL with passive red-light emission (Year 2) OD: MCL with passive red-light emission; OS: MCL
干预措施: MCL (Device)
Group A
(Year 1) OD: SVL with passive red-light emission; OS: SVL (Year 2) OD: MCL; OS: MCL with passive red-light emission
干预措施: SVL (Device)
Group A
(Year 1) OD: SVL with passive red-light emission; OS: SVL (Year 2) OD: MCL; OS: MCL with passive red-light emission
干预措施: SVL with passive red-light emission (Device)
Group A
(Year 1) OD: SVL with passive red-light emission; OS: SVL (Year 2) OD: MCL; OS: MCL with passive red-light emission
干预措施: MCL (Device)
Group A
(Year 1) OD: SVL with passive red-light emission; OS: SVL (Year 2) OD: MCL; OS: MCL with passive red-light emission
干预措施: MCL with passive red-light emission (Device)
Group B
(Year 1) OD: SVL; OS: SVL with passive red-light emission (Year 2) OD: MCL with passive red-light emission; OS: MCL
干预措施: SVL (Device)
Group B
(Year 1) OD: SVL; OS: SVL with passive red-light emission (Year 2) OD: MCL with passive red-light emission; OS: MCL
干预措施: SVL with passive red-light emission (Device)
Group B
(Year 1) OD: SVL; OS: SVL with passive red-light emission (Year 2) OD: MCL with passive red-light emission; OS: MCL
干预措施: MCL with passive red-light emission (Device)
结局指标
主要结局
Change in Axial Length
时间窗: From 12 months to 24 months
Change in Axial Length
时间窗: From baseline to 12 months
次要结局
- Change in Spherical Equivalent Refraction(From 12 months to 24 months)
- Change in Spherical Equivalent Refraction(From baseline to 12 months)