Comparison of Efficacy Between Two Myopia Control Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Axial Length
研究概览
简要总结
This is a one-year, mono-centre, randomize, double-masked, monocular cross-over clinical trial designed to test and compare the efficacy of the new lens design in slowing down the increase of axial length and controlling myopia progression.
详细描述
The clinical trial aims to assess the safety and efficacy of a test lens, designed to modify the amount of myopic control signal on the retina without compromising vision. 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
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
As this is a double-masked, randomized controlled trial, both the investigators and subjects will be masked.
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteer subject and guardian, fluent English spoken, willing to follow protocol and able to read, comprehend and sign the informed consent & assent form.
- •Equal to or greater than 6 years and not older than 11 years at time of informed consent and assent.
- •Spherical equivalent refractive error (SER) by manifest refraction between -0.50 and -4.75 D in each eye.
- •Astigmatism, if present, of not more than 2.00 D.
- •Difference in SER between the two eyes (Anisometropia) by manifest refraction not more than 1.00 D.
- •Best corrected visual acuity in each eye better than +0.20 logMAR
- •Agree to wear study spectacles for at least 10 hours a day and 6 days a week
- •Willingness and ability to participate in trial for 1 year
- •Willingness and ability to attend scheduled visits
- •Not to involve concurrently in other myopia control treatments
排除标准
- •History or presence of an Ocular disease, Strabismus, Amblyopia
- •Undergoing any myopia control intervention specifically Atropine and Orthokeratology
- •History of myopia control intervention specifically Atropine, Orthokeratology
研究组 & 干预措施
MCL1
The MCL1 is a myopia control lens that will be worn in one eye for 6 months.
干预措施: Myopia Control Lens-2 (MCL2) (Device)
MCL2
The MCL2 is a myopia control lens that will be worn on the contralateral eye for 6 months.
干预措施: Myopia Control Lens-1 (MCL1) (Device)
MCL2
The MCL2 is a myopia control lens that will be worn on the contralateral eye for 6 months.
干预措施: Myopia Control Lens-2 (MCL2) (Device)
MCL1
The MCL1 is a myopia control lens that will be worn in one eye for 6 months.
干预措施: Myopia Control Lens-1 (MCL1) (Device)
结局指标
主要结局
Change in Axial Length
时间窗: 12 months
To evaluate the effectiveness of the MCL2 in slowing myopia progression with respect to the change in Axial Length (AL) from baseline compared to MCL1 at 12-month.
次要结局
- Change in Spherical Equivalent Refraction(12 months)