Clinical Investigation of Targeted Lens Intervention in the Management of Myopic Anisometropia in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in axial length difference between the eyes
研究概览
简要总结
The goal of this clinical trial is to learn if our research spectacles will lower the difference in prescription (spectacles degree) between the eyes in children between 6 to 13 years old with anisometropic myopia. Anisometropic myopia is when the difference in myopia prescription between the two eyes are more than 1 diopter. The main question it aims to answer is:
- How the eye responds to the research spectacles over time by measuring:
- Change in axial length: the physical length of the eye from front to back.
- Change in cycloplegic spherical equivalent refraction: an accurate measurement of the eye's prescription taken while the focusing muscles are temporarily relaxed with eye drops.
Participants will:
- Wear the study spectacles
- Visit Essilor R&D Centre and an eye clinic for follow-up sessions
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent of parent/guardian and assent of participant
- •Age equal to or greater than 6 years old and less than 13 years at the time of signing informed consent and assent
- •SER equal or less than -0.50 D and equal or greater than .5.00 D with astigmatism not more than 2.50 D
- •Difference in SER (anisometropia) between two eyes .1.00 D
- •Best corrected visual acuity (BCVA) better than or equal to +0.20 LogMAR in each eye
- •Agree to wear study spectacles for .12 hours/day and 7 days/week
- •Willingness and ability to participate in investigation for 12 months and attend scheduled visits punctually
- •Agree for no concurrent involvement in other myopia control treatment
排除标准
- •History or presence of an ocular disease affecting refractive status
- •History or presence of strabismus
- •Presence of amblyopia
- •Current or previous use of atropine and/or orthokeratology
- •Known allergy to cycloplegic agents
- •Contraindication to cycloplegic agents
- •Cognitive or psychological vulnerability
研究组 & 干预措施
More myopic eye: MCL1; Less myopic eye: MCL2
Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL1) and Myopia Control Lens 2 (MCL2) design, with one type of lens in each eye throughout the study period. MCL1 will be worn in the more myopic eye, and MCL2 in the less myopic eye for a period of 12 months.
干预措施: More myopic eye: MCL1; Less myopic eye: MCL2 (Device)
结局指标
主要结局
Change in axial length difference between the eyes
时间窗: Base line, 12 months
Change in cycloplegic spherical equivalent refraction between the eyes
时间窗: Baseline, 12 months
次要结局
- Change in axial length difference between the eyes(Baseline, 6 months)