EVALUATING THE EFFECT OF A MYOPIA CONTROL SPECTACLE LENS COMPARED TO A SINGLE VISION SPECTACLE LENS AMONG CHILDREN IN ISRAEL
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Refractive error
研究概览
简要总结
The purpose of this trial is evaluating the clinical effect of a myopia control spectacle lens compared to a single vision spectacle lens in slowing down the progression of myopia in children living in Israel.
详细描述
TRIAL PLAN
Screening visit (VISIT 1)
- Enrollment criteria verification
- Signing informed consent
- Baseline documentation of medical history, parental and siblings myopia, indoor and outdoor activities profile and socioeconomic profile
- Lensmeter measurements of participants spectacles
- Performing baseline measurements including best corrected VA, objective & subjective refraction under cycloplegia, PR under cycloplegia*, slit lamp examination, functional tests: cover test, titmus test, worth four dot test, axial length** and pupil size measurements
- Frame selection and frame measurements
- Lens order completion and sending to manufacturing
Randomization Procedures (following VISIT 1) Randomization procedures should be performed by the trial coordinator following visit 1. The participant will then be allocated to the test or control group.
Manufacturing Procedures (following VISIT 1) The manufacturing technician will take care of the manufacturing processes according to the lens type (test or control) and the mounting on the frame. The test spectacles will then be sent to the site for delivery.
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, Care Provider, Investigator)
盲法说明
This will be a controlled, randomized, double-masked trial. The Test group will wear the myopia control spectacle lens and the Control group will wear the single vision spectacle lens.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent form signed and fully comprehended by the parent/legal representative of the participant
- •Age from 6 to 12 years old
- •Both male and female
- •Spherical Equivalent refractive error (cycloplegic objective) of -0.50D to -5.00D
- •Astigmatism not higher than -1.50D
- •Corrected Visual Acuity of not less than 6/7.5 or 20/25
- •Willing to wear the trial spectacles for the defined period according the protocol plan
排除标准
- •Current participation in another clinical trial
- •Any general health or ocular health pathology that could affect the treatment
- •Allergy or intolerance to cycloplegic eye drops (name should be stated here)
- •Strabismus
- •Amblyopia
- •History of ocular injury or ocular surgery
- •Previously been treated with any myopia control treatments (Orthokeratology, myopia control spectacle/contact lenses, multifocal lenses, bifocal lenses, atropine)
研究组 & 干预措施
Myopia control design spectacle lens
Test lenses
干预措施: Lenses (Device)
Single Vision design spectacle lens
Control lenses
干预措施: Lenses (Device)
结局指标
主要结局
Refractive error
时间窗: 3 seconds
Objective cycloplegic refractive error (Sphere equivalent)
次要结局
- Axial length(3 seconds)