A Randomized Clinical Trial on the Effectiveness of Novel Spectacle Lenses for Myopia Prevention in Pre-myopic Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 388
- 试验地点
- 1
- 主要终点
- One-year cumulative myopia incidence in either eye
研究概览
简要总结
Evaluate the efficacy, safety and wearing time compliance of novel plano spectacle lenses in delaying myopia onset in pre-myopic children and provide scientific basis for the development of myopia prevention strategies for children.
详细描述
Children aged 6-9 years old with pre-myopia are randomly assigned to a control group and an intervention group at a 1:1 ratio. The intervention group uses novel plano spectacle lenses for at least 8 hours a day, and the control group doesn't receive any intervention. The efficacy of novel plano spectacle lenses in delaying myopia onset in pre-myopia children is evaluated by comparing the one-year incidence of myopia onset between intervention group and control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At the time of signing the informed consent form, the subject's age must be ≥6 years and <10 years (6-9.99 years);
- •Both eyes are not myopic (SE>-0.50D under cycloplegia) and at least one eye meets the pre-myopia condition ( -0.50D< SE under cycloplegia ≤+0.75D); [spherical equivalent (SE)=Sph+Cyl/2]
- •Astigmatism ≤1.00D in each eye;
- •Difference in SER (Anisometropia) between the two eyes should not exceed ≤1.50D;
- •Unaided distance and near visual acuity of at least 0.1 logMAR in each eye ;
- •Be in good general health;
- •Be able to actively cooperate with the intervention plan and ophthalmological examination;
- •Normal binocular vision
- •At least one parent with SER ≤-3.00 D
排除标准
- •Incapable of expressing consent
- •All categories of persons particularly protected by law
- •Subject in another study which might have an influence on vision or interfere with study assessment.
- •Previous use of other prevention solutions, such as but not limited to red light therapy within 6 months, Atropine and other interventions were used within 3 months;
- •History or presence of an ocular disease, systemic disease, strabismus or amblyopia or other binocular vision abnormalities, accommodation dysfunction, cataract and eye surgery;
- •Those who are allergic cycloplegic drugs;
- •Other reasons that the investigator considers inappropriate for inclusion in the study.
研究组 & 干预措施
Intervention group
Use of novel plano spectacle lenses for at least 8 hours a day with objective wearing time measured by smart frame and objective outdoor time measured by smart bracelet.
干预措施: Novel plano spectacle lenses (Device)
Control group
Objectively measuring outdoor time by smart bracelet.
结局指标
主要结局
One-year cumulative myopia incidence in either eye
时间窗: From enrollment to the end of intervention for one year
One-year cumulative myopia incidence in either eye
次要结局
- Changes of spherical equivalent under cycloplegia(From enrollment to the end of intervention for one year)
- Changes of axial length(From enrollment to the end of intervention for one year)
- Changes of choroidal thickness(From enrollment to the end of intervention for one year)
- Changes of unaided distance visual acuity(From enrollment to the end of intervention for one year)
- Changes of visual acuity with novel spectacle lenses and Single Vision spectacle lenses(From enrollment to the end of intervention for one year)
- Changes of accommodation function(From enrollment to the end of intervention for one year)
- Wearing time recorded in the questionnaire and smart frame(From enrollment to the end of intervention for one year)
- Objective outdoor time recorded with smart bracelet(From enrollment to the end of intervention for one year)