Project on Myopia Surveillance and Intervention Services for Preschool Children in Shanghai
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 508
- 试验地点
- 1
- 主要终点
- Changes in cycloplegic spherical equivalence
研究概览
简要总结
The prevalence of myopia among children has been increasing year by year, which has become a globle public health issue. Studies have shown that defocusing lenses and atroping eyedrops can control the progression of myopia, but there is little evidence of its efficacy in myopia intervention of young pre-schoolers who will face a greater risk of progression to high myopia later in life. Therefore, this study aims to evaluate the effectiveness and safety of spectacle lenses with highly aspherical lenslets (Essilor's Stellest) , as well as 0.01% and 0.05% low concentration atropine eyedrops in myopia intervention among young children aged 3-6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 3-6 years, gender unrestricted;
- •Bilateral cycloplegic spherical equivalent (SE) ≤ +0.75 D, astigmatism ≤-2.5 D, anisometropia ≤2.5 D;
- •Best corrected visual acuity: ≥0.5 for ages 3-5, ≥0.7 for age 6;
- •Accept regular follow-up, written informed consent from guardians, verbal informed consent from children;
- •Possess normal thinking and language communication skills, and can actively cooperate to wear spectacles as required.
排除标准
- •Existence of strabismus or amblyopia or other binocular vision abnormalities, accommodation dysfunction, cataract and history of eye surgery;
- •Any ocular or systemic disease that may affect vision and refractive development (e.g., Keratoconus, Marfan syndrome, retinopathy of prematurity, etc.);
- •Current or previous use of other treatments for myopia intervention, such as pharmacological (atropine) and optical (orthokeratology lenses or DIMS spectacle lenses) approaches, interrupt use for at least 4 weeks;
- •Allergy or contraindication to cycloplegic drugs;
- •Epilepsy or other mental disorders unable to expressing consent;
- •Other conditions deemed unsuitable for participation by the researcher.
研究组 & 干预措施
Spectacle Lenses with Highly Aspherical Lenslets
Wearing spectacle lenses with highly aspherical lenslets for myopia control
干预措施: Spectacle lenses with highly aspherical lenslets (Device)
0.01% Atropine
Nightly use of 0.01% atropine eyedrops for myopia control
干预措施: 0.01% atropine eye drops (Drug)
0.05% Atropine
Nightly use of 0.05% atropine eyedrops for myopia control
干预措施: 0.05% atropine eye drops (Drug)
结局指标
主要结局
Changes in cycloplegic spherical equivalence
时间窗: 2 year
Measured by an auto-refractometer
次要结局
- Proportion of subjects with non-rapid myopia progression(2 years)
- Changes in axial length(2 years)
- The duration of non-rapid myopia progression(2 years)