Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Changes in axial length
研究概览
简要总结
Pre-myopia refers to a condition in which children have not yet developed myopia but exhibit insufficient hyperopic reserve (≤ +0.75 D). This is particularly relevant for young children aged 6 years and under; if their hyperopic reserve is depleted prematurely and they progress into the pre-myopia stage, the likelihood of developing myopia or even high myopia in the future becomes extremely high. Therefore, this study plans to conduct a parallel-design, open-label, single-center randomized controlled clinical trial to evaluate the efficacy and safety of artificial intelligence-assisted defocus incorporated multiple segments (DIMS) based spectacle lens in preventing and controlling myopia in pre-myopic children aged 3 to 6 years.
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
- Single (Investigator)
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 between 3 and 6 years (inclusive), regardless of gender or ethnicity.
- •Cycloplegic spherical equivalent refraction (SER) of the worse eye > -0.50 D and ≤ +0.75 D, absolute cylindrical power ≤ 1.0 D, anisometropia ≤ 1.5 D.
- •Best corrected monocular distance high contrast VA ≥ 0.5 for ages 3-5; ≥ 0.7 for age
- •At least one parent with SER ≤-3.00D
排除标准
- •Individuals with any ocular or systemic diseases that may affect vision and refractive development (e.g., keratoconus, abnormalities in lens shape or position, Marfan syndrome, retinopathy of prematurity, etc.).
- •Individuals with known allergies or contraindications to cycloplegic agents.
- •Previous use of myopia management treatment (spectacles, atropine; CLs).
- •Individuals with binocular vision abnormalities: manifest strabismus, monocular suppression, abnormal fusion function, or impaired stereopsis.
- •Individuals unable to cooperate with examinations or communicate.
- •Any other conditions deemed by the investigator as unsuitable for participation in the study.
研究组 & 干预措施
Control group
Wear smartwatches
干预措施: Smartwatches (Device)
Intervention group
Wear AI-assisted DIMS-based spectacle lens (at least 10 hours a day), as well as smartwatches
干预措施: Smartwatches (Device)
Intervention group
Wear AI-assisted DIMS-based spectacle lens (at least 10 hours a day), as well as smartwatches
干预措施: Artificial Intelligence Assisted DIMS based Spectacle Lens (Device)
结局指标
主要结局
Changes in axial length
时间窗: From baseline to the 12-month follow-up
次要结局
- Changes in Choroidal Thickness (CT)(From baseline to the 12-month follow-up)
- Spectacle-wearing compliance and spectacle-wearing time(From baseline to the 12-month follow-up)
- Changes in Cycloplegic Spherical Equivalent Refraction (SER)(From baseline to the 12-month follow-up)