Effect of WRAD Lens on Axial Growth and Refraction in Low-hyperopic Chinese Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 117
- 主要终点
- Changes in the axial length
研究概览
简要总结
Myopia is one of the most common visual impairments worldwide.This not only poses long-term risks to individual health but also imposes significant medical and economic burdens on society. [6] Therefore, delaying the onset of myopia and effectively controlling its progression has become an urgent issue that needs to be addressed.In recent years, a new type of highly aspherical lenslet (HAL) has been proposed. Its optical design includes a refractive correction area in the central region and a peripheral annular area. This annular area can form a "myopic defocus zone", increasing the myopic defocus signal around the retina. Studies have confirmed that this design can effectively slow down the progression of myopia in already myopic children. However, it is currently unclear whether this lens has a preventive effect on children who are not yet myopic but have a risk of developing myopia.
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
- 是
入选标准
- •Children aged 6 to 9 with low hyperopia, regardless of gender
- •The refractive error is between 0 and 2.00D
- •The best corrected visual acuity of both eyes is ≥ 0.10 LogMAR
- •The subjects themselves and their guardians voluntarily participated
排除标准
- •Systemic diseases or eye diseases
- •Received myopia control treatment through medication or optical
- •Any situation where participation is deemed unsuitable by the investigator
结局指标
主要结局
Changes in the axial length
时间窗: baseline, 6-month, 12-month, 18-month, 24-month
The changes in axial length of the eyes in the experimental group and the control group in the first and second years
Change in the spherical equivalent
时间窗: Baseline, 6-month, 12-month, 18-month, 24-month
The changes in spherical equivalent in the experimental group and the control group in the first and second years
次要结局
- Changes in axial length(Baseline, 6-month, 12-month, 18-month, 24-month)
- Change in equivalent spherical(Baseline, 6-month, 12-month, 18-month, 24-month)