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临床试验/NCT03538002
NCT03538002已完成不适用

Does Blue-light Filtering Spectacle Lens Promote Myopia Progression in Schoolchildren

The Hong Kong Polytechnic University2 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2018年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
148
试验地点
2
主要终点
Cycloplegic refraction

研究概览

简要总结

The purpose of this study is to investigate if the blue-light filtering spectacle lenses promote myopia progression in schoolchildren.

详细描述

The effect of blue light on ocular health has been studied extensively. Shorter wavelength such as blue light could cause damage to the retina. The damage was more evident in the ageing eye. Since the tablets and mobile with blue LED backlight display are widely used, thus blue-light filtering spectacle lenses are now available in the market. However, whether this kind of lenses could affect the eye growth in schoolchildren is unknown. This study is then designed to investigate if the blue-light filtering spectacle lenses affect myopia progression in Hong Kong Chinese schoolchildren. The schoolchildren will be randomly allocated to either blue-light filtering spectacle lens group (treated) or conventional spectacle lens group (control). Their axial length and refraction will be monitored every 6 months for 2 years. The changes between two group will then be compared.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
8 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Refraction: myopia of -1.00 dioptres (D) to -5.00D
  • Astigmatism: equal or less than -1.50D
  • Anisometropia: equal or less than 1.00D
  • Best corrected monocular visual acuity: 0.0 LogMAR or better after full correction
  • Parents' understanding and acceptance of random allocation of grouping

排除标准

  • any ocular and systemic abnormalities might affect visual functions or refractive development
  • prior treatment of myopic control, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc.

结局指标

主要结局

Cycloplegic refraction

时间窗: 2 years

Refraction done under cycloplegia

次要结局

  • Axial length(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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