The Clinical Trial of Myopia Control in Schoolchildren Using the Multi-segment (MS) Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 2
- 主要终点
- Cycloplegic Refraction Change in SER
研究概览
简要总结
The purpose of this study is to determine if the Multiple-Segment (MS) spectacle lens can slow myopia progression in Hong Kong schoolchildren.
MS lens is also called Defocus Incorporated Multiple Segments (DIMS) spectacle lens
详细描述
MS lens is a novel lens designed in attempt to slow myopia progression. It is a multifocal spectacle lens which corrects distance refractive error and at the same time produces myopic defocus images on the retina for all distances. The myopic defocus aims at slowing down myopia progression. The purpose of this study is to investigate if the MS lens can slow myopia progression in Hong Kong Chinese schoolchildren. The subjects will be randomly assigned to either treatment group (wear MS lenses) or control group (wear ordinary single vision lenses). Their cycloplegic refraction and axial length will be monitored every six months over 2 years. The changes in refractive errors and axial length in two groups will 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
- 是
入选标准
- •Age at enrolment: 8-13 year
- •Spherical equivalent refractions (SER): -1.00 to -5.00 Dioptres (D)
- •Astigmatism and anisometropia of 1.50 D or less
- •Spectacle corrected monocular logMAR visual acuity: 0 or better
- •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 Change in SER
时间窗: Baseline and 2 years
Change in cycloplegic SER (in diopter) that was measured using Shin-Nippon NVision-K 5001 autorefractor.
次要结局
- Axial Length(Baseline and 2 years)
研究者
Carly Lam
Professor
The Hong Kong Polytechnic University