Control of Myopia Progression in Myopic Children Using Simultaneous Vision Approach
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The changes of cycloplegic refractive errors
研究概览
简要总结
To determine if the 'Defocus Incorporated Soft Contact' (DISC) lens slows myopia progression in Hong Kong schoolchildren using simultaneous vision approach.
详细描述
The investigators hypothesize that the natural process of emmetropization in human is regulated by the equilibrium between the opposite hyperopic and myopic defocus. A sharp focus of retinal image (foveal fixation) is fundamental for co-ordination of the equilibrium. The DISC lens is a custom-made multi-zone bifocal soft contact lens which is based on simultaneously provides clear vision and defocus at all viewing distances. It comprises of correcting zones for correcting distant prescription(correction of refractive error, and defocusing zones to incorporate constant myopic defocus for slowing down myopia progression.
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, Investigator)
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 8-13 years
- •Myopia (SE) between -1D to -5D
- •Astigmatism less than or equal to -1D
- •Anisometropia: less than or equal to 1.25D
- •aided VA (monocular): 0.00 log MAR or better
- •willingness to wear contact lens constantly
- •availability for follow-up for at least 2.5 years
- •parents' understanding and acceptance
- •willing to provide refractive status of grandparents
排除标准
- •Severe ocular or systemic allergies
- •Taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial
- •Ocular or systemic condition that might affect refractive development
- •Strabismus at distance or near
- •Prior use of bifocal or progressive lenses
- •Prior use of rigid gas permeable lenses and Ortho-K lenses
结局指标
主要结局
The changes of cycloplegic refractive errors
时间窗: every 6 months for 2 years
Refractive error was measured using Shin-Nippon NVision-K 5001 autorefractor The changes of cycloplegic objective refractive errors between the treatment and the control were compared.
次要结局
- The changes of axial length(every 6 months for 2 years)
研究者
Carly Lam
Head of School
The Hong Kong Polytechnic University