Eleven Years of Menicon Z Night Contact Lens Wear in Reducing Myopia Progression in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Axial length
研究概览
简要总结
To compare axial length growth of white European myopic children wearing Menicon Z Night orthokeratology contact lenses to a control group of distance, single-vision glasses and contact lenses over an 11-year period.
详细描述
This prospective, controlled, parallel, longitudinal study compared the axial length growth of white European myopic children wearing Menicon Z Night orthokeratology contact lenses to a control group of distance, single-vision glasses and or distance, single-vision soft contact lenses over an 11-year period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be 6 to 12 years of age, both ages inclusive
- •A low-to-moderate level of myopia (between 0.75 and 4.00 D) and of astigmatism (≤ 1.00 D)
- •Neophyte contact lens wearer
- •Be successfully fitted with spectacles or orthokeratology contact lenses
- •Be able to achieve, through spherical refraction correction, a logMAR visual acuity of 0.8 or better in each eye
- •Be willing and able to follow the subject instructions and to meet the protocol-specified schedule of follow-up visits
- •White European ethnicity
排除标准
- •Systemic or ocular disease affecting ocular health
- •Use of any systemic or topical medications that could affect ocular physiology or contact lens performance
- •Any lid or anterior segment abnormalities for which contact lens wear could be contraindicated
- •CCLRU grade ≥ 2 for any given anterior segment ocular clinical signs
- •Aphakic, amblyopic, and atopic individuals
- •Refractive astigmatism ≥ ½ spherical refraction
- •Previous contact lens wear
结局指标
主要结局
Axial length
时间窗: 11 years
To compare axial length growth of white European myopic children wearing Menicon Z Night orthokeratology contact lenses to a control group of distance, single-vision glasses and soft contact lens wearers. Measurements of axial length were taken with the Zeiss IOLMaster (Carl Zeiss Jena GmbH, Jena, Germany). Three separate measurements of axial length were recorded per subject and per visit, and a mean obtained.
次要结局
未报告次要终点