Long-term Efficacy of Orthokeratology Contact Lens Wear in Controlling the Progression of Childhood Myopia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Axial length
研究概览
简要总结
To assess the long-term efficacy of the Menicon Z Night orthokeratology contact lens in controlling the progression of childhood myopia
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 over a 7-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
研究组 & 干预措施
Menicon Z Night
The experimental arm includes a group of children wearing Menicon Z Night orthokeratology contact lenses for 7 years
干预措施: Menicon Z Night (Device)
Control
The active comparator arm includes a control group of children wearing distance, single-vision glasses or soft contact lenses
干预措施: Control (Device)
结局指标
主要结局
Axial length
时间窗: Seven years
To compare 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 or soft contact lenses
次要结局
未报告次要终点