Myopia Control With Orthokeratology Contact Lenses in Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 主要终点
- Axial length
研究概览
简要总结
The purpose of this prospective study is to assess the efficacy, safety and patient-reported outcomes of the Menicon Z Night orthokeratolgy contact lens for reducing myopia progression in children.
详细描述
The purpose of this prospective study is to assess the efficacy, safety and patient-reported outcomes of the Menicon Z Night orthokeratolgy contact lens for reducing myopia progression in children in comparison with a group of distance, single-vision glasses over a 2-year period. Efficacy was evaluated by assessing differences in the axial length between groups. Safety was evaluated by comparing the incidence of adverse events between groups. Differences between groups in patient-reported outcomes were evaluated using a questionnaire that assessed vision-related quality-of-life measures.
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: Two years
To compare axial length growth between white children with myopia wearing Menicon Z Night orthokeratology contact lenses and distance single-vision glasses. Measurements of axial length (in millimeters) 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
- Patient-reported outcomes(Two years)
- Adverse events(Two years)