NCT04806698已完成不适用
Long-term Efficacy of Orthokeratology Contact Lens Wear in Controlling the Progression of Childhood Myopia
适应症
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
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
研究者
相似试验
已完成
不适用
Myopia Control With Orthokeratology Contact Lenses in SpainMyopia, ProgressiveChildren, OnlyContact Lens ComplicationPerception, SelfAxial MyopiaNCT04806763Menicon Co., Ltd.69
Unknown
不适用
Orthokeratology for KeratoconusOrthokeratologyKeratoconusNCT00816569Hadassah Medical Organization30
Unknown
不适用
Overminus Lens Therapy in IntermittentIntermittent ExotropiaMyopia OvercorrectionOver-minus TherapyMyopia ProgressionNCT03952702Ege University65
已完成
不适用
Clinical Trial of Orthokeratology Lens (MCOK-01)MyopiaNCT06037850Menicon Co., Ltd.390
Unknown
不适用
Long Term Effects of Multifocal Orthokeratology on Corneal and Choroidal Structures in Healthy Subjects With Myopia- A Pilot StudyMyopiaNCT02700295Medical University of Vienna10