NCT02700295Unknown不适用
Long Term Effects of Multifocal Orthokeratology on Corneal and Choroidal Structures in Healthy Subjects With Myopia- A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Quantitative changes in the corneal thickness
研究概览
简要总结
Orthokeratology has the benefit for slowing down myopia progression and enabling unaided vision during the day. To investigate proposed possible changes of conventional and multifocal orthokeratology in the cornea and choroid this study will image both structures with high resolution optical coherence tomographs over a six month period. Findings will help to plan larger trials over a longer period of time in adults and teenagers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged over 18 years
- •Myopia defined as between -1D and -6 D with an increase of 0.5D within the last 18months prior to inclusion
- •Prospect orthokeratology contact lens wearers
- •Normal findings in the slit lamp examination, no corneal pathologies
排除标准
- •Participation in a clinical trial in the previous 3 weeks
- •Presence of any abnormalities (such as refractive surgery) preventing reliable measurements as judged by the investigator
- •Current contact lens wearers
- •Pregnancy, planned pregnancy or lactating
结局指标
主要结局
Quantitative changes in the corneal thickness
时间窗: 1 year
Qualitative changes in the corneal structure
时间窗: 1 year
次要结局
- Quantitative changes in the choroidal thickness(1 year)
- Qualitative changes in the choroidal structure(1 year)
研究者
Gerhard Garhofer
MD, PhD
Medical University of Vienna
研究点 (1)
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