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临床试验/NCT02700295
NCT02700295Unknown不适用

Long Term Effects of Multifocal Orthokeratology on Corneal and Choroidal Structures in Healthy Subjects With Myopia- A Pilot Study

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年2月最近更新:
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gerhard Garhofer

MD, PhD

Medical University of Vienna

研究点 (1)

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