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临床试验/NCT05298917
NCT05298917已完成不适用

Influence of Silicone Hydrogel Extended Contact Lens Wear on Corneal Sensitivity

Daniela Nosch2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
difference in corneal sensitivity threshold baseline and after 7 days of extended contact lens wear

研究概览

简要总结

Soft contact lens wear reduces the amount of oxygen reaching the eye, which may have an influence on corneal sensitivity. The aim of this study is to measure corneal sensitivity with means of liquid jet esthesiometry at baseline and after 6 days of continuous, extended contact lens wear.

详细描述

Contact lens wear may have an influence on corneal sensitivity, by three mechanisms: hypoxic, mechanical and inflammatory. Extended silicone hydrogel contact lens wear increases the risk of infections. A change in corneal sensitivity may be considered as an indicator for change in corneal physiology. It is there the aim of this study is to measure corneal sensitivity with means of liquid jet esthesiometry at baseline and after 6 days of continuous, extended contact lens wear.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • no contact lens wear three days before first visit
  • corneal radius between 7.4 and 8.0; if corneal radius >8.0, corneal diameter must be at least 12 mm; if corneal radius < 7.4, corneal diameter must be < 12.0
  • OSDI score no higher than 13 points

排除标准

  • systemic disease that may have an influence ocular healtjh
  • active ocular disease and no history of ocular surgery

结局指标

主要结局

difference in corneal sensitivity threshold baseline and after 7 days of extended contact lens wear

时间窗: 7+/-1 days

The difference in corneal sensitivity threshold baseline versus after 7 days of extended contact lens wear will be determined. Corneal sensitivity measurement will take place with the Swiss Liquid Jet Aesthesiometer for Corneal Sensitivity (SLACS) and will be recorded in mbar.

次要结局

  • correlation between corneal sensitvity threshold and subjective symptoms(7+/-1 days)

研究者

发起方
Daniela Nosch
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Daniela Nosch

Clinical Professor

University of Applied Sciences and Arts Northwestern Switzerland

研究点 (2)

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