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临床试验/NCT02894489
NCT02894489Unknown不适用

Changes of Visual Function, Ocular Surface Structures and Physiology After Long-Termed Contact Lens Wear

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Ocular inflammatory mediators

研究概览

简要总结

Our study is aimed to observe the long termed effect of contact lens wear on ocular surface, especially focused on visual function and ocular inflammation mediators.

详细描述

Contact lens fitting are important treatments for many ocular diseases as they provide three main therapeutic applications: visual correction, protection of ocular surface, and cosmetic or sport purposes. The ophthalmology department of NTUH has set up contact lens special clinic as one of our comprehensive refractive services. The investigators provided corneal lenses or Rose K lenses for optical correction of keratoconus patients; the investigators also fitted large scleral lenses for the correction of irregular astigmatism for post-penetrating keratoplasty and post-refractive surgery patients. In addition, contact lenses can be an adjuvant therapy for ocular surface disorders as severe dry eye and limbal insufficiency. There were researches that proved the inflammatory mediators and neutrophils increased after long-termed wear of silicon hydrogel soft lenses or over night orthokeratology lenses. They also concluded that lens wear affected corneal epithelial proliferation. However, the physiological changes after long-termed wear of large diameter scleral lenses are still pending. In addition, we still do not understand the lens effects on high order aberration and ocular surface structures. The purpose of our study is to analyze the epidemiologic data and treatment results of the patients fitted with specialty lenses in our contact lens clinic from Aug 2016 to Aug 2018. Patients will be categorized into different groups by the diagnoses and the type of lens wear. After 6 months of follow up, the change of visual acuity, visual function related quality of life, the changes of ocular surface structures and physiology will be analyzed. The investigators hope to share the experiences of specialty contact lens fitting and understand the effects of long-term contact lens wear on ocular surface.

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
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •age 20 to 65
  • •contact lens wear
  • •willing to be followed for at least 6 months

排除标准

  • •active ocular infection
  • •active corneal melting
  • •inability to follow lens cleaning instructions
  • •pregnancy

研究组 & 干预措施

corneal lenses

Experimental

patients that wear corneal lenses ( Hiclear Rigid Gas Permeable Lenses)

干预措施: corneal lenses (Device)

large diameter lenses

Experimental

patients that wear scleral lenses (Paragon Normaleyes)

干预措施: large diameter lenses (Device)

结局指标

主要结局

Ocular inflammatory mediators

时间窗: 6 months

to monitor the change of tear inflammatory mediators 6 months after lens wear

次要结局

未报告次要终点

研究者

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

Hsiao Sang Chu, MD

Principal Investigator

National Taiwan University Hospital

研究点 (1)

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