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临床试验/NCT02131740
NCT02131740已完成不适用

Relationship Between Eye Rubbing and Transient Changes in Corneal Parameters in Healthy Volunteers: A Randomised-Controlled Trial

Sussex Eye Hospital2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2014年3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
52
试验地点
2
主要终点
changes in corneal parameters following eye rubbing

研究概览

简要总结

This study addresses the research question:

How does eye rubbing affect corneal (clear part of eye) parameters in healthy volunteers

The study objectives are:

  1. To determine the corneal changes following eye rubbing
  2. To assess tear film changes following eye rubbing
  3. To investigate if there is an association between eye rubbing and axial length of the eye.

详细描述

Background

A human eye has a front clear window called cornea. This cornea should ideally be spherical but in some subjects, this cornea gets deformed to a cone shape. This cone shaped cornea is called keratoconus. This keratoconus will cause blurring of vision which may require the use of a rigid contact lens or surgical intervention to improve vision. One of the etiological factors for keratoconus is eye rubbing. Eye rubbing is very common in subjects with eczema and other chronic allergic conditions. It is believed that constant eye rubbing every few minutes over years may lead to permanent changes to corneal curvature leading to formation of keratoconus.

It is known from previous studies that eye rubbing causes transient changes in the shape of the clear window of the eye, these changes are returned to baseline at 5 minutes following 1 minute of eye rubbing.

Although clinicians routinely advise such subject to refrain from eye rubbing and prescribe them long term anti allergic medication, there is paucity of scientific evidence on this.

With the knowledge of rubbing induced changes to the clear part of the eye in relation to the axial length we will have a further understanding of those subjects who are more susceptible to moulding and mechanical injury of the clear part of the eye. If we can identify a relationship between eye rubbing and eye length then those subjects with a chronic stimulus to eye-rubbing, such as allergy etc, efforts can be made to protect the eye from rubbing induced changes to prevent disease progression (Keratoconus).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
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

  • aged 18 years or above healthy

排除标准

  • aged less than 18 years
  • subjects with: terminal illness, poor English language skills or a confused state history of previous ocular problems or surgeries history of contact lens wear not will to undergo simple & quick scans and eye examinations

结局指标

主要结局

changes in corneal parameters following eye rubbing

时间窗: pre and post eye rubbing for 2 minutes

To study the change in anterior and posterior corneal parameters

次要结局

  • Relationship between eyeball dimensions following eye rubbing(pre and post eye rubbing for 2 minutes)

研究者

发起方
Sussex Eye Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mayank A. Nanavaty

Consultant Ophthalmic Surgeon

Sussex Eye Hospital

研究点 (2)

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