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Eye Rubbing and Transient Change in Corneal Parameters

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ClinicalTrials.gov Identifier: NCT02131740
Recruitment Status : Completed
First Posted : May 6, 2014
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Mayank A. Nanavaty, Sussex Eye Hospital

Study Description
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Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Ectasia Other: Eye rubbing Other: No eye rubbing Not Applicable

Detailed Description:

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).

The aim of this study is to assess transient changes (if any) in corneal and surface tear film parameters in healthy volunteers after rubbing of the right eye for 2 minutes. The volunteers will undergo a tear film assessment and a corneal scan before and after eye rubbing on both eyes. In addition to these, the volunteers will also undergo a simple scan (IOLMaster scan) to assess the overall dimension of their eyeballs before eye rubbing. The data from both eyes will be analysed.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Relationship Between Eye Rubbing and Transient Changes in Corneal Parameters in Healthy Volunteers: A Randomised-Controlled Trial
Study Start Date : March 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: Eye rubbing intervention
eye rubbing performed for 1 minute in horizontal direction, clockwise rest for 5 seconds eye rubbing for a further 1 minute
 Other: Eye rubbing
eye rubbing for 1 minute in horizontal direction clockwise, 5 second rest & eye rubbing for a further 1 minute.
Active Comparator: No eye rubbing
no eye rubbing - comparator
 Other: No eye rubbing
This eye will not be rubbed


Outcome Measures
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Primary Outcome Measures :
  1. changes in corneal parameters following eye rubbing [ Time Frame: pre and post eye rubbing for 2 minutes ]
    To study the change in anterior and posterior corneal parameters


Secondary Outcome Measures :
  1. Relationship between eyeball dimensions following eye rubbing [ Time Frame: pre and post eye rubbing for 2 minutes ]
    To study the relationship between the dimensions of the eye and the changes in corneal parameters following eye rubbing


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • aged 18 years or above healthy

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02131740


Locations
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United Kingdom
Sussex Eye Hospital
Brighton, East Sussex, United Kingdom, BN2 5BF
Sponsors and Collaborators
Sussex Eye Hospital
Investigators
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Principal Investigator: Mayank Nanavaty, Consultant Sussex Eye Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mayank A. Nanavaty, Consultant Ophthalmic Surgeon, Sussex Eye Hospital
ClinicalTrials.gov Identifier: NCT02131740    
Other Study ID Numbers: 140622
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014
Keywords provided by Mayank A. Nanavaty, Sussex Eye Hospital:
corneal
eye rubbing
Additional relevant MeSH terms:
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Dilatation, Pathologic
Pathological Conditions, Anatomical