Eye Rubbing and Transient Change in Corneal Parameters

Sponsor
Sussex Eye Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02131740
Collaborator
(none)
52
1
2
2
25.9

Study Details

Study Description

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
  • Other: Eye rubbing
  • Other: No eye rubbing
N/A

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

Study Type:
Interventional
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 :
Mar 1, 2014
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

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

Primary Outcome Measures

  1. changes in corneal parameters following eye rubbing [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 [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Sussex Eye Hospital Brighton East Sussex United Kingdom BN2 5BF

Sponsors and Collaborators

  • Sussex Eye Hospital

Investigators

  • Principal Investigator: Mayank Nanavaty, Consultant, Sussex Eye Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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
Last Update Posted:
Dec 2, 2014
Last Verified:
Nov 1, 2014
Keywords provided by Mayank A. Nanavaty, Consultant Ophthalmic Surgeon, Sussex Eye Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 2, 2014