Eye Rubbing and Transient Change in Corneal Parameters

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

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.

Study Overview

• Status: Completed
• Conditions: Ectasia
• Intervention / Treatment: Other: Eye rubbing; Other: No eye rubbing

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • East Sussex
    • Brighton, East Sussex, United Kingdom, BN2 5BF
      • Sussex Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in corneal parameters following eye rubbing	To study the change in anterior and posterior corneal parameters	pre and post eye rubbing for 2 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between eyeball dimensions following eye rubbing	To study the relationship between the dimensions of the eye and the changes in corneal parameters following eye rubbing	pre and post eye rubbing for 2 minutes

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Chervenkoff JV, Hawkes E, Ortiz G, Horney D, Nanavaty MA. A randomized, fellow eye, comparison of keratometry, aberrometry, tear film, axial length and the anterior chamber depth after eye rubbing in non-keratoconic eyes. Eye Vis (Lond). 2017 Aug 14;4:19. doi: 10.1186/s40662-017-0084-8. eCollection 2017.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: April 30, 2014
• First Submitted That Met QC Criteria: May 2, 2014
• First Posted (ESTIMATE): May 6, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): December 2, 2014
• Last Update Submitted That Met QC Criteria: November 28, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: corneal; eye rubbing
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: 140622