Eye Rubbing and Transient Change in Corneal Parameters

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

Tracking Information

• First Submitted Date: April 30, 2014
• First Posted Date: May 6, 2014
• Last Update Posted Date: December 2, 2014
• Study Start Date: March 2014
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 2, 2014)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 2, 2014)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Eye Rubbing and Transient Change in Corneal Parameters
• Official Title: Relationship Between Eye Rubbing and Transient Changes in Corneal Parameters in Healthy Volunteers: A Randomised-Controlled Trial

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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Ectasia

Intervention

• Other: Eye rubbing
  eye rubbing for 1 minute in horizontal direction clockwise, 5 second rest & eye rubbing for a further 1 minute.
• Other: No eye rubbing
  This eye will not be rubbed

Study Arms

• 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
  Intervention: Other: Eye rubbing
• Active Comparator: No eye rubbing
  no eye rubbing - comparator
  Intervention: Other: No eye rubbing

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 28, 2014): 52
• Original Estimated Enrollment (submitted: May 2, 2014): 50
• Actual Study Completion Date: May 2014
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT02131740
• Other Study ID Numbers: 140622
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Mayank A. Nanavaty, Sussex Eye Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Sussex Eye Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Sussex Eye Hospital
• Verification Date: November 2014