Eye Rubbing and Transient Change in Corneal Parameters
Primary Purpose
Ectasia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Eye rubbing
No eye rubbing
Sponsored by
About this trial
This is an interventional diagnostic trial for Ectasia focused on measuring corneal, eye rubbing
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
Sites / Locations
- Sussex Eye Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Eye rubbing intervention
No eye rubbing
Arm Description
eye rubbing performed for 1 minute in horizontal direction, clockwise rest for 5 seconds eye rubbing for a further 1 minute
no eye rubbing - comparator
Outcomes
Primary Outcome Measures
changes in corneal parameters following eye rubbing
To study the change in anterior and posterior corneal parameters
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02131740
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sussex Eye Hospital
4. Oversight
Data Monitoring Committee
No
5. 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:
To determine the corneal changes following eye rubbing
To assess tear film changes following eye rubbing
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ectasia
Keywords
corneal, eye rubbing
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eye rubbing intervention
Arm Type
Experimental
Arm Description
eye rubbing performed for 1 minute in horizontal direction, clockwise rest for 5 seconds eye rubbing for a further 1 minute
Arm Title
No eye rubbing
Arm Type
Active Comparator
Arm Description
no eye rubbing - comparator
Intervention Type
Other
Intervention Name(s)
Eye rubbing
Intervention Description
eye rubbing for 1 minute in horizontal direction clockwise, 5 second rest & eye rubbing for a further 1 minute.
Intervention Type
Other
Intervention Name(s)
No eye rubbing
Intervention Description
This eye will not be rubbed
Primary Outcome Measure Information:
Title
changes in corneal parameters following eye rubbing
Description
To study the change in anterior and posterior corneal parameters
Time Frame
pre and post eye rubbing for 2 minutes
Secondary Outcome Measure Information:
Title
Relationship between eyeball dimensions following eye rubbing
Description
To study the relationship between the dimensions of the eye and the changes in corneal parameters following eye rubbing
Time Frame
pre and post eye rubbing for 2 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mayank Nanavaty, Consultant
Organizational Affiliation
Sussex Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sussex Eye Hospital
City
Brighton
State/Province
East Sussex
ZIP/Postal Code
BN2 5BF
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
28815191
Citation
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.
Results Reference
derived
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Eye Rubbing and Transient Change in Corneal Parameters
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