Eye Rubbing and Transient Change in Corneal Parameters
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02131740|
Recruitment Status : Completed
First Posted : May 6, 2014
Last Update Posted : December 2, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Ectasia||Other: Eye rubbing Other: No eye rubbing||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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
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
|Sussex Eye Hospital|
|Brighton, East Sussex, United Kingdom, BN2 5BF|
|Principal Investigator:||Mayank Nanavaty, Consultant||Sussex Eye Hospital|