NCT02131740

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. 1.To determine the corneal changes following eye rubbing
  2. 2.To assess tear film changes following eye rubbing
  3. 3.To investigate if there is an association between eye rubbing and axial length of the eye.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2014

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

2 months

First QC Date

April 30, 2014

Last Update Submit

November 28, 2014

Conditions

Keywords

cornealeye rubbing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Relationship between eyeball dimensions following eye rubbing

    pre and post eye rubbing for 2 minutes

Study Arms (2)

Eye rubbing intervention

EXPERIMENTAL

eye rubbing performed for 1 minute in horizontal direction, clockwise rest for 5 seconds eye rubbing for a further 1 minute

Other: Eye rubbing

No eye rubbing

ACTIVE COMPARATOR

no eye rubbing - comparator

Other: No eye rubbing

Interventions

eye rubbing for 1 minute in horizontal direction clockwise, 5 second rest \& eye rubbing for a further 1 minute.

Eye rubbing intervention

This eye will not be rubbed

No eye rubbing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18 years or above healthy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sussex Eye Hospital

Brighton, East Sussex, BN2 5BF, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Dilatation, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mayank Nanavaty, Consultant

    Sussex Eye Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Ophthalmic Surgeon

Study Record Dates

First Submitted

April 30, 2014

First Posted

May 6, 2014

Study Start

March 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations