- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02407015
The Effect of 3D Autostereoscopic Video-game Play on the Visual Fatigue in Children
October 12, 2015 updated by: Mrs Louisa Haine, University of Sheffield
A Randomised Control Trial to Evaluate the Effect of 3D Autostereoscopic Video-game Play on the Total Horizontal Fusional Vergence Amplitudes of 7 to 11 Year Old Children
This study aims to examine the specific effect that 3D game play has on the control of the eyes horizontal movements.
It will examine the youngest group of consumers this technology is marketed to, 7 to 11-year-olds and no children under 7 years of age will be recruited to this study as per Nintendo's hardware guidelines, which recommends that children under 7 years of age not play in 3D mode.
It will examine the effect of playing in 3D for 30 minutes on horizontal fusional amplitudes compared with a control group playing in 2D for 30 minutes.
Study Overview
Detailed Description
This study will be a prospective blind randomised control trial.
The participants will be randomised into one study group, with participants playing a game in 3D; and a control group, with participants playing the same game in 2D.
The study is blind due to the use of an independent assessor, reducing testing bias by ensuring that the tester does not know the randomisation results.
The known dependant variables are the total horizontal fusional amplitudes at 1/3m and 6m and the independent variable is the use of 2D or 3D game play.
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Cambridgeshire
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Cambridge, Cambridgeshire, United Kingdom, CB20QQ
- Cambridge University Hospitals NHS Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 11 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female 7 to 11-year-olds with no prior history of binocular vision / ocular motility dysfunction.
Exclusion Criteria:
Corrected visual acuity of less than 0.000 tested with SLT at 3m.
- Interocular visual acuity difference of 0.100 (tested with SLT) or greater, which could indicate the presence of Amblyopia.
- The presence of any manifest deviation (Tropia).
- Presence of any ocular motility dysfunction, which affects primary position.
- Reduced binocular convergence of 10 centimetres or less.
- Stereoacuity of less than 170" (this may indicate the presence of a microtropia or other undiagnosed pathology).
- Any prior or existing medical history of epilepsy or seizures.
- Any prior or existing medical history of repetitive strain injury.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 3D gameplay
Participants will play a game for 30 minutes on the Nintendo 3DS in 3D.
|
|
|
Active Comparator: 2D gameplay
Participants will play a game for 30 minutes on the nintendo 3DS in 2D.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in horizontal fusional amplitude
Time Frame: Immediately following gameplay
|
Immediately following gameplay
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Louisa A Haine, BSc, University of Sheffield
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
March 30, 2015
First Submitted That Met QC Criteria
April 1, 2015
First Posted (Estimate)
April 2, 2015
Study Record Updates
Last Update Posted (Estimate)
October 14, 2015
Last Update Submitted That Met QC Criteria
October 12, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- URMS 138673
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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