Back to resultsThe Effect of 3D Autostereoscopic Video-game Play on the Visual Fatigue in Children
Primary Purpose
Visual Fatigue
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Nintendo 3DS gameplay
Sponsored by
About this trial
This is an interventional basic science trial for Visual Fatigue
Eligibility Criteria
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.
Sites / Locations
- Cambridge University Hospitals NHS trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
3D gameplay
2D gameplay
Arm Description
Participants will play a game for 30 minutes on the Nintendo 3DS in 3D.
Participants will play a game for 30 minutes on the nintendo 3DS in 2D.
Outcomes
Primary Outcome Measures
Change in horizontal fusional amplitude
Secondary Outcome Measures
Full Information
NCT ID
NCT02407015
First Posted
March 30, 2015
Last Updated
October 12, 2015
Sponsor
University of Sheffield
1. Study Identification
Unique Protocol Identification Number
NCT02407015
Brief Title
The Effect of 3D Autostereoscopic Video-game Play on the Visual Fatigue in Children
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sheffield
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Fatigue
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3D gameplay
Arm Type
Active Comparator
Arm Description
Participants will play a game for 30 minutes on the Nintendo 3DS in 3D.
Arm Title
2D gameplay
Arm Type
Active Comparator
Arm Description
Participants will play a game for 30 minutes on the nintendo 3DS in 2D.
Intervention Type
Other
Intervention Name(s)
Nintendo 3DS gameplay
Primary Outcome Measure Information:
Title
Change in horizontal fusional amplitude
Time Frame
Immediately following gameplay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louisa A Haine, BSc
Organizational Affiliation
University of Sheffield
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cambridge University Hospitals NHS trust
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB20QQ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
The Effect of 3D Autostereoscopic Video-game Play on the Visual Fatigue in Children
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