The Effect of 3D Autostereoscopic Video-game Play on the Visual Fatigue in Children

NCT ID: NCT02407015

Last Updated: 2015-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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Visual Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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3D gameplay

Participants will play a game for 30 minutes on the Nintendo 3DS in 3D.

Group Type ACTIVE_COMPARATOR

Nintendo 3DS gameplay

Intervention Type OTHER

2D gameplay

Participants will play a game for 30 minutes on the nintendo 3DS in 2D.

Group Type ACTIVE_COMPARATOR

Nintendo 3DS gameplay

Intervention Type OTHER

Interventions

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Nintendo 3DS gameplay

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sheffield

OTHER

Sponsor Role lead

Responsible Party

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Mrs Louisa Haine

Lead Orthoptic Clinical Tutor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Louisa A Haine, BSc

Role: PRINCIPAL_INVESTIGATOR

University of Sheffield

Locations

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Cambridge University Hospitals NHS trust

Cambridge, Cambridgeshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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URMS 138673

Identifier Type: -

Identifier Source: org_study_id

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