NCT02407015

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

5 months

First QC Date

March 30, 2015

Last Update Submit

October 12, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in horizontal fusional amplitude

    Immediately following gameplay

Study Arms (2)

3D gameplay

ACTIVE COMPARATOR

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

Other: Nintendo 3DS gameplay

2D gameplay

ACTIVE COMPARATOR

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

Other: Nintendo 3DS gameplay

Interventions

2D gameplay3D gameplay

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Male and female 7 to 11-year-olds with no prior history of binocular vision / ocular motility dysfunction.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge University Hospitals NHS trust

Cambridge, Cambridgeshire, CB20QQ, United Kingdom

Location

MeSH Terms

Conditions

Asthenopia

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Louisa A Haine, BSc

    University of Sheffield

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lead Orthoptic Clinical Tutor

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 2, 2015

Study Start

December 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations