Visual FatigueNCT02407015
The Effect of 3D Autostereoscopic Video-game Play on the Visual Fatigue in Children
A study testing Nintendo 3DS gameplay in people with Visual Fatigue, run by University of Sheffield at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Fatigue
- What is being tested?
- Nintendo 3DS gameplay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male and female 7 to 11-year-olds with no prior history of binocular vision / ocular motility dysfunction.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospitals NHS trust
Cambridge, Cambridgeshire, CB20QQ
About this study
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
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.
Read the 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.
- Conditions
- Visual Fatigue
- Being tested
- Nintendo 3DS gameplay
- Medical subject headings
- Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintendo 3DS gameplayOther
| Study group | Role | What they receive |
|---|---|---|
| 3D gameplay | Active comparator | Participants will play a game for 30 minutes on the Nintendo 3DS in 3D. Receives: Other: Nintendo 3DS gameplay |
| 2D gameplay | Active comparator | Participants will play a game for 30 minutes on the nintendo 3DS in 2D. Receives: Other: Nintendo 3DS gameplay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in horizontal fusional amplitude
Measured: Immediately following gameplay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startDec 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mrs Louisa Haine, University of Sheffield
- Investigators
- Louisa A Haine, BSc, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407015
- Sponsor's protocol ID
- URMS 138673
- Status last verified
- Oct 2015
- First submitted
- 30 Mar 2015
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02407015
- Acronym / sponsor ID
- URMS 138673
- Conditions
- Visual Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D gameplay | Active comparator | Other: Nintendo 3DS gameplayParticipants will play a game for 30 minutes on the Nintendo 3DS in 3D. |
| 2D gameplay | Active comparator | Other: Nintendo 3DS gameplayParticipants will play a game for 30 minutes on the nintendo 3DS in 2D. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Male and female 7 to 11-year-olds with no prior history of binocular vision / ocular motility dysfunction.
Key exclusion criteria (8 listed)
- Corrected visual acuity of less than 0.000 tested with SLT at 3m.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nintendo 3DS gameplay | Other | 2D gameplay, 3D gameplay |
Primary outcome
Change in horizontal fusional amplitude
Time frame: Immediately following gameplay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louisa A Haine, BSc principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nintendo 3DS gameplay in people with Visual Fatigue, run by University of Sheffield at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in horizontal fusional amplitude (time frame: Immediately following gameplay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.