AmblyopiaNCT04313257
Monocular Action Video Game Treatment of Amblyopia
A study testing Monocular Active Occlusion and Monocular Passive Occlusion in people with Amblyopia and Amblyopia Occlusion, run by Universitat Politècnica de Catalunya at 1 site in Spain.
Trial summary
This study evaluates the effectiveness of the monocular treatment with action video-games in comparison with the occlusion therapy alone in amblyopic patients, and the satisfaction with the different evaluated treatments. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Amblyopia, Amblyopia Occlusion, Unilateral Amblyopia
- What is being tested?
- Monocular Active Occlusion and Monocular Passive Occlusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 17 Sep 2019to 16 Jan 2023
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 4-10 years old
- Anisometropic amblyopia
- Strabismic amblyopia or mixed
- Interocular visual acuity (VA) difference of at least 0.2 logMAR
- No history of eye surgery
Who cannot join
- Non-comitant and/or large constant strabismus (>30 prism diopters)
- Any ocular pathological condition or nystagmus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monocular Action Video Game Versus Passive Occlusion In The Treatment Of Amblyopia: A Randomized Controlled Trial
This study evaluates the effectiveness of the monocular treatment with action video-games in comparison with the occlusion therapy alone in amblyopic patients, and the satisfaction with the different evaluated treatments.
Read the detailed description
Amblyopia is the condition in which there is a decrease in monocular visual acuity or, less frequently, binocular, in absence of structural anomalies or ocular pathology. It is a reversible condition that affects up to 5% of the population, and that is the result of an abnormal visual experience during the most sensitive period of visual development.
The aim of this study is reviewing, analyzing and, if applicable, updating the current treatment model for amblyopia.
A randomized clinical trial will be performed to evaluate the effectiveness of the monocular treatment with action video-games in comparison with the occlusion therapy alone in amblyopic patients, and the satisfaction with the different evaluated treatments. The participants will be distributed in two groups. The first group will include those participants who will follow a daily occlusive treatment and the second group will include patients who will be treated with monocular therapy with video-games.The sample will include subjects between 4 to 10 years old with a diagnosis of refractive and / or strabismic amblyopia.
- Conditions
- Amblyopia, Amblyopia Occlusion, Unilateral Amblyopia, Anisometropic Amblyopia, Strabismic Amblyopia
- Being tested
- Monocular Active Occlusion, Monocular Passive Occlusion
- Keywords
- Action Video Games, Amblyopia treatment
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monocular Active OcclusionOther
Occlusion treatment of one hour daily with action video game.
Monocular Passive OcclusionOther
Occlusion treatment of two hour daily.
| Study group | Role | What they receive |
|---|---|---|
| Passive Occlusion | Active comparator | This arm will include those participants who will follow a daily occlusive treatment of 2 hours. Receives: Other: Monocular Passive Occlusion |
| Active Occlusion | Experimental | This arm will include patients who will be treated with monocular therapy with video-games of one hour on a daily regimen. Receives: Other: Monocular Active Occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline visual acuity (VA) at 14 hours , 28 hours , and 42 hours comparing passive occlusion vs active occlusion (with action video games).
Visual Acuity (VA in logMAR) will be evaluated by E Snellen Test through an Ipad and the app AmblyopiaVA. The AmblyopiaVA test is designed based on the standard protocol for measuring Visual Acuity in children with Amblyopia.The measure will be performed at 2 m.
Measured: Baseline and 14, 28 and 42 hours post treatment.
Change from baseline stereopsis (ST) at 14 hours , 28 hours , and 42 hours comparing passive occlusion vs active occlusion (with action video games).
Stereopsis (ST in logMAR) will be evaluated by a Multiple Random Points test through an Ipad, the app StereoTAB and anaglyphic glasses. The measures will be performed at 50 cm.
Measured: Baseline and 14, 28 and 42 hours post treatment.
Change from baseline contrast sensitivity function (CSF) at 14 hours , 28 hours , and 42 hours comparing passive occlusion vs active occlusion (with action video games).
The effect of treatment on Contrast Sensitivity Function (CSF in logMAR) will be evaluated by ClinicCFS test using sine grids of four different spatial frequencies: 3, 6, 12 and 18 cpd.
Measured: Baseline and 14, 28 and 42 hours post treatment.
Secondary outcomes (2)
Satisfaction assessed by an ordinal questionnaire designed based on the Treatment Satisfaction Questionnaire for Medication (TSQM).
Satisfaction assessed by an ordinal questionnaire (1 to 5, as 1 the lowest satisfaction and 5 the highest satisfaction),based on the TSQM (Treatment Satisfaction Questionnaire for Medication) version 1.4 to provide data regarding the degree of satisfaction and sensation of parents and children in relation to treatment.
Measured: 42 hours
Rate of Compliance comparing passive occlusion vs active occlusion (with action video games) assessed by Google Analytics and written questionnaire.
Rate of Compliance assessed through the registration of parent-reported adherence and log file data in Google Analytics (descriptive scale of time in hours/day) for active group and parent's questionnaire for passive group (subjective scale in hours/day)
Measured: Baseline and 14h, 28h and 42 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start17 Sep 2019
- Primary completion16 Jan 2023
- Study completion16 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Politècnica de Catalunya
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Mutua de Terrassa, Parc Sanitari Sant Joan de Déu
- Responsible party
- Principal investigator, Laura Asensio Jurado, Universitat Politècnica de Catalunya
- Investigators
- Laura Asensio Jurado, MsC, Principal investigator, Universitat Politècnica de CatalunyaMarc Argilés Sans, PhD, Study director, Universitat Politècnica de CatalunyaLluïsa Quevedo i Junyent, PhD, Study director, Universitat Politècnica de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313257
- Sponsor's protocol ID
- PhDLAJE1
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2020
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bavelier D, Green CS, Pouget A, Schrater P. Brain plasticity through the life span: learning to learn and action video games. Annu Rev Neurosci. 2012;35:391-416. doi: 10.1146/annurev-neuro-060909-152832.
PubMed 22715883Li RW, Ngo C, Nguyen J, Levi DM. Video-game play induces plasticity in the visual system of adults with amblyopia. PLoS Biol. 2011 Aug;9(8):e1001135. doi: 10.1371/journal.pbio.1001135. Epub 2011 Aug 30.
PubMed 21912514Bediou B, Adams DM, Mayer RE, Tipton E, Green CS, Bavelier D. Meta-analysis of action video game impact on perceptual, attentional, and cognitive skills. Psychol Bull. 2018 Jan;144(1):77-110. doi: 10.1037/bul0000130. Epub 2017 Nov 27.
PubMed 29172564Gambacorta C, Nahum M, Vedamurthy I, Bayliss J, Jordan J, Bavelier D, Levi DM. An action video game for the treatment of amblyopia in children: A feasibility study. Vision Res. 2018 Jul;148:1-14. doi: 10.1016/j.visres.2018.04.005. Epub 2018 May 12.
PubMed 29709618
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocular Action Video Game Versus Passive Occlusion In The Treatment Of Amblyopia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04313257
- Acronym / sponsor ID
- PhDLAJE1
- Conditions
- Amblyopia, Amblyopia Occlusion, Unilateral Amblyopia, Anisometropic Amblyopia, Strabismic Amblyopia
- Keywords
- Action Video Games, Amblyopia treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universitat Politècnica de CatalunyaUniversity, hospital or other
- Collaborators
- Hospital Mutua de Terrassa, Parc Sanitari Sant Joan de Déu
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 18 Mar 2020 (actual)
- 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 evaluates the effectiveness of the monocular treatment with action video-games in comparison with the occlusion therapy alone in amblyopic patients, and the satisfaction with the different evaluated treatments.
Detailed description
Amblyopia is the condition in which there is a decrease in monocular visual acuity or, less frequently, binocular, in absence of structural anomalies or ocular pathology. It is a reversible condition that affects up to 5% of the population, and that is the result of an abnormal visual experience during the most sensitive period of visual development.
The aim of this study is reviewing, analyzing and, if applicable, updating the current treatment model for amblyopia.
A randomized clinical trial will be performed to evaluate the effectiveness of the monocular treatment with action video-games in comparison with the occlusion therapy alone in amblyopic patients, and the satisfaction with the different evaluated treatments. The participants will be distributed in two groups. The first group will include those participants who will follow a daily occlusive treatment and the second group will include patients who will be treated with monocular therapy with video-games.The sample will include subjects between 4 to 10 years old with a diagnosis of refractive and / or strabismic amblyopia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Passive Occlusion | Active comparator | Other: Monocular Passive OcclusionThis arm will include those participants who will follow a daily occlusive treatment of 2 hours. |
| Active Occlusion | Experimental | Other: Monocular Active OcclusionThis arm will include patients who will be treated with monocular therapy with video-games of one hour on a daily regimen. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 4-10 years old
- Anisometropic amblyopia
- Strabismic amblyopia or mixed
- Interocular visual acuity (VA) difference of at least 0.2 logMAR
- No history of eye surgery
Key exclusion criteria (2 listed)
- Non-comitant and/or large constant strabismus (>30 prism diopters)
- Any ocular pathological condition or nystagmus
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 |
|---|---|---|
| Monocular Active OcclusionOcclusion treatment of one hour daily with action video game. | Other | Active Occlusion |
| Monocular Passive OcclusionOcclusion treatment of two hour daily. | Other | Passive Occlusion |
Primary outcome
Change from baseline visual acuity (VA) at 14 hours , 28 hours , and 42 hours comparing passive occlusion vs active occlusion (with action video games).
Time frame: Baseline and 14, 28 and 42 hours post treatment.
Visual Acuity (VA in logMAR) will be evaluated by E Snellen Test through an Ipad and the app AmblyopiaVA. The AmblyopiaVA test is designed based on the standard protocol for measuring Visual Acuity in children with Amblyopia.The measure will be performed at 2 m.
Change from baseline stereopsis (ST) at 14 hours , 28 hours , and 42 hours comparing passive occlusion vs active occlusion (with action video games).
Time frame: Baseline and 14, 28 and 42 hours post treatment.
Stereopsis (ST in logMAR) will be evaluated by a Multiple Random Points test through an Ipad, the app StereoTAB and anaglyphic glasses. The measures will be performed at 50 cm.
Change from baseline contrast sensitivity function (CSF) at 14 hours , 28 hours , and 42 hours comparing passive occlusion vs active occlusion (with action video games).
Time frame: Baseline and 14, 28 and 42 hours post treatment.
The effect of treatment on Contrast Sensitivity Function (CSF in logMAR) will be evaluated by ClinicCFS test using sine grids of four different spatial frequencies: 3, 6, 12 and 18 cpd.
2 secondary outcomes
Satisfaction assessed by an ordinal questionnaire designed based on the Treatment Satisfaction Questionnaire for Medication (TSQM).
Time frame: 42 hours
Rate of Compliance comparing passive occlusion vs active occlusion (with action video games) assessed by Google Analytics and written questionnaire.
Time frame: Baseline and 14h, 28h and 42 hours.
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 23 Mar 2023.
- Background: PubMed 22715883Bavelier D, Green CS, Pouget A, Schrater P. Brain plasticity through the life span: learning to learn and action video games. Annu Rev Neurosci. 2012;35:391-416. doi: 10.1146/annurev-neuro-060909-152832.
- Background: PubMed 21912514Li RW, Ngo C, Nguyen J, Levi DM. Video-game play induces plasticity in the visual system of adults with amblyopia. PLoS Biol. 2011 Aug;9(8):e1001135. doi: 10.1371/journal.pbio.1001135. Epub 2011 Aug 30.
- Background: PubMed 29172564Bediou B, Adams DM, Mayer RE, Tipton E, Green CS, Bavelier D. Meta-analysis of action video game impact on perceptual, attentional, and cognitive skills. Psychol Bull. 2018 Jan;144(1):77-110. doi: 10.1037/bul0000130. Epub 2017 Nov 27.
- Background: PubMed 29709618Gambacorta C, Nahum M, Vedamurthy I, Bayliss J, Jordan J, Bavelier D, Levi DM. An action video game for the treatment of amblyopia in children: A feasibility study. Vision Res. 2018 Jul;148:1-14. doi: 10.1016/j.visres.2018.04.005. Epub 2018 May 12.
- Individual participant dataSharing planned: No
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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.
Laura Asensio Jurado, MsC principal investigator
Universitat Politècnica de Catalunya
Marc Argilés Sans, PhD study director
Universitat Politècnica de Catalunya
Lluïsa Quevedo i Junyent, PhD study director
Universitat Politècnica de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monocular Active Occlusion and Monocular Passive Occlusion in people with Amblyopia and Amblyopia Occlusion, run by Universitat Politècnica de Catalunya at 1 site in Spain.
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 5 inclusion and 2 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 23 Mar 2023. 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 Spain. 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 from baseline visual acuity (VA) at 14 hours , 28 hours , and 42 hours comparing passive occlusion vs active occlusion (with action video games). (time frame: Baseline and 14, 28 and 42 hours post treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04313257, which also lists 4 linked publications.
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 23 Mar 2023.