Clinical trial NCT04313257: Monocular Action Video Game Treatment of Amblyopia
Official title: Monocular Action Video Game Versus Passive Occlusion In The Treatment Of Amblyopia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amblyopia
Amblyopia Occlusion
Unilateral Amblyopia
Anisometropic Amblyopia
Strabismic Amblyopia
Keywords: Action Video Games
Amblyopia treatment
Lead sponsor: Universitat Politècnica de Catalunya
Sponsor class: OTHER
Collaborators: name: Hospital Mutua de Terrassa
name: Parc Sanitari Sant Joan de Déu
First posted: 2020-03-18
Enrollment: 28
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Non-comitant and/or large constant strabismus (\>30 prism diopters)
* Any ocular pathological condition or nystagmus

Primary outcomes:
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).
timeFrame: Baseline and 14, 28 and 42 hours post treatment.
measure: Change from baseline stereopsis (ST) at 14 hours , 28 hours , and 42 hours comparing passive occlusion vs active occlusion (with action video games).
timeFrame: Baseline and 14, 28 and 42 hours post treatment.
measure: 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).
timeFrame: Baseline and 14, 28 and 42 hours post treatment.
Secondary outcomes:
measure: Satisfaction assessed by an ordinal questionnaire designed based on the Treatment Satisfaction Questionnaire for Medication (TSQM).
timeFrame: 42 hours
measure: Rate of Compliance comparing passive occlusion vs active occlusion (with action video games) assessed by Google Analytics and written questionnaire.
timeFrame: Baseline and 14h, 28h and 42 hours.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Laura Asensio Jurado
Study officials:
affiliation: Universitat Politècnica de Catalunya
name: Laura Asensio Jurado, MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat Politècnica de Catalunya
name: Marc Argilés Sans, PhD
role: STUDY_DIRECTOR
affiliation: Universitat Politècnica de Catalunya
name: Lluïsa Quevedo i Junyent, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Li 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.
citation: Bediou 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.
citation: Gambacorta 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.