Skip to main content
OpenTrials
Completed

NCT Number: NCT04313257

Monocular Action Video Game Treatment of Amblyopia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Amblyopia Amblyopia Occlusion Anisometropic Amblyopia Brain Diseases Central Nervous System Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Strabismic Amblyopia Unilateral Amblyopia Vision Disorders

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laura Asensio Jurado

Barcelona, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Monocular Active Occlusion

Other

Occlusion treatment of one hour daily with action video game.

Monocular Passive Occlusion

Other

Occlusion treatment of two hour daily.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Satisfaction assessed by an ordinal questionnaire designed based on the Treatment Satisfaction Questionnaire for Medication (TSQM).

    Time frame: 42 hours

    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.

  2. 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.

    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)

Sponsors and collaborators

Lead sponsor

Universitat Politècnica de Catalunya

Other

Collaborators

  • Hospital Mutua de Terrassa
  • Parc Sanitari Sant Joan de Déu

Registry information

Official study title

Monocular Action Video Game Versus Passive Occlusion In The Treatment Of Amblyopia: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 18, 2020
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.