Monocular Action Video Game Treatment of Amblyopia

Universitat Politècnica de Catalunya

Status: Completed

Conditions: Unilateral Amblyopia; Amblyopia; Anisometropic Amblyopia; Strabismic Amblyopia; Amblyopia Occlusion

Treatments: Other: Monocular Passive Occlusion; Other: Monocular Active Occlusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04313257

PhDLAJE1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 4 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Passive Occlusion

Active Comparator group

Description:

This arm will include those participants who will follow a daily occlusive treatment of 2 hours.

Treatment:

Other: Monocular Passive Occlusion

Active Occlusion

Experimental group

Description:

This arm will include patients who will be treated with monocular therapy with video-games of one hour on a daily regimen.

Treatment:

Other: Monocular Active Occlusion