Monocular Action Video Game Treatment of Amblyopia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-17

Study Completion Date

2023-01-16

Brief Summary

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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.

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Detailed Description

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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

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Amblyopia Amblyopia Occlusion Unilateral Amblyopia Anisometropic Amblyopia Strabismic Amblyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Passive Occlusion

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

Group Type ACTIVE_COMPARATOR

Monocular Passive Occlusion

Intervention Type OTHER

Occlusion treatment of two hour daily.

Active Occlusion

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

Group Type EXPERIMENTAL

Monocular Active Occlusion

Intervention Type OTHER

Occlusion treatment of one hour daily with action video game.

Interventions

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Monocular Active Occlusion

Occlusion treatment of one hour daily with action video game.

Intervention Type OTHER

Monocular Passive Occlusion

Occlusion treatment of two hour daily.

Intervention Type OTHER

Eligibility Criteria

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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