Monocular Action Video Game Treatment of Amblyopia

March 22, 2023 updated by: Laura Asensio Jurado, Universitat Politècnica de Catalunya

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain
        • Laura Asensio Jurado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Passive Occlusion
This arm will include those participants who will follow a daily occlusive treatment of 2 hours.
Other: Monocular Passive Occlusion
Occlusion treatment of two hour daily.
Experimental: Active Occlusion
This arm will include patients who will be treated with monocular therapy with video-games of one hour on a daily regimen.
Other: Monocular Active Occlusion
Occlusion treatment of one hour daily with action video game.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).
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.
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).
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.
Baseline and 14, 28 and 42 hours post treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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)
Baseline and 14h, 28h and 42 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Politècnica de Catalunya

Collaborators

Parc Sanitari Sant Joan de Déu
Hospital Mutua de Terrassa

Investigators

  • Principal Investigator: Laura Asensio Jurado, MsC, Universitat Politècnica de Catalunya
  • Study Director: Marc Argilés Sans, PhD, Universitat Politècnica de Catalunya
  • Study Director: Lluïsa Quevedo i Junyent, PhD, Universitat Politècnica de Catalunya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2019

Primary Completion (Actual)

January 16, 2023

Study Completion (Actual)

January 16, 2023

Study Registration Dates

First Submitted

March 8, 2020

First Submitted That Met QC Criteria

March 17, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PhDLAJE1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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