Monocular Action Video Game Treatment of Amblyopia

NCT04313257 | Completed

• 1 other identifier: PhDLAJE1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Amblyopia; Amblyopia Occlusion; Unilateral Amblyopia; Anisometropic Amblyopia; Strabismic Amblyopia

Keywords

Action Video Games; Amblyopia treatment

Outcome Measures

Primary Outcomes (3)

• Change from baseline visual acuity (VA) at 14 hours , 28 hours , and 42 hours comparing passive occlusion vs active occlusion (with action video games).

  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).

  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).

  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 Outcomes (2)

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

  42 hours

• Rate of Compliance comparing passive occlusion vs active occlusion (with action video games) assessed by Google Analytics and written questionnaire.

  Baseline and 14h, 28h and 42 hours.

Study Arms (2)

Passive Occlusion

ACTIVE COMPARATOR

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

Other: Monocular Passive Occlusion

Active Occlusion

EXPERIMENTAL

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

Interventions

Monocular Active Occlusion OTHER

Occlusion treatment of one hour daily with action video game.

Active Occlusion

Monocular Passive Occlusion OTHER

Occlusion treatment of two hour daily.

Passive Occlusion

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universitat Politècnica de Catalunya: lead
• Hospital Mutua de Terrassa: collaborator
• Parc Sanitari Sant Joan de Déu: collaborator

Study Sites (1)

Laura Asensio Jurado

Barcelona, Spain

Location

Related Publications (4)

• 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.

  PMID: 22715883 BACKGROUND

• 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.

  PMID: 21912514 BACKGROUND

• 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.

  PMID: 29172564 BACKGROUND

• 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.

  PMID: 29709618 BACKGROUND

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura Asensio Jurado, MsC

  Universitat Politècnica de Catalunya

  PRINCIPAL INVESTIGATOR

• Marc Argilés Sans, PhD

  Universitat Politècnica de Catalunya

  STUDY DIRECTOR

• Lluïsa Quevedo i Junyent, PhD

  Universitat Politècnica de Catalunya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 18, 2020
• Study Start: September 17, 2019
• Primary Completion: January 16, 2023
• Study Completion: January 16, 2023
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)