Monocular Action Video Game Treatment of Amblyopia

Amblyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04313257
• Other study ID #: PhDLAJE1
• Status: Completed
• Phase: N/A
• Start date: September 17, 2019
• Est. completion date: January 16, 2023

Study information

• Verified date: March 2023
• Source: Universitat Politècnica de Catalunya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 16, 2023
• Est. primary completion date: January 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Amblyopia
• Amblyopia Occlusion
• Anisometropic Amblyopia
• Strabismic Amblyopia
• Unilateral Amblyopia

Intervention

Other:
• Monocular Active Occlusion
Occlusion treatment of one hour daily with action video game.
• Monocular Passive Occlusion
Occlusion treatment of two hour daily.

Locations

Country	Name	City	State
Spain	Laura Asensio Jurado	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Universitat Politècnica de Catalunya	Hospital Mutua de Terrassa, Parc Sanitari Sant Joan de Déu

Country where clinical trial is conducted

Spain, 

References & 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. — View Citation

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. Erratum In: Psychol Bull. 2018 Sep;144(9):978-979. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Satisfaction assessed by an ordinal questionnaire designed based on the Treatment Satisfaction Questionnaire for Medication (TSQM).	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
Secondary	Rate of Compliance comparing passive occlusion vs active occlusion (with action video games) assessed by Google Analytics and written questionnaire.	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.