Patching or Gaming as Amblyopia Treatment?

Not Applicable

• Conditions: Amblyopia
• Interventions: Other: Occlusion therapy; Other: Dichoptic video game therapy

• Registration Number: NCT03767985
• Lead Sponsor: Erasmus Medical Center

Brief Summary

Amblyopia affects 3% of the children and is caused by strabismus, anisometropia or both. Standard treatment is glasses and patching therapy. From North-America, behavioural training, i.e. dichoptic training, perceptual learning and video gaming, has become increasingly popular to improve visual acuity not only in children but also in adults. In this study we aim to compare the standard occlusion therapy with dichoptic video gaming.

Detailed Description

Amblyopia affects 3% of the children and is caused by strabismus, anisometropia or both. The standard treatment is glasses and patching therapy. From North-America, behavioural training, i.e. dichoptic training, perceptual learning and video gaming, has become increasingly popular. The rationale behind these games is by using dichoptic stimulation, with the contrast of the stimuli presented to the good eye reduced to match the appearance of the same stimuli when shown to the amblyopic eye, suppression can be alleviated. The many studies now conducted, demonstrate improvement in visual acuity with the games, the effect however is limited, but the rate of improvement is higher. In these studies, prescribed patching-time was compared to realised game-time. We have demonstrated in multiple studies that electronically measured compliance is low: on average only 50%.

In this study we aim to compare the effect of patching therapy, using the ODM to objectively measure compliance, with the effect of a novel dichoptic action video game in children as well as in adults. In addition, the adult participants will undergo fMRI scans to document any changes in the visual cortex before and after either therapy.

Study Timeline

• Study Start: 2017-12-18
• Study First Submitted: 2018-12-06
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-07
• Primary Completion: 2020-06-24
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-25
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Amblyopia; an interocular difference in visual acuity of at least 2 logMAR lines.

Exclusion Criteria

• A non-comitant or large angle constant strabismus >30Prism Dioptres, a neurological disorder, nystagmus, other eye disorders and diminished acuity due to medication, brain damage or trauma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Occlusion therapy	Occlusion therapy	Participants are prescribed 2 hours of occlusion therapy per day, 7 days a week.
Dichoptic video game therapy	Dichoptic video game therapy	Participants receive dichoptic video game therapy: 1 hour per week at the out-patient clinic under direct supervision.

Primary Outcome Measures

Name	Time	Method
Visual Acuity improvement	24 weeks	Visual Acuity improvement (logMAR units/time period) in children with amblyopia treated with patching therapy vs dichoptic video gaming

Trial Locations

Locations (1)

Erasmus Medical Center; 🇳🇱 Rotterdam, South-Holland, Netherlands