NCT03767985

Patching or Gaming as Amblyopia Treatment?

A Randomised Clinical Trial Objectively Comparing the Effect of Patching Therapy With Video Gaming for Amblyopia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 4 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amblyopia

Interventions

Type	Name	Description
OTHER	Dichoptic video game therapy	Dichoptic video gaming for 1 hour per week, viewed through the Oculus Rift.
OTHER	Occlusion therapy	Occlusion therapy for 2 hours per day, 7 days a week

Timeline

• Start date: 2017-12-18
• Primary completion: 2020-06-24
• Completion: 2021-12-31
• First posted: 2018-12-07
• Last updated: 2021-08-25

Locations

1 site across 1 country: Netherlands