Patching or Gaming as Amblyopia Treatment?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-18

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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

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Amblyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomized to either the standard patching therapy or the dichoptic video game therapy.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

The research orthoptist that does the orthoptic examinations is masked to the randomization.

Study Groups

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Occlusion therapy

Participants are prescribed 2 hours of occlusion therapy per day, 7 days a week.

Group Type ACTIVE_COMPARATOR

Occlusion therapy

Intervention Type OTHER

Occlusion therapy for 2 hours per day, 7 days a week

Dichoptic video game therapy

Participants receive dichoptic video game therapy: 1 hour per week at the out-patient clinic under direct supervision.

Group Type EXPERIMENTAL

Dichoptic video game therapy

Intervention Type OTHER

Dichoptic video gaming for 1 hour per week, viewed through the Oculus Rift.

Interventions

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Dichoptic video game therapy

Dichoptic video gaming for 1 hour per week, viewed through the Oculus Rift.

Intervention Type OTHER

Occlusion therapy

Occlusion therapy for 2 hours per day, 7 days a week

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No