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Patching or Gaming as Amblyopia Treatment?

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Erasmus University

Status

Unknown

Conditions

Amblyopia

Treatments

Other: Occlusion therapy
Other: Dichoptic video game therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03767985
MEC-2016-439

Details and patient eligibility

About

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.

Full 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.

Enrollment

124 estimated patients

Sex

All

Ages

4 to 55 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

124 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Aveen Kadhum, Bsc; Sjoukje E Loudon, MD, PhD

Data sourced from clinicaltrials.gov

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