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Patching or Gaming as Amblyopia Treatment?

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03767985
Enrollment
124
Registered
2018-12-07
Start date
2017-12-18
Completion date
2021-12-31
Last updated
2021-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amblyopia

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.

Interventions

OTHERDichoptic video game therapy

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

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

Sponsors

Lijf & Leven
CollaboratorUNKNOWN
ODAS Stichting
CollaboratorUNKNOWN
Uitzicht
CollaboratorUNKNOWN
University of Applied Sciences Utrecht
CollaboratorOTHER
Erasmus Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Masking description

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

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
4 Years to 55 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Acuity improvement24 weeksVisual Acuity improvement (logMAR units/time period) in children with amblyopia treated with patching therapy vs dichoptic video gaming

Countries

Netherlands

Contacts

Primary ContactSjoukje E Loudon, MD, PhD
s.loudon@erasmusmc.nl+31(0)624927128
Backup ContactAveen Kadhum, Bsc
a.kadhum@erasmusmc.nl+31 (0)10 7032103

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026