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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03767985
Other study ID # MEC-2016-439
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 18, 2017
Est. completion date December 31, 2021

Study information

Verified date August 2021
Source Erasmus Medical Center
Contact Sjoukje E Loudon, MD, PhD
Phone +31(0)624927128
Email s.loudon@erasmusmc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 124
Est. completion date December 31, 2021
Est. primary completion date June 24, 2020
Accepts healthy volunteers No
Gender All
Age group 4 Years to 55 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Netherlands Erasmus Medical Center Rotterdam South-Holland

Sponsors (5)

Lead Sponsor Collaborator
Erasmus Medical Center Lijf & Leven, ODAS Stichting, Uitzicht, University of Applied Sciences Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Acuity improvement Visual Acuity improvement (logMAR units/time period) in children with amblyopia treated with patching therapy vs dichoptic video gaming 24 weeks
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