Patching or Gaming as Amblyopia Treatment?

Amblyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03767985
• Other study ID #: MEC-2016-439
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Amblyopia

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