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Validation of New Virtual Reality Treatment for Children With Lazy Eye Using the Vedea Amblyopia Therapy (VAT)
Sponsor: Vedea Healthware BV
Summary
The purpose of this clinical study is to validate the effectiveness of the Vedea Amblyopia Therapy (VAT) as a treatment for children with lazy eye. The main question it aims to answer is to prove that the VAT is as effective or more effective than the current gold standard for treating children with lazy eye. This is occlusion therapy by patching the dominant eye. Participants will play VR-games specifically designed for children with lazy eye for 30 minutes per day, 5 days per week for 16 weeks. This group of children will be compared to children that undergo regular occlusion therapy to see how both treatments options compare.
Official title: 'Validation and Development of New Dichoptic VR-gaming Method to Treat Childhood Amblyopia; Vedea Amblyopia Therapy (VAT)
Key Details
Gender
All
Age Range
4 Years - 10 Years
Study Type
INTERVENTIONAL
Enrollment
74
Start Date
2023-02-22
Completion Date
2024-12-01
Last Updated
2024-07-15
Healthy Volunteers
No
Interventions
Vedea Amblyopia Therapy (VAT)
Children will use the VAT for 5 days per week, 30 minutes per day. They play VR-games using a VR-headset, which content is optimized for dichoptic training.
Occlusion therapy
Children are given an eye patch to occlude their dominant eye with for a prescribed number of hours per day. This may typically range anywhere between 2-8 hours per day, depending on the severity of the amblyopia.
Locations (2)
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, Netherlands
The Rotterdam Eye Hospital
Rotterdam, South Holland, Netherlands