NCT05620173

Validation of New Virtual Reality Treatment for Children With Lazy Eye Using the Vedea Amblyopia Therapy (VAT)

'Validation and Development of New Dichoptic VR-gaming Method to Treat Childhood Amblyopia; Vedea Amblyopia Therapy (VAT)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Vedea Healthware BV · Industry
• Sex: All
• Age: 4 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amblyopia, Anisometropic
• Amblyopia Strabismic
• Amblyopia

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2023-02-22
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2022-11-17
• Last updated: 2024-07-15

Locations

2 sites across 1 country: Netherlands