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

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

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.

Sponsors & Collaborators

• Health Holland

  collaborator OTHER

• Oogziekenhuis Rotterdam

  collaborator OTHER

• Rotterdams Oogheelkundig Instituut

  collaborator UNKNOWN

• Elisabeth-TweeSteden Ziekenhuis

  collaborator OTHER

• Jeroen Bosch Ziekenhuis

  collaborator OTHER

• Vedea Healthware BV

  lead INDUSTRY

Principal Investigators

• Martha Tjon-Fo-Sang, PhD · The Rotterdam Eye Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

4 Years

Max Age

10 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-22

Primary Completion

2024-12-01

Completion

2024-12-01

Countries

• Netherlands

Study Locations