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

Vedea Healthware

Status: Active, not recruiting

Conditions: Amblyopia; Amblyopia, Anisometropic; Amblyopia Strabismic

Treatments: Device: Occlusion therapy; Device: Vedea Amblyopia Therapy (VAT)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05620173

NL79107.000.22

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 4 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• wearing the full corrected refraction for ≥14 weeks to adapt to the glasses
• diagnosed with an unilateral anisometropic, strabismic and/or deprivation amblyopia.

Amblyopia was defined as an intraocular difference (IOD) in visual acuity (VA) of 0.2 log MAR (2 lines) or more. Angle of strabismus ≤ 10 prism diopters at near and distance fixation. Current clear media (in case of deprivation amblyopia after successful surgery).

• currently under treatment or starting treatment for unilateral amblyopia
• participants must have easy access to an Android device equal to or higher than a Samsung Galaxy S8
• written informed consent by parents or legal guardians

Exclusion criteria

• current treatment with atropine penalisation
• documented history of severe negative side effects that occur with exposure to VR usage (eg. seizures or epileptic spasms)
• photosensitivity
• no developmental delay
• coexisting ocular pathology or systemic diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Vedea Amblyopia Therapy (VAT) then Vedea Amblyopia Therapy

Experimental group

Description:

Children in this intervention arm will use the VAT for 16 weeks. After the initial 16 weeks of treatment these children will be allowed to use the VAT for another 16 weeks.

Treatment:

Device: Vedea Amblyopia Therapy (VAT)

Occlusion therapy then Vedea Amblyopia Therapy (VAT)

Active Comparator group

Description:

Children in this intervention arm will adhere to a 'care as usual' regimen consisting of occlusion therapy as prescribed by their health care provider. They will do so for 16 weeks. After the initial 16 weeks of treatment these children will crossover into the experimental arm to examine if they are still responsive to the VAT after already completing 16 weeks of traditional treatment.

Treatment:

Device: Vedea Amblyopia Therapy (VAT)

Device: Occlusion therapy