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

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

Conditions
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Amblyopia, Anisometropic, Amblyopia Strabismic, Amblyopia

Intervention / Treatment
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* Device: Vedea Amblyopia Therapy (VAT)
* Device: Occlusion therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vedea Amblyopia Therapy (VAT) then Vedea Amblyopia Therapy<br>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. | Device: Vedea Amblyopia Therapy (VAT)<br>* 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.<br>|
| Active Comparator: Occlusion therapy then Vedea Amblyopia Therapy (VAT)<br>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. | Device: Vedea Amblyopia Therapy (VAT)<br>* 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.<br>Device: Occlusion therapy<br>* 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.<br>* Other names: Patching;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Visual Acuity measured in LogMAR lines | The LogMAR method is a validated and often used method of measuring visual acuity in children (with or without amblyopia). Possible scores range from 0 (perfect vision) to 1.0 or higher as really bad vision. | Each clinical visit (approximately 1 month) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment adherence to the VAT defined as time played per day | Adherence will be calculated using the following framework: 30 minutes per day = excellent treatment adherence 20-29 minutes per day = good treatment adherence 15-19 minutes per day = average treatment adherence ≤ 14 minutes per day = bad treatment adherence | Daily registration of time played up to week 16 | 
| Rate of change in visual acuity outcomes | Rate of change is defined as the number of weeks it takes to reach the highest visual acuity score. | Each clinical visit (approximately 1 month) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCT, children, Virtual Reality