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

Not Applicable

Active, not recruiting

• Conditions: Amblyopia Strabismic; Amblyopia, Anisometropic; Amblyopia
• Interventions: Device: Vedea Amblyopia Therapy (VAT); Device: Occlusion therapy

• Registration Number: NCT05620173
• Lead Sponsor: Vedea Healthware BV

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-11-10
• Study First Posted: 2022-11-17
• Study Start: 2023-02-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-15
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vedea Amblyopia Therapy (VAT) then Vedea Amblyopia Therapy	Vedea Amblyopia Therapy (VAT)	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.
Occlusion therapy then Vedea Amblyopia Therapy (VAT)	Vedea Amblyopia Therapy (VAT)	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.
Occlusion therapy then Vedea Amblyopia Therapy (VAT)	Occlusion therapy	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Visual Acuity measured in LogMAR lines	Each clinical visit (approximately 1 month)	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.

Secondary Outcome Measures

Name	Time	Method
Treatment adherence to the VAT defined as time played per day	Daily registration of time played up to week 16	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
Rate of change in visual acuity outcomes	Each clinical visit (approximately 1 month)	Rate of change is defined as the number of weeks it takes to reach the highest visual acuity score.

Trial Locations

Locations (2)

Jeroen Bosch Ziekenhuis; 🇳🇱 's-Hertogenbosch, Noord Brabant, Netherlands

The Rotterdam Eye Hospital; 🇳🇱 Rotterdam, Zuid Holland, Netherlands