Clinical trial NCT05620173: Validation of New Virtual Reality Treatment for Children With Lazy Eye Using the Vedea Amblyopia Therapy (VAT)
Official title: 'Validation and Development of New Dichoptic VR-gaming Method to Treat Childhood Amblyopia; Vedea Amblyopia Therapy (VAT)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Amblyopia, Anisometropic
Amblyopia Strabismic
Amblyopia
Keywords: RCT
children
Virtual Reality
Lead sponsor: Vedea Healthware BV
Sponsor class: INDUSTRY
Collaborators: name: Health Holland
name: Oogziekenhuis Rotterdam
name: Rotterdams Oogheelkundig Instituut
name: Elisabeth-TweeSteden Ziekenhuis
name: Jeroen Bosch Ziekenhuis
First posted: 2022-11-17
Enrollment: 74
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Visual Acuity measured in LogMAR lines
timeFrame: Each clinical visit (approximately 1 month)
Secondary outcomes:
measure: Treatment adherence to the VAT defined as time played per day
timeFrame: Daily registration of time played up to week 16
measure: Rate of change in visual acuity outcomes
timeFrame: Each clinical visit (approximately 1 month)
Other outcomes:
measure: Change on Disease specific quality of life measured with the CAT-QoL
timeFrame: Baseline and at crossover (16 weeks after baseline)
measure: System Usability using the System Usability Scale (SUS)
timeFrame: At crossover (after 16 weeks) for the experimental group and at the end of crossover (after 32 weeks) for the active comparator group
measure: Change in stereopsis measured in seconds of arch
timeFrame: Each clinical visit (approximately 1 month)
measure: Change in the prism cover test using angle of deviation
timeFrame: Each clinical visit (approximately 1 month)
measure: Change in suppression/fusion measured in degrees
timeFrame: Each clinical visit (approximately 1 month)
measure: Diplopia using a standardized questionnaire
timeFrame: Each clinical visit (approximately 1 month)
Locations:
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
state: Noord Brabant
city: Rotterdam
country: Netherlands
facility: The Rotterdam Eye Hospital
state: Zuid Holland
Study officials:
affiliation: The Rotterdam Eye Hospital
name: Martha Tjon-Fo-Sang, PhD
role: PRINCIPAL_INVESTIGATOR
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