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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
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.
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.
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, Netherlands
The Rotterdam Eye Hospital
Rotterdam, South Holland, Netherlands
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.
Time frame: Each clinical visit (approximately 1 month)
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
Time frame: 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.
Time frame: Each clinical visit (approximately 1 month)
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