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NCT05620173
Validation of New Virtual Reality Treatment for Children With Lazy Eye Using the Vedea Amblyopia Therapy (VAT)
Conditions: Amblyopia, Anisometropic, Amblyopia Strabismic, Amblyopia
Sex: All
Ages: 4 Years – 10 Years
Phase: NA
Enrollment: 74
Sponsor: Vedea Healthware BV
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 glassesdiagnosed 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 amblyopiaparticipants must have easy access to an Android device equal to or higher than a Samsung Galaxy S8written informed consent by parents or legal guardiansExclusion Criteria:current treatment with atropine penalisationdocumented history of severe negative side effects that occur with exposure to VR usage (eg.
seizures or epileptic spasms)photosensitivityno developmental delaycoexisting ocular pathology or systemic diseases
Source: ClinicalTrials.gov (NCT05620173). StuddyBuddy aggregates publicly available trial information.