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'Validation and Development of New Dichoptic VR-gaming Method to Treat Childhood Amblyopia; Vedea Amblyopia Therapy (VAT)
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.
Age
4 - 10 years
Sex
ALL
Healthy Volunteers
No
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, Netherlands
The Rotterdam Eye Hospital
Rotterdam, South Holland, Netherlands
Start Date
February 22, 2023
Primary Completion Date
December 1, 2024
Completion Date
December 1, 2024
Last Updated
July 15, 2024
74
ESTIMATED participants
Vedea Amblyopia Therapy (VAT)
DEVICE
Occlusion therapy
DEVICE
Lead Sponsor
Vedea Healthware BV
Collaborators
NCT07417046
NCT04378790
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06380517