PEDIG Amblyopia Treatment Study (ATS20)
Why we are doing this study:
The Amblyopia Treatment Study (ATS20) is a study for children aged 4 to 12 years old who have amblyopia, sometimes referred to as lazy eye, a condition where one of the eyes does not see as well as the other. This study will look at using a game played on an iPad® to spectacle treatment alone to treat amblyopia. The aim is to find out if playing this game is more effective than spectacle treatment alone for improving vision in the lazy eye.
Who can be in the study:
- Children aged 4 to 12 years with amblyopia
- No amblyopia treatment (ie. drops, patching, filters, vision therapy) in the past 2 weeks
Specific screening questions will be asked before scheduling a study appointment
What the study involves:
The length of the study is 8 weeks with follow-ups at weeks 4 and 8. The first visit will take approximately 2 hours and follow-up visits ½-1 hour. At the end of the first study visit, if they are eligible, your child will be randomized (like the toss of a coin) to receive either just spectacle correction or the iPad® video game and spectacle correction. Video game play on the iPad® is prescribed for 1 hour/day, 5 days/week for 8 weeks, and the amount of game play is logged on a calendar.
Participants who are randomized to spectacle correction only will be offered the iPad® game treatment at week 8, and asked to return for a follow-up at week 16.
Will you directly benefit from the study?
There may or may not be a benefit to your child by being in the study, but there is no guarantee.
Other things you should know about the study:
- Parental consent is required to participate in this study
- Glasses are only provided if needed based on the child’s prescription and their current glasses do not meet the eligibility requirements