A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age

What this Trial Is About

Researchers are studying children aged 4 to 7 years with amblyopia to compare two treatments watching dichoptic movies or shows using the Luminopia headset versus patching the fellow eye. The goal is to see if the Luminopia headset treatment used one hour per day, six days per week, is not worse than patching for two hours per day, seven days per week, in improving vision in the amblyopic eye over 26 weeks. This phase 3 randomized trial evaluates changes in distance visual acuity as the primary outcome. Participants will be randomly assigned to one of two groups. One group uses the Luminopia headset to watch dichoptic content for one hour daily which can be split into shorter sessions six days a week, wearing optical correction if needed. The other group uses an eye patch on the fellow eye for two hours daily also split into shorter sessions seven days a week, with optical correction as needed. After 26 weeks, those initially in the patching group who still have significant vision difference may be offered the Luminopia treatment and followed for an additional 26 weeks. Throughout the study, participants will undergo clinical assessments at 13 and 26 weeks, with follow-up visits at 39 and 52 weeks for those switching to Luminopia. Researchers will measure changes in distance visual acuity in the amblyopic eye, tracking treatment effects over time. Parents will maintain communication with the study team, and participants will continue using required spectacles or contact lenses. The total study duration varies up to 52 weeks depending on treatment response and group assignment.

Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age