Poland

Researchers are evaluating treatments for amblyopia in children aged 4 to 7 years. The study compares watching dichoptic movies or shows using the Luminopia virtual reality headset for 1 hour per day, 6 days per week, to traditional eye patching for 2 hours per day, 7 days per week. This Phase 3 trial aims to determine if the Luminopia treatment is not worse than patching in improving vision in the weaker eye over 26 weeks. Participants will be randomly assigned to either the Luminopia headset group or the patching group. Clinical assessments occur at 13 and 26 weeks after starting treatment. At 26 weeks, those initially assigned to patching who show less improvement may choose to try Luminopia therapy and continue follow-up visits at 39 and 52 weeks. Other participants will end the study at 26 weeks. During the study, children will have their vision tested at scheduled visits to measure changes in distance visual acuity in the amblyopic eye. Researchers will monitor treatment adherence and safety. The total participation can last up to 52 weeks for some children, with primary outcomes assessed at 26 weeks to evaluate vision improvement.