Randomized Study of Two Virtual Reality Dichoptic Treatments Versus Optical Correction Alone for Amblyopia in Children Ages 8 to 12

What this Trial Is About

Researchers are evaluating dichoptic treatments for children aged 8 to 12 years with amblyopia, a condition affecting vision. This phase 3 randomized trial compares two types of virtual reality-based dichoptic therapy, Luminopia and Vivid Vision, against continued use of optical correction alone. The study aims to understand how these treatments impact vision improvement, specifically measuring changes in the amblyopic eyes visual acuity. Participants are randomly assigned to one of three groups Luminopia, involving watching dichoptic movies or shows using a headset for 1 hour daily six days a week Vivid Vision, playing dichoptic video games with a headset for about 25 minutes daily six days a week or continuing optical correction with glasses or contact lenses alone. Those initially assigned to optical correction alone who show limited improvement after 18 weeks may be re-randomized to receive one of the dichoptic therapies, with follow-up visits extending to 36 weeks. During the study, participants attend clinical assessments at 9 and 18 weeks after starting treatment, with additional visits at 27 and 36 weeks for some. Researchers measure visual acuity changes in the amblyopic eye using the logMAR scale and assess quality of life related to vision through a pediatric eye questionnaire. The study includes monitoring adherence to treatment, willingness to wear the headset and optical correction, and safety considerations throughout the 18 to 36-week participation period.

Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age