The US Food and Drug Administration has approved a virtual reality-based treatment for amblyopia in children, the company behind the treatment announced today. Patients watch modified TV shows or movies with virtual reality headsets to improve their vision.
"We are proud of FDA's groundbreaking decision today to approve the first digital treatment that allows patients to watch their favorite TV shows and movies to improve their vision," Scott Shaluminopia, CEO of the company that developed the tool, said in a statement.
About 3 percent of children have amblyopia, which occurs when the brain and eyes stop communicating normally. The brain favors one eye, causing vision problems in the other. This is the leading cause of vision problems in children. Treatment is usually done by blocking the stronger eye with an eye patch or blurring lotion, forcing the brain to rely on the weaker eye.
Luminopia's approach uses television and movies to cultivate the amblyopic eye and train the eyes to work together. Patients watch shows or movies through headphones and images are shown to each eye separately. The stronger eye saw the images with lower contrast, and the images were stacked on top of each other, forcing the brain to use both eyes to see them properly.
In clinical trials of the technology, children who used the treatment and wore glasses showed greater improvement in vision than a group of children who did not use the treatment but wore corrective glasses full-time. After 12 weeks of one-hour a day, six days a week program therapy, 62 percent of the children had a significant improvement in their vision. Only about a third of the children in the control group showed similar improvements over the 12-week course.
Luminopia, which has more than 700 hours of programming in its library, developed the tool in partnership with children's content distributors such as Nelvana and Sesame Workshop. The authors of the clinical trial wrote that they thought the choice of popular videos might be one reason users stuck with the program — people followed the treatment plan 88 percent of the time. Less than 50% of patients insist on using an eye mask or blur lotion.
With the approval, Luminopia is one of only a handful of companies approved to offer digital treatments as prescription treatments for medical conditions. Last year, the FDA approved a prescription video game called Endeavour RX to treat ADHD in children ages 8 to 12.
Luminopia plans to launch the therapy in 2022, it said in a statement.