FDA Approves New ‘Lazy Eye’ Treatment for Children Using Virtual Reality

For centuries, eye patches have been the gold standard for the treatment of amblyopia, also known as “lazy eye”.

Amblyopia is the most common cause of visual impairment in children, according to health experts, and is usually treated by covering the stronger eye with a sticky patch to train the weaker one.

While the treatment works, it can be difficult to get children to stick to it.

“After a year and a half of patching, Camille has become very resistant. She was running and crying, ”said Jaye Setty-Collier, whose 7-year-olddaughter was diagnosed with amblyopia at the age of 3. “And I don’t blame her. When you remove the sticky patch, it feels like your eyebrow is plucked.

Fortunately, for kids like Camille, a new therapy recently approved by the Food and Drug Administration has introduced a modern approach.

The product, called Luminopia One, is a virtual reality headset that streams popular, kid-friendly TV shows and movies. While children watch their favorite programs, the headphones blur the image of one eye to reinforce the other.

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The helmet is FDA approved for children ages 4-7 for one hour a day, six days a week. A study conducted by Luminopia,a digital therapy company and published in the peer-reviewed journal Ophthalmology, found that children’s vision in the weaker eye improved by nearly two eye chart lines in 12 weeks.

“It was a difference day and night” for Camille, who participated in the trial, Setty-Collier. “She went from crying and resisting the patches to asking for more time with the helmet on.”

Patients with amblyopia typically require months or even years of patching before noticeable improvement, said Dr Allison Babiuch, pediatric ophthalmologist at the Cole Eye Institute at the Cleveland Clinic, which is not affiliated with the study. .or product development. And even then, most kids don’t get the full benefit of the patch because eventually they stop wearing it.

“It’s very exciting,” Babiuch said of the helmet. “The treatment for amblyopia has been the same boring thing for so long and it feels like a 21st century treatment.”

The headset feeds data into a physician-accessible dashboard that shows it is being used as prescribed. Although parents reported a 100% compliance rate in the Luminopia study, the headset reported that children were 88% compliant.

Babiuch called this compliance rate “quite good”.

Among participants with a history of patching in the treatment group, 94% of parents said they were “likely” or “very likely” to choose the headset over the patch.

“All of us who treat a lot of patients with amblyopia, it’s a struggle with families. It’s a fight with kids and parents find it hard to comply, ”said Dr. Monte A. Del Monte, Skillman professor of pediatric ophthalmology at the Kellogg Eye Center at the University of Michigan. “The headset is popular and more palatable to children and families. “

He said the extra hour of screen time, which has doubled in children since the start of the COVID-19 pandemic, is not expected to have a big impact on eye health. Plus, virtual reality doesn’t affect near vision like a phone or tablet, said Scott Xiao, co-founder and CEO of Luminopia.

“The special thing about VR is that the optical system projects the images at distances closer to watching something in a movie theater rather than looking at a phone,” he said.

Health experts recommend treating amblyopia early in life, as it usually develops from birth until the age of 7.

In partially sighted patients, the brain begins to shut off its connection to the lazy eye in favor of the stronger eye. As the child grows, Babiuch said, the condition becomes more difficult to treat and can lead to permanent vision loss.

“To see you need to have healthy eyes and a healthy brain diversion,” she said. “The reason the treatment should be done when you are young is that the brain is still malleable. “

The most common type of lazy eye is strabic amblyopia, where muscles in the weaker eye cause the weaker eye to cross or turn and prevent the two eyes from working together.

The second most common type is refractive amblyopia, which is when the eyes have a significant difference in prescription. In some children, lazy eyes can be caused by a combination of these problems.

Health experts suggest parents watch for warning signs in their young children. This can include an eye that wanders in or out, eyes that seem to not work together, poor depth perception, a creasing or closing of the eyes, and a tilt of the head, according to the Mayo Clinic.

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From left to right: Camille's brother Brandon Davis, father Jaye Setty-Collier, Camille Setty-Collier, mother Amber Setty-Collier and brother Jared Davis.

Camille, however, was not exhibiting any of these symptoms when she was diagnosed with amblyopia. Setty-Collier took her to the ophthalmologist after she complained of a white light in her vision.

It’s a lesson “for parents to be diligent with their children’s vision,” said Setty-Collier. “If she hadn’t given us this white light situation, we wouldn’t have taken her to an ophthalmologist this early in life.”

The Luminopia One trial has been over since January 2020, but Camille is still asking her father about the helmet.

The company says it will be available to the public in June 2022. Parents have the choice of purchasing their own compatible headphones and downloading the Luminopia One app, or renting one directly from the company with the app. installed, said Xiao.

While pricing has not been finalized, the company is working with insurance companies to determine coverage and reimbursement options. Researchers also plan to conduct more studies in older children.

“It’s really a total game changer and I’m thankful for the opportunity we had to have our daughter use it,” said Setty-Collier. “The team that made it happen will change so many lives. “

Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.

Patient health and safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial contributions.

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