Luminopia improves amblyopia treatment by improving patient compliance.
Not long ago, the parents of a 5-year-old girl with amblyopia brought their child to David Epley, MD, looking for help. Despite the parents’ and Dr. Epley’s best efforts, unfortunately, they could not get the child to stick with treatment.
“We went through the patching process; that was a complete failure because she didn’t tolerate the sticky patch,” says Dr. Epley, a pediatric ophthalmologist with Pediatrix Eye Care in Kirkland, Wash. “We tried a pair of dummy glasses and a cloth patch on top of that, but she kept throwing off the glasses. And her parents were convinced she wouldn’t tolerate the atropine drops.”
Dr. Epley then turned to Luminopia, an innovative software-based treatment that received FDA marketing approval in 2022 that combines a virtual reality (VR) headset with video content to treat amblyopia. The efficacy of Luminopia was proven in a Phase 3 clinical trial involving 105 amblyopic children ages 4 to 7.
Sure enough, the treatment worked. By her follow-up visit 4 months later, the girl’s vision had improved from 20/50 to 20/25.
“That’s three lines on the eye chart and just one line away from that 20/20 mark. That’s a really great response,” Dr. Epley says, attributing the progress in large part to improved compliance resulting from the child’s enjoyment of the cartoons and other programming. “It worked great for this particular child because it’s essentially watching TV, and putting this headset on was OK because she got to choose a show and do it herself.”
A 'VIRTUAL' PARADIGM SHIFT
According to a 2022 meta-analysis by Hu et al, amblyopia affects up to 5% of the worldwide population, making it one of the most prevalent vision disorders in children. Patching and atropine drops have constituted the standard of care. Patching the stronger eye forces the weaker eye to work harder, stimulating visual development. Atropine, meanwhile, dilates the pupil of the stronger eye, blurring its vision and encouraging the weaker eye to become more active. While both approaches are effective, patching suffers from noncompliance, social stigma and the potential for occlusion amblyopia in the stronger eye. Atropine can cause side effects such as light sensitivity and blurred vision.
Enter Luminopia, one in an emerging class of software-driven interventions that are being used to treat substance abuse, asthma, insomnia and many other conditions. Patients wearing the Luminopia VR headset can watch videos such as SpongeBob SquarePants, Sesame Street or any one of hundreds of other videos in Luminopia’s curated library of more than 3,000 episodes from 75 licensed TV shows. The headset displays the video in a way designed to strengthen the connections between the eye and the brain and promote binocular vision.
CLINICAL TRIAL RESULTS
In the pivotal trial that led to Luminopia’s approval, the 51 subjects in the treatment group used the platform at home for the recommended 1 hour a day, 6 days a week, and wore spectacles full-time. The 54 subjects in the comparison group wore eyeglasses alone full-time. At 12 weeks, amblyopic eye VA improved by 1.8 lines (95% confidence interval [CI], 1.4-2.3 lines; n = 45) in the treatment group and by 0.8 lines (95% CI, 0.4–1.3 lines; n = 45) in the comparison group, Xiao et al reported in Ophthalmology.
At the planned interim analysis (adjusted α = 0.0193), the difference between groups was significant (1.0 lines; P = 0.0011; 96.14% CI, 0.33-1.63 lines) and the study was stopped early for success. No serious adverse events were reported.
“The thing that jumped out to us the most from our clinical trials was the efficacy that we see, even in patients who have been through patching. Typically, that’s a much more difficult group of patients to treat,” says Scott Xiao, founder and CEO of Luminopia Inc. “We were able to see the same improvement in prior-treated patients compared to new patients. We think that’s because of the unique mechanism of action. There are so many patients out there that have tried other treatments that could still use something else.”
ADVANTAGES OF LUMINOPIA
One of the most significant benefits of Luminopia is its ability to enhance patient compliance. Unlike patching, which can be uncomfortable and socially isolating, Luminopia’s VR experience is engaging and enjoyable for children. The increased compliance leads to effective outcomes, says Maanasa Indaram, MD, who has been using the platform in her patients for about 6 months.
Dr. Indaram, medical director of Pediatric Ophthalmology and Adult Strabismus at the University of California-San Francisco Medical Center, described treating a 6-year-old patient who had had previous surgery for strabismus but was failing to respond to patching.
“He’s just in first grade, and it’s hard for him to be able to patch for 4 hours a day [the standard duration for this treatment],” she says. “[These patients] can’t do it at school because it could really put them at a disadvantage if they only have 20/200 vision in the eye that they’re able to see, and it’s really not fair to ask them to wear a patch at home for that long.”
Since she prescribed Luminopia, Dr. Indaram says, the child has demonstrated significant gains in vision, “to the point where I’m going to continue it beyond the 3-months studied in the trial.”
REAL-TIME MONITORING
Luminopia prescriptions are filled by an online pharmacy that partners exclusively with Luminopia. The pharmacy ships the headsets directly to each family, along with a code that tells the Luminopia software and enables access to Luminopia's online library of TV shows.
“We’re working on [the insurance] front to advocate for more consistent coverage across the board,” Mr. Xiao says. “We’re making good traction with some key regional plans as well as some national health plans. Our hope and our plan is to get to a point where the cost to the patient might be the same as patching or even cheaper than patching, at which point we think that it would really become a no-brainer for physicians and for patients.”
In contrast to drops and patching, which require periodic follow-up visits to assess progress, adherence-tracking technology built into the VR headset allows clinicians to assess patient progress remotely through a web portal.
“You can look at the portal and see how well patients are using it,” Dr. Epley says. “It highlights kids who are using it really well, and you get yellow or red flags if they’re not using it so great. I have one kid that’s right now using it 160% of prescribed time. They’re like, ‘I like this. It’s fun. I’m just going to do it a lot longer.’”
POTENTIAL FOR OLDER PATIENTS, TOO
While Luminopia is indicated for children aged 4 to 7, Drs. Epley and Indaram say they are also using it off-label on older patients. Dr. Epley used the platform to improve the vision of a 17-year-old amblyopic patient who desperately wanted to become a military pilot.
“You need 20/20 vision in both eyes to do that … and he was almost two lines below that,” he says. The patient “had 6 months before he had to take the vision test, so we put him on Luminopia. About 4 months in, he was reading solidly on the 20/20 line. It literally changed his life from not being able to do what he’d been dreaming about doing to being able to meet that criterion.”
CONCLUSION
While Luminopia may not completely replace drops or patching, Dr. Indaram looks at this technology as “another tool that you have in your tool belt.
“A lot of our kids are using a lot of screen time and screen-based energy,” she says, “and we might as well leverage it in a way that is going to be beneficial for their treatment.” OM
Disclosures: Dr. Epley is a consultant to Luminopia. Dr. Indaram reports no relevant relationships.
