(Prashant Sharma, Pixabay. https://pixabay.com/photos/augmented-reality-vr-virtual-reality-3468596/)
14 Sept. 2021. Clinical trial findings show a digital therapy using virtual reality headsets improves vision in children with amblyopia, or lazy eye, more than corrective lenses alone. Results of the trial, testing the Luminopia One system made by Luminopia Inc. in Cambridge, Massachusetts, appear in yesterday’s issue of the journal Ophthalmology.
Amblyopia is a neurological and vision disorder occurring from a breakdown in coordination between one eye and the brain. As a result, the affected eye weakens and often wanders, while the other eye strengthens to compensate. The condition is usually detected in children up to age seven. Amblyopia is a leading cause of decreased vision in children, which according to data cited by Luminopia, affects three percent of children worldwide. Common treatments for amblyopia are wearing an eye patch over the stronger eye to strengthen the affected eye, or wearing prescription glasses to correct impaired vision symptoms.
The Luminopia One system presents videos for children using commercially available virtual reality headsets. The videos — children’s television shows and movies — are digitally altered with algorithms in real time to re-balance visual stimuli between the two eyes. Patients use the system for an hour a day for three to six months. The company says it consulted researchers from Boston Children’s Hospital and the Picower Institute, a neuroscience research center at MIT, in developing the system. Representatives from both institutions are scientific advisors to Luminopia.
The late-stage clinical trial enrolled 105 children at 21 sites in the U.S., age four to seven, diagnosed with amblyopia. Participants were randomly assigned to use a Luminopia One headset for an hour a day, six days a week, for 12 weeks, or continue using their glasses with corrective lenses over this time for comparison. Participants using Luminopia One also wore their corrective-lens glasses at other times.
Greater adherence to headsets than eye patches
The study team looked primarily for changes in scores on standard electronic eye chart tests of visual acuity in both eyes, tested separately. The researchers also measured visual acuity changes after four and eight weeks, and tracked adherence to treatments among Luminopia One users, as well as signs of adverse effects.
The results show more improvement in visual acuity among Luminopia One users than children wearing corrective-lens glasses alone. After 12 weeks, Luminopia One users could read an average of 1.8 more lines on the eye chart tests compared to 0.8 more lines on average for glasses wearers. Moreover, roughly six in 10 (62%) of Luminopia One users advanced two lines or more on eye chart tests after 12 weeks, compared to one-third (33%) of glasses wearers. In both cases, differences were large enough for statistical reliability.
In addition, half or more of the Luminopia One users kept to their prescribed treatment schedules at least 88 percent of the time, which is higher than parents’ reports of previous adherence to eye patches by their children. No serious adverse effects were reported. Because of the consistent differences between treatment and comparison groups, the study team stopped the trial earlier than expected.
“The data from this pivotal trial,” says Robert Langer, biomedical engineering professor at MIT and co-author of the paper, in a company statement released through BusinessWire, “validate Luminopia One as a safe and effective potential new treatment option for amblyopia in young children. These positive data also illustrate the potential of digital therapeutics as a new class of treatments for serious diseases.” Langer is a member of Luminopia’s board.
Luminopia says the Food and Drug Administration is evaluating findings from the trial in its review for medical device clearance of the Luminopia One.
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