NEW YORK (Reuters Health) - A new therapy for amblyopia, which uses a virtual-reality headset to modify videos to promote weaker eye usage and encourage patients' brains to combine the input from both eyes, significantly improves vision, results from a phase-3 trial suggest.
Data from the more than 100 children enrolled in the trial reveal that at 12 weeks, the high-tech therapy improved weak-eye acuity by 1.8 lines on average on a logMAR eye chart, while the weak-eye acuity of children who did not receive the therapy improved by 0.8, researchers report in Ophthalmology.
The device, named Luminopia One, was granted premarket approval by the Food and Drug Administration as a prescription therapy to improve vision in children with amblyopia on October 20.
"To me, this is a very exciting thing," said study coauthor Dr. Gil Binenbaum of the Children's Hospital of Philadelphia. "A very important part is that it allows the child to choose what they want to watch and that alone helps with compliance. But what is really exciting is that it encourages both eyes to work together."
Current therapies for amblyopia, a neurodevelopmental disorder that affects 3% of children, focus only on the weak eye, by blocking or blurring the vision of the other, stronger one. "The advantage to (the new) treatment is it makes the child use both eyes at the same time," Dr. Binenbaum said
To test the treatment, researchers allowed children to choose from a list of popular television shows and movies to watch through a headset, which, using proprietary computer algorithms, altered the video feeds in real time to reduce clarity of the content viewed by the "good" eye, at least in part by reducing the contrast viewed by that eye.
The software also tweaks the feeds that are viewed by each eye. Because different, complementary parts of the images are delivered to the left and right eyes, the device encourages the brain to put together information gathered by each, Dr. Binenbaum said.
He and his colleagues randomly assigned 105 children, aged 4 to 7, to the treatment group or a control group. Those in the intervention group used the digital device one hour per day, six days a week and wore refractive correction glasses the rest of the time. The children in the control group wore the corrective glasses full time. At the end of 12 weeks, 90 of the 105 children had outcome data.
Dr. Binenbaum suspects that vision will improve more than what was seen at 12 weeks if the children continue to use the device.
"Amblyopia is one of the commonest causes of reversible vision loss in childhood," said Dr. Ken Nischal, chief of the division of pediatric ophthalmology, strabismus, and adult motility at the UPMC Children's Hospital of Pittsburgh. "The problem is that (the traditional way of managing amblyopia) often has poor compliance and even if it is successful the quality of the 3D vision . . . is often degraded and there is often a regression of the vision in the affected eye when patching or penalization with dilating drops is stopped."
"So for some time now we have been looking at other methods of treating amblyopia and one such method is dichoptic stimulation," Dr. Nischal, who was not involved in the study, told Reuters Health by email. "This study shows for the first time that, compared to glasses alone, dichoptic training improves vision of amblyopic eyes. More work is needed but this could potentially help improve amblyopia therapy outcomes."
Ophthalmologists may not have to wait long to have access to the device. Scott Xiao, co-founder and CEO of Luminopia, told Reuters Health by email, "We are planning to launch Luminopia One next year."
The study was funded by Luminopia, which participated in all aspects of the research, including preparation of the manuscript. Dr. Binenbaum has financial ties to the company, as do his coauthors.
SOURCE: https://bit.ly/3jKhsYZ Ophthalmology, September 13, 2021
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