Enrollment complete for study of MyopiaX app in children, adolescents
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Dopavision has completed enrollment for its MyopiaX-1 trial, a randomized active-controlled study of the light-based digital treatment for children and adolescents with myopia, the company announced in a press release.
“Pediatric myopia is a global public health problem that presents a significant burden for children, with an increased risk of long-term eye health complications and impaired quality of life,” Mark Wuttke, PhD, CEO of Dopavision, said in the release. “We designed our treatment approach to control myopia progression as a noninvasive, nonpharmaceutical method. Developed as a smartphone application, MyopiaX is accompanied by fun virtual reality content, easy for children to use and has the potential to broaden access for a larger number of people suffering from myopia.”
According to the company, MyopiaX is a digital treatment that targets the eye’s growth mechanisms by directing blue light to the optic nerve head.
The technology will be studied in a 12-month, proof-of-concept trial that includes more than 100 children and adolescents aged 6 to 14 years with progressive myopia and refractive error between –0.75 D and –5.00 D, who were randomized in a 2:1 ratio to receive MyopiaX or myopia control spectacles for 6 months. In the trial’s second 6 months, participants in the MyopiaX group will add myopia control spectacles to their treatment.
The trial includes 10 clinical sites across Germany, the Netherlands, Portugal, Spain and the United Kingdom and is expected to be completed in September 2024, the release stated.
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