The MyopiaX-1 trial studies MyopiaX, a smartphone application that aims to slow the progression of myopia, or nearsightedness, in children and adolescents.
Dopavision has reported successful completion of enrollment in its MyopiaX-1 trial (NCT04967287) of MyopiaX, a smartphone application that aims to slow the progression of myopia, or nearsightedness, in children and adolescents.
The clinical trial, MyopiaX-1, is a randomized, active-controlled trial to evaluate the safety, tolerability, and clinical outcomes of MyopiaX in pediatric participants with myopia.1
More than 100 children between the ages of 6 and 14 years with progressive myopia and a refractive error between –0.75 and –5.00 diopters were randomized to participate in the 12-month trial. The enrolled participants were randomized in a 2:1 ratio to receive either MyopiaX or myopia control spectacles for the first 6 months. During the second half of the study, participants in the MyopiaX group will add the myopia control spectacles.1
Dopavision describes MyopiaX as “a non-invasive, light-based treatment designed to provide a medical effect digitally.” MyopiaX uses a virtual reality headset and wireless controller to deliver the treatment while children engage with age-appropriate digital content.2
Mark Wuttke, CEO of Dopavision, discussed the trial further in the press release from the company.
“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,” said Wuttke. “We designed our treatment approach to control myopia progression as a non-invasive, non-pharmaceutical 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. The MyopiaX app administers an intervention that targets the eye’s innate growth mechanisms using blue light delivered to the optic nerve head. The MyopiaX-1 study is designed to provide the first clinical insight into the effects of MyopiaX, and we are very pleased to have reached this important milestone with the completion of the trial enrollment.”
The first clinical results are expected in the beginning of 2024 and the 12-month MyopiaX-1 trial is scheduled to be completed in September 2024. The MyopiaX-1 trial is being conducted at 10 clinical sites across Germany, the Netherlands, Portugal, Spain, and the United Kingdom.