MyopiaX-1 Safety and Efficacy of a Novel Approach to Slow Juvenile Myopia Progression: A Multicenter, Randomized, Controlled Trial.

Purpose: To investigate the safety, tolerability, and signals of effect of MyopiaX, a smartphone app that selectively delivers blue light to the optic nerve head to control myopia progression in children and adolescents. Design: Multicenter, randomized, active-controlled, examiner-masked proof-of-concept clinical trial (ClinicalTrials.gov identifier NCT04967287). Participants: Eligible children aged 6 to 12 years, with myopia of cycloplegic spherical equivalent refraction (SER) between -0.75 and -5.00 diopters (D) at baseline. Children were screened and enrolled between November 2021 and September 2023. Methods: Children were randomly assigned in a 2:1 ratio to MyopiaX or active control. Participants were instructed to use MyopiaX for 10 minutes twice daily for the first 6 months and, during the second 6 months of the trial, also wear defocus incorporated multiple segments (DIMS) myopia control spectacles. The active control group wore DIMS spectacles for the entire 12-month trial. Main Outcome Measures: The primary outcome was change in axial length (AL) and change in SER at month 6. Clinical safety examinations and the frequency and severity of device-related adverse events (AEs) were analyzed for all participants who began treatment. Results: Of the 124 randomized participants, 101 were enrolled under the 12-month active-control study design (MyopiaX: n = 66, DIMS: n = 35). After 6 months, the mean AL change from baseline in the MyopiaX (n = 50) and DIMS (n = 34) groups, respectively, was 0.14 ± 0.11 mm and 0.08 ± 0.09 mm. The 6-month change in SER was -0.18 ± 0.39 D in the MyopiaX group and -0.16 ± 0.41 D in DIMS participants. Among the 73 participants who used MyopiaX, including those randomized under the original study design (prior to introduction of an active control), there were 23 related AEs among the 16 participants (22%), including transient ocular discomfort and headache, all of which resolved without any need for treatment. Conclusions: MyopiaX was safe and well tolerated over 12 months in treatment-naive children with myopia. This exploratory study provides the first clinical data on the impact of MyopiaX's selective blue light stimulation on myopia progression and ocular growth. This novel approach may offer a complementary therapeutic solution for the clinical management of progressive myopia. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.