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

ABSTRACT:

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

SUBMITTER: Loughman J 

PROVIDER: S-EPMC12719902 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature