Digital therapeutics approach for young children with myopia using SAT-001 (DAYS): study protocol for a randomized controlled trial.

ABSTRACT:

Background

Myopia is a prevailing refractive disorder and rapidly increases the risk of vision-threatening conditions. Earlier intervention is crucial to suppress myopia progression; however, the pharmacological and non-pharmacological therapies currently available have limitations. SAT-001 is a novel digital therapeutic software developed for myopia control and is designed to overcome the limitations of existing therapies. The present study aims to evaluate the efficacy and safety of the software as a medical device, SAT-001, for the inhibition of myopia progression and treatment in pediatric patients with myopia.

Methods

This clinical trial is a two-arm, prospective, randomized, open-label study with a duration of approximately 25 months, comprising a maximum of 52 weeks o

SUBMITTER: Paik HJ 

PROVIDER: S-EPMC11978125 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature