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

Area of Science:

• Ophthalmology
• Digital Therapeutics
• Pediatric Eye Care

Background:

• Myopia is a common refractive error with increasing prevalence, raising the risk of serious vision impairments.
• Current myopia control methods, both pharmacological and non-pharmacological, have limitations.
• SAT-001 is a new digital therapeutic software designed to address these limitations in myopia management.

Purpose of the Study:

• To evaluate the efficacy and safety of SAT-001, a medical device software, for inhibiting myopia progression in pediatric patients.
• To assess SAT-001's potential as a convenient and non-invasive myopia control option.

Main Methods:

• A 25-month, two-arm, prospective, randomized, open-label clinical trial involving 110 pediatric participants (aged 5 to <9 years) with myopia.
• Participants were randomized (1:1) to receive either SAT-001 with single-vision spectacles or single-vision spectacles alone.
• The primary endpoint is the change in spherical equivalent refractive error (SER) at 48 weeks; secondary endpoints include SER change at 24 weeks and axial length changes.

Main Results:

• The study is designed to measure the change in spherical equivalent refractive error (SER) at 48 weeks as the primary outcome.
• Secondary outcomes include changes in SER at 24 weeks and axial length measured every 12 weeks.
• Safety will be assessed by monitoring treatment-emergent adverse events.

Conclusions:

• This randomized controlled trial aims to confirm the efficacy and safety of SAT-001 for slowing pediatric myopia progression.
• Positive findings could position SAT-001 as an accessible, convenient, non-invasive treatment for early-stage myopia control.
• Further research is recommended for moderate-to-high myopia, astigmatism, user engagement, and integration with clinical treatments.