Abstract
Purpose :
To evaluate the efficacy and safety of SAT-001, a novel Software as a Medical Device (SaMD) which designed to impede myopia progression by conducting monitored eye movement exercise.
Methods :
This 48-week, randomized, open-label, multicenter, parallel, exploratory trial (NCT05917041) compared the efficacy and safety of SAT-001 combined with glasses wearing to glasses wearing alone in children (5-12 years) with mild to moderate myopia (spherical equivalent refractive error (SER) ranging from -0.75 dioptor (D) to -5.75 D). During study period, patients allocated in SAT-001 group conducted program guided eye movement exercise. Cycloplgeic refraction, axial length, adverse events (AE) were evaluated at baseline, 12, 24, 36, 48 weeks. Data on refractive growth and axial length change from each eye was analyzed in a separated manner (oculus sinister; OS, oculus dexter; OD) and subgroup analysis was performed according to age; younger (5-8 years) and older (9-12 years) sub-groups.
Results :
Total 60 patients were randomly assigned to SAT-001 and glasses only control, and 52 (27 in SAT-001, 25 in control) have finished 48 months follow up. Mean age of these 52 subjects was 8.52±2.05 years; 25 were male and 27 female. At 48 weeks, SAT-001 group showed a trend toward smaller myopic shift (SER change -0.62 D in OS, -0.53 D in OD) in both eyes compared to controls (SER change -0.85 D in OS, -0.84 D in OD), there found no statistical significance (P=0.21 in OS, P=0.07 in OD). When we performed subgroup analysis, in younger age group, the amount of myopia progression during 48 weeks was significantly smaller in SAT-001 (mean SER change -0.61 D in OS, -0.50 D in OD) than in control subjects (mean SER change -1.18 D in OS, -1.22 D in OD) in both eyes (P=0.03 in OS, P<0.01 in OD) The degree of axial length growth was also significantly smaller in OD of SAT-001 group (mean axial growth of 0.38 mm) than that of controls (mean axial growth of 0.59 mm) with statistical significance (P=0.03). No serious AEs or device-related AEs occurred in all subjects.
Conclusions :
The use of SAT-001 software application effectively and safely suppressed myopia progression in patients with mild to moderate myopia, especially in younger age group. This novel, non-invasive SaMD may enable early, safe management of pediatric myopia.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.