Short-term choroidal thickness modulation with SAT-001 digital software intervention in pediatric myopia: a randomized pilot study

Myopia progression in children is associated with excessive axial elongation, leading to structural changes in the eye, including choroidal thinning. This two-center, randomized, open-label, parallel-group, exploratory study aimed to investigate the effects of SAT-001, a software-based digital therapeutic device, and its modified version (mSAT-001) on choroidal thickness (ChT) in pediatric myopia. A total of 20 myopic children (9.00 ± 2.20 years) were divided into two groups. Group 1 ( N = 10) used SAT-001, requiring 30 min of device application (structured eye-movements and rest modules), while Group 2 ( N = 10) used mSAT-001, requiring 15 min of device application (structured eye-movements only). ChT was measured at the subfoveal and four additional anatomical locations (two nasal, two temporal points from the fovea) in the right eye at baseline, immediately before, and after device application. Both groups showed ChT increases after device application, but Bonferroni-adjusted within-group significance observed only in Group 1. Between-group differences were significant subfoveally and nasally, with subfoveal significance retained in sensitivity analyses (adjusted P < 0.05). These findings suggest that SAT-001 may acutely modulate ChT in children with myopia and support the potential utility of ChT as an exploratory physiological biomarker for evaluating short-term responses to digital therapeutic interventions.