Factual Evidence on Digital Therapeutics in Pediatric Amblyopia: Insights into Rapid Axial Elongation Risk.

Abstract

To evaluate the impact of daily digital therapeutics (DTx) on the risk of rapid axial elongation (RAE) in children with amblyopia using data from clinical settings. Retrospective cohort study. One thousand three hundred ninety-four children 3-to-12 years of age with amblyopia, 477 of whom received DTx. Children in the DTx group underwent 30 minutes of daily vision therapy, with axial length (AL) measured at baseline and during follow-up. Cox proportional hazards models were used to assess the risk of RAE, defined as an annual axial elongation exceeding safety thresholds based on age and myopia status. The primary outcome was the hazard ratio (HR) for RAE associated with DTx, adjusted for age, sex, best-corrected visual acuity, cycloplegic spherical equivalent refraction, amblyopic eye, type of amblyopia, and baseline AL. Six hundred forty-one children (45.98%) experienced RAE. Use of DTx increased the risk of RAE by 65% (HR, 1.65; 95% confidence interval, 1.40-1.96; P < 0.001), with consistent findings across all subgroups (P > 0.05 for interaction). The increased risk was noted particularly in children with hyperopia, suggesting the potential for DTx to influence axial growth in this population. Digital therapeutics are associated with an increased risk of RAE in children with amblyopia, highlighting the need for careful monitoring of AL during therapy. Although DTx offers visual acuity improvements, its potential impact on ocular growth should be balanced, particularly in children with hyperopia and premyopia. Proprietary or commercial disclosure may be found after the references in the Footnotes and Disclosures at the end of this article.