Real-World Evidence on Digital Therapeutics in Pediatric Amblyopia: Insights into Rapid Axial Elongation Risk.

Objective: To evaluate the impact of daily digital therapeutics (DTx) on the risk of rapid axial elongation (RAE) in children with amblyopia using real-world data.

Design: Retrospective cohort study.

Subjects: A total of 1,394 children aged 3 to 12 years with amblyopia, of which 477 received DTx.

Methods: 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.

Main outcome measures: The primary outcome was the hazard ratio (HR) for RAE associated with DTx, adjusted for age, gender, best-corrected visual acuity (BCVA), cycloplegic spherical equivalent refraction (SER), amblyopic eye, type of amblyopia, and baseline AL.

Results: A total of 641 children (45.98%) experienced RAE. DTx use increased the risk of RAE by 65% (HR: 1.65; 95% CI: 1.40-1.96; P < 0.001), with consistent findings across all subgroups (P for interaction >0.05). The increased risk was particularly noted in children with hyperopia, suggesting the potential for DTx to influence axial growth in this population.

Conclusions: DTx is associated with an increased risk of RAE in children with amblyopia, highlighting the need for careful monitoring of AL during therapy. While DTx offers visual acuity improvements, its potential impact on ocular growth should be balanced, particularly in hyperopic and pre-myopic children.