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Factual Evidence on Digital Therapeutics in Pediatric Amblyopia: Insights into Rapid Axial Elongation Risk
Ying Yao1, Yunsi He1, Yun Wen1
1State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, China.
Insights
Digital therapeutics (DTx) may increase the risk of rapid axial elongation (RAE) in children with amblyopia. Careful monitoring of axial length is crucial during DTx therapy, especially for those with hyperopia.
Area of Science:
- Ophthalmology
- Pediatric Eye Care
- Digital Health
Background:
- Amblyopia, or "lazy eye," affects visual development in children.
- Axial elongation is a key factor in myopia progression and ocular health.
- Digital therapeutics (DTx) offer novel treatment modalities for various conditions.
Purpose of the Study:
- To assess the association between daily digital therapeutics (DTx) and rapid axial elongation (RAE) in pediatric amblyopia patients.
- To evaluate the risk of RAE in children with amblyopia receiving DTx therapy.
- To analyze clinical data for the impact of DTx on axial length changes.
Main Methods:
- Retrospective cohort study involving 1,394 children (3-12 years) with amblyopia.
- 477 children received daily 30-minute vision therapy via DTx.
- Cox proportional hazards models analyzed RAE risk, adjusted for multiple clinical factors.
Main Results:
- Rapid axial elongation (RAE) occurred in 45.98% of children.
- DTx use was associated with a 65% increased risk of RAE (HR, 1.65; P < 0.001).
- This increased risk was consistent across subgroups, notably in children with hyperopia.
Conclusions:
- Digital therapeutics are linked to a higher risk of RAE in children with amblyopia.
- Close monitoring of axial length is essential during DTx treatment.
- The benefits of DTx for visual acuity must be weighed against potential ocular growth impacts, especially in hyperopic or premyopic children.
Purpose:
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.
Design:
Retrospective cohort study.
Participants:
One thousand three hundred ninety-four children 3-to-12 years of age with amblyopia, 477 of whom 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, sex, best-corrected visual acuity, cycloplegic spherical equivalent refraction, amblyopic eye, type of amblyopia, and baseline AL.
Results:
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.
Conclusions:
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.
Financial Disclosure(S):
Proprietary or commercial disclosure may be found after the references in the Footnotes and Disclosures at the end of this article.
