Prospective observational study of three real-world amblyopia treatments in children: clinical outcomes and predictive factors.

BACKGROUND

Amblyopia is a leading cause of reduced visual acuity in children. While patching alone remains standard care, combining patching with atropine or visual stimulation may yield superior outcomes. This prospective observational study aimed to (1) compare the effectiveness of three real-world amblyopia treatments-patching alone, patching plus atropine, and patching plus visual stimulation-and (2) identify factors predictive of successful visual outcomes.

METHODS

A total of 283 children (mean age 6.9 ± 2.3 years) with clinically diagnosed amblyopia were enrolled at a single center in China and followed for 12 months. Treatment selection was based on routine clinical practice and parent/physician preference. Best-corrected visual acuity (VA) in logMAR and stereopsis (arc seconds) were measured at baseline, 3, 6, and 12 months. Adherence was monitored via diaries/interviews, and adverse events were documented. Multivariable logistic regression examined predictive factors for successful outcome, defined as final VA ≤ 0.3 logMAR and stereopsis ≤ 40 arc seconds.

RESULTS

Of the 283 enrolled children, 95 received patching alone, 90 underwent patching plus atropine, and 98 received patching plus visual stimulation; baseline characteristics were similar among groups (p > 0.05). By 12 months, mean logMAR VA improved from 0.55 ± 0.11 to 0.33 ± 0.07 (patching alone), 0.56 ± 0.10 to 0.26 ± 0.05 (patching + atropine), and 0.54 ± 0.12 to 0.22 ± 0.05 (patching + visual stimulation) (p < 0.01), while stereopsis (seconds of arc) improved from 59 ± 7 to 40 ± 6, 60 ± 8 to 32 ± 5, and 58 ± 8 to 28 ± 5, respectively (p < 0.01). Photophobia (10.0%) and blurred near vision (7.8%) were reported only in the atropine group, and overall adherence (≥ 80% patching hours) ranged from 58.9% in the atropine group to 67.3% in the visual stimulation group. Multivariable analysis showed that receiving patching + atropine (OR = 2.10, 95% CI 1.25-3.52) or patching + visual stimulation (OR = 3.65, 95% CI 2.05-6.48), along with better baseline VA (OR = 0.75, 95% CI 0.62-0.89, per 0.1 logMAR), and ≥ 80% adherence (OR = 2.42, 95% CI 1.56-3.76), significantly increased the odds of achieving successful final outcomes (p < 0.01 for all).

CONCLUSION

Combining patching with atropine or visual stimulation led to greater improvements in both VA and stereopsis compared to patching alone, with high adherence and better baseline VA serving as strong predictors of success.