Evaluation of digital binocular therapies for amblyopia after refractive adaptation in treatment-naive children aged 3–13 years: A systematic review and meta-analysis of randomised controlled trials

Background: Patching has been the mainstay of unilateral amblyopia treatment, but adherence is challenging. Digital binocular therapies have emerged as a novel approach; however, evidence in treatment-naive children remains limited, as existing studies have predominantly included previously treated children. Objective: To evaluate the effectiveness of digital binocular therapies versus patching for improving visual acuity in treatment-naive children aged 3–13 years with unilateral amblyopia following refractive adaptation. Design: A systematic review and meta-analysis of randomised controlled trials was conducted in accordance with PRISMA 2020 guidelines and registered in PROSPERO (CRD420261278100). Comprehensive literature searches were conducted from January 2000 to December 2025. Two independent reviewers screened and selected studies, extracted data, and assessed risk of bias using the Cochrane RoB 2 tool. The primary outcome was change in best-corrected visual acuity. Data were pooled using a random-effects model. The GRADE approach was used to rate the certainty of evidence. Results: Five RCTs (n = 225) were included in the primary analysis. Digital binocular therapies showed no statistically significant difference in visual acuity compared with patching using a random-effects model (MD 0.00 logMAR, 95% CI −0.09 to 0.10; I2 = 50.2%). Sensitivity analysis including two additional RCTs judged to be at high risk of bias, one of which compared digital binocular therapy plus spectacles with spectacles alone (7 RCTs; n = 292), yielded similar results (MD 0.04 logMAR, 95% CI −0.03 to 0.10; I2 = 75.2%). The certainty of evidence for visual acuity was moderate, downgraded for inconsistency. Conclusion: Digital binocular therapies may serve as adjunctive treatment options when adherence to patching is challenging. However, current evidence does not demonstrate superiority over patching in treatment-naive children with unilateral amblyopia. The evidence remains limited by the small number of RCTs and modest sample sizes. Registration: This systematic review and meta-analysis was registered in the International Prospective Register of Systematic Reviews (PROSPERO) under registration number CRD420261278100 on 4 January 2026.