PurposeThe objective of this study was to evaluate the clinical efficacy of a 4D digital strabismus and amblyopia visual function correction system (4D-DSAAVFCS) in combination with conventional modalities compared with conventional modalities alone in children with anisometropic amblyopia.MethodsThis nonrandomized controlled study collected data on best-corrected visual acuity (BCVA), simultaneous vision, fusion vision, near stereoscopic vision, the amplitude of P100 wave (graphic evoked visual potentials), and the latency of P100 wave from both eyes at the beginning of the treatment and one year later. The Mann‒Whitney U test was used to compare BCVA contrasts in different subgroups, and the independent samples t test was used to compare the amplitude and latency of P100 wave contrasts in different subgroups. The basic cure rate, simultaneous vision recovery rate, fusion vision recovery rate, and near stereoscopic vision recovery rate contrasts in different subgroups were compared via the chi-square test.ResultsThis study included 393 children (217 boys and 176 girls) aged 3 to 12 years with anisometropic amblyopia who were treated at the Aier Eye Hospital of Wuhan University from January 2020 to December 2022. The children were divided into two groups, the 4D group (263 cases) and the traditional group (130 cases), on the basis of the treatment modality. The children in the traditional group received treatment through the conventional method of occlusion and regular training. Meanwhile, the children in the 4D group received treatment through the traditional method and the 4D-DSAAVFCS. The 4D group was divided into two age groups: 3 ~ 6 years (161 cases) and 6 ~ 12 years (102 cases). The basic cure rate of the 4D group was significantly better than that of the traditional group (χ2 = 4.318, P < 0.05). There were no statistically significant differences in the BCVA, the latency of P100 wave, or the amplitude of P100 wave between the 4D group and the traditional group before treatment (U=-0.117, t=-0.05, all P > 0.05 ). After one year of treatment, a statistically significant difference was observed between the 4D group and the conventional group in terms of BCVA, the latency of P100 wave, and the amplitude of P100 wave (U=-1.243, t=-0.853, t=-1.546, all P < 0.05). These results suggest that the therapeutic effect was greater in the 4D group than in the conventional group. The recovery rates of simultaneous vision, convergent fusion, divergent fusion, and near stereoscopic vision were significantly greater in the 4D group than in the conventional group (χ2 = 4.344, 4.726, 5.123, and 2.036, respectively; all P < 0.05). Additionally, the basic cure rate of children aged 3 ~ 6 years in the 4D group was significantly greater than that of children aged 6 ~ 12 years (χ2 = 2.365, P < 0.05). In this study, BCVA was significantly lower in the 3 ~ 6-year-old group than in the 6 ~ 12-year-old group (U = -1.267, P < 0.05). Similarly, the amplitude of P100 wave was also significantly greater in the 3 ~ 6-year-old group than in the 6 ~ 12-year-old group (t = -1877, P < 0.05). The latency of P100 wave was lower in the 3 ~ 6-year-old group than in the 6 ~ 12-year-old group (t=-0.998, P < 0.05). Additionally, the recovery rate of near stereoscopic vision was significantly greater in the 3 ~ 6-year-old group than in the 6 ~ 12-year-old group (χ2 = 4.534, P < 0.05).ConclusionThe combination of the traditional method with the 4D-DSAAVFCS was more effective than the traditional method alone in treating amblyopic children. This approach was particularly helpful in improving the visual acuity of the children and restoring their optic nerve conduction function, simultaneous vision, fusion vision, and near stereoscopic vision. The combination of the traditional method and the 4D-DSAAVFCS is more effective for younger children.