Clinical Study Summary: Evaluation of AmblyoPlay® in Pediatric Anisometropic Amblyopia

Study Background and Rationale

Amblyopia is a neurodevelopmental visual disorder characterized by reduced best-corrected visual acuity in one or both eyes without identifiable structural abnormalities. Among its various subtypes, anisometropic amblyopia arises from unequal refractive error between the eyes, leading to chronic cortical suppression of the more ametropic eye and impaired binocular development. Although traditional amblyopia management—most notably occlusion therapy and pharmacological penalization—has demonstrated efficacy in young children, these approaches are limited by age dependency, poor adherence, psychosocial burden, and a predominant focus on monocular visual acuity rather than binocular and sensorimotor function.

Emerging evidence suggests that amblyopia is not solely a visual acuity deficit but a broader multisystem condition affecting binocular integration, oculomotor control, postural stability, and visuomotor coordination. Digital, gamified dichoptic therapies have therefore attracted growing interest as alternatives or adjuncts to conventional treatment, as they aim to restore binocular interaction while promoting engagement and adherence. AmblyoPlay® is a commercially available, app-based multimodal visual training platform built on dichoptic principles and designed to stimulate binocular vision through adaptive, game-based exercises. Prior to this study, however, no peer-reviewed clinical data had evaluated its therapeutic effects.

Study Design and Methods

This prospective, non-randomized, controlled pilot study was conducted to assess the impact of a six-month AmblyoPlay®-based visual rehabilitation program on visual, oculomotor, and sensorimotor outcomes in children with anisometropic amblyopia. Twenty-nine children aged 7 to 13 years were enrolled. Fourteen children with anisometropic amblyopia constituted the intervention group, while fifteen age- and sex-matched typically developing children with normal vision served as a control group.

Children in the amblyopia group completed a home-based AmblyoPlay® training program five days per week. Each session lasted approximately 30 minutes and was performed using red–green anaglyph glasses to enable dichoptic presentation. The software dynamically adjusted contrast, spatial frequency, and task difficulty based on real-time performance metrics, ensuring individualized and progressively challenging stimulation. All participants wore their full spectacle correction during training. Outcome measures were collected at baseline and at 1, 3, and 6 months for the amblyopia group, while controls were evaluated at baseline and at 6 months.

The primary outcome was best-corrected visual acuity (logMAR). Secondary outcomes included stereopsis, oculomotor function (saccades, smooth pursuit, and optokinetic responses measured via video-nystagmography), postural stability (computerized dynamic posturography), and motor proficiency (Bruininks–Oseretsky Test of Motor Proficiency, balance and upper-limb coordination subtests).

Key Findings

Visual Acuity and Binocular Vision

Children undergoing AmblyoPlay® therapy exhibited statistically and clinically meaningful improvements in visual acuity in the amblyopic eye. Mean logMAR acuity improved from 0.23 at baseline to 0.08 at six months, corresponding to an approximate gain of 1.5 logMAR chart lines. Improvements were detectable as early as one month and continued progressively throughout the intervention, suggesting a cumulative therapeutic effect.

Stereopsis also improved markedly. Mean stereoacuity thresholds decreased from approximately 494 arcseconds at baseline to 61 arcseconds at six months, representing a substantial enhancement in binocular depth perception. In contrast, the control group demonstrated stable visual acuity and stereopsis over time, supporting the conclusion that observed changes were attributable to the intervention rather than maturation or test–retest effects.

Oculomotor Function

The study demonstrated significant improvements in multiple oculomotor parameters in the amblyopia group. Saccadic latency decreased in both the amblyopic and fellow eyes, indicating faster visual processing and improved eye movement initiation. Smooth pursuit gain increased across all tested temporal frequencies, reflecting enhanced accuracy in tracking moving targets. Optokinetic gain also improved, suggesting better integration of motion signals across the visual field.

Importantly, these oculomotor changes were not observed in the control group, underscoring the specificity of the effect. Correlation analyses further revealed meaningful associations between improvements in visual acuity and oculomotor performance, supporting the hypothesis that dichoptic visual training facilitates broader recalibration of visual–motor pathways.

Motor Proficiency and Postural Stability

Beyond visual outcomes, AmblyoPlay® therapy was associated with significant gains in sensorimotor function. Performance on the BOT-2 balance and upper-limb coordination subtests improved significantly over six months, indicating enhanced postural control and hand–eye coordination. While computerized dynamic posturography showed a positive trend toward improved balance, changes did not reach statistical significance, likely due to the limited sample size and relatively short intervention duration.

These findings align with growing evidence that impaired binocular vision in amblyopia can negatively affect motor development, and that targeted visual–motor training may promote functional gains extending beyond the visual system.

Clinical and Scientific Implications

The results of this pilot study suggest that AmblyoPlay® represents a promising multimodal digital intervention for pediatric anisometropic amblyopia. By combining dichoptic stimulation with adaptive, gamified tasks targeting visual, oculomotor, and visuomotor systems, the program appears capable of producing improvements not only in visual acuity but also in functional binocular vision and motor coordination.

Clinically, these findings support a paradigm shift away from treatments focused exclusively on monocular acuity toward integrative approaches that address amblyopia as a multisystem disorder. The home-based, engaging nature of the AmblyoPlay® platform may also mitigate common barriers associated with traditional therapies, including poor compliance and psychosocial burden.

From a scientific perspective, this study provides initial evidence that digital dichoptic therapy can modulate oculomotor behavior and sensorimotor integration in school-aged children, a population traditionally considered less responsive to amblyopia treatment. The observed correlations between visual, oculomotor, and motor improvements further suggest shared neuroplastic mechanisms that merit investigation in larger, randomized trials.

Limitations and Future Directions

As an exploratory pilot study, the findings should be interpreted in light of certain limitations, including the non-randomized design, modest sample size, and absence of a parallel conventional-treatment comparison group. The six-month follow-up period, while sufficient to demonstrate medium-term gains, does not establish long-term sustainability of treatment effects. Additionally, visual acuity and stereopsis assessments relied on Snellen and Titmus tests, which have recognized measurement limitations.

Future research should include multicenter randomized controlled trials comparing AmblyoPlay® with standard treatments, longer follow-up intervals, and the use of gold-standard visual outcome measures. Incorporating cognitive and quality-of-life assessments would further clarify the broader developmental impact of multimodal digital therapy.

Conclusion

Overall, this study provides the first peer-reviewed clinical evidence supporting the efficacy and feasibility of AmblyoPlay® as a multimodal, app-based dichoptic therapy for pediatric anisometropic amblyopia. The demonstrated improvements across visual, oculomotor, and motor domains suggest that AmblyoPlay® may serve as a valuable component of modern amblyopia management and warrants further clinical investigation.