OBJECTIVE: The treatment of unilateral amblyopia involves refractive adaptation, occlusion therapy or penalization with atropine drops. However, in recent years, the use of binocular digital therapy has shown promising results. Aim of this systematic review was to evaluate the effectiveness of binocular treatment of amblyopia compared with standard treatments or placebo therapy.
METHODS: This systematic review was conducted in accordance to PRISMA statement. Electronic literature was thoroughly searched for articles published between 2013 and May 2024, in the following electronic database; Pubmed, CENTRAL, MedlinePlus, Medline Europe, PLOS, Scopus, Clinicaltrials.gov. The review comprised randomized control trials (RCTs) including patients with unilateral amblyopia, who received binocular therapy or standard amblyopia or placebo treatment for more than two weeks and who had visual acuity assessment pre- and post-treatment. Only articles written in English were included. Risk of bias was assessed with the Rob2 tool, while study quality was evaluated with the modified Jadad scale.
RESULTS: Twenty RCTs, including 1769 patients, were incorporated into this systematic review. Twelve different types of binocular amblyopia treatments were identified and categorized into two main types. The first type involves the presentation of low-contrast images in the fellow eye, including stimuli presented only in the amblyopic eye. The second type combines this approach with complementary dichoptic deficits in the images presented to both eyes to encourage their simultaneous use.
CONCLUSIONS: Binocular amblyopia treatment has shown promising results in addressing unilateral anisometropic, strabismic or mixed type of amblyopia. Nevertheless, further randomized controlled trials are essential to establish the exact dosage, type and duration of binocular therapy as a standard component of amblyopia care.

OBJECTIVE: To compare the effectiveness and safety of a novel binocular eye-tracking-based-home-treatment (CureSight) to patching for the treatment of amblyopia.
METHODS: Prospective, masked, randomized controlled noninferiority trial.
METHODS: Multicenter, multinational, home treatment.
METHODS: One hundred forty-nine children 4 to < 9 years with anisometropic, small-angle strabismic, or mixed-mechanism amblyopia were randomized to either binocular treatment (n=75) or patching (n=74).
METHODS: The binocular treatment group used the CureSight system for 90 min/day, 5 days/week for 16 weeks (120 hours). The patching group received 2-hour patching 7 days/week (224 hours).
METHODS: The primary outcome was the mean improvement from baseline in amblyopic eye visual acuity (VA) to week 16 in both study groups (non-inferiority of ≤0.10 logarithm of the minimum angle of resolution [logMAR]). Other outcomes included changes in stereoacuity and binocular VA from baseline to week 16.
RESULTS: The mean improvement from baseline at week 16 in the binocular treatment group was noninferior to patching group improvement in the modified intent-to-treat (mITT) dataset (LS mean difference between groups in improvement from baseline: 0.034 logMAR (95% CI -0.009 to 0.076)). In the per-protocol (PP) dataset, the mean improvement from baseline at week 16 in the binocular treatment group was superior to patching group improvement (LS mean difference between groups in improvement from baseline: 0.05 logMAR ([95% CI; 0.007 to 0.097]). At week 16, both groups showed significant median improvement in stereoacuity, with no significant between-group difference in the magnitude of improvement in both the mITT and the PP datasets. Binocular VA was also improved in both groups (p<0.0001). Median adherence in the mITT binocular treatment group (94.0%) was also significantly higher than in the patching group (83.9%; p=0.0038).
CONCLUSIONS: Binocular, eye-tracking-based amblyopia home treatment is at least as effective as patching.

To report the long-term outcomes of a noninferiority randomized controlled trial (RCT) with a binocular eye-tracking-based home treatment (CureSight; NovaSight, Ltd.) in patients with amblyopia.
Prospective, multicenter, nonrandomized, long-term follow-up observational study of an RCT.
Forty-three children 4 to <9 years of age with anisometropic, small-angle strabismic, or mixed-mechanism amblyopia were initially treated for 16 weeks (NCT05185076) with CureSight. In this planned observational follow-up study, 38 patients with no additional amblyopia treatment were evaluated at 12 weeks post-treatment, and 27 were evaluated at 1-year post-treatment. The main outcome measures were visual acuity (VA), stereoacuity, and amblyopia recurrence at 12- and 52-week post-treatment.
At 12-week post-treatment, improvement in amblyopic eye VA was maintained vs baseline (0.27 ± 0.14 logMAR, P< .0001), with no change vs the end-of-treatment visit (P > .05). At 1 year there was a partial reduction in the amblyopic eye VA gain of 0.085±0.1 logMAR compared to end-of-treatment (P = .001), but the residual gain of 0.20±0.14 logMAR compared to baseline was statistically significant (P < .0001). Gains in stereoacuity and binocular VA were maintained vs baseline at both 12-weeks and 1-year post-treatment (P < .0001), with no change vs end-of-treatment (P > .05). Amblyopia recurrence (a worsening of ≥2 logMAR levels compared with end-of-treatment) occurred in 2/38 patients at 12-weeks post-treatment (5.3%), and in 5/27 patients at 1-year post-treatment (20.4%).
VA and stereopsis gains following binocular treatment with CureSight were maintained at 1 year without additional treatment.

UNASSIGNED: To assess visual acuity (VA) and stereoacuity (SA) improvements in children with amblyopia treated with either binocular dichoptic treatment or patching treatment.
UNASSIGNED: In this pilot prospective coherent study, 34 participants between 4 and 9 years of age with unilateral anisometropic amblyopia and without history of prior amblyopia treatment were enrolled into three groups. Full treatment group (FTG; n = 12): participants were prescribed the binocular dichoptic treatment to watch for 90 minutes per day, 5 days a week. Part-time treatment group (PTTG; n = 8): participants were prescribed the same binocular treatment as FTG, 90 minutes per day, 3 days per week. Patching treatment group (PTG; n = 14): participants wore an adhesive patch over the dominant eye for 2 hours per day, 7 days per week. Amblyopic-eye distance visual acuity (DVA), near visual acuity (NVA) and SA were evaluated at baseline, 4, 8, and 12 weeks.
UNASSIGNED: At 12 weeks, mean amblyopic-eye DVA improved 1.8 lines (95% CI, 1.1-2.5) in FTG, 1.5 lines (95% CI, 0.4-2.7) in PTTG and 3.0 lines (95% CI, 2.0-4.0) in PTG. The amblyopic-eye NVA improved 2.9 lines (95% CI, 2.4-3.5) in FTG, 1.7 lines (95% CI, 0.5-3.0) in PTTG and 2.8 lines (95% CI, 1.8-3.9) in PTG. The SA improved 0.38 log-arcseconds (95% CI, 0.24-0.53) in FTG, 0.59 log-arcseconds (95% CI, 0.36-0.82) in PTTG and 0.40 log-arcseconds (95% CI, 0.13-0.67) in PTG. No significant differences were found in DVA, NVA or SA improvement between FTG and PTG at 12 weeks.
UNASSIGNED: VA and SA after binocular dichoptic treatment produced a similar therapeutic outcome to patching, suggesting a potential value for binocular therapy when treating anisometropic moderate degree of Children\'s amblyopia.

Amblyopia is a global public health issue with extensive, multifaceted impacts on vision and quality of life (QoL) for both patients and families. Geographical variation exists in the management of amblyopia, with traditional mainstay treatments, optical correction, and fellow eye occlusion most successful when implemented at an early age. In recent years, however, studies demonstrating meaningful improvements in older children and adults have challenged the concept of a complete loss of visual processing plasticity beyond the critical period of visual development, with growing evidence supporting the potential efficacy of emerging, more engaging, binocular therapies in both adults and children. Binocular approaches aim to restore deficits in amblyopia that extend beyond monocular visual acuity impairment, including binocular fusion and visuomotor skills. In view of this, incorporating outcome measures that evaluate the visual performance and functional ability of individuals with amblyopia will provide a clearer understanding of the effect of amblyopia on QoL and a more comprehensive evaluation of amblyopia therapies.

Comparing visual outcomes after use of a novel binocular eye-tracking-based home treatment (CureSight; NovaSight, Ltd) with patching.
Prospective, multicenter, randomized, masked, controlled, noninferiority pivotal trial.
One hundred three children 4 to < 9 years with anisometropic, small-angle strabismic or mixed-mechanism amblyopia were randomized 1:1 to either CureSight treatment or patching.
The CureSight treatment uses combined anaglyph glasses and an eye tracker to induce real-time blur around the fellow eye fovea in dichoptic streamed video content. Participants used the device for 90 minutes/day, 5 days/week for 16 weeks (120 hours). The patching group received 2 hours of patching 7 days/week (224 hours). The prespecified noninferiority margin was 1 line.
The primary outcome was the improvement in the amblyopic eye visual acuity (VA), modeled with a repeated measures analysis of covariance. Secondary outcomes included stereoacuity, binocular VA, and treatment adherence rates, analyzed by a 1-sample Wilcoxon test within each group and a 2-sample Wilcoxon test comparing groups. Safety outcomes included the frequency and severity of study-related adverse events (AEs).
CureSight group VA improvement was found to be noninferior to patching group improvement (0.28 ± 0.13 logarithm of the minimum angle of resolution [logMAR] [P < 0.0001] and 0.23 ± 0.14 logMAR [P < 0.0001], respectively; 90% confidence interval [CI] of difference, -0.008 to 0.076). Stereoacuity improvement of 0.40 log arcseconds (P < 0.0001) and improved binocular VA (0.13 logMAR; P < 0.0001) were observed in the binocular treatment group, with similar improvements in the patching group in stereoacuity (0.40 log arcseconds; P < 0.0001) and binocular VA (0.09 logMAR; P < 0.0001), with no significant difference between improvements in the 2 groups in either stereoacuity (difference, 0; 95% CI, -0.27 to -0.27; P = 0.76) or binocular VA (difference, 0.041; 95% CI, -0.002 to 0.085; P = 0.07). The binocular treatment group had a significantly higher adherence than the patching group (91% vs. 83%; 95% CI, -4.0% to 21%; P = 0.011). No serious AEs were found.
Binocular treatment was well tolerated and noninferior to patching in amblyopic children 4 to < 9 years of age. High adherence may provide an alternative treatment option for amblyopia.
Proprietary or commercial disclosure may be found after the references.

Occlusion therapy has a long history as the gold standard treatment for amblyopia. Over the past two decades, large multicenter randomized controlled trials and objective dose-monitoring studies have characterized the effects of refractive correction, patching, and atropine penalization, providing insights into the impact of factors such as age and treatment dose. More recent approaches, whose development has been accelerated by advances in technology, are designed to provide different stimulation to the amblyopic eye and the fellow eye. This review explores a variety of such dichoptic approaches, categorized according to whether they primarily feature requisite use of the amblyopic eye in the face of fellow-eye masking, integration of visual information from both eyes, or reduction of stimulus salience in the fellow eye. It is still unclear whether dichoptic treatments are superior to traditional, low-cost treatment methods or whether their therapeutic mechanisms are fundamentally different from those of established treatments.

Amblyopia is the most common cause of monocular poor vision affecting up to 3.7% of the global population. Classically, the first step in treatment has been optical correction, followed by patching and/or pharmacological treatment. However, this is an evolving scenario, since researchers and clinicians are interested in new binocular treatments due to the increasing development of new technologies. In this article main, current binocular treatments as Dig Rush, falling blocks, I-BiT, Occlu-tab, Vivid Vision, and movies are reviewed for binocular amblyopia management.

BACKGROUND: To evaluate the effectiveness of binocularity-stimulating treatment in children with residual amblyopia following occlusion therapy for more than 6 months.
METHODS: Of patients with amblyopia caused by anisometropia and/or strabismus, patients with residual amblyopia following more than 6 months of occlusion therapy were included. Subjects underwent one of the following types of binocularity-stimulating therapy: Bangerter foil (BF), head-mounted display (HMD) game, or BF/HMD combination (BF + HMD). Factors including age, sex, types of amblyopia, visual acuity, and duration of treatment were investigated. Baseline and final (after at least 2 months of treatment) visual acuity were also compared.
RESULTS: Twenty-two patients with a mean age of 8.7 ± 1.3 years were included. Seven patients had anisometropic amblyopia, 8 patients had strabismic amblyopia, and 7 patients had combined amblyopia. After 4.4 ± 1.8 months of treatment, logarithm of the minimum angle of resolution (logMAR) visual acuity in the amblyopic eye improved from 0.22 ± 0.20 to 0.18 ± 0.15. Five of 22 patients (22.7%) gained more than 0.2 logMAR, including 1 of 10 patients (10.0%) in the BF group, 2 of 7 patients (28.6%) in the HMD group, and 2 of 5 patients (40.0%) in the BF + HMD group. No significant differences in clinical characteristics were identified among the three groups.
CONCLUSIONS: Binocularity-stimulating therapy is somewhat beneficial in children with residual amblyopia and might be attempted when children no longer benefit from sufficient long-term period of occlusion therapy.

Children with deprivation amblyopia due to childhood cataract have been excluded from much of the emerging research into amblyopia treatment. An investigation was conducted to determine whether contrast-balanced binocular treatment - a strategy currently being explored for children with anisometropic and strabismic amblyopia - may be effective in children with deprivation amblyopia.
An unmasked, case-series design intended to assess proof of principle was employed. Eighteen children with deprivation amblyopia due to childhood cataracts (early bilateral n = 7, early unilateral n = 7, developmental n = 4), as well as 10 children with anisometropic (n = 8) or mixed anisometropic and strabismic amblyopia (n = 2) were prescribed one hour a day of treatment over a six-week period. Supervised treatment was available. Visual acuity, contrast sensitivity, global motion perception and interocular suppression were measured pre- and post-treatment.
Visual acuity improvements occurred in the anisometropic/strabismic group (0.15 ± 0.05 logMAR, p = 0.014), but contrast sensitivity did not change. As a group, children with deprivation amblyopia had a smaller but statistically significant improvement in weaker eye visual acuity (0.09 ± 0.03 logMAR, p = 0.004), as well a significant improvement in weaker eye contrast sensitivity (p = 0.004). Subgroup analysis suggested that the children with early bilateral deprivation had the largest improvements, while children with early unilateral cataract did not improve. Interestingly, binocular contrast sensitivity also improved in children with early bilateral deprivation. Global motion perception improved for both subgroups with early visual deprivation, as well as children with anisometropic or mixed anisometropic/strabismic amblyopia. Interocular suppression improved for all subgroups except children with early unilateral deprivation.
These data suggest that supervised contrast-balanced binocular treatment should be further investigated as a treatment option for children with deprivation amblyopia. However, for children with more severe deprivation amblyopia due to early unilateral cataracts, supplementary or alternative options should also be explored.