Binocular treatment for amblyopia: a systematic review.

PURPOSE: 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. CONCLUSION: 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.

An Eye-Tracking-Based Dichoptic Home Treatment for Amblyopia: A Multicenter Randomized Clinical Trial.

PURPOSE: Comparing visual outcomes after use of a novel binocular eye-tracking-based home treatment (CureSight; NovaSight, Ltd) with patching. DESIGN: Prospective, multicenter, randomized, masked, controlled, noninferiority pivotal trial. PARTICIPANTS: 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. METHODS: 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. MAIN OUTCOME MEASURES: 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). RESULTS: 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. CONCLUSIONS: 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. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Binocular treatment for amblyopic children: a review.

The narrative review was planned to investigate the efficiency of binocular treatment for amblyopic children, and to compare it with the standard methods. Literature search was conducted for articles in English language available on PubMed, Cochrane Library, Embase, Medline and PsycInfo databases as well as through bibliographies of peer-reviewed studies. Studies in the field of binocular treatment for amblyopia were included. Visual outcomes considered were visual acuity, types of amblyopia and stereoacuity. Studies on deprivation amblyopia, animal studies, literature review of amblyopia treatment, case reports, and trials targeting participants in whom previous amblyopia treatment had failed were excluded. Of the 40 studies found, 21(52.5%) met the inclusion criteria. Visual acuity and binocular function improved with binocular treatment for treating amblyopia in children by decreasing suppression depth extent and increasing stereopsis. Binocular treatment for amblyopic children was found to be an effective and fast process for the recovery of visual functions, especially in the critical time of visual development.

Effectiveness of binocularity-stimulating treatment in children with residual amblyopia following occlusion.

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.

A Prospective Trial to Assess the Efficacy of Eye-Tracking-Based Binocular Treatment versus Patching for Children's Amblyopia: A Pilot Study.

PURPOSE: To assess visual acuity (VA) and stereoacuity (SA) improvements in children with amblyopia treated with either binocular dichoptic treatment or patching treatment. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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: A review of unmet needs, current treatment options, and emerging therapies.

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.

Recent Treatment Advances in Amblyopia.

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.

Current Management of Amblyopia with New Technologies for Binocular Treatment.

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.

Comparison between patching and interactive binocular treatment in amblyopia: A randomized clinical trial.

PURPOSE: To compare the effect of amblyopia therapy on cases who received interactive binocular treatment (I-BiT™) with those who received standard patching of the dominant eye with placebo I-BiT™. METHODS: In this randomized clinical trial, 38 unilateral amblyopic children (3-10 years old) were studied. All unilateral amblyopic children who had best corrected visual acuity (BCVA) worse than 0.30 logMAR or a difference of two Snellen lines of BCVA between their two eyes were included, and children who did not complete at least 75% of amblyopia treatment were excluded from this study. Eventually, a total of 19 and 21 subjects were included in case and control groups, respectively. Cases played I-BiT™ games, while controls had standard patch therapy and played with placebo I-BiT™ games, both for one month. All subjects were examined at baseline and after one-month therapy. RESULTS: BCVA improved significantly in both groups after one-month treatment (case: P = 0.003, control: P < 0.001), while in comparison with each other, there was not any difference between them (P = 0.52). Although stereopsis improved in the case (P < 0.001) and control (P < 0.001), there was no significant difference between them pre and post-therapy. Our children played games for about 6 h total during one month in both groups, and their compliance was 87.5% and 76% in cases and controls, respectively. Two children were excluded due to their lower compliance of playing I-BiT™ games (n = 38). CONCLUSIONS: I-BiT™ game and patching with placebo game had similar BCVA improvement in amblyopic children after one-month treatment. It is suggested to conduct further randomized clinical trials with a larger sample size and longer duration of study and assessment of its recurrence.

Contrast-balanced binocular treatment in children with deprivation amblyopia.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

The role of Interactive Binocular Treatment system in amblyopia therapy.

PURPOSE: To determine the role of Interactive Binocular Treatment (I-BiT™) as a complementary method of patching in amblyopia therapy. METHODS: In this randomized clinical trial study, 50 unilateral amblyopic children (25 male/25 female) between 3 and 10 years with either best corrected visual acuity (BCVA) ≤20/30 in the amblyopic eye or a difference of BCVA ≥ 2 lines between the two eyes were included. They were randomly classified into the case and control groups (25 in each). Patching was recommended in both groups, and cases also received I-BiT™. Cases were asked to play I-BiT™ games through appropriate glasses with conjugate colored filters. Moving and fixed targets were shown to the amblyopic and non-amblyopic eyes, respectively. Playing games was continued 20 min in each session for 5 days a week within one month (total time: 6.6 h). Patching was continued for one month more in both groups to evaluate the continuous effect of I-BiT™. BCVA was measured at baseline, one month after beginning I-BiT™, and one month after cessation of I-BiT™. RESULTS: BCVA of amblyopic eyes in cases and controls were 0.34 ± 0.14 and 0.33 ± 0.17LogMAR at baseline which improved to 0.17 ± 0.14 and 0.26 ± 0.17 at one month, respectively. The difference was significant in each group (p < 0.001 for cases and p = 0.024 for controls) with more improvement in the case group (p < 0.001). One month after cessation of I-BiT™, BCVA difference between the two groups was not statistically significant. There was no case with recurrence of amblyopia. CONCLUSION: Based on our results, I-BiT™ seems to be effective in amblyopia therapy accompanied with patching. We recommend comparing I-BiT™ alone with patching in further studies. ClinicalTrials.gov Identifier: NCT02740725.

Tratamiento binocular de la ambliopía basado en la realidad virtual / Binocular treatment of amblyopia based on virtual reality

Aunque los tratamientos predominantes de la ambliopía son monoculares, estos tienen poca aceptación y baja efectividad en el restablecimiento de la combinación binocular. Numerosas evidencias apoyan la idea de que la ambliopía es en esencia un problema binocular y que la supresión juega un papel clave. En esta revisión se exponen dos estrategias para el tratamiento binocular de la ambliopía basado en la realidad virtual; la primera con el objetivo primario de mejorar la agudeza visual y la segunda con el propósito de mejorar las funciones binoculares a través de la reducción de la supresión. Este enfoque binocular expone al paciente a condiciones artificiales de visión con estímulos dicópticos en imágenes relacionadas. Los estudios clínicos realizados, tanto en niños como adultos, reportan mejorías de la agudeza visual y la estereopsia en un tiempo muy inferior al requerido por la oclusión. Los resultados clínicos sugieren que un enfoque binocular que combine ambas estrategias puede utilizarse como complemento de los tratamientos clásicos y como alternativa en adultos y niños con historial de tratamientos fracasados o rechazados(AU)

Although predominant amblyopia treatments are monocular, they have poor compliance and low effectiveness in re-establishing binocular combination. There are many evidences supporting the idea that amblyopia is essentially a binocular problem and its suppression plays a key role. This review showed two binocular treatment strategies of amblyopia based in Virtual Reality. In the first one, the primary goal is to improve visual acuity whereas in the second one the purpose is to improve the binocular functions through reduction of suppression. In this binocular approach, the patient is exposed to artificial vision conditions with dichoptic stimuli in related images. Clinical studies in children and adults have reported improvements of visual acuity and stereopsis in less time than that required by occlusion. Clinical outcomes suggest that a binocular approach with a combination of both strategies can be used as a supplement to classic treatment and as an alternative in adults and children with history of failed or rejected treatments(AU)