ArticleTrials2025
Efficacy and safety of augmented-reality pathway-specific binocular training in patients with unilateral amblyopia (ARPSBT): study protocol for a multicenter randomized controlled trial.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06498206 (Dichoptic Augmented Reality), which is not on this map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Dichoptic Augmented Reality (AR) Training Versus Patching for Unilateral Amblyopia in Children and Adults
Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
13 authors.
Funding
Abstract
backgroundAmblyopia is a common developmental disorder with reduced visual acuity and impairment in binocular functions. Patching the fellow eye, as the gold standard therapy in amblyopia, sometimes fails to achieve satisfactory outcomes because of poor adherence or delayed intervention. Recently, dichoptic/binocular digital therapy in amblyopia has been developed, but no evidence-based binocular treatments with superiority are available. Based on our previous study findings in neural deficits of unilateral amblyopia, we develop a paradigm of pathway-specific visual training using augmented-reality techniques, in which functions of the parvocellular pathway in the amblyopic eye are selectively pushed under binocular viewing. The aim of this trial is to assess the efficacy and safety of this innovative binocular, home-based treatment for children and adults with unilateral amblyopia. We hypothesize that augmented-reality pathway-specific binocular training will significantly improve visual functions compared with traditional patching.
methodsThis is a superiority, multi-center, randomized, controlled trial involving 114 patients, aged between 5 and 55 years, with a diagnosis of unilateral amblyopia. Participants will be randomized 1:1 to either binocular training or patching, and will receive home-based treatment for 2 hours per day over a 13-week period. Their visual functions will be assessed at baseline, mid-treatment (week 2, week 4, week 9), and the end of treatment (week 13). The primary outcome is the change in best-corrected visual acuity at distance in the amblyopic eye from baseline to 13 weeks after treatment. Secondary outcomes include contrast sensitivity, near and far stereoacuity, interocular suppression, treatment adherence, and the incidence of adverse events at each visit. DISCUSSION: This study is the first multi-center randomized controlled trial investigating a home-based augmented-reality binocular therapy targeting neural deficits in children and adults with unilateral amblyopia. We expect that the trial will generate findings that can provide an evidence-based basis for the efficacy and safety of this innovative approach to amblyopia treatment.
trial registrationClinicalTrials.gov identifier: NCT06498206. Registered on July 12, 2024.
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