Related Experiment Video
Updated: Sep 17, 2025
Comparison of Three Clinical Stereoscopic Methods for Measuring Binocular Visual Function During Amblyopic Treatment in Unilateral Amblyopia
Published on: September 27, 2024
Efficacy and safety of augmented-reality pathway-specific binocular training in patients with unilateral amblyopia
Yulian Zhou1,2,3,4, Shuyang Guo1,2,3,4, Ling Ling1,2,3,4
1Department of Ophthalmology & Visual Science, Eye & ENT Hospital, Shanghai Medical College, Fudan University, Shanghai, 200031, China.
Background:
Amblyopia 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.
Methods:
This 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 Registration:
ClinicalTrials.gov identifier: NCT06498206. Registered on July 12, 2024.
