Zhou Yulian, Guo Shuyang, Ling Ling, Gao Yige, Duan Xinyan, Liu Yan, Liu Rui, Liu Hu, Wang Huihang, Lin Jing, Zhao Chen, Zhang Peng, Wen Wen
Department of Ophthalmology & Visual Science, Eye & ENT Hospital, Shanghai Medical College, Fudan University, Shanghai, 200031, China.
State Key Laboratory of Medical Neurobiology and MOE Frontiers Center for Brain Science, Institutes of Brain Science, Fudan University, Shanghai, 200032, China.
Trials. 2025 Jul 1;26(1):232. doi: 10.1186/s13063-025-08927-2.
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.
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.
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.
ClinicalTrials.gov identifier: NCT06498206. Registered on July 12, 2024.
弱视是一种常见的发育性疾病，表现为视力下降和双眼功能受损。遮盖健眼作为弱视的金标准治疗方法，有时由于依从性差或干预延迟而无法取得满意的效果。近年来，弱视的双眼数字疗法已被开发出来，但尚无具有优势的循证双眼治疗方法。基于我们之前关于单眼弱视神经缺陷的研究结果，我们开发了一种使用增强现实技术的特定通路视觉训练模式，在双眼视觉条件下，选择性地强化弱视眼的小细胞通路功能。本试验的目的是评估这种创新的针对儿童和成人单眼弱视的家庭式双眼治疗的疗效和安全性。我们假设，与传统遮盖疗法相比，增强现实特定通路双眼训练将显著改善视觉功能。
这是一项优效性、多中心、随机对照试验，纳入114例年龄在5至55岁之间、诊断为单眼弱视的患者。参与者将按1:1随机分为双眼训练组或遮盖组，并在13周内每天接受2小时的家庭治疗。在基线、治疗中期（第2周、第4周、第9周）和治疗结束时（第13周）评估他们的视觉功能。主要结局是弱视眼从基线到治疗后13周的最佳矫正远视力变化。次要结局包括对比敏感度、远近立体视锐度、双眼抑制、治疗依从性以及每次随访时不良事件的发生率。
本研究是首个多中心随机对照试验，研究针对儿童和成人单眼弱视神经缺陷的家庭式增强现实双眼疗法。我们预计该试验将产生相关结果，为这种创新的弱视治疗方法的疗效和安全性提供循证依据。
ClinicalTrials.gov标识符：NCT06498206。于2024年7月12日注册。
