Misawa Mariana, Bajin Inci Yaman, Zhang Bill, Daibert-Nido Monica, Tchao Danielle, Garcia-Giler Eduardo, Cheung Kyle, Appel Lora, Nasir Pi, Reginald Arun, Tabori Uri, Bartels Ute, Ramaswamy Vijay, Markowitz Samuel N, Bouffet Eric, Reber Michael
Ophthalmology and Vision Science, University of Toronto, 27 King's College Cir, Toronto, ON, M5S1A1, Canada.
Toronto Western Hospital, University Health Network, 399 Bathurst St, Toronto, ON, M5T2S8, Canada.
EClinicalMedicine. 2024 Nov 29;78:102955. doi: 10.1016/j.eclinm.2024.102955. eCollection 2024 Dec.
Brain tumor in children can induce hemianopia, a loss of conscious vision, profoundly impacting their development and quality of life, yet no effective intervention exists for this pediatric population. This study aimed to explore the feasibility, safety, and potential effectiveness of a home-based audiovisual stimulation in immersive virtual-reality (3D-MOT-IVR) to improve visual function and functional vision.
In a phase 2a, open-labeled, nonrandomized, single-arm study, conducted from July 2022 to October 2023 (NCT05065268), 10 children and adolescents with stable hemianopia were enrolled to perform 20-min sessions of 3D-MOT-IVR every other day for six weeks from home. We assessed feasibility by monitoring adoption, adherence and completion rates, remote data transfer and qualitative feedback. Safety was evaluated using validated cybersickness questionnaires. Comprehensive vision assessments following standardized low-vision evaluation procedures were conducted pre- and post-intervention, with follow-ups at 1- and 6 months.
The home-based 3D-MOT-IVR intervention proved both feasible and safe, with no reported adverse events. All participants completed the prescribed stimulations and the pre- and post-intervention assessment points, 90% completed the follow-ups. Nine out of ten participants showed clinically meaningful enhancement in visual function and/or functional vision, namely binocular visual field restoration and increased reading speed, but two showed concomitant deterioration in monocular visual field. These positive effects were sustained at the 6-month follow-up. Exploratory outcomes revealed a significant positive correlation between the performance at the 3D-MOT-IVR intervention and the visual perception at the binocular visual field test.
Our findings underscore the feasibility and safety of home-based audiovisual stimulation in immersive virtual-reality as a potential intervention for improving visual perception in children/adolescents with hemianopia consecutive to a pediatric brain tumor. These promising results lay a strong foundation for a larger randomized controlled trial, offering hope for a meaningful breakthrough in visual rehabilitation for this vulnerable population.
Meagan Bebenek Foundation and University Health Network Foundation.
儿童脑肿瘤可导致偏盲，即有意识视力丧失，对其发育和生活质量产生深远影响，但针对这一儿科人群尚无有效的干预措施。本研究旨在探讨基于家庭的沉浸式虚拟现实视听刺激（3D-MOT-IVR）改善视觉功能和功能性视力的可行性、安全性和潜在效果。
在一项2a期、开放标签、非随机、单臂研究中，于2022年7月至2023年10月进行（NCT05065268），招募了10名患有稳定偏盲的儿童和青少年，在家中每隔一天进行20分钟的3D-MOT-IVR训练，持续六周。我们通过监测采用率、依从率和完成率、远程数据传输和定性反馈来评估可行性。使用经过验证的晕动病问卷评估安全性。在干预前后按照标准化的低视力评估程序进行全面的视力评估，并在1个月和6个月时进行随访。
基于家庭的3D-MOT-IVR干预被证明既可行又安全，未报告不良事件。所有参与者都完成了规定的刺激以及干预前后的评估点，90%完成了随访。十名参与者中有九名在视觉功能和/或功能性视力方面有临床意义的改善，即双眼视野恢复和阅读速度提高，但有两名单眼视野出现恶化。这些积极效果在6个月随访时持续存在。探索性结果显示，3D-MOT-IVR干预的表现与双眼视野测试中的视觉感知之间存在显著正相关。
我们的研究结果强调了基于家庭的沉浸式虚拟现实视听刺激作为改善儿童/青少年因小儿脑肿瘤导致偏盲后的视觉感知的潜在干预措施的可行性和安全性。这些有前景 的结果为更大规模的随机对照试验奠定了坚实基础，为这一弱势群体的视觉康复带来有意义的突破带来了希望。
梅根·贝贝克基金会和大学健康网络基金会。
