Effectiveness of AmblyoPlay-Based Multimodal Therapy in Children With Anisometropic Amblyopia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Visual acuity
研究概览
简要总结
This study aims to evaluate whether a six-month app-based visual therapy program, called AmblyoPlay, can improve visual acuity, oculomotor skills, and balance in children with anisometropic amblyopia (a type of "lazy eye" caused by unequal refractive errors between the eyes). The therapy uses interactive games to train visual and motor functions. The study compares children who receive this therapy with a control group of children who do not receive any intervention. Researchers aim to explore the effectiveness of a multidisciplinary, technology-assisted approach that addresses visual and sensorimotor functions through an integrated, child-centered perspective.
详细描述
This study investigates the effects of a six-month, app-based multimodal visual therapy program-AmblyoPlay-on visual acuity, oculomotor skills, hand-eye coordination, and postural control in children diagnosed with anisometropic amblyopia. Unlike traditional approaches that focus solely on monocular visual improvement, this study adopts a multidimensional, integrative framework that engages both visual and sensorimotor systems through gamified, child-friendly digital exercises.
The intervention is grounded in principles of dichoptic stimulation and neuroplasticity, aiming to reduce interocular suppression while promoting binocular cooperation. Through real-time adaptive difficulty algorithms, AmblyoPlay delivers personalized visual-motor challenges tailored to the developmental level of each participant.
Assessments are conducted at multiple time points to track progression across visual, motor, and postural domains. A control group of age- and sex-matched children with normal development is used for comparative analysis.
This study is designed to contribute evidence on the feasibility and efficacy of a multidisciplinary therapeutic model for pediatric amblyopia, highlighting the importance of addressing not only visual deficits but also associated functional impairments in balance and coordination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 7 and 13 years
- •Diagnosed with anisometropic amblyopia according to AAO (American Academy of Ophthalmology) guidelines
- •No vestibular pathology within the past 6 months
- •No cognitive or mental impairments
- •No history of prior ophthalmologic treatment for amblyopia
- •Able to adhere to the treatment protocol
- •Written informed consent obtained from a parent or legal guardian
排除标准
- •Age outside the range of 7 to 13 years
- •Presence of strabismus or other ocular pathologies (e.g., cataract, retinal disease)
- •Diagnosed neurological, developmental, or psychiatric disorders
- •Use of medications that may affect vision or balance
- •Participation in another clinical trial within the past 6 months
- •Inability to attend scheduled follow-up evaluations or comply with study procedures
结局指标
主要结局
Visual acuity
时间窗: Baseline, 1 month, 3 months, and 6 months
Visual acuity (VA) was assessed using a standard Snellen chart under both monocular and binocular viewing conditions. Participants were instructed to read optotypes from a distance of 6 meters for distance vision and 40 cm for near vision. Each eye was tested separately, followed by binocular testing. The smallest optotype correctly identified was recorded as the VA score. Results were documented in Snellen fractions and converted to decimal values for statistical analysis (e.g., 20/20 = 1.0; 20/40 = 0.5; 20/100 = 0.2). Higher decimal values represented better visual acuity.
次要结局
- Stereopsis (Stereoacuity)(Baseline, 1 month, 3 months, and 6 months)
研究者
Yusa Basoglu
Istanbul Medipol University
Medipol University