The Research to Evaluate the Efficacy and Safety of the Shilangqing Smart Reading Aid for Improving Reading Ability in Children With Low Vision (SLQ-001)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Asthenopia score
研究概览
简要总结
This clinical trial aims to assess the efficacy and safety of the Shilangqing Smart Reading Aid, a head-mounted device integrating XR and AI technologies, in improving reading performance and quality of life among children with low vision. The study employs a multicenter, randomized, controlled design with two parallel groups: an experimental group using the Shilangqing device and a control group using traditional optical magnifiers. Participants will undergo a 12-week intervention period, with primary outcomes focusing on reading speed, accuracy, and user satisfaction. Secondary outcomes include changes in visual acuity, eye health metrics (e.g., tear film stability, visual fatigue), and device-related adverse events. The trial builds on preliminary data from Zhongshan Ophthalmic Center and user feedback indicating high efficacy and safety. An estimated 120 participants aged 6-18 years with best-corrected visual acuity of 0.05 to <0.3 will be recruited from multiple sites in China. Results will inform clinical adoption and regulatory approvals for low-vision assistive devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The study included healthy individuals older than 18 years of age with a best-corrected visual acuity (BCVA) of <0.1 logarithm of minimum angle of resolution (logMAR) and no ongoing or prior history of ocular or systemic disease.
排除标准
- •The study excluded healthy individuals younger than 18 years of age with a best-corrected visual acuity (BCVA) of >0.1 logarithm of minimum angle of resolution (logMAR) with ongoing or prior history of ocular or systemic disease.
研究组 & 干预措施
Experimental Group
Using the "Shilangqing" device, conduct reading practice at a brightness level of 400 nit, and measure the eye health indicators before and after the reading session.
干预措施: "Langshiqng" visual aid device (Device)
结局指标
主要结局
Asthenopia score
时间窗: 30 min
Participants completed the Visual Fatigue Subjective Scale questionnaire post 30-minute reading session (MEMC and non-MEMC). This 20-item scale assessed eye strain, headaches, perceived clarity, and general comfort, with responses analyzed to identify differences in subjective visual fatigue between conditions.
次要结局
- Motion sickness score(30 min)
- The first tear film break-up time(30 min)
- distance eye position(30 min)
- near eye position(30 min)
- AC/A(30 min)
- Accommodative responses(30 min)
- Intra-ocular pressure(30 min)
- visual acuity(30 min)
研究者
Jin Yuan
PHD
Beijing Tongren Hospital