Illuminate Children's Reading World: Research and Development of Virtual Reality Reading Aids for Low-Vision Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in Phoria
研究概览
简要总结
Low vision substantially impairs reading ability and educational participation in adolescents. Existing assistive technologies, including optical magnifiers and electronic visual aids, are often limited by fragmented system architectures and insufficient support for multimodal cognitive processing.
This study aimed to develop and evaluate a virtual reality (VR)-based intelligent reading aid integrating image enhancement, optical character recognition (OCR), text-to-speech (TTS), and large language model (LLM)-based semantic summarization for low-vision users.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Safety Evaluation Cohort Inclusion Criteria：
- •Healthy adult volunteers aged 18-40 years
- •Best-corrected binocular visual acuity of 0.8 or better
- •Stereopsis of 60 arcsec or better
- •Tear film break-up time of at least 10 seconds,Horizontal phoria within 15 prism diopters at both distance and near,Spherical equivalent refractive errors between plano and -6.00 D,Astigmatism not exceeding 3.00 D,Anisometropia not exceeding 2.00 D
- •Intraocular pressure between 10 and 21 mmHg
- •All participants provided written informed consent before enrollment
排除标准
- •Any current or previous organic ocular disease (such as keratitis, glaucoma, or retinal detachment)
- •Previous ophthalmic surgery (including refractive surgery or vitreoretinal surgery)
- •Systemic or psychiatric disorders that could affect study participation
- •Inability or unwillingness to complete the examination procedures
- •Functional Evaluation Cohort:
- •Inclusion Criteria:
- •Aged 9-17 years
- •Clinically diagnosed with visual impairment, meeting the inclusion criteria for low vision or severe visual impairment
- •Sufficient basic reading ability to complete the experimental tasks
- •Written informed consent obtained from all participants and their legal guardians prior to participation
- •Exclusion Criteria:
- •Systemic or psychiatric disorders affecting participation
- •Inability or unwillingness to complete the examination procedures Functional Evaluation Cohort
研究组 & 干预措施
Baseline: Unaided Reading
Arm Name：Unaided Reading (Baseline) Arm Type：Active Comparator Intervention Type：Device Intervention Name：Natural Vision Reading (No Assistive Device) Intervention Description： Participants complete standardized Chinese reading tasks relying on natural vision without any visual aid. Each task contains 100 Chinese characters. Reading performance and user satisfaction are evaluated.
干预措施: VR-Based Intelligent Reading Aid (Device)
Experimental: VR-Assisted Reading
Arm Name：VR-Based Intelligent Reading Aid Arm Type：Experimental Intervention Type：Device Intervention Name：VR-Based Multimodal Intelligent Reading Aid (Langshiqing Low-Vision Device) Intervention Description： Participants use the VR head-mounted intelligent reading aid to complete the same standardized reading tasks. The device integrates image enhancement, OCR, text-to-speech (TTS) and LLM-based semantic summarization. The test luminance is set at 400 nit (maximum recommended brightness). Each task contains 100 Chinese characters.
Duration：Single session, approximately 5 minutes
干预措施: Natural Vision Reading (No Assistive Device) (Device)
结局指标
主要结局
Change in Phoria
时间窗: within 10 minutes after all reading tasks
Variation of ocular phoria before and after single-session VR intelligent reading aid use, to evaluate the impact of near-eye VR optical system on adult eye position stability.
Reading Completion Time
时间窗: within 10 minutes after all reading tasks
Time to finish standardized 100-character Chinese reading tasks (unit: second). Compare results between unaided and VR-assisted conditions.
次要结局
- Tear Break-Up Time (TBUT)(within 10 minutes after all reading tasks)
- Accommodative Function(within 10 minutes after all reading tasks)
- Simulator Sickness Questionnaire (SSQ)(within 10 minutes after all reading tasks)
- Best-Corrected Visual Acuity (BCVA)(within 10 minutes after all reading tasks)
- Intraocular Pressure (IOP)(within 10 minutes after all reading tasks)
- User Satisfaction Score(within 10 minutes after all reading tasks)
研究者
Jinyuan,MD
Professor and Chief Physician
Beijing Tongren Hospital