Low Vision in Children
Conditions
Brief summary
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.
Interventions
DEVICEVR-Based Intelligent Reading Aid
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
DEVICENatural Vision Reading (No Assistive Device)
Participants complete reading tasks with natural vision, without using any assistive device.
Sponsors
Beijing Tongren Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Phoria | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tear Break-Up Time (TBUT) | within 10 minutes after all reading tasks | Change in tear break-up time before and after VR device use for assessment of ocular surface dryness in adult participants. |
| Accommodative Function | within 10 minutes after all reading tasks | Alteration of eye accommodative function after using the VR reading aid among adult subjects. |
| Simulator Sickness Questionnaire (SSQ) | within 10 minutes after all reading tasks | Scale Description:The SSQ is a self-report questionnaire that assesses VR-related simulator sickness. Each item is rated on a 4-point scale: None (0), Slight (1), Moderate (2), and Severe (3). Through weighted calculations, four scores are derived: Nausea-related subscore (N), Oculomotor-related subscore (O), Disorientation-related subscore (D), and Total Score (TS). Minimum and Maximum Values: * ndividual items: 0 (None) to 3 (Severe) * Total Score (TS): 0 to 235.62 (based on standard weighted scoring) * Nausea subscore (N): 0 to 200.34 * Oculomotor subscore (O): 0 to 200.34 * Disorientation subscore (D): 0 to 292.32 Interpretation:Higher scores indicate worse outcomes (more severe simulator sickness/cybersickness). |
| Best-Corrected Visual Acuity (BCVA) | within 10 minutes after all reading tasks | Change in best-corrected visual acuity before and after VR reading session for adult low-vision users. |
| Intraocular Pressure (IOP) | within 10 minutes after all reading tasks | Fluctuation of intraocular pressure pre and post VR device reading task in adult participants. |
| User Satisfaction Score | within 10 minutes after all reading tasks | 100-point satisfaction scale. VR group includes four sub-items: magnification, text-to-speech, OCR and AI summarization (25 points each). |
Countries
China
Outcome results
None listed