Research and Development of Reading Visual Aids for Low-Vision Individuals Based on Virtual Reality Technology

Illuminate Children's Reading World: Research and Development of Virtual Reality Reading Aids for Low-Vision Populations

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.

Study Overview

• Status: Completed
• Conditions: Low Vision in Children
• Intervention / Treatment: Device: VR-Based Intelligent Reading Aid; Device: Natural Vision Reading (No Assistive Device)

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Specialized School for Visually Impaired Students in Guangdong Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Exclusion Criteria:

• Systemic or psychiatric disorders affecting participation
• Inability or unwillingness to complete the examination procedures Functional Evaluation Cohort

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: VR-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
Experimental: 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	Device: Natural Vision Reading (No Assistive Device); Participants complete reading tasks with natural vision, without using any assistive device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Phoria	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.	within 10 minutes after all reading tasks
Reading Completion Time	Time to finish standardized 100-character Chinese reading tasks (unit: second). Compare results between unaided and VR-assisted conditions.	within 10 minutes after all reading tasks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear Break-Up Time (TBUT)	Change in tear break-up time before and after VR device use for assessment of ocular surface dryness in adult participants.	within 10 minutes after all reading tasks
Accommodative Function	Alteration of eye accommodative function after using the VR reading aid among adult subjects.	within 10 minutes after all reading tasks
Simulator Sickness Questionnaire (SSQ)	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).	within 10 minutes after all reading tasks
Best-Corrected Visual Acuity (BCVA)	Change in best-corrected visual acuity before and after VR reading session for adult low-vision users.	within 10 minutes after all reading tasks
Intraocular Pressure (IOP)	Fluctuation of intraocular pressure pre and post VR device reading task in adult participants.	within 10 minutes after all reading tasks
User Satisfaction Score	100-point satisfaction scale. VR group includes four sub-items: magnification, text-to-speech, OCR and AI summarization (25 points each).	within 10 minutes after all reading tasks

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: June 15, 2026
• First Submitted That Met QC Criteria: July 12, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2024LSPJ164

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No