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

NCT07703449 | Completed

• 1 other identifier: 2024LSPJ164
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Vision in Children

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (2)

Baseline: Unaided Reading

EXPERIMENTAL

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

Experimental: VR-Assisted Reading

EXPERIMENTAL

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)

Interventions

VR-Based Intelligent Reading Aid 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

Baseline: Unaided Reading

Natural Vision Reading (No Assistive Device) DEVICE

Participants complete reading tasks with natural vision, without using any assistive device.

Experimental: VR-Assisted Reading

Eligibility Criteria

• Age: 9 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Aged 9-17 years
• Sufficient basic reading ability to complete the experimental tasks
• Written informed consent obtained from all participants and their legal guardians prior to participation
• Systemic or psychiatric disorders affecting participation
• Inability or unwillingness to complete the examination procedures Functional Evaluation Cohort

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Specialized School for Visually Impaired Students in Guangdong Province

Guangzhou, Guangdong, 510060, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Physician

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: July 14, 2026
• Study Start: June 15, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 14, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)