Skip to main content
OpenTrials
Completed

NCT Number: NCT07703449

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Low Vision in Children

Age range

9 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Specialized School for Visually Impaired Students in Guangdong Province

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Natural Vision Reading (No Assistive Device)

Device

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

Primary outcomes

  1. Change in Phoria

    Time frame: 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.

  2. Reading Completion Time

    Time frame: 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 outcomes

  1. Tear Break-Up Time (TBUT)

    Time frame: 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.

  2. Accommodative Function

    Time frame: within 10 minutes after all reading tasks

    Alteration of eye accommodative function after using the VR reading aid among adult subjects.

  3. Simulator Sickness Questionnaire (SSQ)

    Time frame: 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).

  4. Best-Corrected Visual Acuity (BCVA)

    Time frame: within 10 minutes after all reading tasks

    Change in best-corrected visual acuity before and after VR reading session for adult low-vision users.

  5. Intraocular Pressure (IOP)

    Time frame: within 10 minutes after all reading tasks

    Fluctuation of intraocular pressure pre and post VR device reading task in adult participants.

  6. User Satisfaction Score

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.