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CompletedNCT07703449Updated Jul 14, 2026

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

An interventional study of VR-Based Intelligent Reading Aid and Natural Vision Reading (No Assistive Device) in Low Vision in Children, sponsored by Beijing Tongren Hospital. Completed at 1 site in China. Open to participants aged 9 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by Beijing Tongren Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Jun 2024, registered Jun 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
9 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Low Vision in Children
03

In context

Lead sponsor

Beijing Tongren Hospital is the lead sponsor of 154 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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

Exclusion Criteria:

  • Systemic or psychiatric disorders affecting participation
  • Inability or unwillingness to complete the examination procedures Functional Evaluation Cohort
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • 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

  • 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)

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: within 10 minutes after all reading tasks

  2. Reading Completion Time

    Time to finish standardized 100-character Chinese reading tasks (unit: second). Compare results between unaided and VR-assisted conditions.

    Time frame: within 10 minutes after all reading tasks

Secondary outcomes

  1. 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.

    Time frame: within 10 minutes after all reading tasks

  2. Accommodative Function

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

    Time frame: within 10 minutes after all reading tasks

  3. 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).

    Time frame: within 10 minutes after all reading tasks

  4. Best-Corrected Visual Acuity (BCVA)

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

    Time frame: within 10 minutes after all reading tasks

  5. Intraocular Pressure (IOP)

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

    Time frame: within 10 minutes after all reading tasks

  6. User Satisfaction Score

    100-point satisfaction scale. VR group includes four sub-items: magnification, text-to-speech, OCR and AI summarization (25 points each).

    Time frame: within 10 minutes after all reading tasks

07

Study locations

1 site
  • Specialized School for Visually Impaired Students in Guangdong Province
    Guangzhou, Guangdong 510060, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07703449
Lead sponsor
Beijing Tongren Hospital
Responsible party
Jinyuan,MD (Professor and Chief Physician, Beijing Tongren Hospital) — Principal investigator
First posted
Jul 14, 2026
Start date
Jun 15, 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
Jul 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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