Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

12. juli 2026 opdateret af: Jinyuan,MD, Beijing Tongren Hospital

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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

58

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.

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

Eksperimentel: 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

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Phoria
Tidsramme: 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.
within 10 minutes after all reading tasks
Reading Completion Time
Tidsramme: 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.
within 10 minutes after all reading tasks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tear Break-Up Time (TBUT)
Tidsramme: 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.
within 10 minutes after all reading tasks
Accommodative Function
Tidsramme: within 10 minutes after all reading tasks
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)
Tidsramme: 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).
within 10 minutes after all reading tasks
Best-Corrected Visual Acuity (BCVA)
Tidsramme: within 10 minutes after all reading tasks
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)
Tidsramme: within 10 minutes after all reading tasks
Fluctuation of intraocular pressure pre and post VR device reading task in adult participants.
within 10 minutes after all reading tasks
User Satisfaction Score
Tidsramme: 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).
within 10 minutes after all reading tasks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. juni 2024

Primær færdiggørelse (Faktiske)

31. december 2024

Studieafslutning (Faktiske)

31. december 2024

Datoer for studieregistrering

Først indsendt

15. juni 2026

Først indsendt, der opfyldte QC-kriterier

12. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2024LSPJ164

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med VR-Based Intelligent Reading Aid

3
Abonner