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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Guangdong
-
Guangzhou, Guangdong, Čína, 510060
- Specialized School for Visually Impaired Students in Guangdong Province
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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 |
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Phoria
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Tear Break-Up Time (TBUT)
Časové okno: 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
Časové okno: 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)
Časové okno: 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:
|
within 10 minutes after all reading tasks
|
|
Best-Corrected Visual Acuity (BCVA)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 2024LSPJ164
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .