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Completed
NCT07703449
Research and Development of Reading Visual Aids for Low-Vision Individuals Based on Virtual Reality Technology
Conditions: Low Vision in Children
Sex: All
Ages: 9 Years – 40 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 58
Sponsor: Beijing Tongren Hospital
Location: Specialized School for Visually Impaired Students in Guangdong Province Guangzhou Guangdong
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.
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
Source: ClinicalTrials.gov (NCT07703449). StuddyBuddy aggregates publicly available trial information.