Low Vision in ChildrenNCT07703449
Research and Development of Reading Visual Aids for Low-Vision Individuals Based on Virtual Reality Technology
A study testing VR-Based Intelligent Reading Aid and Natural Vision Reading (No Assistive Device) in people with Low Vision in Children, run by Beijing Tongren Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Vision in Children
- What is being tested?
- VR-Based Intelligent Reading Aid and Natural Vision Reading (No Assistive Device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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:
- Systemic or psychiatric disorders affecting participation
- Inability or unwillingness to complete the examination procedures Functional Evaluation Cohort
Trial locations and contacts
1 site in 1 country.
China1 site
Specialized School for Visually Impaired Students in Guangdong Province
Guangzhou, Guangdong, 510060
About this study
Official title: 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.
- Conditions
- Low Vision in Children
- Being tested
- VR-Based Intelligent Reading Aid, Natural Vision Reading (No Assistive Device)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-Based Intelligent Reading AidDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Baseline: Unaided Reading | Experimental | 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. Receives: Device: VR-Based Intelligent Reading Aid |
| Experimental: VR-Assisted Reading | Experimental | 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 Receives: Device: Natural Vision Reading (No Assistive Device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 10 minutes after all reading tasks
Reading Completion Time
Time to finish standardized 100-character Chinese reading tasks (unit: second). Compare results between unaided and VR-assisted conditions.
Measured: within 10 minutes after all reading tasks
Secondary outcomes (6)
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.
Measured: within 10 minutes after all reading tasks
Accommodative Function
Alteration of eye accommodative function after using the VR reading aid among adult subjects.
Measured: within 10 minutes after all reading tasks
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).
Measured: within 10 minutes after all reading tasks
Best-Corrected Visual Acuity (BCVA)
Change in best-corrected visual acuity before and after VR reading session for adult low-vision users.
Measured: within 10 minutes after all reading tasks
Intraocular Pressure (IOP)
Fluctuation of intraocular pressure pre and post VR device reading task in adult participants.
Measured: within 10 minutes after all reading tasks
User Satisfaction Score
100-point satisfaction scale. VR group includes four sub-items: magnification, text-to-speech, OCR and AI summarization (25 points each).
Measured: within 10 minutes after all reading tasks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start15 Jun 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Vision in ChildrenStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinyuan,MD, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703449
- Sponsor's protocol ID
- 2024LSPJ164
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Illuminate Children's Reading World: Research and Development of Virtual Reality Reading Aids for Low-Vision Populations
- ClinicalTrials.gov ID
- NCT07703449
- Acronym / sponsor ID
- 2024LSPJ164
- Conditions
- Low Vision in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline: Unaided Reading | Experimental | Device: VR-Based Intelligent Reading AidArm 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. |
| Experimental: VR-Assisted Reading | Experimental | Device: Natural Vision Reading (No Assistive Device)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 |
Who may qualify
- Ages
- 9 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
- Systemic or psychiatric disorders affecting participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-Based Intelligent Reading AidIntervention 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 | Baseline: Unaided Reading |
| Natural Vision Reading (No Assistive Device)Participants complete reading tasks with natural vision, without using any assistive device. | Device | Experimental: VR-Assisted Reading |
Primary outcome
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.
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.
6 secondary outcomes
Tear Break-Up Time (TBUT)
Time frame: within 10 minutes after all reading tasks
Accommodative Function
Time frame: within 10 minutes after all reading tasks
Simulator Sickness Questionnaire (SSQ)
Time frame: within 10 minutes after all reading tasks
Best-Corrected Visual Acuity (BCVA)
Time frame: within 10 minutes after all reading tasks
Intraocular Pressure (IOP)
Time frame: within 10 minutes after all reading tasks
User Satisfaction Score
Time frame: within 10 minutes after all reading tasks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-Based Intelligent Reading Aid and Natural Vision Reading (No Assistive Device) in people with Low Vision in Children, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Phoria (time frame: within 10 minutes after all reading tasks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.