Visual FunctionNCT07081139
Visual Function Screening System With Special Needs Children and Typical Preschoolers
An observational study of Visual Function and Vision, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The early visual screening of children plays a critical role in promoting visual development, especially for those with visual impairments. Among various approaches, eye-tracking based visual assessment has emerged as a promising tool, particularly for infants, toddlers, and children with developmental disabilities… Read more about this study
- Who is it for?
- Ages 0 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Function, Vision, Special Needs Children
- How many people
- 1,300 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Aug 2025to 31 Dec 2027
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: General adults, typically developing preschool children aged 3 to 5 and under 3 years old. Additionally, children with special needs, regardless of the underlying cause, including those with physical or mental disabilities or multiple disabilities, such as autism spectrum disorder, cerebral palsy, visual impairments, and developmental delays.
Who may be able to join
- A. General Group 1. Inclusion Criteria
- General adults:
- Aged over 18 and under 70 years
- Willing to undergo assessment and video recording using the "Deep Visual Tracking System"
- Willing to sign the informed consent form
- Typically developing preschool children aged 3 to 5:
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- Currently aged between 3 (inclusive) and 5 (inclusive) years
- The primary caregiver agrees to allow the child to undergo assessment and video recording using the "Deep Visual Tracking System"
- Children under 3 years old:
- Currently under 3 years of age
- The primary caregiver agrees to allow the child to undergo assessment and video recording using the "Deep Visual Tracking System"
- 2. Exclusion Criteria
- General adults:
- Presence of severe corneal disease or cataract that may interfere with data collection
- Obvious abnormalities in eye or facial appearance, such as ptosis or facial trauma affecting facial structure
- Typically developing preschool children aged 3 to 5:
- Children with physical or mental disabilities
- Children diagnosed with or suspected of having developmental delay
- Children with obvious abnormalities in eye or facial appearance
- Children under 3 years old:
- Children with physical or mental disabilities (2) Children diagnosed with or suspected of having developmental delay (3) Children with obvious abnormalities in eye or facial appearance
- B. Special Needs Group
- Inclusion Criteria (1) Children under the age of 12 with special needs, including physical, mental, or multiple disabilities (2) The primary caregiver agrees to allow the child to undergo assessment and video recording using the "Deep Visual Tracking System"
- Exclusion Criteria (1) Children with refractive errors that are diagnosed by an ophthalmologist to significantly impair vision and are unable to wear corrective glasses during assessment (2) Children who are physiologically or emotionally unstable and unable to adapt and complete at least two assessment sessions
- Special Needs Group
- Inclusion Criteria (1) Children under the age of 12 with special needs, including physical, mental, or multiple disabilities (2) The primary caregiver agrees to allow the child to undergo assessment and video recording using the "Deep Visual Tracking System"
Who cannot join
- A. General Group
- Exclusion Criteria
- General adults:
- Presence of severe corneal disease or cataract that may interfere with data collection
- Obvious abnormalities in eye or facial appearance, such as ptosis or facial trauma affecting facial structure
- Typically developing preschool children aged 3 to 5:
Show all 16Show fewer
- Children with physical or mental disabilities
- Children diagnosed with or suspected of having developmental delay
- Children with obvious abnormalities in eye or facial appearance
- Children under 3 years old:
- Children with physical or mental disabilities
- Children diagnosed with or suspected of having developmental delay
- Children with obvious abnormalities in eye or facial appearance
- Special Needs Group 2. Exclusion Criteria
- Children with refractive errors that are diagnosed by an ophthalmologist to significantly impair vision and are unable to wear corrective glasses during assessment
- Children who are physiologically or emotionally unstable and unable to adapt and complete at least two assessment sessions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, National Taiwan University Hospital
Taipei
Chiun-Ho Hou, PHD, +886-972652487, houjunhe@ntuh.gov.tw
About this study
Official title: Leveraging Deep Learning to Optimize the Individualized Application of Eye-tracking Devices for the Early-stage Visual Function Screening of Both Special Needs Children and Typical Preschoolers
The early visual screening of children plays a critical role in promoting visual development, especially for those with visual impairments. Among various approaches, eye-tracking based visual assessment has emerged as a promising tool, particularly for infants, toddlers, and children with developmental disabilities who are unable to complete traditional vision tests. The object of this study is to design and investigate the effectiveness of using a deep learning based, individualized eye-tracking system to assess visual function, specifically visual acuity and visual field, in typical preschool children and infants under the age of three. This study aims to establish a reliable, noninvasive visual screening method that accommodates the diverse needs and abilities of young children.
Read the detailed description
The investigators will recruit a total of 1,300 participants across four key groups to support the development and validation of an individualized visual function screening system using eye-tracking technology:
- 300 adults to establish a reference dataset for gaze estimation models
- 300 typically developing preschool children aged 3 to 5 years
- 400 typically developing children under the age of 3
- 300 children with special needs, including those with developmental disabilities and visual impairments Data collection will take place over 15 to 22 months, depending on the group.
- Conditions
- Visual Function, Vision, Special Needs Children
- Being tested
- observational study, no interventional
- Keywords
- Children, Ophthalmology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational study, no interventionalOther
no interventions
| Study group | Role | What they receive |
|---|---|---|
| General Population Group | Not described Receives: Other: observational study, no interventional | |
| Special Needs Group | Not described Receives: Other: observational study, no interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Visual Acuity Classification by Deep Vision Tracking System (DVR System), Compared to Standard Clinical Assessment
Compare the DVR system's classification (normal vs. impaired vision) with results from standard clinical tests (e.g., Teller Acuity Cards). Report sensitivity and specificity. Cut-off values: logMAR 0.22 (Snellen decimal: 0.6) and 0.097 (Snellen decimal: 0.8).
Measured: 2 months
Visual Field Detection Accuracy of the DVR System Compared to Standard Evaluation
This outcome assesses the accuracy of the DVR system in detecting visual field response in children, defined by whether the participant successfully fixates on screen-displayed peripheral stimuli. The DVR system's outputs will be compared to clinical observation. Accuracy will be evaluated via sensitivity and specificity.
Measured: 2 months
Secondary outcomes (2)
Criterion validity of DVR system visual acuity estimates (logMAR)
Compare DVR system logMAR estimates with clinical measurements (e.g., Teller Acuity Cards) using linear regression. Report slope coefficient; a slope near 1 indicates strong agreement. Target criterion: slope ≥ 0.8.
Measured: 2 months
Test-retest reliability of DVR system visual acuity measurements
Participants will be re-tested within 2 weeks. Reliability will be assessed using standard error of measurement and coefficient of variation from panel data.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start20 Aug 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual FunctionStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081139
- Sponsor's protocol ID
- 202403039RINA
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Deep Learning to Optimize the Individualized Application of Eye-tracking Devices for the Early-stage Visual Function Screening of Both Special Needs Children and Typical Preschoolers
- ClinicalTrials.gov ID
- NCT07081139
- Acronym / sponsor ID
- 202403039RINA
- Conditions
- Visual Function, Vision, Special Needs Children
- Keywords
- Children, Ophthalmology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Jul 2025 (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.
The early visual screening of children plays a critical role in promoting visual development, especially for those with visual impairments. Among various approaches, eye-tracking based visual assessment has emerged as a promising tool, particularly for infants, toddlers, and children with developmental disabilities who are unable to complete traditional vision tests. The object of this study is to design and investigate the effectiveness of using a deep learning based, individualized eye-tracking system to assess visual function, specifically visual acuity and visual field, in typical preschool children and infants under the age of three. This study aims to establish a reliable, noninvasive visual screening method that accommodates the diverse needs and abilities of young children.
Detailed description
The investigators will recruit a total of 1,300 participants across four key groups to support the development and validation of an individualized visual function screening system using eye-tracking technology:
- 300 adults to establish a reference dataset for gaze estimation models
- 300 typically developing preschool children aged 3 to 5 years
- 400 typically developing children under the age of 3
- 300 children with special needs, including those with developmental disabilities and visual impairments Data collection will take place over 15 to 22 months, depending on the group.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Population Group | – | Other: observational study, no interventional |
| Special Needs Group | – | Other: observational study, no interventional |
Who may qualify
- Ages
- 0 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- General adults, typically developing preschool children aged 3 to 5 and under 3 years old. Additionally, children with special needs, regardless of the underlying cause, including those with physical or mental disabilities or multiple disabilities, such as autism spectrum disorder, cerebral palsy, visual impairments, and developmental delays.
Key inclusion criteria (26 listed)
- A. General Group 1. Inclusion Criteria
- Aged over 18 and under 70 years
- Willing to undergo assessment and video recording using the "Deep Visual Tracking System"
- Willing to sign the informed consent form
- Currently aged between 3 (inclusive) and 5 (inclusive) years
Key exclusion criteria (16 listed)
- Exclusion Criteria
- Presence of severe corneal disease or cataract that may interfere with data collection
- Obvious abnormalities in eye or facial appearance, such as ptosis or facial trauma affecting facial structure
- Children with physical or mental disabilities
- Children diagnosed with or suspected of having developmental delay
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 |
|---|---|---|
| observational study, no interventionalno interventions | Other | General Population Group, Special Needs Group |
Primary outcome
Accuracy of Visual Acuity Classification by Deep Vision Tracking System (DVR System), Compared to Standard Clinical Assessment
Time frame: 2 months
Compare the DVR system's classification (normal vs. impaired vision) with results from standard clinical tests (e.g., Teller Acuity Cards). Report sensitivity and specificity. Cut-off values: logMAR 0.22 (Snellen decimal: 0.6) and 0.097 (Snellen decimal: 0.8).
Visual Field Detection Accuracy of the DVR System Compared to Standard Evaluation
Time frame: 2 months
This outcome assesses the accuracy of the DVR system in detecting visual field response in children, defined by whether the participant successfully fixates on screen-displayed peripheral stimuli. The DVR system's outputs will be compared to clinical observation. Accuracy will be evaluated via sensitivity and specificity.
2 secondary outcomes
Criterion validity of DVR system visual acuity estimates (logMAR)
Time frame: 2 months
Test-retest reliability of DVR system visual acuity measurements
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Function and Vision, run by National Taiwan University Hospital at 1 site in Taiwan.
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 26 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 24 Aug 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiun-Ho Hou, PHD (+886-972652487, houjunhe@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Visual Acuity Classification by Deep Vision Tracking System (DVR System), Compared to Standard Clinical Assessment (time frame: 2 months). 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 24 Aug 2026.