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Clinical trial Recruiting at 1 site Observational Ages 0 to 70

Deep-learning eye-tracking vision screening for infants, preschoolers, and children with special needs

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

Run by National Taiwan University Hospital · NCT07081139 · Data updated 2026-11-12

This project will try a deep-learning eye-tracking system to measure visual acuity and visual field in infants under 3, preschoolers aged 3–5, and children with developmental disabilities, using adults as a reference group.

Quick facts

Study typeObservational
Ages0 Years to 70 Years
SexAll
Enrollment1300 (estimated)
SponsorNational Taiwan University Hospital
Academic / other
Locations1 site (Taipei)
StatusRecruiting
StartedAugust 20, 2025
Main results expectedJune 30, 2027
Study endsDecember 31, 2027
Registry record updatedAugust 24, 2026
Trial IDNCT07081139 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults 18–70 for the reference dataset, typically developing children under 3, typically developing preschoolers aged 3–5, and children with developmental disabilities or visual impairments whose caregivers consent to video-recorded eye-tracking sessions.

Probably not a fit

Patients unlikely to benefit include those older than the target age ranges, individuals with severe corneal disease or dense cataract or major facial/ocular abnormalities that prevent reliable eye tracking, and anyone unwilling to be video recorded or who needs immediate diagnostic or therapeutic intervention rather than screening.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study will recruit 1,300 participants across four groups (300 adults, 300 typically developing preschoolers aged 3–5, 400 typically developing children under 3, and 300 children with special needs) to develop and validate an individualized eye-tracking screening system. Participants will undergo noninvasive video-recorded visual tasks while a deep learning model estimates gaze, visual acuity, and visual field parameters. Data from adults will form a reference dataset for gaze estimation, and pediatric data will be used to train and validate age- and ability-specific models. Data collection is planned to take 15–22 months depending on the participant group and is observational with no interventional procedures.

Why it matters

Potential benefit: If successful, this could provide a quick, noninvasive screening tool that helps detect vision problems earlier in young children and those with developmental disabilities, enabling earlier referral and treatment.

How similar studies have gone: Previous eye-tracking approaches for infant and pediatric vision screening have shown promise, but fully individualized deep-learning eye-tracking systems for broad pediatric and special-needs populations remain relatively new.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* A. General Group 1. Inclusion Criteria

General adults:

1. Aged over 18 and under 70 years
2. Willing to undergo assessment and video recording using the "Deep Visual Tracking System"
3. Willing to sign the informed consent form

Typically developing preschool children aged 3 to 5:

1. Currently aged between 3 (inclusive) and 5 (inclusive) years
2. 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:

1. Currently under 3 years of age
2. 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:

1. Presence of severe corneal disease or cataract that may interfere with data collection
2. Obvious abnormalities in eye or facial appearance, such as ptosis or facial trauma affecting facial structure

Typically developing preschool children aged 3 to 5:

1. 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

Children under 3 years old:

(1) 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

1. 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"
2. 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

B. Special Needs Group

1. 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:
   * A. General Group
2. Exclusion Criteria

General adults:

1. Presence of severe corneal disease or cataract that may interfere with data collection
2. Obvious abnormalities in eye or facial appearance, such as ptosis or facial trauma affecting facial structure

Typically developing preschool children aged 3 to 5:

1. 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

Children under 3 years old:

1. 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 2. 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

Where it's running

  • Department of Ophthalmology, National Taiwan University Hospital
    Taipei, Taiwan     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.