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

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

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 type: Observational
• Enrollment: 1300 (estimated)
• Ages: 0 Years to 70 Years
• Sex: All
• Sponsor: National Taiwan University Hospital (Academic / other)
• Locations: 1 site (Taipei)
• Trial ID: NCT07081139 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Taipei

• Department of Ophthalmology, National Taiwan University Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Study coordinator: Chiun-Ho Hou, PHD

Conditions Visual Function; Vision; Special Needs Children; Children; Ophthalmology