Actively Recruiting

Age: 0Years - 70Years
All Genders
Healthy Volunteers
ID07081139

Leveraging Deep Learning to Optimize Individualized Eye-tracking for Early Visual Screening of Special Needs Children and Typical Preschoolers

Led by National Taiwan University Hospital · Updated on 2025-11-18

1300

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Early visual screening is crucial for supporting visual development, especially in children with visual impairments or developmental disabilities who cannot complete traditional vision tests. Researchers are evaluating a deep learning-based, individualized eye-tracking system to assess visual function, including visual acuity and visual field, in typical preschool children and infants under age three. This study aims to create a reliable, noninvasive visual screening method that meets the diverse needs of young children, including those with special needs. The study involves 1,300 participants divided into four groups: 300 adults to create reference data, 300 typically developing preschool children aged 3 to 5 years, 400 typically developing children under 3 years old, and 300 children with special needs such as developmental disabilities or visual impairments. Data collection will last from 15 to 22 months depending on the group. The study does not involve treatment but focuses on observation using the eye-tracking system. Participants will undergo assessments and video recordings with the Deep Visual Tracking System to measure visual acuity and visual field. Researchers will compare the system's accuracy to standard clinical evaluations over two months. They will also assess the reliability and validity of the eye-tracking measurements. The study includes children, adults, and special needs groups, with continuous monitoring to ensure data quality and participant safety throughout the observation period.

CONDITIONS

Brief Title

Visual Function Screening System With Special Needs Children and Typical Preschoolers

Who Can Participate

Age: 0Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged over 18 and under 70 years willing to undergo assessment and video recording using the Deep Visual Tracking System and sign informed consent
  • Typically developing preschool children aged 3 to 5 years with caregiver consent for assessment and video recording
  • Children under 3 years old with caregiver consent for assessment and video recording
  • Children under 12 years old with special needs, including physical, mental, or multiple disabilities, with caregiver consent for assessment and video recording
Not Eligible

You will not qualify if you...

  • Adults with severe corneal disease or cataract that may interfere with data collection
  • Adults with obvious abnormalities in eye or facial appearance, such as ptosis or facial trauma affecting facial structure
  • Typically developing preschool children with physical or mental disabilities
  • Typically developing preschool children diagnosed with or suspected of developmental delay
  • Typically developing preschool children with obvious abnormalities in eye or facial appearance
  • Children under 3 years with physical or mental disabilities
  • Children under 3 years diagnosed with or suspected of developmental delay
  • Children under 3 years with obvious abnormalities in eye or facial appearance
  • Special needs children with refractive errors that significantly impair vision and who cannot wear corrective glasses during assessment
  • Special needs children who are physiologically or emotionally unstable and unable to complete at least two assessment sessions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 15 to 22 months depending on the group

Participants undergo assessment using the Deep Visual Tracking System and video recording to collect visual function data.

1 to 2 visits depending on group assignment

Long-term Monitoring

Duration - 15 to 22 months depending on the group

Collected data is used to support the development and validation of the individualized visual function screening system over the study period.

Ongoing assessments during data collection period

Trial Site Locations

Total: 1 location

1

Department of Ophthalmology, National Taiwan University Hospital

Taipei, Taiwan

Actively Recruiting

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Research Team

C

Chiun-Ho Hou, PHD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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