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RECRUITING

NCT07081139

Visual Function Screening System With Special Needs Children and Typical Preschoolers

Sponsor: National Taiwan University Hospital

View on ClinicalTrials.gov

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 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.

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

Key Details

Gender

All

Age Range

0 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

1300

Start Date

2025-08-20

Completion Date

2027-12-31

Last Updated

2025-11-18

Healthy Volunteers

Yes

Conditions

Visual Function Vision Special Needs Children

Interventions

OTHER

observational study, no interventional

no interventions

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

Locations (1)

Department of Ophthalmology, National Taiwan University Hospital

Taipei, Taiwan