NCT07081139

Visual Function Screening System With Special Needs Children and Typical Preschoolers

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,300 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 0 Years – 70 Years
• Healthy volunteers: Accepted

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.

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: 1. 300 adults to establish a reference dataset for gaze estimation models 2. 300 typically developing preschool children aged 3 to 5 years 3. 400 typically developing children under the age of 3 4. 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

Interventions

Type	Name	Description
OTHER	observational study, no interventional	no interventions

Timeline

• Start date: 2025-08-20
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2025-07-23
• Last updated: 2025-11-18

Locations

1 site across 1 country: Taiwan