Visual Function Screening System With Special Needs Children and Typical Preschoolers

NCT07081139 | Recruiting DMC

• 1 other identifier: 202403039RINA
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Visual Function; Vision; Special Needs Children

Keywords

Children; Ophthalmology

Outcome Measures

Primary Outcomes (2)

• Accuracy of Visual Acuity Classification by Deep Vision Tracking System (DVR System), Compared to Standard Clinical Assessment

  Compare the DVR system's classification (normal vs. impaired vision) with results from standard clinical tests (e.g., Teller Acuity Cards). Report sensitivity and specificity. Cut-off values: logMAR 0.22 (Snellen decimal: 0.6) and 0.097 (Snellen decimal: 0.8).

  2 months

• Visual Field Detection Accuracy of the DVR System Compared to Standard Evaluation

  This outcome assesses the accuracy of the DVR system in detecting visual field response in children, defined by whether the participant successfully fixates on screen-displayed peripheral stimuli. The DVR system's outputs will be compared to clinical observation. Accuracy will be evaluated via sensitivity and specificity.

  2 months

Secondary Outcomes (2)

• Criterion validity of DVR system visual acuity estimates (logMAR)

  2 months

• Test-retest reliability of DVR system visual acuity measurements

  2 months

Study Arms (2)

General Population Group

Other: observational study, no interventional

Special Needs Group

Other: observational study, no interventional

Interventions

observational study, no interventional OTHER

no interventions

General Population Group; Special Needs Group

Eligibility Criteria

• Age: 0 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General adults, typically developing preschool children aged 3 to 5 and under 3 years old. Additionally, children with special needs, regardless of the underlying cause, including those with physical or mental disabilities or multiple disabilities, such as autism spectrum disorder, cerebral palsy, visual impairments, and developmental delays.

You may qualify if:

• General adults:
• Aged over 18 and under 70 years
• Willing to undergo assessment and video recording using the "Deep Visual Tracking System"
• Willing to sign the informed consent form
• Typically developing preschool children aged 3 to 5:
• Currently aged between 3 (inclusive) and 5 (inclusive) years
• 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:
• Currently under 3 years of age
• The primary caregiver agrees to allow the child to undergo assessment and video recording using the "Deep Visual Tracking System"

You may not qualify if:

• General adults:
• Presence of severe corneal disease or cataract that may interfere with data collection
• Obvious abnormalities in eye or facial appearance, such as ptosis or facial trauma affecting facial structure
• Typically developing preschool children aged 3 to 5:
• Children with physical or mental disabilities
• Children diagnosed with or suspected of having developmental delay
• 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
• B. Special Needs Group
• A. General Group
• General adults:
• Presence of severe corneal disease or cataract that may interfere with data collection
• Obvious abnormalities in eye or facial appearance, such as ptosis or facial trauma affecting facial structure

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Ophthalmology, National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Chiun-Ho Hou, PHD

CONTACT

+886-972652487; houjunhe@ntuh.gov.tw

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 23, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)