Visual Function Screening System With Special Needs Children and Typical Preschoolers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-70
SponsorNational Taiwan University Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
A. General Group 1. Inclusion Criteria
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
Disqualifiers
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
Children with physical or mental disabilities
Children diagnosed with or suspected of having developmental delay
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
observational study, no interventional
Other interventionno interventions
Treatment groups
1,300 Participants
are divided into 2 treatment groupsGroup A: General Population Group1 intervention
Group B: Special Needs Group1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
2 months2
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.
Time frame
2 monthsSecondary outcomes
1
Criterion validity of DVR system visual acuity estimates (logMAR)
Compare DVR system logMAR estimates with clinical measurements (e.g., Teller Acuity Cards) using linear regression. Report slope coefficient; a slope near 1 indicates strong agreement. Target criterion: slope ≥ 0.8.
Time frame
2 months2
Test-retest reliability of DVR system visual acuity measurements
Participants will be re-tested within 2 weeks. Reliability will be assessed using standard error of measurement and coefficient of variation from panel data.
Time frame
2 monthsSponsors and contacts
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Source ClinicalTrials.gov