Department of Ophthalmology, National Taiwan University Hospital
Taipei, Taiwan
Location status: Recruiting
NCT Number: NCT07081139
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.
Interested in participating?
Request Info0 year–70 year
All sexes
Observational
Taipei, Taiwan
Location status: Recruiting
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
General adults:
Typically developing preschool children aged 3 to 5:
Children under 3 years old:
General adults:
Typically developing preschool children aged 3 to 5:
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
Exclusion criteria
General adults:
Typically developing preschool children aged 3 to 5:
Children under 3 years old:
B. Special Needs Group 2. Exclusion Criteria
no interventions
Time frame: 2 months
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 months
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 months
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 months
Participants will be re-tested within 2 weeks. Reliability will be assessed using standard error of measurement and coefficient of variation from panel data.
Contact information is provided by the study sponsor or research team.
National Taiwan University Hospital
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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