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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General Population Group |
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| Special Needs Group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observational study, no interventional | Other | no interventions |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months |
| Test-retest reliability of DVR system visual acuity measurements |
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Inclusion Criteria:
General adults:
Typically developing preschool children aged 3 to 5:
Children under 3 years old:
2. Exclusion Criteria
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
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:
Exclusion Criteria
General adults:
Typically developing preschool children aged 3 to 5:
Children under 3 years old:
B. Special Needs Group 2. Exclusion Criteria
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chiun-Ho Hou, PHD | Contact | +886-972652487 | houjunhe@ntuh.gov.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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Participants will be re-tested within 2 weeks. Reliability will be assessed using standard error of measurement and coefficient of variation from panel data. |
| 2 months |