NCT07081139 Visual Function Screening System With Special Needs Children and Typical Preschoolers
| NCT ID | NCT07081139 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | Visual Function |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,300 participants |
| Start Date | 2025-08-20 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,300 participants in total. It began in 2025-08-20 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * A. General Group 1. Inclusion Criteria General adults: 1. Aged over 18 and under 70 years 2. Willing to undergo assessment and video recording using the "Deep Visual Tracking System" 3. Willing to sign the informed consent form Typically developing preschool children aged 3 to 5: 1. Currently aged between 3 (inclusive) and 5 (inclusive) years 2. 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: 1. Currently under 3 years of age 2. The primary caregiver agrees to allow the child to undergo assessment and video recording using the "Deep Visual Tracking System" 2\. Exclusion Criteria General adults: 1. Presence of severe corneal disease or cataract that may interfere with data collection 2. Obvious abnormalities in eye or facial appearance, such as ptosis or facial trauma affecting facial structure Typically developing preschool children aged 3 to 5: 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 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 1. 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" 2. Exclusion Criteria (1) Children with refractive errors that are diagnosed by an ophthalmologist to significantly impair vision and are unable to wear corrective glasses during assessment (2) Children who are physiologically or emotionally unstable and unable to adapt and complete at least two assessment sessions B. Special Needs Group 1. 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: * A. General Group 2. Exclusion Criteria General adults: 1. Presence of severe corneal disease or cataract that may interfere with data collection 2. Obvious abnormalities in eye or facial appearance, such as ptosis or facial trauma affecting facial structure Typically developing preschool children aged 3 to 5: 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 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 2. Exclusion Criteria 1. Children with refractive errors that are diagnosed by an ophthalmologist to significantly impair vision and are unable to wear corrective glasses during assessment 2. Children who are physiologically or emotionally unstable and unable to adapt and complete at least two assessment sessions
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07081139 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 70 Years, studying Visual Function. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07081139 currently recruiting?
Yes, NCT07081139 is actively recruiting participants. Contact the research team at houjunhe@ntuh.gov.tw for enrollment information.
Where is the NCT07081139 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT07081139 clinical trial?
NCT07081139 is sponsored by National Taiwan University Hospital. The trial plans to enroll 1,300 participants.