Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3652 participants
OBSERVATIONAL
2020-01-14
2022-02-28
Brief Summary
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Here, the investigators focused on thousands of human infants who suffered varying degrees of visual stimuli deficiency in early stages, while their behavioral systems remained sensitive and thus retained high behavioral plasticity. Having access to this unique population provides an unprecedented opportunity to investigate the effect of diverse visual conditions on the behavioral system and develop a domestic apparatus for screening visual impariment of infants.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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severe visual impairment group
The "severe visual impairment" group is defined as the BCVA of at least one eye outside the 99% referenced range or worse than light perception with structural abnormalities or other examination results.
Video recording for behaviors
A domenstic apparatus, scenario, and procedure is applied to record all the behavioral phenotypes.
For each standardized procedure, the guardian sits in the chair, holding the infant facing the mobile phone screen. Each infant is given a few minutes to adapt to the surroundings and to be calm before recording. No hints or simulations are permitted during the entire process. The recording process lasted for about 3 minutes to ensure that behavioral phenotypes could be completely recorded.
likely healthy group
For the "likely healthy" group, the visual acuity of both eyes is in the 95% referenced range with no structural abnormalities.
The referenced range could be found in the following publication:
Mayer, DL., et al. Monocular acuity norms for the Teller Acuity Cards between ages one month and four years. Investigative Ophthalmology \& Visual Science. 36(3):671 (1995)
Video recording for behaviors
A domenstic apparatus, scenario, and procedure is applied to record all the behavioral phenotypes.
For each standardized procedure, the guardian sits in the chair, holding the infant facing the mobile phone screen. Each infant is given a few minutes to adapt to the surroundings and to be calm before recording. No hints or simulations are permitted during the entire process. The recording process lasted for about 3 minutes to ensure that behavioral phenotypes could be completely recorded.
mild visual impairment group
The "mild visual impairment" group is defined as the BCVA in the 99% referenced range in both eyes with abnormalities of structure or other examination results.
Video recording for behaviors
A domenstic apparatus, scenario, and procedure is applied to record all the behavioral phenotypes.
For each standardized procedure, the guardian sits in the chair, holding the infant facing the mobile phone screen. Each infant is given a few minutes to adapt to the surroundings and to be calm before recording. No hints or simulations are permitted during the entire process. The recording process lasted for about 3 minutes to ensure that behavioral phenotypes could be completely recorded.
Interventions
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Video recording for behaviors
A domenstic apparatus, scenario, and procedure is applied to record all the behavioral phenotypes.
For each standardized procedure, the guardian sits in the chair, holding the infant facing the mobile phone screen. Each infant is given a few minutes to adapt to the surroundings and to be calm before recording. No hints or simulations are permitted during the entire process. The recording process lasted for about 3 minutes to ensure that behavioral phenotypes could be completely recorded.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
4 Years
ALL
Yes
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Haotian Lin
Principal Investigator
Principal Investigators
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Yizhi Liu, Ph.D
Role: STUDY_CHAIR
Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
Locations
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Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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CCPMOH2019-China-7
Identifier Type: -
Identifier Source: org_study_id
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