Video Screening for Visual Impairment of Infants

Visual Impairment Clinical Trial

Official title:

Video Screening for Visual Impairment of Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04237350
• Other study ID #: CCPMOH2019-China-7
• Status: Completed
• Start date: January 14, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: November 2022
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An individual senses the world and reflects feedbacks via independent behaviors. Such precise collaboration of the sensory and behavioral systems is fundamental to survival and evolution. When a sensory modality is altered, the behavioral system has the potential to fit in a substitute modality. However, the specific dynamics of human behaviors in response to sensory loss remain largely unknown due to the paucities of representative situations and large-scale samples.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3652
• Est. completion date: February 28, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 4 Years

Eligibility

Inclusion Criteria:

• Younger than 4 years of age

Exclusion Criteria:

• Any brain and mental illnesses, or other known illnesses that may affect the behavioral patterns

Related Conditions & MeSH terms

• Behavioral Dynamics
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The AUC of model based on analyzing the behavioral dynamics	Normal or abnormal behavioral dynamics of infants are recorded by mobile phones. Five experienced ophthalmologists identify the occurence of abnormal behaviors independently, and 2 professors with over 10 years of experience in pediatric ophthalmology department are consulted in cases of disagreement. The AUC of model based on analyzing the behavioral dynamics will be calculated.	baseline