Video Screening for Visual Impairment of Infants

NCT04237350 | Completed DMC

• 1 other identifier: CCPMOH2019-China-7
• Study Type: observational
• Target: 3,652
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Behavioral Dynamics; Visual Impairment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

Behavioral: Video recording for behaviors

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)

Behavioral: Video recording for behaviors

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.

Behavioral: Video recording for behaviors

Interventions

Video recording for behaviors BEHAVIORAL

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; mild visual impairment group; severe visual impairment group

Eligibility Criteria

• Age: Up to 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Younger than 4 years of age

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yizhi Liu, Ph.D

  Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 23, 2020
• Study Start: January 14, 2020
• Primary Completion: January 30, 2022
• Study Completion: February 28, 2022
• Last Updated: December 1, 2022

Record last verified: 2022-11

Locations

CN (1)