Video Screening for Visual Impairment of Infants

Completed

• Conditions: Visual Impairment; Behavioral Dynamics
• Interventions: Behavioral: Video recording for behaviors

• Registration Number: NCT04237350
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-14
• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-23
• Primary Completion: 2022-01-30
• Study Completion: 2022-02-28
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3652

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
severe visual impairment group	Video recording for behaviors	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.
likely healthy group	Video recording for behaviors	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)
mild visual impairment group	Video recording for behaviors	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.

Primary Outcome Measures

Name	Time	Method
The AUC of model based on analyzing the behavioral dynamics	baseline	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.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity; 🇨🇳 Guangzhou, Guangdong, China