Behavioral Dynamics Between Infants With Visual Loss and Healthy Controls

Visual Impairment Clinical Trial

Official title:

Comparison of the Behavioral Dynamics Between Visually Impaired Infants and Healthy Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03431207
• Other study ID #: CCPMOH2018-China-1
• Status: Completed
• Phase: N/A
• First received: January 30, 2018
• Last updated: February 12, 2018
• Start date: January 1, 2014
• Est. completion date: October 31, 2017

Study information

• Verified date: February 2018
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4196
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Years

Eligibility

Inclusion Criteria:

• Younger than 3 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

Other:
• Standardized video recording for behaviors
A standardized apparatus, scenario, and procedure was applied to record all the behavioral phenotypes with minimized background interference and stimulation. For each standardized procedure, the guardian sits in the chair, holding the infant facing the stage. 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 over 5 minutes to ensure that behavioral phenotypes could be completely recorded.

Locations

Country	Name	City	State
China	Zhognshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

Japyassú HF, Malange J. Plasticity, stereotypy, intra-individual variability and personality: handle with care. Behav Processes. 2014 Nov;109 Pt A:40-7. doi: 10.1016/j.beproc.2014.09.016. Epub 2014 Sep 18. Review. — View Citation

Long E, Lin Z, Chen J, Liu Z, Cao Q, Lin H, Chen W, Liu Y. Monitoring and Morphologic Classification of Pediatric Cataract Using Slit-Lamp-Adapted Photography. Transl Vis Sci Technol. 2017 Nov 2;6(6):2. doi: 10.1167/tvst.6.6.2. eCollection 2017 Nov. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral dynamics	Eyeball movement (strabismus, nystagmus, and incongruous binocular movement); hand-related behaviors (eye rubbing, pressing, and poking); fixation-related behaviors (compulsive light gazing, compensatory head position, motionless fixation, and poor fixation); and eyelid reaction (frequent blinking, squint, and frown). Five experienced ophthalmologists identified the behaviors independently, and 2 professors with over 10 years of experience in pediatric ophthalmology department were consulted in cases of disagreement.	baseline