Behavioral Dynamics Between Infants With Visual Loss and Healthy Controls

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT03431207
Collaborator
(none)
4,196
1
46
91.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Standardized video recording for behaviors

Study Design

Study Type:
Observational
Actual Enrollment :
4196 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Comparison of the Behavioral Dynamics Between Visually Impaired Infants and Healthy Controls
Actual Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Oct 31, 2017
Actual Study Completion Date :
Oct 31, 2017

Arms and Interventions

Arm Intervention/Treatment
healthy group

For the "healthy" group, the visual acuity of both eyes was 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)

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.

mildly impaired group

The "mildly impaired" group was defined as a VA out of the 95% reference range in at least 1 eye, but the VA of both eyes was in the 99% referenced range with structural abnormalities.

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.

severely impaired group

For the "severely impaired" group, the VA of both eyes was out of the 99% referenced range or worse than light perception with structural abnormalities.

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.

Outcome Measures

Primary Outcome Measures

  1. Behavioral dynamics [baseline]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 3 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhognshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong China 510060

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

  • Study Chair: Yizhi Liu, Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Haotian Lin, Principal Investigator, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT03431207
Other Study ID Numbers:
  • CCPMOH2018-China-1
First Posted:
Feb 13, 2018
Last Update Posted:
Feb 13, 2018
Last Verified:
Feb 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 13, 2018