Behavioral Dynamics Between Infants With Visual Loss and Healthy Controls

NCT ID: NCT03431207

Last Updated: 2018-02-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4196 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2017-10-31

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.

Conditions

Behavioral Dynamics; Visual Impairment

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

Standardized video recording for behaviors

Intervention Type: OTHER

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.

Standardized video recording for behaviors

Intervention Type: OTHER

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.

Standardized video recording for behaviors

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Haotian Lin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yizhi Liu, Ph.D

Role: STUDY_CHAIR

Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

Locations

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 29134133 (View on PubMed)

Japyassu 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.

Reference Type: BACKGROUND

PMID: 25241306 (View on PubMed)

Other Identifiers

CCPMOH2018-China-1

Identifier Type: -

Identifier Source: org_study_id