- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03431207
Behavioral Dynamics Between Infants With Visual Loss and Healthy Controls
Comparison of the Behavioral Dynamics Between Visually Impaired Infants and Healthy Controls
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Zhognshan Ophthalmic Center, Sun Yat-sen University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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) |
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.
|
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavioral dynamics
Time Frame: 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.
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Yizhi Liu, Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCPMOH2018-China-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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