An observational study in Behavioral Dynamics and Visual Impairment, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged Up to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-13.
Sponsored by Sun Yat-sen University · Observational
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.
360 studies on the registry are indexed under Vision Disorders; 84 are open to participants now.
This study's enrollment of 4,196 is above the median of 126 across 97 observational studies indexed under Vision Disorders.
Browse Vision Disorders studies →Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 619 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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.
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.
Time frame: baseline
Plan to share: No
Ran from Jan 2014 to primary completion in Oct 2017, 45 months.
Of 51 non-industry observational studies under Vision Disorders, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 42. This study's 45 months is above that.
Counting every sponsor, half of 58 studies reached it within 23 months; a quarter within 12 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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