Behavioral DynamicsNCT03431207
Behavioral Dynamics Between Infants With Visual Loss and Healthy Controls
An observational study of Behavioral Dynamics and Visual Impairment, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages Up to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavioral Dynamics, Visual Impairment
- What is being tested?
- Standardized video recording for behaviors
- How many people
- 4,196 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 31 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 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.
Who may be able to join
- Younger than 3 years of age
Who cannot join
- Any brain and mental illnesses, or other known illnesses that may affect the behavioral patterns
Trial locations and contacts
1 site in 1 country.
China1 site
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: 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.
- Conditions
- Behavioral Dynamics, Visual Impairment
- Being tested
- Standardized video recording for behaviors
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized video recording for behaviorsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Standardized video recording for behaviors | |
| 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. Receives: Other: Standardized video recording for behaviors | |
| 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. Receives: Other: Standardized video recording for behaviors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 Jan 2014
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Behavioral DynamicsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4,196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Yizhi Liu, Ph.D, Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431207
- Sponsor's protocol ID
- CCPMOH2018-China-1
- Status last verified
- Feb 2018
- First submitted
- 30 Jan 2018
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29134133Japyassu 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.
PubMed 25241306
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Behavioral Dynamics Between Visually Impaired Infants and Healthy Controls
- ClinicalTrials.gov ID
- NCT03431207
- Acronym / sponsor ID
- CCPMOH2018-China-1
- Conditions
- Behavioral Dynamics, Visual Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,196 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy group | – | Other: Standardized video recording for behaviorsFor 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) |
| mildly impaired group | – | Other: Standardized video recording for behaviorsThe "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. |
| severely impaired group | – | Other: Standardized video recording for behaviorsFor the "severely impaired" group, the VA of both eyes was out of the 99% referenced range or worse than light perception with structural abnormalities. |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (1 listed)
- Younger than 3 years of age
Key exclusion criteria (1 listed)
- Any brain and mental illnesses, or other known illnesses that may affect the behavioral patterns
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized video recording for behaviorsA 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. | Other | healthy group, mildly impaired group, severely impaired group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Background: PubMed 29134133Long 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.
- Background: PubMed 25241306Japyassu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yizhi Liu, Ph.D study chair
Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behavioral Dynamics and Visual Impairment, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral dynamics (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03431207, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.