HealthyNCT04226729
Associations Between Vision and Brain Function
An observational study of Healthy and Vision; Disorder, Loss, run by Sun Yat-sen University at 1 site in China.
Trial summary
Case-control studies and meta-analysis have reported that several ocular features, especially the thickness of the peripapillary retinal nerve fiber layer and visual acuity, are related to the brain degeneration and cognitive impairment. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Vision; Disorder, Loss
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2022to 30 Apr 2023
- 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 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy children aged 3 to 12 years old. Patients who have been diagnosed with nervous system diseases were excluded.
Who may be able to join
- age from 3 to 12 years old
Who cannot join
- diagnosed with nervous system disease before
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
Guangzhou, Guangdong, 510060
Haotian Lin, Ph.D, +86-020-87330274, gddlht@aliyun.com
Haotian Lin, Ph.D
About this study
Official title: Quantitative Assessment of the Vison Using Structural and Functional Indicators and Associations With Brain Function
Case-control studies and meta-analysis have reported that several ocular features, especially the thickness of the peripapillary retinal nerve fiber layer and visual acuity, are related to the brain degeneration and cognitive impairment. In our study, we aim to quantitatively assess ocular features using structural and functional indicators and define its associations with brain development and intelligence in children.
- Conditions
- Healthy, Vision; Disorder, Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy group | Not described | |
| Mild visual impairment group | Not described | |
| Moderate and severe visual impairment group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the visual information processing function
collected with the electroencephalogram
Measured: recorded at enrollment
best corrected visual acuity
collected with visual acuity chart
Measured: recorded at enrollment
Secondary outcomes (3)
refractive status
the refractive status of both eyes
Measured: recorded at enrollment
intraocular pressure
the intraocular pressure of both eyes
Measured: recorded at enrollment
fundus picture
the fundus pictures of both eyes
Measured: recorded at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start25 Jan 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
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
- Haotian Lin, M.D,Ph.D, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226729
- Sponsor's protocol ID
- VISION202201
- Status last verified
- Aug 2022
- First submitted
- 30 Dec 2019
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Assessment of the Vison Using Structural and Functional Indicators and Associations With Brain Function
- ClinicalTrials.gov ID
- NCT04226729
- Acronym / sponsor ID
- VISION202201
- Conditions
- Healthy, Vision; Disorder, Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 13 Jan 2020 (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.
Case-control studies and meta-analysis have reported that several ocular features, especially the thickness of the peripapillary retinal nerve fiber layer and visual acuity, are related to the brain degeneration and cognitive impairment. In our study, we aim to quantitatively assess ocular features using structural and functional indicators and define its associations with brain development and intelligence in children.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy group | – | – |
| Mild visual impairment group | – | – |
| Moderate and severe visual impairment group | – | – |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy children aged 3 to 12 years old. Patients who have been diagnosed with nervous system diseases were excluded.
Key inclusion criteria (1 listed)
- age from 3 to 12 years old
Key exclusion criteria (1 listed)
- diagnosed with nervous system disease before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the visual information processing function
Time frame: recorded at enrollment
collected with the electroencephalogram
best corrected visual acuity
Time frame: recorded at enrollment
collected with visual acuity chart
3 secondary outcomes
refractive status
Time frame: recorded at enrollment
intraocular pressure
Time frame: recorded at enrollment
fundus picture
Time frame: recorded at enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
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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.
Haotian Lin, M.D,Ph.D principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
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 Healthy and Vision; Disorder, Loss, 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: status not confirmed, as of the sponsor's last update on 16 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yifan Xiang, M.D (18826234461, 565098660@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the visual information processing function (time frame: recorded at enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2022.