Visual AcuityNCT04433130
Eye Health in Children and Adolescents: Repeated Cross-sectional Survey
An observational study of Visual Acuity, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
The investigator will take a mixed-methods approach to gather relevant information from both children or adolescents, and their parents on profiles of eye health, as well as routinely available indicators. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Visual Acuity
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2020to 31 Aug 2024
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subjects seeking care on refractive error or vision problems and their parents
Who may be able to join
- Subjects with valid information on eye health-related profiles
- Completion of eye health examination delivered by trained ophthalmic professionals
Who cannot join
- Inability to give informed consent
- Unable to retrieve individual records on eye health examination
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Yuting LI, MPH, +86-020-87334687, ytdorothy@163.com
About this study
The investigator will take a mixed-methods approach to gather relevant information from both children or adolescents, and their parents on profiles of eye health, as well as routinely available indicators. This includes a series of baselining and follow-up analyses of cohort data collected on epidemiological, clinical, therapeutic, and service aspects of eye health and individual-level outcomes
Read the detailed description
The investigator will take a mixed-methods approach to gather relevant information from both children or adolescents, and their parents on profiles of eye health, as well as routinely available indicators. This includes a series of baselining and follow-up analyses of cohort data collected on epidemiological, clinical, therapeutic, and service aspects of eye health (e.g., social environment, preventive behaviours, risk factors, knowledge and attitudes, health and social care, etc.) and individual-level outcomes (e.g., clinical parameters and symptoms, biomarkers, self-reported measures, risk profiles, etc.).
- Conditions
- Visual Acuity
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
The primary aims of the research project are to explore the profiles of eye health and how lifestyle behaviours, social environment, and individual risk factors are associated with health outcomes.
Measured: Baseline and changes up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start16 Jun 2020
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual AcuityStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University, Chinese University of Hong Kong
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433130
- Sponsor's protocol ID
- SYSU-OPH-006
- Status last verified
- Jul 2020
- First submitted
- 12 Jun 2020
- Last updated
- 24 Jul 2020
- 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 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye Health in Children and Adolescents: Repeated Cross-sectional Survey
- ClinicalTrials.gov ID
- NCT04433130
- Acronym / sponsor ID
- SYSU-OPH-006
- Conditions
- Visual Acuity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-sen University, Chinese University of Hong Kong
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 16 Jun 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.
The investigator will take a mixed-methods approach to gather relevant information from both children or adolescents, and their parents on profiles of eye health, as well as routinely available indicators. This includes a series of baselining and follow-up analyses of cohort data collected on epidemiological, clinical, therapeutic, and service aspects of eye health and individual-level outcomes
Detailed description
The investigator will take a mixed-methods approach to gather relevant information from both children or adolescents, and their parents on profiles of eye health, as well as routinely available indicators. This includes a series of baselining and follow-up analyses of cohort data collected on epidemiological, clinical, therapeutic, and service aspects of eye health (e.g., social environment, preventive behaviours, risk factors, knowledge and attitudes, health and social care, etc.) and individual-level outcomes (e.g., clinical parameters and symptoms, biomarkers, self-reported measures, risk profiles, etc.).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects seeking care on refractive error or vision problems and their parents
Key inclusion criteria (2 listed)
- Subjects with valid information on eye health-related profiles
- Completion of eye health examination delivered by trained ophthalmic professionals
Key exclusion criteria (2 listed)
- Inability to give informed consent
- Unable to retrieve individual records on eye health examination
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
visual acuity
Time frame: Baseline and changes up to 4 years
The primary aims of the research project are to explore the profiles of eye health and how lifestyle behaviours, social environment, and individual risk factors are associated with health outcomes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
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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.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, China
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 Visual Acuity, run by Zhongshan Ophthalmic Center, 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 2 inclusion and 2 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 24 Jul 2020. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual acuity (time frame: Baseline and changes up to 4 years). 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 24 Jul 2020.