<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04433130</url>
  </required_header>
  <id_info>
    <org_study_id>SYSU-OPH-006</org_study_id>
    <nct_id>NCT04433130</nct_id>
  </id_info>
  <brief_title>Eye Health in Children and Adolescents: Repeated Cross-sectional Survey</brief_title>
  <official_title>Eye Health in Children and Adolescents: Repeated Cross-sectional Survey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhongshan Ophthalmic Center, Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Zhongshan Ophthalmic Center, Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigator will take a mixed-methods approach to gather relevant information from both&#xD;
      children or adolescents, and their parents on profiles of eye health, as well as routinely&#xD;
      available indicators. This includes a series of baselining and follow-up analyses of cohort&#xD;
      data collected on epidemiological, clinical, therapeutic, and service aspects of eye health&#xD;
      and individual-level outcomes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigator will take a mixed-methods approach to gather relevant information from both&#xD;
      children or adolescents, and their parents on profiles of eye health, as well as routinely&#xD;
      available indicators. This includes a series of baselining and follow-up analyses of cohort&#xD;
      data collected on epidemiological, clinical, therapeutic, and service aspects of eye health&#xD;
      (e.g., social environment, preventive behaviours, risk factors, knowledge and attitudes,&#xD;
      health and social care, etc.) and individual-level outcomes (e.g., clinical parameters and&#xD;
      symptoms, biomarkers, self-reported measures, risk profiles, etc.).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>visual acuity</measure>
    <time_frame>Baseline and changes up to 4 years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Visual Acuity</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects seeking care on refractive error or vision problems and their parents&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          -  Subjects with valid information on eye health-related profiles&#xD;
&#xD;
          -  Completion of eye health examination delivered by trained ophthalmic professionals&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Unable to retrieve individual records on eye health examination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zhongshan Ophthalmic Center, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuting LI, MPH</last_name>
      <phone>+86-020-87334687</phone>
      <email>ytdorothy@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04433130
org study id: SYSU-OPH-006
nct id: NCT04433130
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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
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.).
observational model: Other
time perspective: Prospective
measure: visual acuity
time frame: Baseline and changes up to 4 years
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 18 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor