<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/NCT03750630</url>
  </required_header>
  <id_info>
    <org_study_id>201510078RINB</org_study_id>
    <nct_id>NCT03750630</nct_id>
  </id_info>
  <brief_title>A Pilot Survey to Establish Vision Health Surveillance Indicators for Children and Adolescent in Taiwan</brief_title>
  <official_title>A Pilot Survey to Establish Vision Health Surveillance Indicators for Children and Adolescent in Taiwan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</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 purpose of this research project is to develop a vision surveillance system, in order of&#xD;
      understanding the vision health status of children and adolescents in Taiwan.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this research project is to develop a vision surveillance system, in order of&#xD;
      understanding the vision health status of children and adolescents in Taiwan. It can serve as&#xD;
      a basis for the government to establish a nationwide vision surveillance system, invest&#xD;
      research resources, and make national policies.&#xD;
&#xD;
      This research project also classified the urbanization of sampling school as high, medium and&#xD;
      low based on the location of school.This research project explored and analyzed the health&#xD;
      status of myopic schoolchildren and associated factors such as families, genetics, school&#xD;
      environment, living environment and behaviors among north, south, west and east regions of&#xD;
      Taiwan.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 14, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Refractive status</measure>
    <time_frame>1 day</time_frame>
    <description>Cycloplegic spherical refraction measured by auto-refractometer (Diopter) in children and adolescents.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Axial length</measure>
    <time_frame>1 day</time_frame>
    <description>The axial length is the distance between the anterior surface of the cornea and the fovea and is the primary determinant of non-syndromic myopia. In this research project, investigators measure the axial length in children and adolescents by A-scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraocular pressure</measure>
    <time_frame>1 day</time_frame>
    <description>Intraocular pressure is the pressure created by the continual renewal of fluids within the eye. In this research project, investigators measure the intraocular pressure in children and adolescents by Icare Tonometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corneal thickness</measure>
    <time_frame>1 day</time_frame>
    <description>Corneal thickness is an important factor in accurately diagnosing eye pressure. In this report project, investigators measure the corneal thickness in children and adolescents by A-scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fundus examination</measure>
    <time_frame>1 day</time_frame>
    <description>The fundus is the portion of the inner eye that can be seen during an eye examination by looking through the pupil. In this research project, investigators perform the fundus examination in children and adolescents by ophthalmoscope.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious and non-Serious Adverse Events</measure>
    <time_frame>1 day</time_frame>
    <description>The adverse events in children and adolescents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire</measure>
    <time_frame>1 day</time_frame>
    <description>Associated factors such as families, genetics, school environment, living environment and behaviors</description>
  </secondary_outcome>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Vision Status</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Students with age between 3 to 18 years old&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Students with age between 3 to 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Students have any special ocular disease.&#xD;
&#xD;
          2. non-compliance with screening protocol&#xD;
&#xD;
          3. orthokeratology user&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>I-Jong Wang</last_name>
    <phone>886-2-23123456</phone>
    <phone_ext>65729</phone_ext>
    <email>ijong@ntu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei, Taiwan</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>I-Jong Wang</last_name>
      <phone>886-2-23123456</phone>
      <phone_ext>65729</phone_ext>
      <email>ijong@ntu.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 20, 2018</last_update_submitted>
  <last_update_submitted_qc>November 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vision, children, adolescent</keyword>
  <!-- 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/NCT03750630
org study id: 201510078RINB
nct id: NCT03750630
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research project is to develop a vision surveillance system, in order of
      understanding the vision health status of children and adolescents in Taiwan.
The purpose of this research project is to develop a vision surveillance system, in order of
      understanding the vision health status of children and adolescents in Taiwan. It can serve as
      a basis for the government to establish a nationwide vision surveillance system, invest
      research resources, and make national policies.

      This research project also classified the urbanization of sampling school as high, medium and
      low based on the location of school.This research project explored and analyzed the health
      status of myopic schoolchildren and associated factors such as families, genetics, school
      environment, living environment and behaviors among north, south, west and east regions of
      Taiwan.
observational model: Case-Only
time perspective: Prospective
measure: Refractive status
time frame: 1 day
description: Cycloplegic spherical refraction measured by auto-refractometer (Diopter) in children and adolescents.
measure: Axial length
time frame: 1 day
description: The axial length is the distance between the anterior surface of the cornea and the fovea and is the primary determinant of non-syndromic myopia. In this research project, investigators measure the axial length in children and adolescents by A-scan.
measure: Intraocular pressure
time frame: 1 day
description: Intraocular pressure is the pressure created by the continual renewal of fluids within the eye. In this research project, investigators measure the intraocular pressure in children and adolescents by Icare Tonometer.
measure: Corneal thickness
time frame: 1 day
description: Corneal thickness is an important factor in accurately diagnosing eye pressure. In this report project, investigators measure the corneal thickness in children and adolescents by A-scan.
measure: Fundus examination
time frame: 1 day
description: The fundus is the portion of the inner eye that can be seen during an eye examination by looking through the pupil. In this research project, investigators perform the fundus examination in children and adolescents by ophthalmoscope.
measure: Serious and non-Serious Adverse Events
time frame: 1 day
description: The adverse events in children and adolescents
measure: Questionnaire
time frame: 1 day
description: Associated factors such as families, genetics, school environment, living environment and behaviors
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: I-Jong Wang
phone: 886-2-23123456
phone ext: 65729
email: ijong@ntu.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor