<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/NCT03244670</url>
  </required_header>
  <id_info>
    <org_study_id>TEX2017</org_study_id>
    <nct_id>NCT03244670</nct_id>
  </id_info>
  <brief_title>The Incidence and Progression of Myopia: Cohort Study</brief_title>
  <official_title>A Cohort Study on Incidence and Progression of Myopia in a Group of Medical Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Essilor International</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A cohort study on incidence and progression of myopia in a group of medical students&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective cohort study to investigate the refractive error development, progression and&#xD;
      their risk factors in young adult population comprises a group of medical students in China&#xD;
      for two years&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Actual">September 19, 2019</completion_date>
  <primary_completion_date type="Actual">July 19, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>refraction</measure>
    <time_frame>Change from baseline for two years</time_frame>
    <description>The participants will be measured for their refractive error by optometrist, and observe the rate of progression of myopia</description>
  </primary_outcome>
  <enrollment type="Actual">350</enrollment>
  <condition>Myopia</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation study only, no specific intervention</intervention_name>
    <description>Observation study only, no specific intervention</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        First-year medical college student from Zhongshan University&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Volunteer subject, , willing to follow the protocol and able to read, comprehend and&#xD;
             sign the informed consent form,&#xD;
&#xD;
          -  Age between 17 and 23 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vulnerability of the subject,&#xD;
&#xD;
          -  Participation in another study which might have an influence on vision or interfere&#xD;
             with study assessments,&#xD;
&#xD;
          -  Aphakic or pseudophakic (intraocular lens)&#xD;
&#xD;
          -  Participants who are wearing ortho-K lenses, or undergone any kind of myopia control&#xD;
             treatments or undergone refractive surgery.&#xD;
&#xD;
          -  Any current or evolving pathology manifested in the eye or the appendages which might&#xD;
             have an influence on vision, or interfere with study assessments (e.g. AMD,&#xD;
             glaucoma…),&#xD;
&#xD;
          -  Any previous ocular surgery which might have an influence on vision or interfere with&#xD;
             study assessments (e.g. iridectomy, refractive surgery…),&#xD;
&#xD;
          -  Any untreated and/or uncontrolled systemic condition which might have an influence on&#xD;
             vision, or interfere with study assessments (e.g. uncontrolled diabetes, uncontrolled&#xD;
             high blood pressure…),&#xD;
&#xD;
          -  Any medical treatment or medication which might have an influence on vision or&#xD;
             interfere with study assessments (e.g. antidepressants, drugs with atropinic&#xD;
             effects…),&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>23 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chen xiang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhongshan Ophthalmic Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>September 19, 2019</last_update_submitted>
  <last_update_submitted_qc>September 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Xiang Chen</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Myopia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03244670
org study id: TEX2017
nct id: NCT03244670
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
A cohort study on incidence and progression of myopia in a group of medical students
A prospective cohort study to investigate the refractive error development, progression and
      their risk factors in young adult population comprises a group of medical students in China
      for two years
observational model: Cohort
time perspective: Prospective
measure: refraction
time frame: Change from baseline for two years
description: The participants will be measured for their refractive error by optometrist, and observe the rate of progression of myopia
intervention type: Other
intervention name: Observation study only, no specific intervention
description: Observation study only, no specific intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 17 Years
maximum age: 23 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chen xiang
role: Principal Investigator
affiliation: Associate Professor
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Xiang Chen
investigator title: Associate Professor
mesh term: Myopia
sharing ipd: No