xml: <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/NCT05967702</url>
    </required_header>
    <id_info>
      <org_study_id>KY-2023040</org_study_id>
      <nct_id>NCT05967702</nct_id>
    </id_info>
    <brief_title>A 3-year Cross-sectional Assessment of the Tianjin Child and Adolescent Large-scale Eye Study</brief_title>
    <official_title>A 3-year Cross-sectional Assessment of the Tianjin Child and Adolescent Large-scale Eye Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tianjin Eye Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tianjin Eye Hospital</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>
        This is a school-based, cross-sectional study to assess the incidence and prevalence, risk&#xD;
        factors of myopia among schoolchildren in both eye-use environment, eye-use habits,&#xD;
        lifestyle, and family and subjective factors before and during COVID-19. Large population and&#xD;
        representative study subjects. Environmental exposure and daily within and out-of-school&#xD;
        activities will be evaluated in a random subgroup.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Myopia is the most common refractive error and a major reason for reducing uncorrected visual&#xD;
        acuity among schoolchildren. It was reported that during COVID-19, home confinement resulted&#xD;
        in a significant increase in myopia due to the changed lifestyle of schoolchildren&#xD;
        dramatically. However, it is unclear which kind of risk factors should be the first to bear&#xD;
        the brunt before and during COVID-19. And which factors should be emphasized and confronted&#xD;
        as the optimum strategy for myopia prevention and control? This cohort study aims to&#xD;
        determine the risk factors, prevalence, and incidence of myopia, and SE changes among&#xD;
        schoolchildren before and during COVID-19, hence identifying the factors that impact the&#xD;
        onset and progression of myopia.&#xD;
  &#xD;
        This is a 3-year cross-sectional study. This study plans to enroll 126,810 participants (aged&#xD;
        6-18 years) from Tianjin, China. All grade students from 10 regions of Tianjin City, China&#xD;
        will be analyzed. Over a 3-year follow-up period, students will receive detailed eye&#xD;
        examinations annually and complete questionnaires about eye-use environment, eye-use habits,&#xD;
        lifestyle, and family and subjective factors. In a 5% random sample size of this cohort&#xD;
        study, outdoor activity, light intensity, eye use habits, and eye use environment data will&#xD;
        be obtained using objective measuring devices. Myopia was defined as spherical equivalent&#xD;
        refractive (SER) of ≤ -0.5D.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 1, 2019</start_date>
    <completion_date type="Actual">December 31, 2021</completion_date>
    <primary_completion_date type="Actual">December 31, 2021</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Prevalence of myopia</measure>
      <time_frame>One day measurement</time_frame>
      <description>Myopia was defined as an equivalent spherical refraction ≤ -0.50D in either eye</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Prevalence of high myopia</measure>
      <time_frame>One day measurement</time_frame>
      <description>High myopia was defined as an equivalent spherical refraction ≤ -6.00D in either eye</description>
    </primary_outcome>
    <enrollment type="Actual">126810</enrollment>
    <condition>Myopia</condition>
    <eligibility>
      <study_pop>
        <textblock>
          All 6-18-year students with no significant systemic or eye diseases are eligible for vision&#xD;
          screening&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All 6-18 years students&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  No eye diseases such as cataracts, glaucoma, keratoconus, etc.&#xD;
  &#xD;
            -  No psychiatric disorders&#xD;
  &#xD;
            -  Astigmatism ≤ -6.00D&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yan Wang, director</last_name>
      <role>Study Director</role>
      <affiliation>Tianjin Eye Hospital and Eye Institute, Nankai University Affiliated Eye Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Tianjin Eye Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <results_reference>
      <citation>Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.</citation>
      <PMID>26875007</PMID>
    </results_reference>
    <results_reference>
      <citation>Modjtahedi BS, Abbott RL, Fong DS, Lum F, Tan D; Task Force on Myopia. Reducing the Global Burden of Myopia by Delaying the Onset of Myopia and Reducing Myopic Progression in Children: The Academy's Task Force on Myopia. Ophthalmology. 2021 Jun;128(6):816-826. doi: 10.1016/j.ophtha.2020.10.040. Epub 2020 Dec 30.</citation>
      <PMID>33388160</PMID>
    </results_reference>
    <results_reference>
      <citation>Hu Y, Zhao F, Ding X, Zhang S, Li Z, Guo Y, Feng Z, Tang X, Li Q, Guo L, Lu C, Yang X, He M. Rates of Myopia Development in Young Chinese Schoolchildren During the Outbreak of COVID-19. JAMA Ophthalmol. 2021 Oct 1;139(10):1115-1121. doi: 10.1001/jamaophthalmol.2021.3563. Erratum In: JAMA Ophthalmol. 2021 Oct 21;:</citation>
      <PMID>34529002</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 9, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>
  
  
text: 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/NCT05967702
  org study id: KY-2023040
  nct id: NCT05967702
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a school-based, cross-sectional study to assess the incidence and prevalence, risk
        factors of myopia among schoolchildren in both eye-use environment, eye-use habits,
        lifestyle, and family and subjective factors before and during COVID-19. Large population and
        representative study subjects. Environmental exposure and daily within and out-of-school
        activities will be evaluated in a random subgroup.
  Myopia is the most common refractive error and a major reason for reducing uncorrected visual
        acuity among schoolchildren. It was reported that during COVID-19, home confinement resulted
        in a significant increase in myopia due to the changed lifestyle of schoolchildren
        dramatically. However, it is unclear which kind of risk factors should be the first to bear
        the brunt before and during COVID-19. And which factors should be emphasized and confronted
        as the optimum strategy for myopia prevention and control? This cohort study aims to
        determine the risk factors, prevalence, and incidence of myopia, and SE changes among
        schoolchildren before and during COVID-19, hence identifying the factors that impact the
        onset and progression of myopia.
  
        This is a 3-year cross-sectional study. This study plans to enroll 126,810 participants (aged
        6-18 years) from Tianjin, China. All grade students from 10 regions of Tianjin City, China
        will be analyzed. Over a 3-year follow-up period, students will receive detailed eye
        examinations annually and complete questionnaires about eye-use environment, eye-use habits,
        lifestyle, and family and subjective factors. In a 5% random sample size of this cohort
        study, outdoor activity, light intensity, eye use habits, and eye use environment data will
        be obtained using objective measuring devices. Myopia was defined as spherical equivalent
        refractive (SER) of ≤ -0.5D.
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: Prevalence of myopia
  time frame: One day measurement
  description: Myopia was defined as an equivalent spherical refraction ≤ -0.50D in either eye
  measure: Prevalence of high myopia
  time frame: One day measurement
  description: High myopia was defined as an equivalent spherical refraction ≤ -6.00D in either eye
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yan Wang, director
  role: Study Director
  affiliation: Tianjin Eye Hospital and Eye Institute, Nankai University Affiliated Eye Hospital
  facility: 
  country: China
  citation: Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.
  PMID: 26875007
  citation: Modjtahedi BS, Abbott RL, Fong DS, Lum F, Tan D; Task Force on Myopia. Reducing the Global Burden of Myopia by Delaying the Onset of Myopia and Reducing Myopic Progression in Children: The Academy's Task Force on Myopia. Ophthalmology. 2021 Jun;128(6):816-826. doi: 10.1016/j.ophtha.2020.10.040. Epub 2020 Dec 30.
  PMID: 33388160
  citation: Hu Y, Zhao F, Ding X, Zhang S, Li Z, Guo Y, Feng Z, Tang X, Li Q, Guo L, Lu C, Yang X, He M. Rates of Myopia Development in Young Chinese Schoolchildren During the Outbreak of COVID-19. JAMA Ophthalmol. 2021 Oct 1;139(10):1115-1121. doi: 10.1001/jamaophthalmol.2021.3563. Erratum In: JAMA Ophthalmol. 2021 Oct 21;:
  PMID: 34529002
  responsible party type: Sponsor
  mesh term: Myopia
  sharing ipd: No