<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/NCT03021629</url>
  </required_header>
  <id_info>
    <org_study_id>tjykdxykyy6</org_study_id>
    <nct_id>NCT03021629</nct_id>
  </id_info>
  <brief_title>Comparison of Vitamin D Status and Vitamin D Receptor Polymorphisms in Patients With High Myopia and Primary Open-angle Glaucoma</brief_title>
  <official_title>Comparison of Vitamin D Status and Vitamin D Receptor Polymorphisms in Patients With High Myopia and Primary Open-angle Glaucoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lv Yingjuan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin Medical University Eye Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vitamin D deficiency is known to be significantly associated with high myopia. This study&#xD;
      investigated the vitamin D status in patients with high myopia and primary open-angle&#xD;
      glaucoma, in order to understand the relationship between high myopia and the development of&#xD;
      primary open-angle glaucoma.110 primary open-angle glaucoma patients, 110 high myopia&#xD;
      patients and 110 age-matched people in the Han population were enrolled. Serum levels of 1a,&#xD;
      25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay.Vitamin D&#xD;
      receptor polymorphic analysis was studied by polymerase chain reaction-restriction fragment&#xD;
      length polymorphism technique.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Serum levels of 1a, 25-Dihydroxyvitamin D3</measure>
    <time_frame>1 day visit</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>gene polymorphisms of vitamin D receptor</measure>
    <time_frame>1 day visit</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">500</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <condition>Primary Open-angle Glaucoma</condition>
  <condition>High Myopia</condition>
  <condition>Vitamin D Receptor Polymorphisms</condition>
  <arm_group>
    <arm_group_label>primary open-angle glaucoma patients</arm_group_label>
    <description>Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high myopia patients</arm_group_label>
    <description>Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay</description>
  </arm_group>
  <arm_group>
    <arm_group_label>age-matched people</arm_group_label>
    <description>Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay</intervention_name>
    <arm_group_label>age-matched people</arm_group_label>
    <arm_group_label>high myopia patients</arm_group_label>
    <arm_group_label>primary open-angle glaucoma patients</arm_group_label>
    <other_name>Vitamin D receptor polymorphic analysis was studied by polymerase chain reaction-restriction fragment length polymorphism technique</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        primary open-angle glaucoma patients, high myopia patients and age-matched people in the&#xD;
        Han population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -primary open-angle glaucoma (1) intraocular pressure above 21 mmHg or more in each eye&#xD;
        without therapy; (2) wide anterior chamber angle; (3)glaucomatous optic neuropathy&#xD;
        (Glaucomatous optic nerve damage was defined as cup-to-disc ratio higher than 0.7 or focal&#xD;
        loss of the nerve fiber layer (notch) associated with a consistent glaucomatous visual&#xD;
        field defect in at least one eye;(4) visual field loss consistent with optic nerve damage&#xD;
        and visual fields were performed by using standard automated perimetry in at least one eye.&#xD;
&#xD;
        c(with refractive error &gt;6D) were recruited.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the presence of any secondary glaucoma with an exfoliation syndrome or a history of&#xD;
             ocular trauma, high myopia, macular degeneration, other ocular diseases, and also a&#xD;
             known history of systemic diseases and administration of vitamin D3 or other analog.&#xD;
&#xD;
        High myopia patients with ocular disease such as glaucoma, a history of administration of&#xD;
        vitamin D3 or other analog or a history of retinopathy or connective tissue disorders&#xD;
        associated with myopia, such as Stickler or Marfan syndromes, were not included.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tianjin Medical University Eye Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300384</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>July 13, 2017</last_update_submitted>
  <last_update_submitted_qc>July 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Tianjin Medical University Eye Hospital</investigator_affiliation>
    <investigator_full_name>Lv Yingjuan</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Myopia</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
    <mesh_term>Vitamin D Deficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Dihydroxycholecalciferols</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03021629
org study id: tjykdxykyy6
nct id: NCT03021629
lead sponsor: 
has dmc: Yes
Vitamin D deficiency is known to be significantly associated with high myopia. This study
      investigated the vitamin D status in patients with high myopia and primary open-angle
      glaucoma, in order to understand the relationship between high myopia and the development of
      primary open-angle glaucoma.110 primary open-angle glaucoma patients, 110 high myopia
      patients and 110 age-matched people in the Han population were enrolled. Serum levels of 1a,
      25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay.Vitamin D
      receptor polymorphic analysis was studied by polymerase chain reaction-restriction fragment
      length polymorphism technique.
observational model: Case-Control
time perspective: Prospective
measure: Serum levels of 1a, 25-Dihydroxyvitamin D3
time frame: 1 day visit
measure: gene polymorphisms of vitamin D receptor
time frame: 1 day visit
arm group label: primary open-angle glaucoma patients
description: Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay
arm group label: high myopia patients
description: Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay
arm group label: age-matched people
description: Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay
intervention type: Other
intervention name: Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay
arm group label: age-matched people
arm group label: high myopia patients
arm group label: primary open-angle glaucoma patients
other name: Vitamin D receptor polymorphic analysis was studied by polymerase chain reaction-restriction fragment length polymorphism technique
blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 55 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Tianjin Medical University Eye Hospital
investigator full name: Lv Yingjuan
investigator title: Director
mesh term: Glaucoma
mesh term: Myopia
mesh term: Glaucoma, Open-Angle
mesh term: Vitamin D Deficiency
mesh term: Vitamin D
mesh term: Dihydroxycholecalciferols