<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/NCT04487795</url>
  </required_header>
  <id_info>
    <org_study_id>SSOCT-lens tilt</org_study_id>
    <nct_id>NCT04487795</nct_id>
  </id_info>
  <brief_title>Age-related Changes of Crystalline Lens Tilt and Decentration: A Swept-source Optical Coherence Tomography Study</brief_title>
  <official_title>Age-related Changes of Crystalline Lens Tilt and Decentration: A Swept-source Optical Coherence Tomography Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yune Zhao</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wenzhou Medical 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>
      230 participants at Eye Hospital of Wenzhou Medical University during June, 2019 and August,&#xD;
      2019 were enrolled in this study. 230 right eyes and 88 left eyes were included for the&#xD;
      measurement. All the measurements were performed under non-mydriatic conditions in a dim&#xD;
      examination room using the CASIA2 swept-source AS-OCT system.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2020</start_date>
  <completion_date type="Actual">May 17, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>crystalline lens tilt</measure>
    <time_frame>2020.4.30</time_frame>
    <description>magnitude and direction of crystalline lens lilt</description>
  </primary_outcome>
  <primary_outcome>
    <measure>crystalline lens decentration</measure>
    <time_frame>2020.4.30</time_frame>
    <description>magnitude and direction of crystalline lens decentration</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">230</enrollment>
  <condition>Crystalline Cataract</condition>
  <condition>Lens; Anomaly</condition>
  <arm_group>
    <arm_group_label>under 18 years old</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>18-40 years old</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>41-60 years old</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>over 60 years old</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy volunteers and patients with age-related cataract at Eye hospital of Wenzhou&#xD;
        Medical University&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria：&#xD;
&#xD;
          -  healthy volunteers and patients with age-related cataract&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  aphakia or pseudophakia&#xD;
&#xD;
          -  any other ocular diseases with the exception of senile cataract&#xD;
&#xD;
          -  any history of ocular surgery&#xD;
&#xD;
          -  fixation difficulties caused by any reasons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ophthalmology and Optometry Hospital</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325027</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Wenzhou Medical University</investigator_affiliation>
    <investigator_full_name>Yune Zhao</investigator_full_name>
    <investigator_title>Vice president of Eye Hospital of Wenzhou Medical University</investigator_title>
  </responsible_party>
  <keyword>crystalline lens tilt</keyword>
  <keyword>crystalline lens decentration</keyword>
  <keyword>swept-source optical coherence tomography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
  </condition_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/NCT04487795
org study id: SSOCT-lens tilt
nct id: NCT04487795
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
230 participants at Eye Hospital of Wenzhou Medical University during June, 2019 and August,
      2019 were enrolled in this study. 230 right eyes and 88 left eyes were included for the
      measurement. All the measurements were performed under non-mydriatic conditions in a dim
      examination room using the CASIA2 swept-source AS-OCT system.
observational model: Case-Only
time perspective: Retrospective
measure: crystalline lens tilt
time frame: 2020.4.30
description: magnitude and direction of crystalline lens lilt
measure: crystalline lens decentration
time frame: 2020.4.30
description: magnitude and direction of crystalline lens decentration
arm group label: under 18 years old
arm group label: 18-40 years old
arm group label: 41-60 years old
arm group label: over 60 years old
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Wenzhou Medical University
investigator full name: Yune Zhao
investigator title: Vice president of Eye Hospital of Wenzhou Medical University
mesh term: Cataract