<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/NCT02194543</url>
  </required_header>
  <id_info>
    <org_study_id>1-2014-0002</org_study_id>
    <nct_id>NCT02194543</nct_id>
  </id_info>
  <brief_title>High-Definition 3D Visualization System for Ophthalmic Surgery</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To validate a high-definition (HD) three-dimensional (3D) visualization system in cataract&#xD;
      surgery&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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>the best corrected visual acuity</measure>
    <time_frame>1 month after the operation</time_frame>
    <description>operation time, total phacoemulsification time, and postoperative visual outcome</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>HD 3D</arm_group_label>
    <description>The patients received surgeries with HD 3D on their left eyes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional</arm_group_label>
    <description>The patients received surgeries with conventional method on the other eye.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Cataract&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patients are scheduled to cataract surgery on both eyes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patients who have other complicating ophthalmic diseases or previous history of&#xD;
             ophthalmic surgeries were excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Ophthalmology, Severance Hospital, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>July 16, 2014</last_update_submitted>
  <last_update_submitted_qc>July 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cataract</keyword>
  <keyword>HD 3D</keyword>
  <keyword>Microscope</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/NCT02194543
org study id: 1-2014-0002
nct id: NCT02194543
lead sponsor: 
has dmc: No
To validate a high-definition (HD) three-dimensional (3D) visualization system in cataract
      surgery
observational model: Case-Control
time perspective: Prospective
measure: the best corrected visual acuity
time frame: 1 month after the operation
description: operation time, total phacoemulsification time, and postoperative visual outcome
arm group label: HD 3D
description: The patients received surgeries with HD 3D on their left eyes.
arm group label: Conventional
description: The patients received surgeries with conventional method on the other eye.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Cataract