<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/NCT04457999</url>
  </required_header>
  <id_info>
    <org_study_id>2019-03-011</org_study_id>
    <nct_id>NCT04457999</nct_id>
  </id_info>
  <brief_title>Clinical Outcome of Lipiflow Treatment Prior to Cataract Surgery in Dry Eye Patients</brief_title>
  <official_title>Clinical Outcome of Lipiflow Treatment Prior to Cataract Surgery in Dry Eye Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</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>
      To investigate the clinical outcome of Lipiflow treatment prior to cataract surgery in&#xD;
      patients with meibomian gland dysfunction and dry eye disease&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 20, 2020</start_date>
  <completion_date type="Anticipated">July 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 2, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>improvement of dry eye symptom</measure>
    <time_frame>1 month</time_frame>
    <description>ocular dryness</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Dry Eye</condition>
  <arm_group>
    <arm_group_label>Lipiflow treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lipiflow thermal pulsation prior to cataract surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lipiflow Thermal pulsation</intervention_name>
    <description>Single vectored thermal pulsation treatment for dry eye</description>
    <arm_group_label>Lipiflow treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 21, who will get catarct surgeyr&#xD;
&#xD;
          -  Patients whose visual acuity anticipated better than 20/25 after surgery&#xD;
&#xD;
          -  Patients with informed consent&#xD;
&#xD;
          -  Patients with meibomian gland dysfunction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ocular injury, active injection&#xD;
&#xD;
          -  uncontrolled systemic disease&#xD;
&#xD;
          -  Contact lens wear within 1 month&#xD;
&#xD;
          -  Allergic to fluorescein sodium or topical anesthetics&#xD;
&#xD;
          -  ocular surgery or trauma within 6 months&#xD;
&#xD;
          -  disorder of lid anatomy&#xD;
&#xD;
          -  other reason for decreased vision other than cataract&#xD;
&#xD;
          -  anticipated visual acuity less than 20/25&#xD;
&#xD;
          -  Patients less than 20 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Tae-Young Chung, MD. PhD</last_name>
    <phone>82-2-3410-3563</phone>
    <email>tychung@skku.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tae-Young Chung</last_name>
      <phone>+82-10-9933-3563</phone>
      <email>tychung@skku.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>tae-young chung</investigator_full_name>
    <investigator_title>M.D. Ph.D</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</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/NCT04457999
org study id: 2019-03-011
nct id: NCT04457999
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To investigate the clinical outcome of Lipiflow treatment prior to cataract surgery in
      patients with meibomian gland dysfunction and dry eye disease
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: improvement of dry eye symptom
time frame: 1 month
description: ocular dryness
arm group label: Lipiflow treatment
arm group type: Experimental
description: Lipiflow thermal pulsation prior to cataract surgery
intervention type: Device
intervention name: Lipiflow Thermal pulsation
description: Single vectored thermal pulsation treatment for dry eye
arm group label: Lipiflow treatment
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tae-Young Chung, MD. PhD
phone: 82-2-3410-3563
email: tychung@skku.edu
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: tae-young chung
investigator title: M.D. Ph.D
mesh term: Cataract
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
sharing ipd: No