<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/NCT03276182</url>
  </required_header>
  <id_info>
    <org_study_id>4-2015-0851</org_study_id>
    <nct_id>NCT03276182</nct_id>
  </id_info>
  <brief_title>Evaluation of Meibomian Gland Dysfunction Before and After Cataract Surgery</brief_title>
  <official_title>Evaluation of Meibomian Gland Dysfunction Before and After Cataract Surgery</official_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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare cataract patients before and after phacoemulsification. Evaluations&#xD;
      will be performed before and 1 and 3 months following cataract surgery, including parameters&#xD;
      of dry eye syndrome and MGD. Dry eye syndrome parameters included TBUT, Schirmer's test type&#xD;
      I, Oxford staining score, and the Ocular Surface Disease Index (OSDI) Questionnaire. MGD&#xD;
      parameters consisted of lipid layer thickness (LLT), lid margin abnormality, meibum quality,&#xD;
      meibum expressibility, MG orifice obstruction, MGD stage, and MG dropout.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2015</start_date>
  <completion_date type="Actual">May 31, 2016</completion_date>
  <primary_completion_date type="Actual">May 31, 2016</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the change of parameters associated with dry eye syndrome</measure>
    <time_frame>baseline and 1 month after POD(postoperative day)</time_frame>
    <description>Analysis the change of parameters associated with dry eye syndrome before and after cataract surgery measured by lipiview 2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the change of parameters associated with meibomiangland dysfunction</measure>
    <time_frame>baseline and 1 month after POD(postoperative day)</time_frame>
    <description>Analysis the change of parameters associated with meibomiangland dysfunction before and after cataract surgery measured by lipiview 2.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Cataract Patients</condition>
  <arm_group>
    <arm_group_label>cataract patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cataract patients undergoing phacoemulsification</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lipiview 2</intervention_name>
    <description>Tear film lipid layer thickness and meibomian gland dropout were measured by LipiView interferometer (TearScience Inc, Morrisville, NC)</description>
    <arm_group_label>cataract patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with cataract surgery planning with phacoemulsification and intraocular lens&#xD;
             implantation with or without mild dry eye syndrome&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the previous use of eye drops, except artificial tears within 3 months before cataract&#xD;
             surgery&#xD;
&#xD;
          -  a history of previous ocular surgery or trauma&#xD;
&#xD;
          -  the presence of ocular comorbidities such as glaucoma, uveitis, cystoid macular edema,&#xD;
             and any surgical complications including rupture of the posterior capsule during&#xD;
             cataract surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Ophthalmology, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</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>Cataract</mesh_term>
    <mesh_term>Meibomian Gland Dysfunction</mesh_term>
    <mesh_term>Capsule Opacification</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/NCT03276182
org study id: 4-2015-0851
nct id: NCT03276182
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will compare cataract patients before and after phacoemulsification. Evaluations
      will be performed before and 1 and 3 months following cataract surgery, including parameters
      of dry eye syndrome and MGD. Dry eye syndrome parameters included TBUT, Schirmer's test type
      I, Oxford staining score, and the Ocular Surface Disease Index (OSDI) Questionnaire. MGD
      parameters consisted of lipid layer thickness (LLT), lid margin abnormality, meibum quality,
      meibum expressibility, MG orifice obstruction, MGD stage, and MG dropout.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: the change of parameters associated with dry eye syndrome
time frame: baseline and 1 month after POD(postoperative day)
description: Analysis the change of parameters associated with dry eye syndrome before and after cataract surgery measured by lipiview 2.
measure: the change of parameters associated with meibomiangland dysfunction
time frame: baseline and 1 month after POD(postoperative day)
description: Analysis the change of parameters associated with meibomiangland dysfunction before and after cataract surgery measured by lipiview 2.
arm group label: cataract patients
arm group type: Experimental
description: cataract patients undergoing phacoemulsification
intervention type: Device
intervention name: Lipiview 2
description: Tear film lipid layer thickness and meibomian gland dropout were measured by LipiView interferometer (TearScience Inc, Morrisville, NC)
arm group label: cataract patients
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Cataract
mesh term: Meibomian Gland Dysfunction
mesh term: Capsule Opacification
sharing ipd: No