<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/NCT01692665</url>
  </required_header>
  <id_info>
    <org_study_id>1-2012-0031</org_study_id>
    <nct_id>NCT01692665</nct_id>
  </id_info>
  <brief_title>Changes of Keratometric Value and Ocular Aberration After Treatment of Meibomian Gland Dysfunction</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>
      Ocular aberration may play a role in determining optical quality. Recently performed study&#xD;
      reported that ocular aberration of preocular tear film would be important factor in not only&#xD;
      diagnosing the dry eye but also determining the efficacy of treatment. Therefore, in this&#xD;
      study, the investigators will aim to prove the improvement of quality of vision via ocular&#xD;
      aberration changes indirectly after the proper treatment for moderate and severe meibomian&#xD;
      gland dysfunction. Also, the investigators will evaluate the changes of keratometric values&#xD;
      after treatment for moderate and severe meibomian gland dysfunction, which could be&#xD;
      demonstrated by autokeratometry, IOLMaster, Pentacam, and iTrace.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of keratometric value and ocular aberration</measure>
    <time_frame>a minimum of four minutes, once or twice dailybefore treatment, after 1 month, and after 2 months of treatment</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Moderate and Severe Meibomiang Gland Dysfunction (Stage 3 or Stage 4 Meibomiang Gland Dysfunction)</condition>
  <arm_group>
    <arm_group_label>stage 3 or stage 4 meibomiang gland dysfunction patients</arm_group_label>
    <description>stage 3 or stage 4 meibomiang gland dysfunction patients</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        stage 3 or stage 4 meibomiang gland dysfunction patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (1) stage 3 or 4 meibomian gland dysfunction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. history of previous ocular or intraocular surgery&#xD;
&#xD;
          2. ocular infection, non dry eye ocular inflammation, ocular allergy, autoimmune disease,&#xD;
&#xD;
          3. history of intolerance or hypersensitivity to any component of the study medications,&#xD;
&#xD;
          4. wearing contact lenses during the study period, presence of current punctal occlusion,&#xD;
&#xD;
          5. pregnancy, lactating women, and children.&#xD;
&#xD;
          6. Additionally, patients were excluded if they were using any topical ocular or systemic&#xD;
             medication that could be used for the treatment MGD or dry eye, including topical or&#xD;
             oral antibiotics, topical cyclosporine A, topical or oral steroids, topical&#xD;
             non-steroidal anti-inflammatory drugs, topical ocular allergy medications or&#xD;
             artificial tears&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <removed_countries>
    <country>Korea, Republic of</country>
  </removed_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>September 16, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>February 17, 2014</last_update_submitted>
  <last_update_submitted_qc>February 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>meibomian gland dysfunction</keyword>
  <keyword>keratometric value</keyword>
  <keyword>ocular aberration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meibomian Gland Dysfunction</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/NCT01692665
org study id: 1-2012-0031
nct id: NCT01692665
lead sponsor: 
has dmc: No
Ocular aberration may play a role in determining optical quality. Recently performed study
      reported that ocular aberration of preocular tear film would be important factor in not only
      diagnosing the dry eye but also determining the efficacy of treatment. Therefore, in this
      study, the investigators will aim to prove the improvement of quality of vision via ocular
      aberration changes indirectly after the proper treatment for moderate and severe meibomian
      gland dysfunction. Also, the investigators will evaluate the changes of keratometric values
      after treatment for moderate and severe meibomian gland dysfunction, which could be
      demonstrated by autokeratometry, IOLMaster, Pentacam, and iTrace.
observational model: Case-Only
time perspective: Prospective
measure: Changes of keratometric value and ocular aberration
time frame: a minimum of four minutes, once or twice dailybefore treatment, after 1 month, and after 2 months of treatment
arm group label: stage 3 or stage 4 meibomiang gland dysfunction patients
description: stage 3 or stage 4 meibomiang gland dysfunction patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Meibomian Gland Dysfunction