<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/NCT01704014</url>
  </required_header>
  <id_info>
    <org_study_id>2010-01-034</org_study_id>
    <nct_id>NCT01704014</nct_id>
  </id_info>
  <brief_title>Intraoperative Floppy Iris Syndrome in Korean Patients Taking α1-Adrenergic Receptor Antagonists</brief_title>
  <official_title>Intraoperative Floppy Iris Syndrome in Korean Patients Taking α1-Adrenergic Receptor Antagonists</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>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intraoperative floppy iris syndrome (IFIS) is a recently described condition observed during&#xD;
      cataract surgery. It has been hypothesized that irreversible atrophy of the iris dilator&#xD;
      muscle associated with α1-adrenergic receptor antagonists (α1-ARA) is responsible for IFIS.&#xD;
      However the prevalence of IFIS in Korean population is not reported. The purpose of this&#xD;
      study is to evaluate the prevalence and clinical manifestations of IFIS in relation to iris&#xD;
      anatomical change in Korean patients taking α1-ARA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">March 2010</completion_date>
  <primary_completion_date type="Actual">March 2010</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>occurrence of intraoperative floppy iris syndrome</measure>
    <time_frame>intraoperative</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Intraoperative Floppy Iris Syndrome</condition>
  <arm_group>
    <arm_group_label>α1-ARA Group</arm_group_label>
    <description>All patients on α1-ARA(α1-adrenergic receptor antagonists) medication who underwent cataract surgeries.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>Age and sex-matched control subjects</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All korean patients who underwent cataract surgeries in Samsung Medical Center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical diagnosis of cataract&#xD;
&#xD;
          -  korean patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of iridocyclitis, iris neovascularization, or prior iris surgery&#xD;
&#xD;
          -  traumatic cataracts, zonular dialysis, or cataracts associated with ocular disease&#xD;
             (e.g., uveitis)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>October 10, 2012</last_update_submitted>
  <last_update_submitted_qc>October 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 11, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>occurrence of</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</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/NCT01704014
org study id: 2010-01-034
nct id: NCT01704014
lead sponsor: 
has dmc: Yes
Intraoperative floppy iris syndrome (IFIS) is a recently described condition observed during
      cataract surgery. It has been hypothesized that irreversible atrophy of the iris dilator
      muscle associated with α1-adrenergic receptor antagonists (α1-ARA) is responsible for IFIS.
      However the prevalence of IFIS in Korean population is not reported. The purpose of this
      study is to evaluate the prevalence and clinical manifestations of IFIS in relation to iris
      anatomical change in Korean patients taking α1-ARA.
observational model: Case-Control
time perspective: Prospective
measure: occurrence of intraoperative floppy iris syndrome
time frame: intraoperative
arm group label: α1-ARA Group
description: All patients on α1-ARA(α1-adrenergic receptor antagonists) medication who underwent cataract surgeries.
arm group label: Control Group
description: Age and sex-matched control subjects
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Syndrome