<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/NCT01664689</url>
  </required_header>
  <id_info>
    <org_study_id>OVD12</org_study_id>
    <nct_id>NCT01664689</nct_id>
  </id_info>
  <brief_title>Intraoperative and Postoperative Outcomes of Three Ophthalmic Viscosurgical Devices During Phacoemulsification</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Iladevi Cataract and IOL Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Iladevi Cataract and IOL Research Center</source>
  <brief_summary>
    <textblock>
      Ophthalmic Viscosurgical Devices (OVDs) play a crucial role during phacoemulsification, by&#xD;
      providing endothelial protection, maintaining space, as well as facilitating surgical&#xD;
      maneuvers, including IOL implantation. Equally important is the ease of use, good&#xD;
      visualisation and easy removal of the OVD from the eye. Currently, 3 popularly used OVDs as a&#xD;
      single injection sufficing for surgery are: Healon 5, DiscoVisc, and Celoftal (2%&#xD;
      hydroxypropylmethylcellulose). Whereas, there are studies showing efficacy of each of these&#xD;
      in clinical scenarios, there is no randomized trial comparing intraoperative performance and&#xD;
      postoperative outcomes. The aim of this study was to compare intraoperative performance and&#xD;
      postoperative outcomes following microcoaxial phacoemulsification when using one of the three&#xD;
      OVDs&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Corneal clarity on postoperative day 1</measure>
    <time_frame>postoperative day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Central corneal thickness on postoperative day 1 and week 1</measure>
    <time_frame>day 1 and week 1</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Intraoperative Performance and Postoperative Outcomes Following Cataract Surgery</condition>
  <arm_group>
    <arm_group_label>DiscoVisc</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>microcoaxial phacoemulsification performed with discovisc</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healon 5</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>microcoaxial phacoemulsification using healon 5</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Celoftal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>microcoaxial phacoemulsification using celoftal</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Microcoaxial Phacoemulsification</intervention_name>
    <arm_group_label>Celoftal</arm_group_label>
    <arm_group_label>DiscoVisc</arm_group_label>
    <arm_group_label>Healon 5</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age related, uncomplicated senile cataracts&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of glaucoma,&#xD;
&#xD;
          -  shallow anterior chamber (ACD &lt; 2.1mm),&#xD;
&#xD;
          -  pupillary dilatation &lt; 6mm,&#xD;
&#xD;
          -  extremely dense cataracts,&#xD;
&#xD;
          -  posterior polar cataract,&#xD;
&#xD;
          -  subluxated cataract,&#xD;
&#xD;
          -  white mature cataract,&#xD;
&#xD;
          -  diabetic retinopathy,&#xD;
&#xD;
          -  high myopia (defined as AL &gt; 25mm),&#xD;
&#xD;
          -  uveitis, or&#xD;
&#xD;
          -  previous ocular trauma/surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Iladevi Cataract &amp; IOL Research Centre</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380052</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>August 13, 2012</last_update_submitted>
  <last_update_submitted_qc>August 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 14, 2012</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>
  </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/NCT01664689
org study id: OVD12
nct id: NCT01664689
lead sponsor: 
Ophthalmic Viscosurgical Devices (OVDs) play a crucial role during phacoemulsification, by
      providing endothelial protection, maintaining space, as well as facilitating surgical
      maneuvers, including IOL implantation. Equally important is the ease of use, good
      visualisation and easy removal of the OVD from the eye. Currently, 3 popularly used OVDs as a
      single injection sufficing for surgery are: Healon 5, DiscoVisc, and Celoftal (2%
      hydroxypropylmethylcellulose). Whereas, there are studies showing efficacy of each of these
      in clinical scenarios, there is no randomized trial comparing intraoperative performance and
      postoperative outcomes. The aim of this study was to compare intraoperative performance and
      postoperative outcomes following microcoaxial phacoemulsification when using one of the three
      OVDs
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Corneal clarity on postoperative day 1
time frame: postoperative day 1
measure: Central corneal thickness on postoperative day 1 and week 1
time frame: day 1 and week 1
arm group label: DiscoVisc
arm group type: Active Comparator
description: microcoaxial phacoemulsification performed with discovisc
arm group label: Healon 5
arm group type: Active Comparator
description: microcoaxial phacoemulsification using healon 5
arm group label: Celoftal
arm group type: Active Comparator
description: microcoaxial phacoemulsification using celoftal
intervention type: Procedure
intervention name: Microcoaxial Phacoemulsification
arm group label: Celoftal
arm group label: DiscoVisc
arm group label: Healon 5
criteria: 
gender: All
minimum age: 45 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: India
responsible party type: Sponsor
mesh term: Cataract