<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/NCT02208232</url>
  </required_header>
  <id_info>
    <org_study_id>EK Nr: 1267/2012</org_study_id>
    <nct_id>NCT02208232</nct_id>
  </id_info>
  <brief_title>Observation of Rotation of an Intraocular Lens</brief_title>
  <official_title>Observation of Rotation of the MC 6125 AS Intraocular Lens</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the axial IOL rotation after surgery with an MC 6125&#xD;
      AS IOL.&#xD;
&#xD;
      At the end of surgery the orientation of the IOL is documented with a short video clip via&#xD;
      the operating microscope unit. Follow-up examinations are performed 1 hour, 1 week and 6&#xD;
      months after surgery. Rotational stability of the IOL is assessed using retroillumination&#xD;
      images with a method to avoid bias from cyclorotation or head tilt.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 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>
  <primary_outcome>
    <measure>IOL rotation</measure>
    <time_frame>6 months</time_frame>
    <description>The rotation of the IOLs over the first 6 postoperative months</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>MC 6125 AS IOL</arm_group_label>
    <description>cataract surgery with implantation of intraocular lens MC 6125 AS in one eye</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cataract surgery</intervention_name>
    <description>cataract surgery with implantation of intraocular lens</description>
    <arm_group_label>MC 6125 AS IOL</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Eyes of patients with uni- or bilateral cataract applying for cataract surgery at the&#xD;
        Department of Ophthalmology, Medical University Vienna.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Uni or bilateral age-related cataract necessitating phacoemulsification extraction and&#xD;
             posterior IOL implantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preceding ocular surgery or trauma&#xD;
&#xD;
          -  Recurrent intraocular inflammation of unknown etiology&#xD;
&#xD;
          -  Uncontrolled glaucoma&#xD;
&#xD;
          -  Uncontrolled systemic or ocular disease&#xD;
&#xD;
          -  Blind fellow eye&#xD;
&#xD;
          -  Microphthalmus&#xD;
&#xD;
          -  Corneal abnormality&#xD;
&#xD;
          -  History of uveitis/iritis&#xD;
&#xD;
          -  Iris neovascularization&#xD;
&#xD;
          -  Pseudoexfoliation&#xD;
&#xD;
          -  Proliferative diabetic retinopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Ophthalmology and Optometry of the Medical University Vienna</name>
      <address>
        <city>Vienna</city>
        <state>Viena</state>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>March 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 1, 2014</last_update_submitted>
  <last_update_submitted_qc>August 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Rupert Menapace</investigator_full_name>
    <investigator_title>Ao.Univ.-Prof. Dr.med.univ.</investigator_title>
  </responsible_party>
  <keyword>IOL rotation</keyword>
  <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/NCT02208232
org study id: EK Nr: 1267/2012
nct id: NCT02208232
lead sponsor: 
The purpose of this study is to assess the axial IOL rotation after surgery with an MC 6125
      AS IOL.

      At the end of surgery the orientation of the IOL is documented with a short video clip via
      the operating microscope unit. Follow-up examinations are performed 1 hour, 1 week and 6
      months after surgery. Rotational stability of the IOL is assessed using retroillumination
      images with a method to avoid bias from cyclorotation or head tilt.
measure: IOL rotation
time frame: 6 months
description: The rotation of the IOLs over the first 6 postoperative months
arm group label: MC 6125 AS IOL
description: cataract surgery with implantation of intraocular lens MC 6125 AS in one eye
intervention type: Procedure
intervention name: cataract surgery
description: cataract surgery with implantation of intraocular lens
arm group label: MC 6125 AS IOL
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Rupert Menapace
investigator title: Ao.Univ.-Prof. Dr.med.univ.
mesh term: Cataract