<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/NCT01731743</url>
  </required_header>
  <id_info>
    <org_study_id>839 MP HEN 402-11</org_study_id>
    <nct_id>NCT01731743</nct_id>
  </id_info>
  <brief_title>Evaluation of Visual Acuity and Patient Satisfaction With AT LISA TRI 839MP Intraocular Lenses</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carl Zeiss Meditec AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Carl Zeiss Meditec AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the far, intermediate and near visual acuities with a&#xD;
      trifocal IOL.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After bilateral cataract surgery, monocular and binocular uncorrected (UCVA) and best&#xD;
      distance corrected visual acuity (BCVA) will be measured at far (4m), intermediate (80 cm)&#xD;
      and near (40 cm) distance as well as the subjective refraction.&#xD;
&#xD;
      A patient questionnaire will be used to assess the patient satisfaction and spectacle&#xD;
      independence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intermediate visual acuity</measure>
    <time_frame>up to 3 months postoperatively</time_frame>
    <description>Monocular and binocular uncorrected and best distance corrected</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>near and far visual acuity</measure>
    <time_frame>1 and 3 month postoperatively</time_frame>
    <description>Monocular and binocular uncorrected and best distance corrected</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient satisfaction and spectacle independence</measure>
    <time_frame>1 and 3 month postoperatively</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">107</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>implantation of a trifocal IOL (AT LISA tri 839MP)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AT LISA tri 839MP</intervention_name>
    <arm_group_label>implantation of a trifocal IOL (AT LISA tri 839MP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Man or woman, over 50 years of age&#xD;
&#xD;
          -  Bilateral implantation of a trifocal intraocular lens&#xD;
&#xD;
          -  Capsular bag implantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Existing ocular pathology&#xD;
&#xD;
          -  Surgical complications&#xD;
&#xD;
          -  Corneal astigmatism ≥ 1.0D&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Carl Zeiss Meditec AG</name>
      <address>
        <city>Berlin</city>
        <zip>10589</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>January 25, 2018</last_update_submitted>
  <last_update_submitted_qc>January 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2018</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/NCT01731743
org study id: 839 MP HEN 402-11
nct id: NCT01731743
lead sponsor: 
has dmc: No
The purpose of the study is to evaluate the far, intermediate and near visual acuities with a
      trifocal IOL.
After bilateral cataract surgery, monocular and binocular uncorrected (UCVA) and best
      distance corrected visual acuity (BCVA) will be measured at far (4m), intermediate (80 cm)
      and near (40 cm) distance as well as the subjective refraction.

      A patient questionnaire will be used to assess the patient satisfaction and spectacle
      independence.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Intermediate visual acuity
time frame: up to 3 months postoperatively
description: Monocular and binocular uncorrected and best distance corrected
measure: near and far visual acuity
time frame: 1 and 3 month postoperatively
description: Monocular and binocular uncorrected and best distance corrected
measure: Patient satisfaction and spectacle independence
time frame: 1 and 3 month postoperatively
arm group label: implantation of a trifocal IOL (AT LISA tri 839MP)
arm group type: Other
intervention type: Device
intervention name: AT LISA tri 839MP
arm group label: implantation of a trifocal IOL (AT LISA tri 839MP)
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Cataract