<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/NCT02985723</url>
  </required_header>
  <id_info>
    <org_study_id>2012-A01671-42</org_study_id>
    <nct_id>NCT02985723</nct_id>
  </id_info>
  <brief_title>Visual Outcome, Cylinder Correction and Patient Satisfaction After Implantation of AT LISA Tri Toric 939MP Intraocular Lenses</brief_title>
  <acronym>VICTORI</acronym>
  <official_title>Prospective Study to Evaluate the Visual Outcome, Cylinder Correction and Patient Satisfaction After Implantation of AT LISA Tri Toric 939MP Intraocular Lenses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carl Zeiss Meditec AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Carl Zeiss Meditec AG</source>
  <brief_summary>
    <textblock>
      The aim of the present study is to evaluate the postoperative visual acuity for distance,&#xD;
      intermediate and near vision as well as the cylinder correction and the patient satisfaction&#xD;
      after bilateral implantation of AT LISA tri toric 939MP IOLs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Best distance-corrected visual acuity for intermediate vision after bilateral implantation</measure>
    <time_frame>12 months after surgery</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>939MP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AT LISA tri toric 939MP intraocular lens</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AT LISA tri toric 939MP</intervention_name>
    <arm_group_label>939MP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient informed of the consequences and constraints of the protocol and who has given&#xD;
             his/her written informed consent&#xD;
&#xD;
          -  Man or woman, over 50 years of age&#xD;
&#xD;
          -  Healthy eyes with bilateral cataract requiring surgical treatment for both eyes&#xD;
&#xD;
          -  Bilateral regular corneal astigmatism (confirmed by topography measurement)&#xD;
&#xD;
          -  Only patients requiring intraocular lenses of a power comprised between sphere +0.0&#xD;
             and +28.0 dioptres and between a cylindrical range of +1.0 to +4.0D in both eyes will&#xD;
             be able to participate in the trial.&#xD;
&#xD;
          -  Biometry measurement/cataract density compatible with the IOLMaster evaluation&#xD;
&#xD;
          -  Bilateral uncomplicated cataract surgery and implantation into capsular bag by&#xD;
             injector&#xD;
&#xD;
          -  Assured follow-up examinations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to meet the limitations of the protocol or likely of non cooperation&#xD;
             during the trial,&#xD;
&#xD;
          -  Patients whose freedom is impaired by administrative or legal order,&#xD;
&#xD;
          -  Monophtalmic patient.&#xD;
&#xD;
          -  Previous ocular surgery, including corneal/refractive surgery,&#xD;
&#xD;
          -  Chronic or recurrent uveitis,&#xD;
&#xD;
          -  Acute ocular disease or external/internal infection,&#xD;
&#xD;
          -  Any kind of macular degeneration and impairment of retina (clinical diagnosis/OCT&#xD;
             examination)&#xD;
&#xD;
          -  Diabetes with retinal changes,&#xD;
&#xD;
          -  Pseudoexfoliation syndrome&#xD;
&#xD;
          -  Pathologic myosis&#xD;
&#xD;
          -  Irregular astigmatism, especially keratoconus,&#xD;
&#xD;
          -  Endothelial corneal dystrophy&#xD;
&#xD;
          -  Glaucoma or IOP higher than 21mmHg under ocular hypertension treatment&#xD;
&#xD;
          -  Aniridia&#xD;
&#xD;
          -  Pseudophakia&#xD;
&#xD;
          -  Cornea guttata; keratoplasty&#xD;
&#xD;
          -  Amotio operation; anamnesis with vitreous surgery&#xD;
&#xD;
          -  Amblyopia&#xD;
&#xD;
          -  Intraocular tumours; endotamponade&#xD;
&#xD;
          -  Phlogistic intraocular processes or other pre-existing processes that permanently&#xD;
             limit the best corrected visual acuity to &gt; 0.3 logMAR&#xD;
&#xD;
          -  Any other pathology or condition presenting, according to the investigator opinion, a&#xD;
             risk for the patient&#xD;
&#xD;
          -  Pupil diameter over 6 mm in mesopic condition&#xD;
&#xD;
          -  Corneal opacity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Piovella, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CMA - Centro Microchirurgia Ambulatoriale</affiliation>
  </overall_official>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</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/NCT02985723
org study id: 2012-A01671-42
nct id: NCT02985723
lead sponsor: 
The aim of the present study is to evaluate the postoperative visual acuity for distance,
      intermediate and near vision as well as the cylinder correction and the patient satisfaction
      after bilateral implantation of AT LISA tri toric 939MP IOLs.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Best distance-corrected visual acuity for intermediate vision after bilateral implantation
time frame: 12 months after surgery
arm group label: 939MP
arm group type: Experimental
description: AT LISA tri toric 939MP intraocular lens
intervention type: Device
intervention name: AT LISA tri toric 939MP
arm group label: 939MP
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Piovella, Dr
role: Principal Investigator
affiliation: CMA - Centro Microchirurgia Ambulatoriale
responsible party type: Sponsor
mesh term: Cataract