<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/NCT02990689</url>
  </required_header>
  <id_info>
    <org_study_id>LISA tri 839MP HEN 301-11</org_study_id>
    <nct_id>NCT02990689</nct_id>
  </id_info>
  <brief_title>Clinical Study to Evaluate the Visual Performance of Three Multifocal IOLs</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 this study is to compare the performances of 2 bifocal IOLs and 1 trifocal IOL&#xD;
      for far, near and intermediate vision.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intermediate visual acuity</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distance visual acuity</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Near visual acuity</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Visual Acuity</condition>
  <arm_group>
    <arm_group_label>809M</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>bifocal intraocular lens (IOL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>839MP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>trifocal intraocular lens (IOL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SN6AD1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>bifocal intraocular lens (IOL)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Trifocal Intraocular Lens</intervention_name>
    <description>bifocal intraocular lens (IOL)</description>
    <arm_group_label>839MP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bifocal Intraocular Lens</intervention_name>
    <description>trifocal intraocular lens (IOL)</description>
    <arm_group_label>809M</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Low Addition Bifocal Intraocular Lens</intervention_name>
    <description>low near addition intraocular lens (IOL)</description>
    <arm_group_label>SN6AD1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of any gender, aged 50 to 80 years&#xD;
&#xD;
          -  Signed informed consent form&#xD;
&#xD;
          -  Healthy eyes besides cataract&#xD;
&#xD;
          -  Assured follow-up examinations&#xD;
&#xD;
          -  Stable corneal conditions within the last 12 months&#xD;
&#xD;
          -  Corneal astigmatism less than 1D&#xD;
&#xD;
          -  Implantation into the capsular bag by injector&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or&#xD;
             retinal disorders)&#xD;
&#xD;
          -  Pseudophakia&#xD;
&#xD;
          -  Cornea guttata; keratoplasty&#xD;
&#xD;
          -  Irregular astigmatism (e.g. Keratoconus)&#xD;
&#xD;
          -  Corneal scarring&#xD;
&#xD;
          -  Diabetic retinopathy&#xD;
&#xD;
          -  Aniridia&#xD;
&#xD;
          -  Amblyopia&#xD;
&#xD;
          -  Amotio operation; anamnesis with vitreous surgery&#xD;
&#xD;
          -  Pseudoexfoliation Syndrome; Uveitis&#xD;
&#xD;
          -  Previous intraocular and corneal surgery&#xD;
&#xD;
          -  Intraocular tumours; endotamponade&#xD;
&#xD;
          -  Glaucoma or IOP higher than 24mmHg&#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;
          -  Need for a dioptre out of the range of +16.0D to +26.0D&#xD;
&#xD;
          -  Inability to achieve secure lens placement in the capsular bag&#xD;
&#xD;
          -  Any other pathology or condition presenting, according to the investigator opinion, a&#xD;
             risk for the patient&#xD;
&#xD;
          -  Intraoperative complications, damaged posterior bag, intraocular haemorrhage, can&#xD;
             opener rhexis&#xD;
&#xD;
          -  Pregnancy or lactation period for female patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>September 4, 2018</last_update_submitted>
  <last_update_submitted_qc>September 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02990689
org study id: LISA tri 839MP HEN 301-11
nct id: NCT02990689
lead sponsor: 
has dmc: No
The purpose of this study is to compare the performances of 2 bifocal IOLs and 1 trifocal IOL
      for far, near and intermediate vision.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Intermediate visual acuity
time frame: 12 months
measure: Distance visual acuity
time frame: 12 months
measure: Near visual acuity
time frame: 12 months
arm group label: 809M
arm group type: Active Comparator
description: bifocal intraocular lens (IOL)
arm group label: 839MP
arm group type: Active Comparator
description: trifocal intraocular lens (IOL)
arm group label: SN6AD1
arm group type: Active Comparator
description: bifocal intraocular lens (IOL)
intervention type: Device
intervention name: Trifocal Intraocular Lens
description: bifocal intraocular lens (IOL)
arm group label: 839MP
intervention type: Device
intervention name: Bifocal Intraocular Lens
description: trifocal intraocular lens (IOL)
arm group label: 809M
intervention type: Device
intervention name: Low Addition Bifocal Intraocular Lens
description: low near addition intraocular lens (IOL)
arm group label: SN6AD1
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor