<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/NCT03839420</url>
  </required_header>
  <id_info>
    <org_study_id>929MP BER-401-18</org_study_id>
    <nct_id>NCT03839420</nct_id>
  </id_info>
  <brief_title>To Compare Early Rotation of Two Extended Depth of Focus Intraocular Lenses</brief_title>
  <acronym>VENUStoric</acronym>
  <official_title>Prospective Randomized Clinical Trial Comparing Early Rotation of Two Extended Depth of Focus 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>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To demonstrate that the Carl Zeiss Meditec (CZM) Extended depth of focus (EDOF) Intraocular&#xD;
      lens (IOL) is superior to the competitor EDOF IOL with respect to Rotational Stability.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 8, 2019</start_date>
  <completion_date type="Actual">February 17, 2021</completion_date>
  <primary_completion_date type="Actual">October 4, 2020</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>
    <intervention_model_description>comparative randomized trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IOL axis</measure>
    <time_frame>Immediately after the surgery</time_frame>
    <description>IOL axis will be analyzed based on images.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>CZM IOL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Competitor IOL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CZM IOL</intervention_name>
    <description>implantation of CZM IOL</description>
    <arm_group_label>CZM IOL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Competitor IOL</intervention_name>
    <description>implantation of Competitor IOL</description>
    <arm_group_label>Competitor IOL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient informed of the consequences and constraints of the Clinical Investigational&#xD;
             Plan and who has given his/her written informed consent&#xD;
&#xD;
          2. Patients of any gender, aged 18 or older&#xD;
&#xD;
          3. Assured follow-up examinations&#xD;
&#xD;
          4. Healthy eyes with clinically significant age related cataract requiring surgical&#xD;
             treatment&#xD;
&#xD;
          5. Corrected distance visual acuity projected to be better than 0.2 logMAR after the&#xD;
             cataract surgery, as determined by Investigator's medical judgment&#xD;
&#xD;
          6. Uni- and/or bilaterally regular corneal astigmatism ≥ 1.0 D and ≤ 3.0 D (confirmed by&#xD;
             topography measurement)&#xD;
&#xD;
        8. Cataract density compatible with biometry measurement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients unable to meet the limitations of the Clinical Investigational Plan or likely&#xD;
             of non-cooperation during the trial&#xD;
&#xD;
          2. Patients whose freedom is impaired by administrative or legal order&#xD;
&#xD;
          3. Current participation in another drug or device investigation that affects patients&#xD;
             vision&#xD;
&#xD;
          4. Ocular disorders, other than cataract, that could potentially cause future acuity loss&#xD;
&#xD;
          5. Have atonic pupil or physiologically small pupil (unable to dilate to at least 5 mm)&#xD;
&#xD;
          6. Any anterior segment pathology that could significantly affect outcomes (e.g. chronic&#xD;
             or recurrent uveitis, iritis, aniridia, rubeosis iridis, etc.)&#xD;
&#xD;
          7. Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal&#xD;
             degeneration, or irregular astigmatism, clinically significant corneal membrane&#xD;
             dystrophies)&#xD;
&#xD;
          8. Any condition in the study eye that could affect IOL stability (e.g. zonular dialysis,&#xD;
             evident zonular weakness or dehiscence, Floppy iris syndrome etc.)&#xD;
&#xD;
          9. History of any clinically significant retinal pathology or ocular diagnosis (e.g.&#xD;
             diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment,&#xD;
             optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmus,&#xD;
             epiretinal membrane, Choroidal hemorrhage etc.) in the study eyes that could alter or&#xD;
             limit final postoperative visual prognosis&#xD;
&#xD;
         10. Pseudoexfoliation syndrome (according to investigator decision)&#xD;
&#xD;
         11. Pathologic miosis or Pharmacotherapy with miotic agent&#xD;
&#xD;
         12. Irregular astigmatism / Keratoconus&#xD;
&#xD;
         13. Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment.&#xD;
&#xD;
         14. All kind of infections (acute ocular disease, external / internal infection, systemic&#xD;
             infection)&#xD;
&#xD;
         15. Traumatic cataract&#xD;
&#xD;
         16. Monophthalmic patient&#xD;
&#xD;
         17. Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus&#xD;
&#xD;
         18. Patient expected to require retinal laser treatment before the end of the last&#xD;
             follow-up examination&#xD;
&#xD;
         19. Patient expected to require refractive laser treatment / refractive laser touch-up&#xD;
             before the end of the last follow-up examination&#xD;
&#xD;
         20. Previous intraocular and corneal / refractive surgery&#xD;
&#xD;
         21. Current Systemic or ocular pharmacotherapy that effects patients vision (according to&#xD;
             investigator decision)&#xD;
&#xD;
         22. Dementia&#xD;
&#xD;
         23. Previous use of cytotoxic drugs or total body irradiation within last 2 years&#xD;
&#xD;
         24. Any other pathology or condition presenting, according to the investigator opinion, a&#xD;
             risk for the patient&#xD;
&#xD;
         25. Pregnancy and / or lactation period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universitätsklinikum Freiburg</name>
      <address>
        <city>Freiburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03839420
org study id: 929MP BER-401-18
nct id: NCT03839420
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To demonstrate that the Carl Zeiss Meditec (CZM) Extended depth of focus (EDOF) Intraocular
      lens (IOL) is superior to the competitor EDOF IOL with respect to Rotational Stability.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: comparative randomized trial
primary purpose: Treatment
masking: None (Open Label)
measure: IOL axis
time frame: Immediately after the surgery
description: IOL axis will be analyzed based on images.
arm group label: CZM IOL
arm group type: Experimental
arm group label: Competitor IOL
arm group type: Active Comparator
intervention type: Device
intervention name: CZM IOL
description: implantation of CZM IOL
arm group label: CZM IOL
intervention type: Device
intervention name: Competitor IOL
description: implantation of Competitor IOL
arm group label: Competitor IOL
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Cataract
sharing ipd: No