xml: <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/NCT06005675</url>
    </required_header>
    <id_info>
      <org_study_id>DIOL111MOLS</org_study_id>
      <nct_id>NCT06005675</nct_id>
    </id_info>
    <brief_title>User Acceptability Evaluation of Pseudophakic Patients Previously Implanted With the TECNIS Odyssey IOL</brief_title>
    <official_title>User Acceptability Evaluation of Pseudophakic Patients Previously Implanted With the TECNIS Odyssey IOL</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Johnson &amp; Johnson Surgical Vision, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Johnson &amp; Johnson Surgical Vision, Inc.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Prospective collection of data from medical records, multicenter, post-market clinical&#xD;
        follow-up study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 5, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Acuities</measure>
      <time_frame>1-month postoperative</time_frame>
      <description>Visual Acuity will be collected via observed case data in units of logMAR.</description>
    </primary_outcome>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Cataracts</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Intervention</intervention_name>
      <description>No study treatments will be administered during this study.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Bilateral pseudophakic subjects previously implanted with the TECNIS Odyssey IOL&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Previously bilaterally implanted with TECNIS Odyssey IOL, following cataract&#xD;
               extraction;&#xD;
  &#xD;
            2. Enrollment at least 21 days after second eye surgery;&#xD;
  &#xD;
            3. Clear intraocular media in each eye;&#xD;
  &#xD;
            4. Signed informed consent and data protection documentation necessary to comply with&#xD;
               applicable privacy laws pertaining to medical treatment in the governing countries;&#xD;
  &#xD;
            5. Availability, willingness, ability, and sufficient cognitive awareness to comply with&#xD;
               examination procedures;&#xD;
  &#xD;
            6. Ability to understand, read, and write in English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Concurrent participation in an interventional clinical trial during the time from&#xD;
               which the data will be collected;&#xD;
  &#xD;
            2. Use of systemic or ocular medication that may affect vision&#xD;
  &#xD;
            3. Prior corneal refractive surgery in each eye (i.e., LASIK, PRK, SMILE, RK, CK); NOTE:&#xD;
               Limbal relaxing incisions (LRI) are permissible as planned at the time of surgery&#xD;
               (intraoperatively) but not postoperatively until after completion of the study visits;&#xD;
  &#xD;
            4. Ongoing adverse events that might impact study measurements, as determined by the&#xD;
               investigator;&#xD;
  &#xD;
            5. Acute or chronic disease or condition, ocular trauma, or surgery that may confound&#xD;
               study measurements (e.g., clinically significant macular degeneration, glaucoma,&#xD;
               cystoid macular edema, proliferative diabetic retinopathy, keratoconus, etc.);&#xD;
  &#xD;
            6. Amblyopia, strabismus, nystagmus in each eye&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Johnson &amp; Johnson, Surgical Vision Inc. Clinical Trial</last_name>
      <role>Study Director</role>
      <affiliation>Johnson &amp; Johnson Surgical Vision, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Study Contact</last_name>
      <phone>714-478-1176</phone>
      <email>pnilplub@ITS.JNJ.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Empire Eye and Laser Center</name>
        <address>
          <city>Bakersfield</city>
          <state>California</state>
          <zip>93309</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Waring Vision Institute</name>
        <address>
          <city>Mount Pleasant</city>
          <state>South Carolina</state>
          <zip>29464</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Vance Thompson Vision</name>
        <address>
          <city>Sioux Falls</city>
          <state>South Dakota</state>
          <zip>57108</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 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>Yes</sharing_ipd>
      <ipd_description>Johnson &amp; Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu</ipd_description>
      <ipd_url>http://yoda.yale.edu</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06005675
  org study id: DIOL111MOLS
  nct id: NCT06005675
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  Prospective collection of data from medical records, multicenter, post-market clinical
        follow-up study.
  observational model: Cohort
  time perspective: Prospective
  measure: Visual Acuities
  time frame: 1-month postoperative
  description: Visual Acuity will be collected via observed case data in units of logMAR.
  intervention type: Device
  intervention name: Intervention
  description: No study treatments will be administered during this study.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Johnson & Johnson, Surgical Vision Inc. Clinical Trial
  role: Study Director
  affiliation: Johnson & Johnson Surgical Vision, Inc.
  last name: Study Contact
  phone: 714-478-1176
  email: pnilplub@ITS.JNJ.com
  facility: 
  facility: 
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Cataract
  sharing ipd: Yes
  ipd description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
  ipd url: http://yoda.yale.edu