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/NCT05991960</url>
    </required_header>
    <id_info>
      <org_study_id>DIOL112MRWD</org_study_id>
      <nct_id>NCT05991960</nct_id>
    </id_info>
    <brief_title>Evaluation of Real-World Data on the Performance of the TECNIS Odyssey™ IOL</brief_title>
    <official_title>Evaluation of Real-World Data on the Performance of 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>
        Retrospective 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">August 14, 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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Acuity</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>
    <primary_outcome>
      <measure>Manifest Refraction</measure>
      <time_frame>1-month postoperative</time_frame>
      <description>Manifest Refraction will be collected via observed case data in units of diopters.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Visual Symptoms/Complaints</measure>
      <time_frame>1-month postoperative</time_frame>
      <description>Visual Symptoms/Complaints will be measured using a questionnaire on a 5-point scale.</description>
    </primary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Cataracts</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Intervention</intervention_name>
      <description>No study treatments will be administered during this retrospective study. However, data will be collected from medical records of patients who have been treated with the subject device of this study.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Pseudophakic patients previously bilaterally implanted with 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 consent and data protection documentation necessary to comply with applicable&#xD;
               privacy laws pertaining to medical treatment in the governing countries.&#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 within the retrospective analysis window;&#xD;
  &#xD;
            4. Ongoing adverse events in each eye that might impact outcomes during the study visit&#xD;
               as determined by the investigator;&#xD;
  &#xD;
            5. Acute or chronic disease or condition, ocular trauma or surgery that may affect vision&#xD;
               in each eye (e.g., clinically significant macular degeneration, glaucoma, cystoid&#xD;
               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>+1-714-478-1176</phone>
      <email>pnilplub@ITS.JNJ.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Assil Eye Institute</name>
        <address>
          <city>Beverly Hills</city>
          <state>California</state>
          <zip>90210</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The Eye Institute of West Florida</name>
        <address>
          <city>Largo</city>
          <state>Florida</state>
          <zip>33770</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Center for Sight</name>
        <address>
          <city>Sarasota</city>
          <state>Florida</state>
          <zip>34239</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Aloha Vision Consultants</name>
        <address>
          <city>Honolulu</city>
          <state>Hawaii</state>
          <zip>96816</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>OCLI Vision</name>
        <address>
          <city>Garden City</city>
          <state>New York</state>
          <zip>11530</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Vance Thompson Vision</name>
        <address>
          <city>W. Fargo</city>
          <state>North Dakota</state>
          <zip>58078</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Cleveland Eye Clinic</name>
        <address>
          <city>Brecksville</city>
          <state>Ohio</state>
          <zip>44141</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Carolina EyeCare Physicians</name>
        <address>
          <city>Mount Pleasant</city>
          <state>South Carolina</state>
          <zip>29464</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Loden Vision Centers</name>
        <address>
          <city>Goodlettsville</city>
          <state>Tennessee</state>
          <zip>37072</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Dell Laser Consultants</name>
        <address>
          <city>Austin</city>
          <state>Texas</state>
          <zip>78746</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Whitsett Vision Group</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77055</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Virginia Eye Consultants</name>
        <address>
          <city>Norfolk</city>
          <state>Virginia</state>
          <zip>23502</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 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/NCT05991960
  org study id: DIOL112MRWD
  nct id: NCT05991960
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  Retrospective collection of data from medical records, multicenter, post-market clinical
        follow-up study.
  observational model: Cohort
  time perspective: Retrospective
  measure: Visual Acuity
  time frame: 1-month postoperative
  description: Visual Acuity will be collected via observed case data in units of logMAR.
  measure: Manifest Refraction
  time frame: 1-month postoperative
  description: Manifest Refraction will be collected via observed case data in units of diopters.
  measure: Visual Symptoms/Complaints
  time frame: 1-month postoperative
  description: Visual Symptoms/Complaints will be measured using a questionnaire on a 5-point scale.
  intervention type: Device
  intervention name: Intervention
  description: No study treatments will be administered during this retrospective study. However, data will be collected from medical records of patients who have been treated with the subject device of 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: +1-714-478-1176
  email: pnilplub@ITS.JNJ.com
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  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