<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/NCT03824028</url>
  </required_header>
  <id_info>
    <org_study_id>ILM171-P001</org_study_id>
    <nct_id>NCT03824028</nct_id>
  </id_info>
  <brief_title>Post-Market Clinical Survey of Clareon® IOL AutonoMe™ in Japanese Subjects</brief_title>
  <official_title>Post-Market Clinical Survey of Clareon® IOL With the AutonoMe™ Automated Preloaded Delivery System With Japanese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alcon Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alcon Research</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>
      This purpose of this survey study is to collect and describe clinical outcomes for the&#xD;
      intraocular lens (IOL) delivery performance of Clareon® IOL AutonoMe™ when used in daily&#xD;
      practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will enroll subjects who underwent prior cataract surgery with phacoemulsification&#xD;
      and were implanted with Clareon intraocular lenses (IOLs) using the Clareon® IOL AutonoMe™&#xD;
      automated preloaded delivery system. Subjects will be enrolled post-operatively and followed&#xD;
      for one year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2019</start_date>
  <completion_date type="Actual">October 20, 2020</completion_date>
  <primary_completion_date type="Actual">October 20, 2020</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>Best-corrected distance visual acuity</measure>
    <time_frame>Up to Year 1 postoperative</time_frame>
    <description>Visual acuity will be collected under well-lit conditions at a distance of five meters using a decimal visual acuity chart.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intraocular lens (IOL) delivery performance</measure>
    <time_frame>Surgery day (retrospective)</time_frame>
    <description>A questionnaire will be used to retrospectively evaluate the usability of AutonoME™. The investigator will respond to 8 questions pertaining to the IOL delivery performance using a 5-point scale where 1 = very good/strongly agree and 5 = very poor/strongly disagree.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference between target refraction and postoperative subjective refraction (spherical equivalent)</measure>
    <time_frame>Up to Year 1 postoperative</time_frame>
    <description>Visual acuity will be collected under well-lit conditions at a distance of five meters using a decimal visual acuity chart. Subjective refraction at best corrected distance vision will be recorded and compared with target refraction determined on day of surgery.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">384</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Clareon IOL AutonoMe</arm_group_label>
    <description>Prior implantation with Clareon intraocular lenses (IOLs) using the Clareon® IOL AutonoMe™ automated preloaded delivery system</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Clareon® IOL AutonoMe™ automated preloaded delivery system</intervention_name>
    <description>Disposable injector preloaded with the Clareon IOL for precise IOL insertion during cataract surgery</description>
    <arm_group_label>Clareon IOL AutonoMe</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be enrolled at approximately 20 investigative sites located in Japan.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to comprehend and willing to sign informed consent.&#xD;
&#xD;
          -  Prior diagnosis of age-related cataracts.&#xD;
&#xD;
          -  Prior cataract surgery with implantation of Clareon IOL in the capsular bag by&#xD;
             AutonoMe™.&#xD;
&#xD;
          -  No ophthalmic disease which might affect visual acuity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alcon Research</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Japan, Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>220-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Yokkaichi</city>
        <state>Mie</state>
        <zip>510-0085</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Hashimoto</city>
        <state>Wakayama</state>
        <zip>648-0073</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>March 9, 2021</last_update_submitted>
  <last_update_submitted_qc>March 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cataract surgery</keyword>
  <keyword>Intraocular lens</keyword>
  <keyword>IOL</keyword>
  <keyword>Clareon</keyword>
  <keyword>AutonoMe</keyword>
  <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/NCT03824028
org study id: ILM171-P001
nct id: NCT03824028
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This purpose of this survey study is to collect and describe clinical outcomes for the
      intraocular lens (IOL) delivery performance of Clareon® IOL AutonoMe™ when used in daily
      practice.
This study will enroll subjects who underwent prior cataract surgery with phacoemulsification
      and were implanted with Clareon intraocular lenses (IOLs) using the Clareon® IOL AutonoMe™
      automated preloaded delivery system. Subjects will be enrolled post-operatively and followed
      for one year.
observational model: Cohort
time perspective: Prospective
measure: Best-corrected distance visual acuity
time frame: Up to Year 1 postoperative
description: Visual acuity will be collected under well-lit conditions at a distance of five meters using a decimal visual acuity chart.
measure: Intraocular lens (IOL) delivery performance
time frame: Surgery day (retrospective)
description: A questionnaire will be used to retrospectively evaluate the usability of AutonoME™. The investigator will respond to 8 questions pertaining to the IOL delivery performance using a 5-point scale where 1 = very good/strongly agree and 5 = very poor/strongly disagree.
measure: Difference between target refraction and postoperative subjective refraction (spherical equivalent)
time frame: Up to Year 1 postoperative
description: Visual acuity will be collected under well-lit conditions at a distance of five meters using a decimal visual acuity chart. Subjective refraction at best corrected distance vision will be recorded and compared with target refraction determined on day of surgery.
arm group label: Clareon IOL AutonoMe
description: Prior implantation with Clareon intraocular lenses (IOLs) using the Clareon® IOL AutonoMe™ automated preloaded delivery system
intervention type: Device
intervention name: Clareon® IOL AutonoMe™ automated preloaded delivery system
description: Disposable injector preloaded with the Clareon IOL for precise IOL insertion during cataract surgery
arm group label: Clareon IOL AutonoMe
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Alcon Research
role: Study Director
affiliation: Alcon Japan, Ltd.
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Cataract
sharing ipd: No