<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/NCT04495049</url>
  </required_header>
  <id_info>
    <org_study_id>1911 Vivity ALC57290333</org_study_id>
    <nct_id>NCT04495049</nct_id>
  </id_info>
  <brief_title>Vivity Insight: A Study of Patient Satisfaction and Visual Performance</brief_title>
  <official_title>Vivity Insight: A Study of Patient Satisfaction and Visual Performance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Research Insight LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Research Insight LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a single arm, open-label, prospective study of patient-reported outcomes of&#xD;
      patients with bilateral implantation of the Vivity or Vivity Toric implant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Existing diffractive extended depth of focus (EDOF) lenses provide two adjacent &quot;zones&quot; of&#xD;
      uncorrected vision (distance and intermediate or intermediate and near) but have a track&#xD;
      record of frequent patient dissatisfaction because of unwanted visual side effects, &quot;spider&#xD;
      webs&quot; or haloes. The Vivity non-diffractive EDOF lens offers this same range ofvision with&#xD;
      contrast sensitivity similar to a monofocal lens, which suggests fewer side effects will be&#xD;
      encountered in clinical practice.&#xD;
&#xD;
      This study is designed to measure postoperative patient-reported outcomes with this new lens&#xD;
      implant. Previous studies we have conducted on the bilateral ReSTOR 3.0, ReSTOR with&#xD;
      ActiveFocus 2.5 (mixed with 3.0 and alone with mini-monovision) have shown high satisfaction,&#xD;
      spectacle independence, and acceptable glare and halo profiles using a validated&#xD;
      questionnaire instrument developed by MDbackline, Inc. The postoperative portions of this&#xD;
      study will be designed to mirror those previous studies using the same instrument.&#xD;
&#xD;
      All subjects will receive the Vivity or Vivity Toric implant binocularly with a target of&#xD;
      plano sphere.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients reporting &quot;not at all&quot; or &quot;just a little&quot; when asked, &quot;With or without glasses, how much do you notice glare or haloes around lights in dim light situations?&quot;</measure>
    <time_frame>8/1/2020 - 7/1/2021</time_frame>
    <description>Percentage of patients reporting &quot;not at all&quot; or &quot;just a little&quot; when asked, &quot;With or without glasses, how much do you notice glare or haloes around lights in dim light situations?&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of postoperative patients who report &quot;rarely&quot; when asked &quot;How often do you need glasses to see the computer?&quot;</measure>
    <time_frame>8/1/2020 - 7/1/2021</time_frame>
    <description>Percentage of postoperative patients who report &quot;rarely&quot; when asked &quot;How often do you need glasses to see the computer?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of postoperative patients who report that they do not require reading glasses for various activities</measure>
    <time_frame>8/1/2020 - 7/1/2021</time_frame>
    <description>Percentage of postoperative patients who report that they do not require reading glasses for various activities (driving, reading, including fine print, seeing computer monitor, watching TV, sports/hobbies when asked &quot;For what types of activities do you need glasses to see (other than sunglasses)?&quot;</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Percentage of patients reporting &quot;very satisfied&quot; when asked, &quot;Overall, how satisfied are you with your vision after your latest surgery?&quot;</measure>
    <time_frame>8/1/2020 - 7/1/2021</time_frame>
    <description>Percentage of patients reporting &quot;very satisfied&quot; when asked, &quot;Overall, how satisfied are you with your vision after your latest surgery?&quot;</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of patients who report &quot;very satisfied&quot; or &quot;satisfied&quot; to the same question.</measure>
    <time_frame>8/1/2020 - 7/1/2021</time_frame>
    <description>Percentage of patients who report &quot;very satisfied&quot; or &quot;satisfied&quot; to the same question.</description>
  </other_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>Cataract</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Alcon Vivity or Vivity Toric IOL</intervention_name>
    <description>Patients who previously underwent cataract surgery with the Alcon Vivity or Vivity Toric IOL in both eyes.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients undergoing cataract surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with cataract and otherwise healthy eyes, not exhibiting any significant&#xD;
             ocular morbidity that would be expected to influence outcome measures.&#xD;
&#xD;
          -  Patients implanted with Vivity or Vivity Toric lenses bilaterally within 6 months of&#xD;
             the survey administration.&#xD;
&#xD;
          -  Patients whose postoperative manifest refraction at the time of the survey is within ±&#xD;
             0.5 D sphere and ≤0.75 D of cylindrical refraction.&#xD;
&#xD;
          -  Patients who have given consent to participate in the survey.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with visually significant co-morbidities (corneal, retina, optic nerve&#xD;
             disease) that could affect their satisfaction with surgery.&#xD;
&#xD;
          -  Patients with surgical complications either during or after surgery (capsule tears,&#xD;
             iris trauma, decentered IOL, cystoid macular edema, etc.) that would, the judgement of&#xD;
             the investigator, influence the outcome measures of the study.&#xD;
&#xD;
          -  Patients with previous refractive surgery within the past 6 months prior to cataract&#xD;
             surgery.&#xD;
&#xD;
          -  Patients with &gt; grade 1 posterior capsule opacity at their last visit.&#xD;
&#xD;
          -  Patients who do not meet the refractive endpoints described in the Inclusion Criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Harvard Eye Associates</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quentin Allen</name>
      <address>
        <city>Palm City</city>
        <state>Florida</state>
        <zip>34990</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quantum Vision Center</name>
      <address>
        <city>Edwardsville</city>
        <state>Illinois</state>
        <zip>62025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>June 2, 2021</last_update_submitted>
  <last_update_submitted_qc>June 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2021</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>
  <!-- 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/NCT04495049
org study id: 1911 Vivity ALC57290333
nct id: NCT04495049
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This will be a single arm, open-label, prospective study of patient-reported outcomes of
      patients with bilateral implantation of the Vivity or Vivity Toric implant.
Existing diffractive extended depth of focus (EDOF) lenses provide two adjacent "zones" of
      uncorrected vision (distance and intermediate or intermediate and near) but have a track
      record of frequent patient dissatisfaction because of unwanted visual side effects, "spider
      webs" or haloes. The Vivity non-diffractive EDOF lens offers this same range ofvision with
      contrast sensitivity similar to a monofocal lens, which suggests fewer side effects will be
      encountered in clinical practice.

      This study is designed to measure postoperative patient-reported outcomes with this new lens
      implant. Previous studies we have conducted on the bilateral ReSTOR 3.0, ReSTOR with
      ActiveFocus 2.5 (mixed with 3.0 and alone with mini-monovision) have shown high satisfaction,
      spectacle independence, and acceptable glare and halo profiles using a validated
      questionnaire instrument developed by MDbackline, Inc. The postoperative portions of this
      study will be designed to mirror those previous studies using the same instrument.

      All subjects will receive the Vivity or Vivity Toric implant binocularly with a target of
      plano sphere.
observational model: Case-Only
time perspective: Prospective
measure: Percentage of patients reporting "not at all" or "just a little" when asked, "With or without glasses, how much do you notice glare or haloes around lights in dim light situations?"
time frame: 8/1/2020 - 7/1/2021
description: Percentage of patients reporting "not at all" or "just a little" when asked, "With or without glasses, how much do you notice glare or haloes around lights in dim light situations?"
measure: Percentage of postoperative patients who report "rarely" when asked "How often do you need glasses to see the computer?"
time frame: 8/1/2020 - 7/1/2021
description: Percentage of postoperative patients who report "rarely" when asked "How often do you need glasses to see the computer?"
measure: Percentage of postoperative patients who report that they do not require reading glasses for various activities
time frame: 8/1/2020 - 7/1/2021
description: Percentage of postoperative patients who report that they do not require reading glasses for various activities (driving, reading, including fine print, seeing computer monitor, watching TV, sports/hobbies when asked "For what types of activities do you need glasses to see (other than sunglasses)?"
measure: Percentage of patients reporting "very satisfied" when asked, "Overall, how satisfied are you with your vision after your latest surgery?"
time frame: 8/1/2020 - 7/1/2021
description: Percentage of patients reporting "very satisfied" when asked, "Overall, how satisfied are you with your vision after your latest surgery?"
measure: Percentage of patients who report "very satisfied" or "satisfied" to the same question.
time frame: 8/1/2020 - 7/1/2021
description: Percentage of patients who report "very satisfied" or "satisfied" to the same question.
intervention type: Device
intervention name: Alcon Vivity or Vivity Toric IOL
description: Patients who previously underwent cataract surgery with the Alcon Vivity or Vivity Toric IOL in both eyes.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cataract