<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/NCT03811249</url>
  </required_header>
  <id_info>
    <org_study_id>VIS-2014-5YR</org_study_id>
    <nct_id>NCT03811249</nct_id>
  </id_info>
  <brief_title>Long Term Follow-up of the VisAbility™ Micro Insert System for Presbyopic Patients</brief_title>
  <official_title>A Prospective, Multicenter Clinical Trial of the VisAbility™ Micro Insert System for the Improvement of Near Visual Acuity in Presbyopic Subjects - Long Term Follow-up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Refocus Group, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Refocus Group, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to obtain an additional 36 months of safety and effectiveness&#xD;
      data from all subjects who were implanted with the VisAbility™ Micro Insert in the VIS-2014&#xD;
      clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      VIS-2014-5YR is a multicenter, observational study to evaluate the long-term safety of the&#xD;
      VisAbility™ Micro Inserts in subjects who were implanted with the VisAbility™ Micro Insert in&#xD;
      the VIS-2014 clinical trial. Study subjects will be examined at 36, 48, and 60 months&#xD;
      post-operatively (based on the anniversary of their first VisAbility™ surgery) with no&#xD;
      planned interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">July 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>A non-randomized single group design. All subjects who were implanted with the VisAbility™ Micro Insert (360 subjects) will be invited to participate. Actual sample size will be determined at the completion of enrollment.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary safety measure - Partial explantation</measure>
    <time_frame>From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.</time_frame>
    <description>Partial explantation (1-3 Micro inserts per eye) or complete explantation (4 Micro inserts per eye) and reason(s). Safety measure will be recorded if the event occurs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary safety measure - Anterior Segment Ischemia</measure>
    <time_frame>From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.</time_frame>
    <description>Anterior Segment Ischemia (Grades 2 - 4). Safety measure will be recorded if the event occurs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary safety measure - Segment exposure.</measure>
    <time_frame>From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.</time_frame>
    <description>Segment exposure due to conjunctival and/or scleral erosion. Safety measure will be recorded if the event occurs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary safety measure - Serious Adverse Events</measure>
    <time_frame>From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.</time_frame>
    <description>Rate of Serious Adverse Events (SAE's). Safety measure will be recorded if the event occurs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary safety measure - Best Corrected Distance Visual Acuity (BCDVA)</measure>
    <time_frame>From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.</time_frame>
    <description>Best Corrected Distance Visual Acuity (BCDVA) will be measured and recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary safety measure - Intraocular Pressure (IOP)</measure>
    <time_frame>From date of enrollment until the date of study withdrawal or study completion, whichever came first, assessed up to 60 months post-surgery.</time_frame>
    <description>IOP increase &gt; 10 mm Hg over baseline or IOP &gt; 30 mm Hg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary safety measure - Slit Lamp</measure>
    <time_frame>From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.</time_frame>
    <description>Slit Lamp findings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary safety measure - Fundus Exam</measure>
    <time_frame>From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.</time_frame>
    <description>Fundus exam findings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary safety measure - Adverse Events</measure>
    <time_frame>From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.</time_frame>
    <description>Rate of Adverse Events (AE's)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary effectiveness measure - Uncorrected and Distance Corrected Near Visual Acuity</measure>
    <time_frame>From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.</time_frame>
    <description>Change in uncorrected and distance corrected near visual acuity and letters correct in the primary eye of bilaterally implanted subjects (with all eight implants in place), as compared to baseline (VIS-2014).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">360</enrollment>
  <condition>Presbyopia</condition>
  <arm_group>
    <arm_group_label>Implantation-Non-randomized</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects that previously participated in the VIS-2014 clinical trial that had VisAbility™ Micro Inserts surgically implanted in the eye(s) will be followed prospectively for an additional 36 month period to measure long term safety and effectiveness outcomes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VisAbility™ Micro Insert</intervention_name>
    <description>No (new) intervention will be administered during the course of this long term follow-up study. Subjects that previously participated in the VIS-2014 clinical trial that had VisAbility™ Micro Inserts surgically implanted in the eye(s) will be followed prospectively.</description>
    <arm_group_label>Implantation-Non-randomized</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who were implanted with the VisAbility™ Micro Insert in Protocol VIS-2014&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  N/A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>47 Years</minimum_age>
    <maximum_age>62 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Schanzlin, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chief Medical Officer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Coastal Vision</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gordon Schanzlin New Vision Institute</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aloha Laser Vision</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Midwest Center for Sight</name>
      <address>
        <city>Des Plaines</city>
        <state>Illinois</state>
        <zip>60016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Surgeons Of Indiana PC</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Care Institute</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Vision Institute</name>
      <address>
        <city>Bloomington</city>
        <state>Minnesota</state>
        <zip>55420</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Shore Eye Care LLP</name>
      <address>
        <city>Wantagh</city>
        <state>New York</state>
        <zip>11793</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physicians Protocol</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive EyeCare of Central Ohio</name>
      <address>
        <city>Westerville</city>
        <state>Ohio</state>
        <zip>43082</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bucci Laser Vision</name>
      <address>
        <city>Wilkes-Barre</city>
        <state>Pennsylvania</state>
        <zip>18702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Key Whitman Eye Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Braverman-Terry-Oei-Eye Associates</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.refocus-group.com</url>
    <description>Sponsor Website</description>
  </link>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>October 15, 2019</last_update_submitted>
  <last_update_submitted_qc>October 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Near Vision</keyword>
  <keyword>Reading Vision</keyword>
  <keyword>Reading Glasses</keyword>
  <keyword>Reading</keyword>
  <keyword>Readers</keyword>
  <keyword>Presbyopic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Presbyopia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>October 24, 2022</submitted>
    <returned>November 21, 2022</returned>
    <submitted>July 12, 2023</submitted>
    <returned>August 2, 2023</returned>
  </pending_results>
  <!-- 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/NCT03811249
org study id: VIS-2014-5YR
nct id: NCT03811249
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
The objective of this study is to obtain an additional 36 months of safety and effectiveness
      data from all subjects who were implanted with the VisAbility™ Micro Insert in the VIS-2014
      clinical trial.
VIS-2014-5YR is a multicenter, observational study to evaluate the long-term safety of the
      VisAbility™ Micro Inserts in subjects who were implanted with the VisAbility™ Micro Insert in
      the VIS-2014 clinical trial. Study subjects will be examined at 36, 48, and 60 months
      post-operatively (based on the anniversary of their first VisAbility™ surgery) with no
      planned interventions.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A non-randomized single group design. All subjects who were implanted with the VisAbility™ Micro Insert (360 subjects) will be invited to participate. Actual sample size will be determined at the completion of enrollment.
primary purpose: Treatment
masking: None (Open Label)
measure: Primary safety measure - Partial explantation
time frame: From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.
description: Partial explantation (1-3 Micro inserts per eye) or complete explantation (4 Micro inserts per eye) and reason(s). Safety measure will be recorded if the event occurs.
measure: Primary safety measure - Anterior Segment Ischemia
time frame: From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.
description: Anterior Segment Ischemia (Grades 2 - 4). Safety measure will be recorded if the event occurs.
measure: Primary safety measure - Segment exposure.
time frame: From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.
description: Segment exposure due to conjunctival and/or scleral erosion. Safety measure will be recorded if the event occurs.
measure: Primary safety measure - Serious Adverse Events
time frame: From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.
description: Rate of Serious Adverse Events (SAE's). Safety measure will be recorded if the event occurs.
measure: Secondary safety measure - Best Corrected Distance Visual Acuity (BCDVA)
time frame: From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.
description: Best Corrected Distance Visual Acuity (BCDVA) will be measured and recorded.
measure: Secondary safety measure - Intraocular Pressure (IOP)
time frame: From date of enrollment until the date of study withdrawal or study completion, whichever came first, assessed up to 60 months post-surgery.
description: IOP increase > 10 mm Hg over baseline or IOP > 30 mm Hg
measure: Secondary safety measure - Slit Lamp
time frame: From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.
description: Slit Lamp findings
measure: Secondary safety measure - Fundus Exam
time frame: From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.
description: Fundus exam findings
measure: Secondary safety measure - Adverse Events
time frame: From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.
description: Rate of Adverse Events (AE's)
measure: Secondary effectiveness measure - Uncorrected and Distance Corrected Near Visual Acuity
time frame: From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.
description: Change in uncorrected and distance corrected near visual acuity and letters correct in the primary eye of bilaterally implanted subjects (with all eight implants in place), as compared to baseline (VIS-2014).
arm group label: Implantation-Non-randomized
arm group type: Experimental
description: Subjects that previously participated in the VIS-2014 clinical trial that had VisAbility™ Micro Inserts surgically implanted in the eye(s) will be followed prospectively for an additional 36 month period to measure long term safety and effectiveness outcomes.
intervention type: Device
intervention name: VisAbility™ Micro Insert
description: No (new) intervention will be administered during the course of this long term follow-up study. Subjects that previously participated in the VIS-2014 clinical trial that had VisAbility™ Micro Inserts surgically implanted in the eye(s) will be followed prospectively.
arm group label: Implantation-Non-randomized
criteria: 
gender: All
minimum age: 47 Years
maximum age: 62 Years
healthy volunteers: No
last name: David Schanzlin, Dr
role: Principal Investigator
affiliation: Chief Medical Officer
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.refocus-group.com
description: Sponsor Website
responsible party type: Sponsor
mesh term: Presbyopia
sharing ipd: No
submitted: October 24, 2022
returned: November 21, 2022
submitted: July 12, 2023
returned: August 2, 2023