<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/NCT04474782</url>
  </required_header>
  <id_info>
    <org_study_id>VT-2019-01</org_study_id>
    <nct_id>NCT04474782</nct_id>
  </id_info>
  <brief_title>Analysis of Defocus Curve of Pre-Presbyopic and Emerging Presbyopic Patients</brief_title>
  <official_title>Analysis of Defocus Curve of Pre-Presbyopic and Emerging Presbyopic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vance Thompson Vision</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alcon Research</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Vance Thompson Vision</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Educating patients on visual performance with presbyopic correcting intraocular lenses is&#xD;
      crucial. Understanding the defocus curve of pre-presbyopic and emerging presbyopic&#xD;
      crystalline lens will provide eye care provides useful information to better educate patients&#xD;
      on visual performance expectations after cataract surgery with a presbyopic correcting&#xD;
      intraocular lens. Our objective will be to assess the subjective range of clear vision of a&#xD;
      pre-presbyopic and emerging presbyopic patient population utilizing a defocus curve. A&#xD;
      comparison of the pre-presbyopic and emerging presbyopic defocus curve to all FDA-approved&#xD;
      presbyopic intraocular lenses will be discussed in the manuscript.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 17, 2019</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Change in LogMar visual acuity during vision testing on ETDRS with loose lenses</measure>
    <time_frame>Screening/enrollment visit</time_frame>
  </primary_outcome>
  <enrollment type="Actual">45</enrollment>
  <condition>Presbyopia</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>There is not an intervention</intervention_name>
    <description>There is not an intervention</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A population of 30-60 subjects will be selected for testing. Subjects can be male or&#xD;
        female, ages 37-48.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Able and willing to provide written informed consent on the IRB approved Informed&#xD;
             Consent Form&#xD;
&#xD;
          2. 37-48 years of age&#xD;
&#xD;
          3. Phakic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous cataract surgery&#xD;
&#xD;
          2. Any pathology for which, in the investigator's judgement, could reduce the subjects&#xD;
             BCVA&#xD;
&#xD;
          3. Subjects that are unable to obtain 20/20 BCVA (i.e. amblyopia, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>37 Years</minimum_age>
    <maximum_age>48 Years</maximum_age>
  </eligibility>
  <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>March 2021</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>March 29, 2021</last_update_submitted>
  <last_update_submitted_qc>March 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 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>Presbyopia</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/NCT04474782
org study id: VT-2019-01
nct id: NCT04474782
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Educating patients on visual performance with presbyopic correcting intraocular lenses is
      crucial. Understanding the defocus curve of pre-presbyopic and emerging presbyopic
      crystalline lens will provide eye care provides useful information to better educate patients
      on visual performance expectations after cataract surgery with a presbyopic correcting
      intraocular lens. Our objective will be to assess the subjective range of clear vision of a
      pre-presbyopic and emerging presbyopic patient population utilizing a defocus curve. A
      comparison of the pre-presbyopic and emerging presbyopic defocus curve to all FDA-approved
      presbyopic intraocular lenses will be discussed in the manuscript.
observational model: Other
time perspective: Prospective
measure: Change in LogMar visual acuity during vision testing on ETDRS with loose lenses
time frame: Screening/enrollment visit
intervention type: Diagnostic Test
intervention name: There is not an intervention
description: There is not an intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 37 Years
maximum age: 48 Years
facility: 
country: United States
responsible party type: Sponsor
mesh term: Presbyopia
sharing ipd: No