<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/NCT01675375</url>
  </required_header>
  <id_info>
    <org_study_id>CS 004</org_study_id>
    <nct_id>NCT01675375</nct_id>
  </id_info>
  <brief_title>Laser Vision Correction Use of an Eye Shield for Maintaining Vision and Mitigating Pain</brief_title>
  <official_title>Laser Vision Correction Use of an Eye Shield for Maintaining Vision and Mitigating Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>FORSIGHT Vision3</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>FORSIGHT Vision3</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to determine if an investigational thin shield can&#xD;
      effectively reduce discomfort following Laser Vision Correction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evidence of maintaining vision and mitigating pain post Laser Vision Correction using an Eye Shield</measure>
    <time_frame>1yr</time_frame>
    <description>Evidence of maintaining vision and mitigating pain post Laser Vision Correction using an Eye Shield by subjective patient questionnaires and objective imaging and slit lamp examination.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Post Laser Vision Correction Pain and Discomfort</condition>
  <arm_group>
    <arm_group_label>Eye shield</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eye shield place on post Laser Vision Correction eye</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Eye Shield</intervention_name>
    <description>one application following refractive surgery</description>
    <arm_group_label>Eye shield</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled to undergo Laser Vision Correction for correction of refractive&#xD;
             error&#xD;
&#xD;
          -  FDA approved treatment guidelines for Laser Vision Correction&#xD;
&#xD;
          -  Age 18-60&#xD;
&#xD;
          -  Patients able to understand the requirements of the study, willing to follow study&#xD;
             instructions, provide written informed consent to participate, and comply with all&#xD;
             study requirements, including the required study follow-up visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any other anterior segment abnormality other than that associated with LAser Vision&#xD;
             Correction&#xD;
&#xD;
          -  Any abnormalities associated with the eye lids&#xD;
&#xD;
          -  Uncontrolled blepharitis or dry eye&#xD;
&#xD;
          -  Prior laser treatment of the retina&#xD;
&#xD;
          -  Any ophthalmic surgery performed within three (3) months prior to study excluding PRK&#xD;
             or LASIK&#xD;
&#xD;
          -  Diagnosis of glaucoma&#xD;
&#xD;
          -  Active diabetic retinopathy&#xD;
&#xD;
          -  Clinically significant inflammation or infection within six (6) months prior to study&#xD;
&#xD;
          -  Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of&#xD;
             the Investigator&#xD;
&#xD;
          -  Participation in any study involving an investigational drug within the past 30&#xD;
             calendar days, or ongoing participation in a study with an investigational material&#xD;
&#xD;
          -  Intolerance or hypersensitivity to topical anesthetics, antibiotics, steroids or any&#xD;
             other pharmaceuticals that may be used pre and post surgically&#xD;
&#xD;
          -  Specifically known intolerance or hypersensitivity to contact lenses or any component&#xD;
             of the investigative material&#xD;
&#xD;
          -  A medical condition, serious concurrent illness, or extenuating circumstance that&#xD;
             would significantly decrease study compliance, including all prescribed follow-up&#xD;
&#xD;
          -  Any condition that, in the opinion of the investigator, would jeopardize the safety of&#xD;
             the patient&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ClearView Eye and Laser</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kraff Eye Institute</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Talamo Laser Eye Consultants</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02451</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physicians Protocol</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vance Thompson Vision</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>February 1, 2013</last_update_submitted>
  <last_update_submitted_qc>February 1, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 5, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01675375
org study id: CS 004
nct id: NCT01675375
lead sponsor: 
has dmc: Yes
The purpose of this research is to determine if an investigational thin shield can
      effectively reduce discomfort following Laser Vision Correction.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Evidence of maintaining vision and mitigating pain post Laser Vision Correction using an Eye Shield
time frame: 1yr
description: Evidence of maintaining vision and mitigating pain post Laser Vision Correction using an Eye Shield by subjective patient questionnaires and objective imaging and slit lamp examination.
arm group label: Eye shield
arm group type: Experimental
description: Eye shield place on post Laser Vision Correction eye
intervention type: Device
intervention name: Eye Shield
description: one application following refractive surgery
arm group label: Eye shield
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor