<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/NCT01693939</url>
  </required_header>
  <id_info>
    <org_study_id>FT-FS200-001</org_study_id>
    <nct_id>NCT01693939</nct_id>
  </id_info>
  <brief_title>Evaluation of the Post-LASIK Flap Thickness of the FS200 Femtosecond Laser Flap</brief_title>
  <official_title>A Single Center Prospective Evaluation of the Post-LASIK Flap Thickness of the FS200 Femtosecond Laser Flap</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Durrie Vision</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alcon Research</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Durrie Vision</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to document the programmed flap thickness to achieved flap&#xD;
      thickness using the FS200 femtosecond laser in performing LASIK procedure. The FS200&#xD;
      Femtosecond laser is a precision surgical device that is used to create a flap in a FDA&#xD;
      approved LASIK procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to evaluate the thickness of the corneal flap created with the&#xD;
      FS 200 Femtosecond laser flap during the LASIK procedure using the Visante and OptiVue OCT&#xD;
      ultrasound devices.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">April 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Flap Thickness</measure>
    <time_frame>1 Week Postoperative visit</time_frame>
    <description>The flap thickness will be measured one week postoperative using the Visante OCT and the Optivue OCT devices</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Uncorrected Visual Acuity at 1 Day, 1 Week, and 1 Month Postoperatively</measure>
    <time_frame>Postoperatively 1 month</time_frame>
    <description>Change in Uncorrected visual acuity will be measured at 1 Day, 1 week, and 1 month postoperatively</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Postoperative Satisfaction Survey over Time</measure>
    <time_frame>Postoperatively Day 1, Week 1, Month 1</time_frame>
    <description>Subject questionnaire will be administered to evaluate overall patient satisfaction postoperatively</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>FS200 Femtosecond Laser</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The LASIK flap will be created using the FS200 Femtosecond Laser</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FS200 Femtosecond Laser</intervention_name>
    <arm_group_label>FS200 Femtosecond Laser</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA&#xD;
&#xD;
        The following are requirements for a potential study patient's inclusion into the study:&#xD;
&#xD;
          -  Male or female in good general health, 18 years of age or older at the time of the&#xD;
             pre-operative examination&#xD;
&#xD;
          -  Patient must be able to read, comprehend and willing to give HIPPA and informed&#xD;
             consent&#xD;
&#xD;
          -  Patient is planning to undergo a bilateral LASIK procedure&#xD;
&#xD;
          -  Both eyes must have a manifest refractive error from -1.00 to -7.00D spherical&#xD;
             equivalent with less than or equal to 3.00 D of refractive astigmatism as expressed in&#xD;
             spectacle minus cylinder form&#xD;
&#xD;
          -  Both eyes must have a BSCVA of 20/25 or better&#xD;
&#xD;
          -  Both eyes must demonstrate refractive stability confirmed by clinical records or&#xD;
             previous glasses. Refractive stability shall be documented by a change of less than or&#xD;
             equal to 0.50 diopter per year (sphere and cylinder) or as documented by clinical&#xD;
             judgment by the investigator.&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
        The following are exclusion criteria for study patients in this study:&#xD;
&#xD;
          -  A patient with evidence of keratoconus, corneal irregularity, or abnormal&#xD;
             videokeratography in either eye&#xD;
&#xD;
          -  A patient requiring the use of any ocular drop(s) and/or medication(s) in either eye&#xD;
             during the study period with the exception of ocular drops and/or medications provided&#xD;
             by the investigator&#xD;
&#xD;
          -  A patient having any surgical procedure within a week preceding the scheduled LASIK&#xD;
             surgery&#xD;
&#xD;
          -  A patient with any UNCONTROLLED systemic disease (i.e., a potential patient in whom&#xD;
             therapy for a systemic disease is not yet stabilized )&#xD;
&#xD;
          -  A patient with a history of prior intraocular or corneal surgery (including cataract&#xD;
             extraction), clinically significant ophthalmic disease or abnormality (including, but&#xD;
             not limited to, uncontrolled clinically significant blepharitis, clinically&#xD;
             significant recurrent corneal erosion, clinically significant dry eye syndrome,&#xD;
             clinically significant lens opacity, evidence of clinically significant trauma&#xD;
             (including scarring inside the visual axis), or evidence of glaucoma or propensity for&#xD;
             narrow angle glaucoma in either eye&#xD;
&#xD;
          -  A patient with a significant history or current evidence of a medical, psychological&#xD;
             or other disorder that, in the investigator's opinion, may increase the risk&#xD;
             associated with study participation or may interfere with the interpretation of study&#xD;
             results&#xD;
&#xD;
          -  A patient with a history of any of the following medical conditions, or any other&#xD;
             condition that could affect wound healing: uncontrolled diabetes, collagen vascular&#xD;
             disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or&#xD;
             simplex, endocrine disorders (including, but not limited to unstable thyroid disorders&#xD;
             and diabetes), lupus, and rheumatoid arthritis&#xD;
&#xD;
          -  A female patient who is pregnant, nursing, planning a pregnancy during the study, or&#xD;
             thinks she may be pregnant at the start of the study&#xD;
&#xD;
          -  Current participation or participation within 30 days prior to the start of this study&#xD;
             in a drug or other investigational device research study.&#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>
  <overall_official>
    <last_name>Daniel S. Durrie, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Durrie Vision</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Durrie Vision</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>January 24, 2013</last_update_submitted>
  <last_update_submitted_qc>January 24, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lasik</keyword>
  <keyword>Myopia</keyword>
  <keyword>Femtosecond Laser</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>February 19, 2015</submitted>
    <returned>March 4, 2015</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/NCT01693939
org study id: FT-FS200-001
nct id: NCT01693939
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to document the programmed flap thickness to achieved flap
      thickness using the FS200 femtosecond laser in performing LASIK procedure. The FS200
      Femtosecond laser is a precision surgical device that is used to create a flap in a FDA
      approved LASIK procedure.
The objective of this study is to evaluate the thickness of the corneal flap created with the
      FS 200 Femtosecond laser flap during the LASIK procedure using the Visante and OptiVue OCT
      ultrasound devices.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Flap Thickness
time frame: 1 Week Postoperative visit
description: The flap thickness will be measured one week postoperative using the Visante OCT and the Optivue OCT devices
measure: Change in Uncorrected Visual Acuity at 1 Day, 1 Week, and 1 Month Postoperatively
time frame: Postoperatively 1 month
description: Change in Uncorrected visual acuity will be measured at 1 Day, 1 week, and 1 month postoperatively
measure: Postoperative Satisfaction Survey over Time
time frame: Postoperatively Day 1, Week 1, Month 1
description: Subject questionnaire will be administered to evaluate overall patient satisfaction postoperatively
arm group label: FS200 Femtosecond Laser
arm group type: Other
description: The LASIK flap will be created using the FS200 Femtosecond Laser
intervention type: Device
intervention name: FS200 Femtosecond Laser
arm group label: FS200 Femtosecond Laser
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel S. Durrie, MD
role: Principal Investigator
affiliation: Durrie Vision
facility: 
country: United States
responsible party type: Sponsor
mesh term: Myopia
submitted: February 19, 2015
returned: March 4, 2015