<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/NCT03292419</url>
  </required_header>
  <id_info>
    <org_study_id>43306</org_study_id>
    <nct_id>NCT03292419</nct_id>
  </id_info>
  <brief_title>Topography-guided LASIK Surgery</brief_title>
  <official_title>A Prospective Evaluation of Topography-guided LASIK Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</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>
      The investigators are analyzing outcomes of topography-guided LASIK surgery in participants&#xD;
      with myopia and myopic astigmatism&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators are analyzing outcomes of topography-guided LASIK surgery in participants&#xD;
      with myopia and myopic astigmatism. The investigators will be monitoring changes in anterior&#xD;
      segment optical coherence tomography epithelial thickness maps. The investigators will&#xD;
      compare preoperative maps to postoperative maps at one, three, six and twelve months. In&#xD;
      addition, the investigators will measure changes in epithelial maps from postoperative month&#xD;
      through twelve months to help understand what is happening to the corneal epithelium to try&#xD;
      to explain why UDVA and CDVA improves over time&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">March 31, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 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>Topography guided</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>N0ne</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Epithelial thickness maps</measure>
    <time_frame>12 months</time_frame>
    <description>Changes in anterior segment optical coherence tomography epithelial thickness maps.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in corrected visual acuity</measure>
    <time_frame>12 months</time_frame>
    <description>Corrected distance visual acuity (CDVA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uncorrected distance visual acuity</measure>
    <time_frame>12 months</time_frame>
    <description>Uncorrected distance visual acuity (UDVA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Vision</measure>
    <time_frame>12 months</time_frame>
    <description>Patient reported outcomes questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Predictability</measure>
    <time_frame>12 months</time_frame>
    <description>Percentage of eyes within +/-0.25, 0.50 and 1.00 diopter of the intended correction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contrast visual acuity</measure>
    <time_frame>12 months</time_frame>
    <description>5 and 25% ETDRS contrast acuity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual astigmatism levels after surgery</measure>
    <time_frame>12 months</time_frame>
    <description>Vector analysis of astigmatic outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in refraction over time</measure>
    <time_frame>12 months</time_frame>
    <description>Change in spherical equivalent over time</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>Topography guided LASI</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Topography-guided LASIK</intervention_name>
    <description>LASIK surgery</description>
    <arm_group_label>Topography guided LASI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects age 18 and older with healthy eyes. Nearsightedness between -0.50 diopters&#xD;
             and -8.00 diopters.&#xD;
&#xD;
          -  Subjects with up to 3.00 diopters of astigmatism.&#xD;
&#xD;
          -  Subjects with a spherical equivalent of up to -9.00 diopters.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects under the age of 18.&#xD;
&#xD;
          -  Subjects with excessively thin corneas.&#xD;
&#xD;
          -  Subjects with topographic evidence of keratoconus.&#xD;
&#xD;
          -  Subjects with ectatic eye disorders.&#xD;
&#xD;
          -  Subjects with autoimmune diseases.&#xD;
&#xD;
          -  Subjects who are pregnant or nursing.&#xD;
&#xD;
          -  Subjects with more than 3.00 diopters of astigmatism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edward E Manche, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Byers Eye Institute at Stanford</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>April 3, 2022</last_update_submitted>
  <last_update_submitted_qc>April 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Edward E. Manche</investigator_full_name>
    <investigator_title>Professor of Ophthalmology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</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/NCT03292419
org study id: 43306
nct id: NCT03292419
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The investigators are analyzing outcomes of topography-guided LASIK surgery in participants
      with myopia and myopic astigmatism
The investigators are analyzing outcomes of topography-guided LASIK surgery in participants
      with myopia and myopic astigmatism. The investigators will be monitoring changes in anterior
      segment optical coherence tomography epithelial thickness maps. The investigators will
      compare preoperative maps to postoperative maps at one, three, six and twelve months. In
      addition, the investigators will measure changes in epithelial maps from postoperative month
      through twelve months to help understand what is happening to the corneal epithelium to try
      to explain why UDVA and CDVA improves over time
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Topography guided
primary purpose: Treatment
masking: None (Open Label)
masking description: N0ne
measure: Epithelial thickness maps
time frame: 12 months
description: Changes in anterior segment optical coherence tomography epithelial thickness maps.
measure: Changes in corrected visual acuity
time frame: 12 months
description: Corrected distance visual acuity (CDVA)
measure: Uncorrected distance visual acuity
time frame: 12 months
description: Uncorrected distance visual acuity (UDVA)
measure: Quality of Vision
time frame: 12 months
description: Patient reported outcomes questionnaire
measure: Predictability
time frame: 12 months
description: Percentage of eyes within +/-0.25, 0.50 and 1.00 diopter of the intended correction
measure: Contrast visual acuity
time frame: 12 months
description: 5 and 25% ETDRS contrast acuity
measure: Residual astigmatism levels after surgery
time frame: 12 months
description: Vector analysis of astigmatic outcomes
measure: Change in refraction over time
time frame: 12 months
description: Change in spherical equivalent over time
arm group label: Topography guided LASI
arm group type: Other
intervention type: Procedure
intervention name: Topography-guided LASIK
description: LASIK surgery
arm group label: Topography guided LASI
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Edward E Manche, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Edward E. Manche
investigator title: Professor of Ophthalmology
mesh term: Myopia
sharing ipd: No