<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/NCT03228784</url>
  </required_header>
  <id_info>
    <org_study_id>5780</org_study_id>
    <nct_id>NCT03228784</nct_id>
  </id_info>
  <brief_title>The Effect of Ablation Depth on Dry Eye After LASIK Treatment of Myopia</brief_title>
  <official_title>The Effect of Ablation Depth on Dry Eye After LASIK Treatment of Myopia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Minia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Minia University</source>
  <brief_summary>
    <textblock>
      The study tried to find the relation between ablation depth and degree of dryness after LASIK&#xD;
      treatment of myopic patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2013</start_date>
  <completion_date type="Actual">May 1, 2014</completion_date>
  <primary_completion_date type="Actual">May 1, 2014</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of dry eye</measure>
    <time_frame>6 months</time_frame>
    <description>Schirmer 1 test in millimeters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Degree of dryness</measure>
    <time_frame>6 months</time_frame>
    <description>Tear break up time in seconds</description>
  </primary_outcome>
  <enrollment type="Actual">53</enrollment>
  <condition>Incidence and Severity of Dry Eye After Myopic LASIK</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>LASIK</intervention_name>
    <other_name>Corneal Flap creation with mechanical microkeratome and stromal ablation with Excimerr laser.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with age ≥ 21 years&#xD;
&#xD;
          -  Normal Pentacam maps&#xD;
&#xD;
          -  Myopia with spherical equation less than 12 D&#xD;
&#xD;
          -  Corneal thickness ≥ 500 Microns&#xD;
&#xD;
          -  Calculated residual stromal bed ≥ 280 microns&#xD;
&#xD;
          -  No signs or symptoms of dry eye.&#xD;
&#xD;
        Exclusion Criteria :&#xD;
&#xD;
          -  Keratoconus and forme fruste keratoconus&#xD;
&#xD;
          -  Auto-immune diseases&#xD;
&#xD;
          -  History of dry eye or previous use of tear substitutes&#xD;
&#xD;
          -  Previous ocular surgery&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 14, 2017</study_first_submitted>
  <study_first_submitted_qc>July 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>July 22, 2017</last_update_submitted>
  <last_update_submitted_qc>July 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Minia University</investigator_affiliation>
    <investigator_full_name>Hosny Ahmed Zein</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</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/NCT03228784
org study id: 5780
nct id: NCT03228784
lead sponsor: 
The study tried to find the relation between ablation depth and degree of dryness after LASIK
      treatment of myopic patients
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Incidence of dry eye
time frame: 6 months
description: Schirmer 1 test in millimeters
measure: Degree of dryness
time frame: 6 months
description: Tear break up time in seconds
intervention type: Procedure
intervention name: LASIK
other name: Corneal Flap creation with mechanical microkeratome and stromal ablation with Excimerr laser.
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
responsible party type: Principal Investigator
investigator affiliation: Minia University
investigator full name: Hosny Ahmed Zein
investigator title: Principle Investigator
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
sharing ipd: No