<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/NCT04477421</url>
  </required_header>
  <id_info>
    <org_study_id>AR200106</org_study_id>
    <nct_id>NCT04477421</nct_id>
  </id_info>
  <brief_title>Femtosecond Small Incision Lenticular Extraction in Comparison to Femtosecond Laser Insitu Keratomileusis Regarding Dry Eye Disease</brief_title>
  <official_title>Femtosecond Small Incision Lenticular Extraction in Comparison to Femtosecond Laser Insitu Keratomileusis Regarding Dry Eye Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Al-Rasheed University College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Al-Rasheed University College</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison of femtosecond small incision lenticule extraction (FS-SMILE) versus Femtosecond&#xD;
      laser Insitu Keratomileusis (FS-LASIK) regarding dry eye disease (DED) and corneal&#xD;
      sensitivity (CS) after those refractive surgeries.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">October 31, 2018</completion_date>
  <primary_completion_date type="Actual">October 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ocular Surface Disease Index</measure>
    <time_frame>After 1 month of surgery</time_frame>
    <description>Ocular Surface Disease Index (the index range from 0 to 100), higher value indicate more severe disease</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ocular Surface Disease Index</measure>
    <time_frame>After 6 months of surgery</time_frame>
    <description>Ocular Surface Disease Index (the index range from 0 to 100), higher value indicate more severe disease</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tear Break-Up Time</measure>
    <time_frame>After 1 month of surgery</time_frame>
    <description>Tear Break-Up Time (in seconds)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tear Break-Up Time</measure>
    <time_frame>After 6 months of surgery</time_frame>
    <description>Tear Break-Up Time (in seconds)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Schirmer I test</measure>
    <time_frame>After 1 month of surgery</time_frame>
    <description>Schirmer I test (in mm/5 minutes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Schirmer I test</measure>
    <time_frame>After 6 months of surgery</time_frame>
    <description>Schirmer I test (in mm/5 minutes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxford score</measure>
    <time_frame>After 1 month of surgery</time_frame>
    <description>Oxford score (the score range from 0 to 5), higher value indicate more severe disease</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxford score</measure>
    <time_frame>After 6 months of surgery</time_frame>
    <description>Oxford score (the score range from 0 to 5), higher value indicate more severe disease</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dry Eye Work Shop scale</measure>
    <time_frame>After 1 month of surgery</time_frame>
    <description>Dry Eye Work Shop scale (value range from 0 to 4), higher value indicate more severe disease</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dry Eye Work Shop scale</measure>
    <time_frame>After 6 months of surgery</time_frame>
    <description>Dry Eye Work Shop scale (value range from 0 to 4), higher value indicate more severe disease</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Dry Eye Disease</condition>
  <arm_group>
    <arm_group_label>FS-LASIK Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 eyes of 50 patients underwent bilateral FS-LASIK (Femtosecond laser Insitu Keratomileusis)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FS-SMILE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 eyes of 50 patients who underwent bilateral FS-SMILE (femtosecond small incision lenticule extraction)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>FS-SMILE</intervention_name>
    <description>Femtosecond small incision lenticule extraction</description>
    <arm_group_label>FS-SMILE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>S-LASIK</intervention_name>
    <description>Femtosecond laser Insitu keratomileusis</description>
    <arm_group_label>FS-LASIK Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  bilateral eyes with spherical correction range from -2 to -6 diopters and cylinder&#xD;
             range from 0 to - 3.5 diopters&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  sign or symptom of dry eye disease (tear film breakup time (TBUT) &gt;10 seconds&#xD;
&#xD;
          -  Schirmer I test &gt;10 mm /5 minutes)&#xD;
&#xD;
          -  corneal or conjunctival staining&#xD;
&#xD;
          -  Meibomian gland dysfunction&#xD;
&#xD;
          -  Previous ocular and or eyelid medical or surgical treatment&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  Chronic systemic disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Al-Rasheed University College</name>
      <address>
        <city>Baghdad</city>
        <state>AL-Adhmia</state>
        <zip>12221</zip>
        <country>Iraq</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iraq</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</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>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
    <mesh_term>Eye Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04477421
org study id: AR200106
nct id: NCT04477421
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Comparison of femtosecond small incision lenticule extraction (FS-SMILE) versus Femtosecond
      laser Insitu Keratomileusis (FS-LASIK) regarding dry eye disease (DED) and corneal
      sensitivity (CS) after those refractive surgeries.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Ocular Surface Disease Index
time frame: After 1 month of surgery
description: Ocular Surface Disease Index (the index range from 0 to 100), higher value indicate more severe disease
measure: Ocular Surface Disease Index
time frame: After 6 months of surgery
description: Ocular Surface Disease Index (the index range from 0 to 100), higher value indicate more severe disease
measure: Tear Break-Up Time
time frame: After 1 month of surgery
description: Tear Break-Up Time (in seconds)
measure: Tear Break-Up Time
time frame: After 6 months of surgery
description: Tear Break-Up Time (in seconds)
measure: Schirmer I test
time frame: After 1 month of surgery
description: Schirmer I test (in mm/5 minutes)
measure: Schirmer I test
time frame: After 6 months of surgery
description: Schirmer I test (in mm/5 minutes)
measure: Oxford score
time frame: After 1 month of surgery
description: Oxford score (the score range from 0 to 5), higher value indicate more severe disease
measure: Oxford score
time frame: After 6 months of surgery
description: Oxford score (the score range from 0 to 5), higher value indicate more severe disease
measure: Dry Eye Work Shop scale
time frame: After 1 month of surgery
description: Dry Eye Work Shop scale (value range from 0 to 4), higher value indicate more severe disease
measure: Dry Eye Work Shop scale
time frame: After 6 months of surgery
description: Dry Eye Work Shop scale (value range from 0 to 4), higher value indicate more severe disease
arm group label: FS-LASIK Group
arm group type: Active Comparator
description: 100 eyes of 50 patients underwent bilateral FS-LASIK (Femtosecond laser Insitu Keratomileusis)
arm group label: FS-SMILE
arm group type: Experimental
description: 100 eyes of 50 patients who underwent bilateral FS-SMILE (femtosecond small incision lenticule extraction)
intervention type: Procedure
intervention name: FS-SMILE
description: Femtosecond small incision lenticule extraction
arm group label: FS-SMILE
intervention type: Procedure
intervention name: S-LASIK
description: Femtosecond laser Insitu keratomileusis
arm group label: FS-LASIK Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Iraq
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Eye Diseases
sharing ipd: Undecided