<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/NCT02210793</url>
  </required_header>
  <id_info>
    <org_study_id>ANH-1</org_study_id>
    <secondary_id>ANH-TPRK1</secondary_id>
    <nct_id>NCT02210793</nct_id>
  </id_info>
  <brief_title>Dry Eye Evaluation After Transepithelial PRK</brief_title>
  <official_title>Evaluation of Dry Eye Following Transepithelial Photorefractive Keratectomy in Comparison to Conventional LASIK: a Comparative Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AL-Nour Eye Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AL-Nour Eye Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate the severity of dry eye syndrome following excimer laser&#xD;
      vision correction using no-touch all-laser photorefractive keratectomy in comparison to&#xD;
      conventional lasik&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective interventional clinical study 2 groups: Group A : 20 eyes of 10 patients&#xD;
      undergoing transepithelial PRK Group B: 20 eyes of 10 patients undergoing LASIK using&#xD;
      mechanical microkeratome Tear Break Up Time and Schirmer 2 tests are used to evaluate&#xD;
      severity of dry eye before surgery and 1 , 3 and 6 months postoperative Follow up period : 6&#xD;
      months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>qualitative assessment of dry eye syndrome</measure>
    <time_frame>6 months</time_frame>
    <description>Tear Break Up time is used as a qualitative measure of dry eye after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>quantitative of dry eye after surgery</measure>
    <time_frame>6 months</time_frame>
    <description>Schirmer test is used as a quantitative measure of dry eye after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>haze</measure>
    <time_frame>6 months</time_frame>
    <description>haze is a known possible complication of surface ablation Its severity can be graded according to a slit lamp scoring system</description>
  </secondary_outcome>
  <other_outcome>
    <measure>healing time of epithelial defect epithelial defect</measure>
    <time_frame>2-5 days</time_frame>
    <description>the period of time in days needed for complete healing of the epithelial defect created during transepithelial PRK</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Dry Eye</condition>
  <arm_group>
    <arm_group_label>Transepithelial PRK</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 eyes to undergo a no touch , all-laser advanced surface ablation technique termed transepithelial PRK using the Amaris laser platform (Schwind eye-tech solutions Gmbh, Germany)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional LASIK</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 eyes to undergo LASIK using a mechanical microkeratome (M2, Moria Surgical, Antony, France) and the Mel 80 excimer laser system(Carl Zeiss Meditec)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>transepithelial PRK</intervention_name>
    <arm_group_label>Transepithelial PRK</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>LASIK</intervention_name>
    <arm_group_label>Conventional LASIK</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Myopia -1 to -6 diopters&#xD;
&#xD;
          -  Astigmatism -0.5 to - 4 diopters&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy and lactation&#xD;
&#xD;
          -  Keratoconus&#xD;
&#xD;
          -  Previous refractive surgery&#xD;
&#xD;
          -  Previous herpetic keratitis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed M Shalaby, MD</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mahmoud H Abu Steit, MD</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed Salah, MBBCH</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Al Nour Eye Hospital</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 2, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>August 5, 2014</last_update_submitted>
  <last_update_submitted_qc>August 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>AL-Nour Eye Hospital</investigator_affiliation>
    <investigator_full_name>Ahmed Mohamed Sherif</investigator_full_name>
    <investigator_title>Dr Ahmed Sherif</investigator_title>
  </responsible_party>
  <keyword>Transepithelial PRK</keyword>
  <keyword>Dry eye</keyword>
  <keyword>Schirmer test</keyword>
  <keyword>Tear break up time</keyword>
  <keyword>Dry eye after advanced surface ablation technique</keyword>
  <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>
  <!-- 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/NCT02210793
org study id: ANH-1
secondary id: ANH-TPRK1
nct id: NCT02210793
lead sponsor: 
has dmc: No
The aim of the study is to evaluate the severity of dry eye syndrome following excimer laser
      vision correction using no-touch all-laser photorefractive keratectomy in comparison to
      conventional lasik
Prospective interventional clinical study 2 groups: Group A : 20 eyes of 10 patients
      undergoing transepithelial PRK Group B: 20 eyes of 10 patients undergoing LASIK using
      mechanical microkeratome Tear Break Up Time and Schirmer 2 tests are used to evaluate
      severity of dry eye before surgery and 1 , 3 and 6 months postoperative Follow up period : 6
      months
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: qualitative assessment of dry eye syndrome
time frame: 6 months
description: Tear Break Up time is used as a qualitative measure of dry eye after surgery
measure: quantitative of dry eye after surgery
time frame: 6 months
description: Schirmer test is used as a quantitative measure of dry eye after surgery
measure: haze
time frame: 6 months
description: haze is a known possible complication of surface ablation Its severity can be graded according to a slit lamp scoring system
measure: healing time of epithelial defect epithelial defect
time frame: 2-5 days
description: the period of time in days needed for complete healing of the epithelial defect created during transepithelial PRK
arm group label: Transepithelial PRK
arm group type: Active Comparator
description: 20 eyes to undergo a no touch , all-laser advanced surface ablation technique termed transepithelial PRK using the Amaris laser platform (Schwind eye-tech solutions Gmbh, Germany)
arm group label: Conventional LASIK
arm group type: Active Comparator
description: 20 eyes to undergo LASIK using a mechanical microkeratome (M2, Moria Surgical, Antony, France) and the Mel 80 excimer laser system(Carl Zeiss Meditec)
intervention type: Procedure
intervention name: transepithelial PRK
arm group label: Transepithelial PRK
intervention type: Procedure
intervention name: LASIK
arm group label: Conventional LASIK
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Ahmed M Shalaby, MD
role: Study Director
affiliation: Cairo University
last name: Mahmoud H Abu Steit, MD
role: Study Director
affiliation: Cairo University
last name: Mohamed Salah, MBBCH
role: Study Director
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: AL-Nour Eye Hospital
investigator full name: Ahmed Mohamed Sherif
investigator title: Dr Ahmed Sherif
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca