<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/NCT04452448</url>
  </required_header>
  <id_info>
    <org_study_id>030490</org_study_id>
    <nct_id>NCT04452448</nct_id>
  </id_info>
  <brief_title>Analysis of I-Trace High Order Aberrations Induced by Wavefront Optimized Ablation Profiles</brief_title>
  <official_title>Analysis of I-Trace High Order Aberrations Induced by Wavefront Optimized Ablation Profiles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This work aims at the analysis of ocular aberrations induced by wave front optimized ablation&#xD;
      profiles WFO using I-Trace aberrometer (Ray -Tracing)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The iTrace (Tracey Technologies, Houston, Tx) is uniquely designed to combine Placido corneal&#xD;
      topography with a ray tracing aberrometer to measure quality of vision in a patient. This&#xD;
      work aims at the analysis of ocular aberrations induced by wave front optimized ablation&#xD;
      profiles WFO using I-Trace aberrometer (Ray -Tracing)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2018</start_date>
  <completion_date type="Actual">June 10, 2020</completion_date>
  <primary_completion_date type="Actual">May 30, 2020</primary_completion_date>
  <phase>Phase 2/Phase 3</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>A prospective clinical study including 20 eyes of 10 cases undergoing LASIK with wave front optimized ablation profile</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of ocular aberrations</measure>
    <time_frame>3 months</time_frame>
    <description>3. Evaluation of ocular aberrations done using iTrace Visual Functional Analyzer (ray tracing technology) to quantify changes in total higher order aberrations, coma, spherical aberrations, secondary astigmatism and trefoil after LASIK surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>3 months</time_frame>
    <description>Unaided as well as best corrected visual acuity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Manifest refraction</measure>
    <time_frame>3 months</time_frame>
    <description>Manifest refraction</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>Laser in situ keratomileusis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A prospective clinical study including 20 eyes of 10 cases undergoing laser in situ keratomileusis (LASIK)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LASIK</intervention_name>
    <description>All cases were operated upon using Wavelight Allegretto EX-500 excimer laser (Alcon Laboratories, Inc., Fort Worth, TX) with wave front optimized ablation profile WFO. The Moria II microkeratome (Moria, Anthony, France) was used in all cases.</description>
    <arm_group_label>Laser in situ keratomileusis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Myopia up to -8.0 D and astigmatism up to -2.0D.&#xD;
&#xD;
          2. Cases above 18 years of age with a stable refraction for at least one year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Keratoconus.&#xD;
&#xD;
          2. Patients with collagen diseases.&#xD;
&#xD;
          3. Previous LASIK or any other refractive surgery.&#xD;
&#xD;
          4. Severe dry eye syndrome.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ehab Mossallam, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandria Faculty of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alexandria Faculty of Medicine</name>
      <address>
        <city>Alexandria</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 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>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/NCT04452448
org study id: 030490
nct id: NCT04452448
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This work aims at the analysis of ocular aberrations induced by wave front optimized ablation
      profiles WFO using I-Trace aberrometer (Ray -Tracing)
The iTrace (Tracey Technologies, Houston, Tx) is uniquely designed to combine Placido corneal
      topography with a ray tracing aberrometer to measure quality of vision in a patient. This
      work aims at the analysis of ocular aberrations induced by wave front optimized ablation
      profiles WFO using I-Trace aberrometer (Ray -Tracing)
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A prospective clinical study including 20 eyes of 10 cases undergoing LASIK with wave front optimized ablation profile
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluation of ocular aberrations
time frame: 3 months
description: 3. Evaluation of ocular aberrations done using iTrace Visual Functional Analyzer (ray tracing technology) to quantify changes in total higher order aberrations, coma, spherical aberrations, secondary astigmatism and trefoil after LASIK surgery
measure: Visual acuity
time frame: 3 months
description: Unaided as well as best corrected visual acuity
measure: Manifest refraction
time frame: 3 months
description: Manifest refraction
arm group label: Laser in situ keratomileusis
arm group type: Experimental
description: A prospective clinical study including 20 eyes of 10 cases undergoing laser in situ keratomileusis (LASIK)
intervention type: Device
intervention name: LASIK
description: All cases were operated upon using Wavelight Allegretto EX-500 excimer laser (Alcon Laboratories, Inc., Fort Worth, TX) with wave front optimized ablation profile WFO. The Moria II microkeratome (Moria, Anthony, France) was used in all cases.
arm group label: Laser in situ keratomileusis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ehab Mossallam, PhD
role: Principal Investigator
affiliation: Alexandria Faculty of Medicine
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Myopia
sharing ipd: No