<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/NCT03786861</url>
  </required_header>
  <id_info>
    <org_study_id>Al Hekma Center</org_study_id>
    <nct_id>NCT03786861</nct_id>
  </id_info>
  <brief_title>Corneal WFG Versus AF Trans PRK in Myopic Patients With High Corneal HOA</brief_title>
  <official_title>Corneal Wavefront Guided Versus Aberration Free Transepithelial Photorefractive Keratectomy in Myopic Patients With High Pre-existing Corneal Higher Order Aberrations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Menoufia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Menoufia 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>
      compare the efficacy, safety and predictability of corneal wavefront guided (WFG) and&#xD;
      aberration free ablation in single-step transepithelial photorefractive keratectomy&#xD;
      (TransPRK) in myopic patients with high pre-existing corneal higher order aberrations (HOAs).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives:to compare the efficacy, safety and predictability of corneal wavefront guided&#xD;
      (WFG) and aberration free ablation in single-step transepithelial photorefractive keratectomy&#xD;
      (TransPRK) in myopic patients with high pre-existing corneal higher order aberrations (HOAs).&#xD;
&#xD;
      Background: Corneal WFG and aberration free treatments have been proposed as methods to&#xD;
      achieve better visual, refractive, and optical outcomes.&#xD;
&#xD;
      Methods: prospective case series was conducted in El-Hekma Eye-LASIK center, Menoufia&#xD;
      governorate, Egypt during the period from January 2017 to December 2017. TransPRK was&#xD;
      performed to eligible myopic patients with or without astigmatism with corneal HOAs ≥ 0.35 µ&#xD;
      utilizing either aberration free or corneal WFG patterns provided by ORKCAM software (SCHWIND&#xD;
      eye-tech-solutions, Kleinostheim, Germany). Uncorrected distance visual acuity (UDVA),&#xD;
      manifest and cycloplegic refractions, best spectacle corrected distance visual acuity (CDVA),&#xD;
      thorough slit lamp examination and corneal topography were assessed and repeated six months&#xD;
      postoperatively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 12, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>corneal wavefront customized treatments and aberration free aspheric treatments</measure>
    <time_frame>1year</time_frame>
    <description>procedure was labeled successful if achieved the desired outcomes in terms of efficacy and safety. Efficacy index was defined as the ratio between the postoperative UDVA to the preoperative CDVA while safety index was defined as the ratio between the postoperative CDVA and the preoperative CDVA. Efficacy index around 1 and safety index more than 1 were desired. Failure was considered when the above outcomes failed to be achieved along with persistence or development of any of the following complications at 6 month postoperative follow up; corneal haze, persistent epithelial defects, ectasia, sterile infiltrate, infectious keratitis, central toxic keratopathy and steroid induced complications</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>42 eyes in aberration free group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TransPRK was performed to eligible myopic patients with or without astigmatism with corneal HOAs ≥ 0.35 µ utilizing aberration free in aberration free group provided by ORKCAM software (SCHWIND eye-tech-solutions, Kleinostheim, Germany)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>24 eyes in corneal WFG group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TransPRK was performed to eligible myopic patients with or without astigmatism with corneal HOAs ≥ 0.35 µ utilizing corneal WFG patterns in corneal WFG group provided by ORKCAM software (SCHWIND eye-tech-solutions, Kleinostheim, Germany)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>corneal WFG group</intervention_name>
    <description>TransPRK using ESIRIS flying spot excimer laser system (SCHWIND AMARIS®500E, SCHWIND eye-tech-solutions, Kleinhostheim, Germany), with 500 Hz repetition rate for faster treatments and scanning spots and with smart pulse technology. Eye-tracking during laser ablation was achieved using a 1050 Hz infrared eye tracker centered on the pupil. Static cyclotorsion control (SCC) compensation was obtained for all patients in corneal WFG group.</description>
    <arm_group_label>24 eyes in corneal WFG group</arm_group_label>
    <arm_group_label>42 eyes in aberration free group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>aberration free group</intervention_name>
    <description>TransPRK was performed to eligible myopic patients with or without astigmatism with corneal HOAs ≥ 0.35 µ utilizing aberration free patterns provided by ORKCAM software (SCHWIND eye-tech-solutions, Kleinostheim, Germany)</description>
    <arm_group_label>24 eyes in corneal WFG group</arm_group_label>
    <arm_group_label>42 eyes in aberration free group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Myopic patients with or without astigmatism&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe dry eye,&#xD;
&#xD;
          -  blepharitis,&#xD;
&#xD;
          -  corneal disease,&#xD;
&#xD;
          -  contact lens warpage,&#xD;
&#xD;
          -  cataract,&#xD;
&#xD;
          -  uveitis&#xD;
&#xD;
          -  posterior segment anomalies involving the macula or optic nerve&#xD;
&#xD;
          -  systemic conditions; diabetes mellitus, connective tissue disease, pregnancy or&#xD;
             nursing. Also, any patient who had previous ocular surgery including keratorefractive&#xD;
             surgery was excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>patients 21 years or older with stable refraction for more than 1 year</gender_description>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>52 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>September 2, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Menoufia University</investigator_affiliation>
    <investigator_full_name>Amin Faisal Ellakwa</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <keyword>aberration free</keyword>
  <keyword>corneal wavefront guided</keyword>
  <keyword>higher order aberrations</keyword>
  <keyword>photorefractive keratectomy.</keyword>
  <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/NCT03786861
org study id: Al Hekma Center
nct id: NCT03786861
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
compare the efficacy, safety and predictability of corneal wavefront guided (WFG) and
      aberration free ablation in single-step transepithelial photorefractive keratectomy
      (TransPRK) in myopic patients with high pre-existing corneal higher order aberrations (HOAs).
Objectives:to compare the efficacy, safety and predictability of corneal wavefront guided
      (WFG) and aberration free ablation in single-step transepithelial photorefractive keratectomy
      (TransPRK) in myopic patients with high pre-existing corneal higher order aberrations (HOAs).

      Background: Corneal WFG and aberration free treatments have been proposed as methods to
      achieve better visual, refractive, and optical outcomes.

      Methods: prospective case series was conducted in El-Hekma Eye-LASIK center, Menoufia
      governorate, Egypt during the period from January 2017 to December 2017. TransPRK was
      performed to eligible myopic patients with or without astigmatism with corneal HOAs ≥ 0.35 µ
      utilizing either aberration free or corneal WFG patterns provided by ORKCAM software (SCHWIND
      eye-tech-solutions, Kleinostheim, Germany). Uncorrected distance visual acuity (UDVA),
      manifest and cycloplegic refractions, best spectacle corrected distance visual acuity (CDVA),
      thorough slit lamp examination and corneal topography were assessed and repeated six months
      postoperatively.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: corneal wavefront customized treatments and aberration free aspheric treatments
time frame: 1year
description: procedure was labeled successful if achieved the desired outcomes in terms of efficacy and safety. Efficacy index was defined as the ratio between the postoperative UDVA to the preoperative CDVA while safety index was defined as the ratio between the postoperative CDVA and the preoperative CDVA. Efficacy index around 1 and safety index more than 1 were desired. Failure was considered when the above outcomes failed to be achieved along with persistence or development of any of the following complications at 6 month postoperative follow up; corneal haze, persistent epithelial defects, ectasia, sterile infiltrate, infectious keratitis, central toxic keratopathy and steroid induced complications
arm group label: 42 eyes in aberration free group
arm group type: Active Comparator
description: TransPRK was performed to eligible myopic patients with or without astigmatism with corneal HOAs ≥ 0.35 µ utilizing aberration free in aberration free group provided by ORKCAM software (SCHWIND eye-tech-solutions, Kleinostheim, Germany)
arm group label: 24 eyes in corneal WFG group
arm group type: Active Comparator
description: TransPRK was performed to eligible myopic patients with or without astigmatism with corneal HOAs ≥ 0.35 µ utilizing corneal WFG patterns in corneal WFG group provided by ORKCAM software (SCHWIND eye-tech-solutions, Kleinostheim, Germany)
intervention type: Procedure
intervention name: corneal WFG group
description: TransPRK using ESIRIS flying spot excimer laser system (SCHWIND AMARIS®500E, SCHWIND eye-tech-solutions, Kleinhostheim, Germany), with 500 Hz repetition rate for faster treatments and scanning spots and with smart pulse technology. Eye-tracking during laser ablation was achieved using a 1050 Hz infrared eye tracker centered on the pupil. Static cyclotorsion control (SCC) compensation was obtained for all patients in corneal WFG group.
arm group label: 24 eyes in corneal WFG group
arm group label: 42 eyes in aberration free group
intervention type: Procedure
intervention name: aberration free group
description: TransPRK was performed to eligible myopic patients with or without astigmatism with corneal HOAs ≥ 0.35 µ utilizing aberration free patterns provided by ORKCAM software (SCHWIND eye-tech-solutions, Kleinostheim, Germany)
arm group label: 24 eyes in corneal WFG group
arm group label: 42 eyes in aberration free group
criteria: 
gender: All
gender based: Yes
gender description: patients 21 years or older with stable refraction for more than 1 year
minimum age: 21 Years
maximum age: 52 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Menoufia University
investigator full name: Amin Faisal Ellakwa
investigator title: assistant professor
mesh term: Myopia
sharing ipd: No