<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/NCT03791684</url>
  </required_header>
  <id_info>
    <org_study_id>Ophth001/2016</org_study_id>
    <nct_id>NCT03791684</nct_id>
  </id_info>
  <brief_title>Accelerated Versus Standard CXL in the Treatment of Ectasia Post Refractive Surgery and Penetrating Keratoplasty.</brief_title>
  <official_title>Accelerated Versus Standard Corneal Cross Linking in the Treatment of Ectasia Post Refractive Surgery and Penetrating Keratoplasty: A Long Term Randomized Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Menoufia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Menoufia University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      WHAT WAS KNOWN&#xD;
&#xD;
      *Standard CXL is the common procedure for treating progressive corneal ectasia. Modifications&#xD;
      of the standard protocol were introduces to reduce its complications especially long exposure&#xD;
      to ultraviolet rays. The Accelerated protocol, while believed to overcome this issue with&#xD;
      comparable outcomes, has not been studied fully in patients with ectasia following corneal&#xD;
      refractive surgery and penetrating keratoplasty.&#xD;
&#xD;
      WHAT THIS PAPER ADDS Accelerated CXL is as safe and effective as the Standard CXL in halting&#xD;
      the progression of ectasia post refractive surgery and penetrating keratoplasty with the&#xD;
      benefit of: reduced ultraviolet exposure, reduced operation time, and reduced patient&#xD;
      discomfort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose:&#xD;
&#xD;
      The aim of this study is to compare the clinical outcomes of the Standard CXL and the AC CXL&#xD;
      in patients with progressive corneal ectasia post refractive surgery and penetrating&#xD;
      keratoplasty.&#xD;
&#xD;
      Setting:&#xD;
&#xD;
      Menoufia University Hospital, Egypt&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Prospective, randomised comparison.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Patients scheduled to receive either Standard CXL (3mW/cm2 for a period of 30 min) or&#xD;
      Accelerated CXL (18mW/cm2 for a period of 5 min).The main outcomes for comparison were the&#xD;
      change in; Maximum-K reading (K-max), manifest refractive spherical equivalent (SE), central&#xD;
      corneal thickness (CCT), and the best corrected distance visual acuity (CDVA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2016</start_date>
  <completion_date type="Actual">June 26, 2017</completion_date>
  <primary_completion_date type="Actual">January 16, 2017</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>K-max changes</measure>
    <time_frame>12 post treatment</time_frame>
    <description>The main outcomes for comparison were the change in; Maximum-K reading (K-max), Patients were followed up clinically on the first day, first week, one month, 6 months and 12 months postoperatively</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>manifest refractive spherical equivalent (SE) in Diopter power</measure>
    <time_frame>12 months postoperatively</time_frame>
    <description>The secondary outcomes for comparison were the change in, manifest refractive spherical equivalent (SE).&#xD;
Patients were followed up clinically on the first day, first week, one month, 6 months and 12 months postoperatively</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">111</enrollment>
  <condition>Refractive Surgery</condition>
  <arm_group>
    <arm_group_label>Accelerated Cross Linking</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ultraviolet A radiation of 365 nm wavelength (CCL-365 vario, Peschke Meditrade GmbH, Switzerland), and an irradiance of 18mW/cm2 (spot size 7mm), at a distance of 45 mm from the cornea, was applied for a period of 5 min, delivering a dose of 5.4 J/cm2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Cross linking</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ultraviolet A radiation of 365 nm wavelength (CCL-365 vario, Peschke Meditrade GmbH, Switzerland), and an irradiance of 3mW/cm2 (spot size 7mm), at a distance of 45 mm from the cornea, was applied for a period of 30 min, delivering a dose of 5.4 J/cm2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cross linking</intervention_name>
    <description>Cross linking strategy either standard or accelerated</description>
    <arm_group_label>Accelerated Cross Linking</arm_group_label>
    <arm_group_label>Standard Cross linking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible patients were:&#xD;
&#xD;
          -  adults aged above 18 years.&#xD;
&#xD;
          -  They have been diagnosed clinically with progressive corneal ectasia following&#xD;
             refractive surgery procedure (LASIK, PRK, ReLex smile), or penetrating keratoplasty&#xD;
&#xD;
          -  CCT above 400µ.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The exclusion criteria involved:&#xD;
&#xD;
          -  history of herpetic ocular diseases (including herpes simplex virus and varicella&#xD;
             zoster virus) in the study eye&#xD;
&#xD;
          -  active or recurrent ocular disease in either eye (e.g., uveitis, chronic moderate to&#xD;
             severe blepharitis or severe dry eye) or sight-threatening diseases (e.g., previous&#xD;
             retinal or optic nerve diseases) that would interfere with the interpretation of the&#xD;
             study data.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>January 2, 2019</last_update_submitted>
  <last_update_submitted_qc>January 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Menoufia University</investigator_affiliation>
    <investigator_full_name>Hany Khairy</investigator_full_name>
    <investigator_title>Consultant Ophthalmology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dilatation, Pathologic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data used to support the findings of this study are restricted by the Ophthalmic Ethics Committee at Menoufia University Hospital, in order to protect patient privacy. Data are available from Mr Hany Khairy (khairyhany@hotmail.com), for researchers who meet the criteria for access to confidential data.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>The data used to support the findings of this study are restricted by the Ophthalmic Ethics Committee at Menoufia University Hospital, in order to protect patient privacy. Data are available from Mr Hany Khairy (khairyhany@hotmail.com), for researchers who meet the criteria for access to confidential data after study publcation</ipd_time_frame>
    <ipd_access_criteria>Data are available for researchers who meet the criteria for access to confidential data as specified by the Ophthalmic Committee of Menoufia University Hospital</ipd_access_criteria>
  </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/NCT03791684
org study id: Ophth001/2016
nct id: NCT03791684
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
WHAT WAS KNOWN

      *Standard CXL is the common procedure for treating progressive corneal ectasia. Modifications
      of the standard protocol were introduces to reduce its complications especially long exposure
      to ultraviolet rays. The Accelerated protocol, while believed to overcome this issue with
      comparable outcomes, has not been studied fully in patients with ectasia following corneal
      refractive surgery and penetrating keratoplasty.

      WHAT THIS PAPER ADDS Accelerated CXL is as safe and effective as the Standard CXL in halting
      the progression of ectasia post refractive surgery and penetrating keratoplasty with the
      benefit of: reduced ultraviolet exposure, reduced operation time, and reduced patient
      discomfort.
Purpose:

      The aim of this study is to compare the clinical outcomes of the Standard CXL and the AC CXL
      in patients with progressive corneal ectasia post refractive surgery and penetrating
      keratoplasty.

      Setting:

      Menoufia University Hospital, Egypt

      Design:

      Prospective, randomised comparison.

      Methods:

      Patients scheduled to receive either Standard CXL (3mW/cm2 for a period of 30 min) or
      Accelerated CXL (18mW/cm2 for a period of 5 min).The main outcomes for comparison were the
      change in; Maximum-K reading (K-max), manifest refractive spherical equivalent (SE), central
      corneal thickness (CCT), and the best corrected distance visual acuity (CDVA).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: K-max changes
time frame: 12 post treatment
description: The main outcomes for comparison were the change in; Maximum-K reading (K-max), Patients were followed up clinically on the first day, first week, one month, 6 months and 12 months postoperatively
measure: manifest refractive spherical equivalent (SE) in Diopter power
time frame: 12 months postoperatively
description: The secondary outcomes for comparison were the change in, manifest refractive spherical equivalent (SE).
Patients were followed up clinically on the first day, first week, one month, 6 months and 12 months postoperatively
arm group label: Accelerated Cross Linking
arm group type: Active Comparator
description: Ultraviolet A radiation of 365 nm wavelength (CCL-365 vario, Peschke Meditrade GmbH, Switzerland), and an irradiance of 18mW/cm2 (spot size 7mm), at a distance of 45 mm from the cornea, was applied for a period of 5 min, delivering a dose of 5.4 J/cm2.
arm group label: Standard Cross linking
arm group type: Active Comparator
description: Ultraviolet A radiation of 365 nm wavelength (CCL-365 vario, Peschke Meditrade GmbH, Switzerland), and an irradiance of 3mW/cm2 (spot size 7mm), at a distance of 45 mm from the cornea, was applied for a period of 30 min, delivering a dose of 5.4 J/cm2.
intervention type: Device
intervention name: Cross linking
description: Cross linking strategy either standard or accelerated
arm group label: Accelerated Cross Linking
arm group label: Standard Cross linking
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Menoufia University
investigator full name: Hany Khairy
investigator title: Consultant Ophthalmology
mesh term: Dilatation, Pathologic
sharing ipd: Yes
ipd description: The data used to support the findings of this study are restricted by the Ophthalmic Ethics Committee at Menoufia University Hospital, in order to protect patient privacy. Data are available from Mr Hany Khairy (khairyhany@hotmail.com), for researchers who meet the criteria for access to confidential data.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: The data used to support the findings of this study are restricted by the Ophthalmic Ethics Committee at Menoufia University Hospital, in order to protect patient privacy. Data are available from Mr Hany Khairy (khairyhany@hotmail.com), for researchers who meet the criteria for access to confidential data after study publcation
ipd access criteria: Data are available for researchers who meet the criteria for access to confidential data as specified by the Ophthalmic Committee of Menoufia University Hospital