<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/NCT03753009</url>
  </required_header>
  <id_info>
    <org_study_id>PCXL</org_study_id>
    <nct_id>NCT03753009</nct_id>
  </id_info>
  <brief_title>Iontophoretic Transepithelial Collagen Cross-linking Versus Epithelium-off Collagen Cross-linking in Pediatric Patients. Three Year Follow up.</brief_title>
  <official_title>Iontophoretic Transepithelial Collagen Cross-linking Versus Epithelium-off Collagen Cross-linking in Pediatric Patients. Three Year Follow up.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bambino Gesù Hospital and Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bambino Gesù Hospital and Research Institute</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>
      To compare 3 year iontophoretic transepithelial corneal cross-linking (I-ON CXL) outcomes&#xD;
      with epithelium-off collagen cross-linking (epi-off CXL)in pediatric patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Forty eyes of 28 consecutive pediatric patients (mean age 14.3±2.5 [SD] years; range, 9 to 18&#xD;
      years) with keratoconus were enrolled in the study. Twenty eyes of 15 patients underwent I-ON&#xD;
      CXL, while 20 eyes of 13 patients underwent epi-off CXL. Corrected distance visual acuity&#xD;
      (CDVA), spherical equivalent, maximum keratometry (Kmax), posterior elevation of the thinnest&#xD;
      point and thickness of the thinnest point mean values were evaluated. A Student t test was&#xD;
      used to compare baseline and 12, 24, and 36 month postoperative data. Keratoconus progression&#xD;
      in function of preoperative Kmax value and cone location was evaluated at 36 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Actual">June 30, 2015</completion_date>
  <primary_completion_date type="Actual">June 30, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>keratoconus stability</measure>
    <time_frame>3 years</time_frame>
    <description>To evaluate change of simulated maximum K (Kmax) that was calculated by a Sirius Scheimpflug camera (CSO, Firenze, Italy) by averaging the axial curvature from the fourth to the eighth Placido rings of the flattest and steepest meridians (the amplitude of the zone taken into consideration, therefore has a vari-able diameter depending on the curvature of the cornea, and the principal meridians are not nec-essarily 90 degrees away)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">28</enrollment>
  <condition>Keratoconus</condition>
  <arm_group>
    <arm_group_label>iontophoretic transepithelial corneal cross-linking (I-ON CXL)</arm_group_label>
    <description>Twenty eyes of 15 patients with keratoconus (mean age 13±3.5 [SD] years, range 9 to 18) underwent Iontophoresis epi-on CXL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>epithelium-off collagen cross-linking (epi-off CXL)</arm_group_label>
    <description>Twenty eyes of 13 patients with keratoconus (14±4 [SD] years, range 10 to 18) underwent standard epi-off CXL</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>corneal cross-linking</intervention_name>
    <description>Epithelium-off CXL was performed according to the Siena (Dresden modified) protocol: 2% pilocarpine was instilled 30 minutes before treatment, the epithelium was removed using a blunt knife. An isotonic solution of riboflavin 0.1% and dextran 20% was instilled for 10 minutes of corneal soaking before starting UV-A irradiation. The solution was administered every 3 minutes for a total of 30 minutes of UV-A exposure at 3mW/cm2.&#xD;
The iontophoresis device was filled with a hypoosmolar riboflavin 0.1% dextran-free solution enriched with ethylenediaminetetraacetic acid and trometamol. The device was then connected to a constant current generator initially set at 0.5 mA and increased to 1.0 mA to find out the individual tolerance. Iontophoresis was then performed for 5 minutes. The corneal device was then removed before performing UVA irradiation. During the irradiation phase (10 mW/cm2 for 9 minutes), good fluorescence was clearly detectable. The total treatment time was 14 minutes.</description>
    <arm_group_label>epithelium-off collagen cross-linking (epi-off CXL)</arm_group_label>
    <arm_group_label>iontophoretic transepithelial corneal cross-linking (I-ON CXL)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Thirty eyes of 28 consecutive pediatric patients (7 female and 21 male; mean age 14.3±2.5&#xD;
        [SD] years; range, 9 to 18 years) affected by keratoconus (diagnosis established according&#xD;
        to global consensus on keratoconus and ectatic diseases) who underwent iontophoresic&#xD;
        transepithelial corneal cross-linking by or epithelium-off corneal cross-linking are&#xD;
        enrolled in this retrospective study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical diagnosis of Keratoconus age &lt; 18 years at the treatment; corneal cross&#xD;
             linking performed at least 3 years before&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &gt; 18 years at the treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Luca Buzzonetti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bambino Gesù Children's Hospital, Rome, Italy</affiliation>
  </overall_official>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>November 22, 2018</last_update_submitted>
  <last_update_submitted_qc>November 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bambino Gesù Hospital and Research Institute</investigator_affiliation>
    <investigator_full_name>Luca Buzzonetti</investigator_full_name>
    <investigator_title>Head of the Ophthalmology Department, Bambino Gesù IRCCS Children's Hospital, Rome, Italy</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keratoconus</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/NCT03753009
org study id: PCXL
nct id: NCT03753009
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To compare 3 year iontophoretic transepithelial corneal cross-linking (I-ON CXL) outcomes
      with epithelium-off collagen cross-linking (epi-off CXL)in pediatric patients.
Forty eyes of 28 consecutive pediatric patients (mean age 14.3±2.5 [SD] years; range, 9 to 18
      years) with keratoconus were enrolled in the study. Twenty eyes of 15 patients underwent I-ON
      CXL, while 20 eyes of 13 patients underwent epi-off CXL. Corrected distance visual acuity
      (CDVA), spherical equivalent, maximum keratometry (Kmax), posterior elevation of the thinnest
      point and thickness of the thinnest point mean values were evaluated. A Student t test was
      used to compare baseline and 12, 24, and 36 month postoperative data. Keratoconus progression
      in function of preoperative Kmax value and cone location was evaluated at 36 months.
observational model: Cohort
time perspective: Retrospective
measure: keratoconus stability
time frame: 3 years
description: To evaluate change of simulated maximum K (Kmax) that was calculated by a Sirius Scheimpflug camera (CSO, Firenze, Italy) by averaging the axial curvature from the fourth to the eighth Placido rings of the flattest and steepest meridians (the amplitude of the zone taken into consideration, therefore has a vari-able diameter depending on the curvature of the cornea, and the principal meridians are not nec-essarily 90 degrees away)
arm group label: iontophoretic transepithelial corneal cross-linking (I-ON CXL)
description: Twenty eyes of 15 patients with keratoconus (mean age 13±3.5 [SD] years, range 9 to 18) underwent Iontophoresis epi-on CXL
arm group label: epithelium-off collagen cross-linking (epi-off CXL)
description: Twenty eyes of 13 patients with keratoconus (14±4 [SD] years, range 10 to 18) underwent standard epi-off CXL
intervention type: Procedure
intervention name: corneal cross-linking
description: Epithelium-off CXL was performed according to the Siena (Dresden modified) protocol: 2% pilocarpine was instilled 30 minutes before treatment, the epithelium was removed using a blunt knife. An isotonic solution of riboflavin 0.1% and dextran 20% was instilled for 10 minutes of corneal soaking before starting UV-A irradiation. The solution was administered every 3 minutes for a total of 30 minutes of UV-A exposure at 3mW/cm2.
The iontophoresis device was filled with a hypoosmolar riboflavin 0.1% dextran-free solution enriched with ethylenediaminetetraacetic acid and trometamol. The device was then connected to a constant current generator initially set at 0.5 mA and increased to 1.0 mA to find out the individual tolerance. Iontophoresis was then performed for 5 minutes. The corneal device was then removed before performing UVA irradiation. During the irradiation phase (10 mW/cm2 for 9 minutes), good fluorescence was clearly detectable. The total treatment time was 14 minutes.
arm group label: epithelium-off collagen cross-linking (epi-off CXL)
arm group label: iontophoretic transepithelial corneal cross-linking (I-ON CXL)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 9 Years
maximum age: 18 Years
last name: Luca Buzzonetti, MD
role: Principal Investigator
affiliation: Bambino Gesù Children's Hospital, Rome, Italy
responsible party type: Principal Investigator
investigator affiliation: Bambino Gesù Hospital and Research Institute
investigator full name: Luca Buzzonetti
investigator title: Head of the Ophthalmology Department, Bambino Gesù IRCCS Children's Hospital, Rome, Italy
mesh term: Keratoconus
sharing ipd: No