<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/NCT04504578</url>
  </required_header>
  <id_info>
    <org_study_id>s5-2019</org_study_id>
    <nct_id>NCT04504578</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety ofCACXL in the Treatment of Keratoconus With Thin Corneas</brief_title>
  <acronym>CACXL</acronym>
  <official_title>Efficacy and Safety of Contact Lens-assisted Corneal Cross- Linking in the Treatment of Keratoconus With Thin Corneas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kasr El Aini Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kasr El Aini Hospital</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>
      The aim of this study is to detect the safety and effectiveness of contact lens assisted&#xD;
      corneal cross linking in managing progressive keratoconus with thin corneas CACXL was done&#xD;
      for 40 eyes of 30 of keratoconic patients presented to cornea outpatient clinic in Kasr&#xD;
      Alainy teaching hospital The UDVA ,BDVA KMAX, thinnest corneal thickness pre-operative and 9&#xD;
      months postoperatively and the endothelial cell count was measured preoperative and 3 months&#xD;
      postoperative Demarcation line was measured after 1 month by using ASOCT There was&#xD;
      statistical significant difference in UDVA and BDVA, there was stabilization of Kmax there&#xD;
      was decrease in endothelial cell count but not statistically significant According to results&#xD;
      the procedure seems to be effective and safe un managing progressive keratoconus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Corneal collagen cross linking showed effective results in stabilizing progressive&#xD;
      keratoconic corneas. It is the only treatment that halts progression of keratoconus, It was&#xD;
      first described in 1998 by Spoerl et al . A major limitation of the procedure that it cannot&#xD;
      be used in corneas with pachymetry less than400 micrometers based on the fact that an&#xD;
      irradiance of 0.37 mW/cm2 has been found to be cytotoxic for the endothelial cell layer.&#xD;
      Since the absorption coefficient for the human corneas is 70 cm-1 and the intended surface&#xD;
      irradiance is 3.0 mW/cm2, the 0.37 mW/cm2 irradiance is reached at 300 microns depth. In a&#xD;
      400 microns thick cornea saturated with riboflavin, the irradiance at the endothelial level&#xD;
      is 0.18 mW/cm2, which is a factor of 2 smaller than the damage threshold. Therefore, the 400&#xD;
      microns limit is considered to be a safe limit to protect the endothelium and intraocular&#xD;
      structures from the hazards of UV irradiation 12 However , the patients with advanced ectasia&#xD;
      who are desperately in need for cxl , are the same ones who have thin corneas often below the&#xD;
      threshold which is considered to be safe for CXL treatment However further studies with&#xD;
      longer follow up and larger numbers of cases are needed to confirm our findings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">February 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 1, 2019</primary_completion_date>
  <phase>N/A</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>patients with progressive keratoconus with thin corneas less than 400 micron</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>kmax</measure>
    <time_frame>tomography after 9 months</time_frame>
    <description>stabilization of the cornea by corneal tomography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of endothelial cell count</measure>
    <time_frame>3 months postoperative by specular microscopy</time_frame>
    <description>number of endothelial cell before and after treatment</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Progressive Keratoconus</condition>
  <arm_group>
    <arm_group_label>patients with progressive keratoconus with thin corneas</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with progressive keratoconus with thin corneas , with thickness less than 400 micron ,will do conventional cross linking but with putting contact lens over the cornea ( will receive Contact lens assisted corneal cross liking )</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>contact lens assisted corneal cross linking</intervention_name>
    <description>40 eyes of 30 patients underwent CACXL. The central 9 mm of corneal epithelium was abraded , Iso-tonic riboflavin 0.1% was applied every 2 minutes for 10 minutes on the debrided cornea. A disposable soft Contact lens without an ultraviolet filter (Soflens, Bausch &amp; Lomb) was placed in the inferior fornix during soaking of the stroma with riboflavin for 10 minutes. The contact lens was applied on the corneal surface and the cornea was exposed to ultraviolet-A irradiation at fluence of 3.0 mW/cm2 for 30 minutes The uncorrected (UDVA) and best corrected (BDVA) visual acuity, and maximum (K max) keratometric values, were assessed before, and after 9 months CXL. Endothelial cell count was assessed before and 3 months after CXL. Anterior segment OCT was done 1 month after CXL to evaluate the presence and depth of the corneal stromal demarcation line.</description>
    <arm_group_label>patients with progressive keratoconus with thin corneas</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age from 18 to 35years old Mild , moderate and severe keratoconic patients with a&#xD;
             corneal thickness from 360-400 µm at the thinnest location .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Previous corneal surgeries such as rings or crosslinking.&#xD;
&#xD;
               -  Patients with stromal corneal scar.&#xD;
&#xD;
               -  Other ocular pathology such as glaucoma or iridocyclitis.&#xD;
&#xD;
               -  Patient with systemic diseases that likely affects wound healing such as insulin&#xD;
                  dependent diabetes mellitus.&#xD;
&#xD;
               -  Patients with collagen vascular diseases, autoimmune or immune deficiency&#xD;
                  diseases.&#xD;
&#xD;
               -  Pregnant or nursing women.&#xD;
&#xD;
               -  Patients taking the following medications ; isotretinoin, amiodarone,&#xD;
                  sumatriptan.&#xD;
&#xD;
               -  Other corneal pathology rather than keratoconus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kasrelaini Hospital</name>
      <address>
        <city>Cairo</city>
        <zip>12654</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
    <investigator_full_name>Moustafa Nour</investigator_full_name>
    <investigator_title>assistant lecturer</investigator_title>
  </responsible_party>
  <keyword>cross linking</keyword>
  <keyword>thin corneas</keyword>
  <keyword>Advanced keratoconus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keratoconus</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/NCT04504578
org study id: s5-2019
nct id: NCT04504578
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to detect the safety and effectiveness of contact lens assisted
      corneal cross linking in managing progressive keratoconus with thin corneas CACXL was done
      for 40 eyes of 30 of keratoconic patients presented to cornea outpatient clinic in Kasr
      Alainy teaching hospital The UDVA ,BDVA KMAX, thinnest corneal thickness pre-operative and 9
      months postoperatively and the endothelial cell count was measured preoperative and 3 months
      postoperative Demarcation line was measured after 1 month by using ASOCT There was
      statistical significant difference in UDVA and BDVA, there was stabilization of Kmax there
      was decrease in endothelial cell count but not statistically significant According to results
      the procedure seems to be effective and safe un managing progressive keratoconus.
Corneal collagen cross linking showed effective results in stabilizing progressive
      keratoconic corneas. It is the only treatment that halts progression of keratoconus, It was
      first described in 1998 by Spoerl et al . A major limitation of the procedure that it cannot
      be used in corneas with pachymetry less than400 micrometers based on the fact that an
      irradiance of 0.37 mW/cm2 has been found to be cytotoxic for the endothelial cell layer.
      Since the absorption coefficient for the human corneas is 70 cm-1 and the intended surface
      irradiance is 3.0 mW/cm2, the 0.37 mW/cm2 irradiance is reached at 300 microns depth. In a
      400 microns thick cornea saturated with riboflavin, the irradiance at the endothelial level
      is 0.18 mW/cm2, which is a factor of 2 smaller than the damage threshold. Therefore, the 400
      microns limit is considered to be a safe limit to protect the endothelium and intraocular
      structures from the hazards of UV irradiation 12 However , the patients with advanced ectasia
      who are desperately in need for cxl , are the same ones who have thin corneas often below the
      threshold which is considered to be safe for CXL treatment However further studies with
      longer follow up and larger numbers of cases are needed to confirm our findings.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: patients with progressive keratoconus with thin corneas less than 400 micron
primary purpose: Treatment
masking: None (Open Label)
measure: kmax
time frame: tomography after 9 months
description: stabilization of the cornea by corneal tomography
measure: number of endothelial cell count
time frame: 3 months postoperative by specular microscopy
description: number of endothelial cell before and after treatment
arm group label: patients with progressive keratoconus with thin corneas
arm group type: Experimental
description: patients with progressive keratoconus with thin corneas , with thickness less than 400 micron ,will do conventional cross linking but with putting contact lens over the cornea ( will receive Contact lens assisted corneal cross liking )
intervention type: Procedure
intervention name: contact lens assisted corneal cross linking
description: 40 eyes of 30 patients underwent CACXL. The central 9 mm of corneal epithelium was abraded , Iso-tonic riboflavin 0.1% was applied every 2 minutes for 10 minutes on the debrided cornea. A disposable soft Contact lens without an ultraviolet filter (Soflens, Bausch & Lomb) was placed in the inferior fornix during soaking of the stroma with riboflavin for 10 minutes. The contact lens was applied on the corneal surface and the cornea was exposed to ultraviolet-A irradiation at fluence of 3.0 mW/cm2 for 30 minutes The uncorrected (UDVA) and best corrected (BDVA) visual acuity, and maximum (K max) keratometric values, were assessed before, and after 9 months CXL. Endothelial cell count was assessed before and 3 months after CXL. Anterior segment OCT was done 1 month after CXL to evaluate the presence and depth of the corneal stromal demarcation line.
arm group label: patients with progressive keratoconus with thin corneas
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Kasr El Aini Hospital
investigator full name: Moustafa Nour
investigator title: assistant lecturer
mesh term: Keratoconus