<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/NCT03801590</url>
  </required_header>
  <id_info>
    <org_study_id>infectious keratitis</org_study_id>
    <nct_id>NCT03801590</nct_id>
  </id_info>
  <brief_title>Crosslinking in Infectious Keratitis</brief_title>
  <official_title>Safety and Efficacy Of Corneal Collagen Crosslinking (CXL) In Infectious Keratitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      Microbial keratitis is an infection of the cornea that is associated with risk of permanent&#xD;
      visual impairment.&#xD;
&#xD;
      It can be caused by bacteria, virus, fungus, protozoa and parasites. The common risk factors&#xD;
      for infectious keratitis include ocular trauma, contact lens wear, recent ocular surgery,&#xD;
      preexisting ocular surface disease, dry eyes, lid deformity, corneal sensation impairment,&#xD;
      chronic use of topical steroids and systemic immunosuppression .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The spectrum of bacterial keratitis can also be influenced by geographic and climatic&#xD;
      factors.&#xD;
&#xD;
      The treatment usually consist of Topical administered antibiotics .the emergence of&#xD;
      multidrug-resistant bacteria is a concern that might complicate the treatment and cure of&#xD;
      infectious keratitis.&#xD;
&#xD;
      Collagen cross linking (CXL) using ultraviolet-A (UV-A) and riboflavin in a treatment that&#xD;
      was developed to increase the biochemical strength of the cornea The procedure is based on&#xD;
      using riboflavin as a photosensitizer, which generates reactive oxygen species when activated&#xD;
      by UV-A at 365 or370 nm.&#xD;
&#xD;
      The standard technique (epi-off) also called Dresden Protocol includes removal of the&#xD;
      epithelium in order to expose the underlying stroma to riboflavin, which is otherwise&#xD;
      incompletely absorbed by the epithelium because of tight junctions. The area of corneal&#xD;
      epithelium removed has a diameter of 6.0 to 8.5 mm. A crosslinking procedure without&#xD;
      epithelial removal could also be performed (epi-on). It would likely be less painful compared&#xD;
      to the standard procedure.&#xD;
&#xD;
      The crosslinking process generates reactive oxygen species that can damage the cell walls of&#xD;
      pathogens. CXL induces formation of new covalent bonds thereby rendering the corneal stroma&#xD;
      biomechanically stronger and more resistant to enzymatic digestion . This can potentially&#xD;
      limit the spread of infection. Furthermore, CXL-induced apoptosis could contribute to the&#xD;
      reduction of inflammatory response during corneal infection .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2021</start_date>
  <completion_date type="Anticipated">January 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2022</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determine the duration for corneal ulcer healing</measure>
    <time_frame>one year</time_frame>
    <description>By follow up with photography before crosslinking and one week after performing cxl.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Infectious Keratitis</condition>
  <arm_group>
    <arm_group_label>CXL on patients with infectious keratitis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the procedure of cross linking(CXL) :combined riboflavin-ultraviolet type A rays (UVA) collagen cross-linking. Radiant energy was 3 milliwatts/cm2 for a 30-minute exposure irradiation of the cornea will be carried out on twenty patients with infectious keratitis .</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Crosslinking with Riboflavin and UV-A</intervention_name>
    <description>the procedure of cross linking(CXL) :combined riboflavin-ultraviolet type A rays (UVA) collagen cross-linking. Radiant energy was 3 milliwatts/cm2 for a 30-minute exposure irradiation of the cornea.</description>
    <arm_group_label>CXL on patients with infectious keratitis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with proved bacterial, fungal, acanthamoeba microbial keratitis .&#xD;
&#xD;
          -  Patient willing to comply with all study procedures .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe corneal scarring or opacification .&#xD;
&#xD;
          -  Patients with viral infectious keratitis&#xD;
&#xD;
          -  Prior herpetic infections .&#xD;
&#xD;
          -  Patients with any coexisting ocular pathology,ocular surface disease .&#xD;
&#xD;
          -  Patients with Autoimmune disease.&#xD;
&#xD;
          -  Pregnant women .&#xD;
&#xD;
          -  Corneal Thickness of less than 400 microns .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Green M, Apel A, Stapleton F. Risk factors and causative organisms in microbial keratitis. Cornea. 2008 Jan;27(1):22-7. doi: 10.1097/ICO.0b013e318156caf2.</citation>
    <PMID>18245962</PMID>
  </reference>
  <reference>
    <citation>Jankov Ii MR, Jovanovic V, Nikolic L, Lake JC, Kymionis G, Coskunseven E. Corneal collagen cross-linking. Middle East Afr J Ophthalmol. 2010 Jan;17(1):21-7. doi: 10.4103/0974-9233.61213.</citation>
    <PMID>20543933</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Amira Asem</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
    <mesh_term>Keratitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Riboflavin</mesh_term>
  </intervention_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/NCT03801590
org study id: infectious keratitis
nct id: NCT03801590
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Microbial keratitis is an infection of the cornea that is associated with risk of permanent
      visual impairment.

      It can be caused by bacteria, virus, fungus, protozoa and parasites. The common risk factors
      for infectious keratitis include ocular trauma, contact lens wear, recent ocular surgery,
      preexisting ocular surface disease, dry eyes, lid deformity, corneal sensation impairment,
      chronic use of topical steroids and systemic immunosuppression .
The spectrum of bacterial keratitis can also be influenced by geographic and climatic
      factors.

      The treatment usually consist of Topical administered antibiotics .the emergence of
      multidrug-resistant bacteria is a concern that might complicate the treatment and cure of
      infectious keratitis.

      Collagen cross linking (CXL) using ultraviolet-A (UV-A) and riboflavin in a treatment that
      was developed to increase the biochemical strength of the cornea The procedure is based on
      using riboflavin as a photosensitizer, which generates reactive oxygen species when activated
      by UV-A at 365 or370 nm.

      The standard technique (epi-off) also called Dresden Protocol includes removal of the
      epithelium in order to expose the underlying stroma to riboflavin, which is otherwise
      incompletely absorbed by the epithelium because of tight junctions. The area of corneal
      epithelium removed has a diameter of 6.0 to 8.5 mm. A crosslinking procedure without
      epithelial removal could also be performed (epi-on). It would likely be less painful compared
      to the standard procedure.

      The crosslinking process generates reactive oxygen species that can damage the cell walls of
      pathogens. CXL induces formation of new covalent bonds thereby rendering the corneal stroma
      biomechanically stronger and more resistant to enzymatic digestion . This can potentially
      limit the spread of infection. Furthermore, CXL-induced apoptosis could contribute to the
      reduction of inflammatory response during corneal infection .
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Determine the duration for corneal ulcer healing
time frame: one year
description: By follow up with photography before crosslinking and one week after performing cxl.
arm group label: CXL on patients with infectious keratitis
arm group type: Experimental
description: the procedure of cross linking(CXL) :combined riboflavin-ultraviolet type A rays (UVA) collagen cross-linking. Radiant energy was 3 milliwatts/cm2 for a 30-minute exposure irradiation of the cornea will be carried out on twenty patients with infectious keratitis .
intervention type: Device
intervention name: Crosslinking with Riboflavin and UV-A
description: the procedure of cross linking(CXL) :combined riboflavin-ultraviolet type A rays (UVA) collagen cross-linking. Radiant energy was 3 milliwatts/cm2 for a 30-minute exposure irradiation of the cornea.
arm group label: CXL on patients with infectious keratitis
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
citation: Green M, Apel A, Stapleton F. Risk factors and causative organisms in microbial keratitis. Cornea. 2008 Jan;27(1):22-7. doi: 10.1097/ICO.0b013e318156caf2.
PMID: 18245962
citation: Jankov Ii MR, Jovanovic V, Nikolic L, Lake JC, Kymionis G, Coskunseven E. Corneal collagen cross-linking. Middle East Afr J Ophthalmol. 2010 Jan;17(1):21-7. doi: 10.4103/0974-9233.61213.
PMID: 20543933
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Amira Asem
investigator title: principal investigator
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Keratitis
mesh term: Riboflavin