<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/NCT04457063</url>
  </required_header>
  <id_info>
    <org_study_id>0304624</org_study_id>
    <nct_id>NCT04457063</nct_id>
  </id_info>
  <brief_title>Endothelial Cell Loss After Penetrating Keratoplasty</brief_title>
  <official_title>Endothelial Cell Loss Following Toric ICL Implantation for Correction of Myopia and Astigmatism After Penetrating Keratoplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria 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>
      This work aimed at the assessment of corneal endothelial cell loss after toric ICL&#xD;
      implantation for correction of myopia and astigmatism after penetrating keratoplasty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Penetrating keratoplasty (PKP) is considered a safe and effective procedure.This work aimed&#xD;
      at the assessment of corneal endothelial cell loss after toric ICL implantation for&#xD;
      correction of myopia and astigmatism after penetrating keratoplasty.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Actual">June 15, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</primary_completion_date>
  <phase>Phase 2/Phase 3</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>A prospective non-comparative non-randomized clinical study which was conducted on 12 eyes of 8 patients 4 males and 4 females who underwent PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Refraction</measure>
    <time_frame>1 year</time_frame>
    <description>Refractive measured by Diopter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>1 year</time_frame>
    <description>The decimal snellens</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intra-ocular pressure</measure>
    <time_frame>1 year</time_frame>
    <description>mg</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Keratoconus</condition>
  <arm_group>
    <arm_group_label>penetrating keratoplasty</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A prospective non-comparative non-randomized clinical study which was conducted on 12 eyes of 8 patients 4 males and 4 females who underwent PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PKP</intervention_name>
    <description>The horizontal axis was marked with a pointed marker at the slit lamp immediately before surgery.&#xD;
TICL loading into the STAAR injector cartridge&#xD;
Temporal clear corneal 3 mm incision &amp; 2-side ports then viscoelastic injection into the AC&#xD;
Implantation of the TICL using the injector, then rotation according to the implantation diagram guided with Mendez protractor, and lastly placement of the haptics under the iris.&#xD;
Pupil constriction with A.Ch.&#xD;
Washing the viscoelastic &amp;Wound hydration.&#xD;
Topical antibiotic steroids (Vigamox and Tobradex) 4 times /day for 3weeks</description>
    <arm_group_label>penetrating keratoplasty</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PKP for keratoconus, and then toric ICL was implanted after minimum of one year with&#xD;
             stable refraction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 and unable to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ehab Mossallam, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandria Faculty of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alexandria Faculty of Medicine</name>
      <address>
        <city>Alexandria</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT04457063
org study id: 0304624
nct id: NCT04457063
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This work aimed at the assessment of corneal endothelial cell loss after toric ICL
      implantation for correction of myopia and astigmatism after penetrating keratoplasty.
Penetrating keratoplasty (PKP) is considered a safe and effective procedure.This work aimed
      at the assessment of corneal endothelial cell loss after toric ICL implantation for
      correction of myopia and astigmatism after penetrating keratoplasty.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A prospective non-comparative non-randomized clinical study which was conducted on 12 eyes of 8 patients 4 males and 4 females who underwent PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction
primary purpose: Treatment
masking: None (Open Label)
measure: Refraction
time frame: 1 year
description: Refractive measured by Diopter
measure: Visual acuity
time frame: 1 year
description: The decimal snellens
measure: Intra-ocular pressure
time frame: 1 year
description: mg
arm group label: penetrating keratoplasty
arm group type: Experimental
description: A prospective non-comparative non-randomized clinical study which was conducted on 12 eyes of 8 patients 4 males and 4 females who underwent PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction
intervention type: Procedure
intervention name: PKP
description: The horizontal axis was marked with a pointed marker at the slit lamp immediately before surgery.
TICL loading into the STAAR injector cartridge
Temporal clear corneal 3 mm incision & 2-side ports then viscoelastic injection into the AC
Implantation of the TICL using the injector, then rotation according to the implantation diagram guided with Mendez protractor, and lastly placement of the haptics under the iris.
Pupil constriction with A.Ch.
Washing the viscoelastic &Wound hydration.
Topical antibiotic steroids (Vigamox and Tobradex) 4 times /day for 3weeks
arm group label: penetrating keratoplasty
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ehab Mossallam, PhD
role: Principal Investigator
affiliation: Alexandria Faculty of Medicine
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Keratoconus
sharing ipd: No