<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/NCT03266406</url>
  </required_header>
  <id_info>
    <org_study_id>effect of hyaluronidase on IOP</org_study_id>
    <nct_id>NCT03266406</nct_id>
  </id_info>
  <brief_title>Effect of Hyaluronidase on Intraocular Pressure</brief_title>
  <official_title>Effect of Hyaluronidase on Intraocular Pressure After Retrobulbar Anaesthesia During Cataract Surgery</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>
      The aim of this study is to evaluate effect of retrobulbar local anaesthesia after addition&#xD;
      of hyaluronidase on IOP during cataract surgery&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">October 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>reduction in IOP</measure>
    <time_frame>within 10minutes</time_frame>
    <description>reduction of complications of high IOP during surgery</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Intraocular Pressure Low</condition>
  <arm_group>
    <arm_group_label>Effect of hyaluronidase on IOP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hyaluronidase</intervention_name>
    <description>4ml of retrobulbar LA with addition of 15IU/ml hyaluronidase to 2% lidocaine</description>
    <arm_group_label>Effect of hyaluronidase on IOP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1-Patients above the age of 50 years. 2-Patients with age related cataract. 3-Normal&#xD;
             IOP.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1History of trauma. 2-Patients with glaucoma. 3-Previous ocular surgery. 4-Patients&#xD;
             with other ocular pathology. 5-Uncontrolled diabetes or hypertension.&#xD;
             6-hypersensitivity to lignocaine. 7-Uncooperative or epileptic patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Eman Yassin</last_name>
    <phone>00201004686028</phone>
    <email>emanyassin08@gmail.com</email>
  </overall_contact>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Eman Yassin Ahmed</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>Ocular Hypotension</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/NCT03266406
org study id: effect of hyaluronidase on IOP
nct id: NCT03266406
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate effect of retrobulbar local anaesthesia after addition
      of hyaluronidase on IOP during cataract surgery
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: reduction in IOP
time frame: within 10minutes
description: reduction of complications of high IOP during surgery
arm group label: Effect of hyaluronidase on IOP
arm group type: Experimental
intervention type: Drug
intervention name: Hyaluronidase
description: 4ml of retrobulbar LA with addition of 15IU/ml hyaluronidase to 2% lidocaine
arm group label: Effect of hyaluronidase on IOP
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
last name: Eman Yassin
phone: 00201004686028
email: emanyassin08@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Eman Yassin Ahmed
investigator title: Principal Investigator
mesh term: Ocular Hypotension