<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/NCT03755752</url>
  </required_header>
  <id_info>
    <org_study_id>17300250</org_study_id>
    <nct_id>NCT03755752</nct_id>
  </id_info>
  <brief_title>Safety of Trypan Blue on Endothelium of Diabetic Retinopathy Patients</brief_title>
  <official_title>Safety of Trypan Blue Capsule Staining to Corneal Endothelium in Patients With Diabetic Retinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study examines the use of Trypan Blue staining of the corneal endothelium in patients&#xD;
      undergoing phacoemulsification. It is a single-center prospective, randomized individual&#xD;
      cohort study. One eye in each patient with diabetic retinopathy will undergo&#xD;
      phacoemulsification without Trypan Blue capsule staining (control eye) while the other eye&#xD;
      will undergo phacoemulsification with Trypan Blue capsule staining (study eye). Both eyes&#xD;
      will undergo intraocular lens implantation. Preoperative and four-week postoperative&#xD;
      quantitative and qualitative morphometric endothelial cell analyses of the cornea will be&#xD;
      performed using noncontact specular microscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 25, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Randomization was done using an envelope technique wherein, after each patient was placed on the operating bed, the surgeon opened the patient's corresponding envelope, which contained information about whether Trypan Blue should be used for anterior capsular staining or not.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Endothelial cell density</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Endothelial cell coefficient of variation</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of hexagonal cells</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean corneal thickness</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Cataract Diabetic</condition>
  <arm_group>
    <arm_group_label>Phacoemulsification with Trypan Blue</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phacoemulsification with Trypan Blue capsule staining of the anterior lens capsule in patients with diabetic retinopathy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phacoemulsification without Trypan Blue</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phacoemulsification without Trypan Blue capsule staining of the anterior lens capsule in patients with</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Phacoemulsification with and without Trypan Blue capsule staining</intervention_name>
    <description>Phacoemulsification for patients with diabetic retinopathy having cataract in both eyes. One eye underwent phacoemulsification with trypan blue capsule staining and the other eye underwent phacoemulsification without trypan blue.</description>
    <arm_group_label>Phacoemulsification with Trypan Blue</arm_group_label>
    <arm_group_label>Phacoemulsification without Trypan Blue</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with bilateral cataract and diabetic retinopathy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of ocular surgery Active&#xD;
&#xD;
          -  ocular inflammation Corneal opacities&#xD;
&#xD;
          -  Pseudoexfoliation syndrome&#xD;
&#xD;
          -  Anterior chamber flare and (or) other signs of possibly altered blood - queous barrier&#xD;
&#xD;
          -  Iris neovascularization (rubeosis)&#xD;
&#xD;
          -  Uncontrolled glaucoma&#xD;
&#xD;
          -  Congenital or traumatic cataracts&#xD;
&#xD;
          -  History or present chronic use of topical or systemic steroids&#xD;
&#xD;
          -  Poor papillary dilatation (&lt;6 mm)&#xD;
&#xD;
          -  Specular microscopy cell density &lt; 2000 cell/mm2&#xD;
&#xD;
          -  Patients who experienced complications fromphacoemulsification&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Khaled Abdelazeem</investigator_full_name>
    <investigator_title>Lecturer of Ophthalmology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diminazene aceturate</mesh_term>
  </intervention_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/NCT03755752
org study id: 17300250
nct id: NCT03755752
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study examines the use of Trypan Blue staining of the corneal endothelium in patients
      undergoing phacoemulsification. It is a single-center prospective, randomized individual
      cohort study. One eye in each patient with diabetic retinopathy will undergo
      phacoemulsification without Trypan Blue capsule staining (control eye) while the other eye
      will undergo phacoemulsification with Trypan Blue capsule staining (study eye). Both eyes
      will undergo intraocular lens implantation. Preoperative and four-week postoperative
      quantitative and qualitative morphometric endothelial cell analyses of the cornea will be
      performed using noncontact specular microscopy.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Investigator)
masking description: Randomization was done using an envelope technique wherein, after each patient was placed on the operating bed, the surgeon opened the patient's corresponding envelope, which contained information about whether Trypan Blue should be used for anterior capsular staining or not.
measure: Endothelial cell density
time frame: 4 weeks
measure: Endothelial cell coefficient of variation
time frame: 4 weeks
measure: Percent of hexagonal cells
time frame: 4 weeks
measure: Mean corneal thickness
time frame: 4 weeks
arm group label: Phacoemulsification with Trypan Blue
arm group type: Experimental
description: Phacoemulsification with Trypan Blue capsule staining of the anterior lens capsule in patients with diabetic retinopathy
arm group label: Phacoemulsification without Trypan Blue
arm group type: Experimental
description: Phacoemulsification without Trypan Blue capsule staining of the anterior lens capsule in patients with
intervention type: Procedure
intervention name: Phacoemulsification with and without Trypan Blue capsule staining
description: Phacoemulsification for patients with diabetic retinopathy having cataract in both eyes. One eye underwent phacoemulsification with trypan blue capsule staining and the other eye underwent phacoemulsification without trypan blue.
arm group label: Phacoemulsification with Trypan Blue
arm group label: Phacoemulsification without Trypan Blue
criteria: 
gender: All
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Khaled Abdelazeem
investigator title: Lecturer of Ophthalmology
mesh term: Cataract
mesh term: Diabetic Retinopathy
mesh term: Diminazene aceturate
sharing ipd: No