<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/NCT04491773</url>
  </required_header>
  <id_info>
    <org_study_id>1516/19</org_study_id>
    <nct_id>NCT04491773</nct_id>
  </id_info>
  <brief_title>Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg for More Than 6 Months</brief_title>
  <official_title>Evaluation of Retinal and Choriocapillary Vascular Changes Using Optical Coherence Tomography Angiography in Patients Undergoing Tadalafil 20mg on Alternative Days for More Than 6 Months: a Single-centre Prospective-control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federico II University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federico II 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 study evaluates the retinal and choriocapillary vascular features in patients under the&#xD;
      effects of Tadalafil 20mg for more than 6 months, using optical coherence tomography&#xD;
      angiography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tadalafil is a an inhibitor of the enzyme phosphodiesterase and it works by increasing blood&#xD;
      flow to the penis thus promoting the erection.&#xD;
&#xD;
      This drug represents an treatment for erectile dysfunction in patients after radical&#xD;
      prostatectomy.&#xD;
&#xD;
      The optical coherence tomography angiography represents a novel and noninvasive diagnostic&#xD;
      technique that allows a detailed and quantitative analysis of retinal and choriocapillary&#xD;
      vascular features.&#xD;
&#xD;
      The study evaluates the changes in optical coherence tomography angiography features after&#xD;
      the somministration of Tadalafil 20 mg orally for more than 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Actual">May 30, 2020</completion_date>
  <primary_completion_date type="Actual">May 25, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The measurements of retinal and choriocapillary vessel density in patients undergoing Tadalafil for more than 6 months</measure>
    <time_frame>More than 6 months</time_frame>
    <description>Changes in retinal and choriocapillary vessel density in patients after radical prostatectomy, undergoing Tadalafil 20 mg orally on alternate days for more than 6 months, using optical coherence tomography angiography.&#xD;
The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillary vessel density</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">54</enrollment>
  <condition>Erectile Dysfunction Following Radical Prostatectomy</condition>
  <arm_group>
    <arm_group_label>Patients undergoing Tadalafil</arm_group_label>
    <description>Patients after radical prostatectomy, undergoing Tadalafil 20 mg orally, on alternative days, for more than 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>Healthy controls without previous surgery of radical prostatectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tadalafil 20 MG</intervention_name>
    <description>To study retinal and choriocapillary features in patients undergoing Tadalafil 20 mg orally, on alternate days, for more than 6 months.</description>
    <arm_group_label>Patients undergoing Tadalafil</arm_group_label>
    <other_name>Cialis</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The participans were older than 45 years with diagnosis of erectile dysfunction due to&#xD;
        surgery of radical prostatectomy. They did not receive previous treatment before Tadalafil.&#xD;
        They did not present any ophthalmological disease, diabetes, heart diseases and&#xD;
        hypertension.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age older than 45 years&#xD;
&#xD;
          -  diagnosis of erectile dysfunction due to surgery of radical prostatectomy&#xD;
&#xD;
          -  treatment-naïve with Tadalafil for erectile dysfunction for more than 6 months&#xD;
&#xD;
          -  absence of diabetes, heart diseases, hypertension&#xD;
&#xD;
          -  absence of drug intake&#xD;
&#xD;
          -  absence of vitreoretinal, vascular retinal diseases&#xD;
&#xD;
          -  absence of previous ocular surgery and congenital eye diseases.&#xD;
&#xD;
          -  absence of errors of refraction&#xD;
&#xD;
          -  absence of lens opacities&#xD;
&#xD;
          -  absence of low-quality OCT and OCTA images&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age younger than 45 years&#xD;
&#xD;
          -  diagnosis of erectile dysfunction due to other causes&#xD;
&#xD;
          -  previous treatments before Tadalafil for erectile dysfunction&#xD;
&#xD;
          -  presence of diabetes, heart diseases, hypertension&#xD;
&#xD;
          -  drug intake&#xD;
&#xD;
          -  vitreoretinal and vascular retinal diseases&#xD;
&#xD;
          -  previous ocular surgery and congenital eye diseases&#xD;
&#xD;
          -  errors of refraction&#xD;
&#xD;
          -  lens opacities&#xD;
&#xD;
          -  low-quality OCT and OCTA images&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gilda Cennamo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federico II University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Naples &quot;Federico II&quot;</name>
      <address>
        <city>Naples</city>
        <zip>80100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>July 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 25, 2020</last_update_submitted>
  <last_update_submitted_qc>July 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federico II University</investigator_affiliation>
    <investigator_full_name>Gilda Cennamo</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>Erectile Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tadalafil</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/NCT04491773
org study id: 1516/19
nct id: NCT04491773
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the retinal and choriocapillary vascular features in patients under the
      effects of Tadalafil 20mg for more than 6 months, using optical coherence tomography
      angiography.
Tadalafil is a an inhibitor of the enzyme phosphodiesterase and it works by increasing blood
      flow to the penis thus promoting the erection.

      This drug represents an treatment for erectile dysfunction in patients after radical
      prostatectomy.

      The optical coherence tomography angiography represents a novel and noninvasive diagnostic
      technique that allows a detailed and quantitative analysis of retinal and choriocapillary
      vascular features.

      The study evaluates the changes in optical coherence tomography angiography features after
      the somministration of Tadalafil 20 mg orally for more than 6 months.
observational model: Cohort
time perspective: Prospective
measure: The measurements of retinal and choriocapillary vessel density in patients undergoing Tadalafil for more than 6 months
time frame: More than 6 months
description: Changes in retinal and choriocapillary vessel density in patients after radical prostatectomy, undergoing Tadalafil 20 mg orally on alternate days for more than 6 months, using optical coherence tomography angiography.
The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillary vessel density
arm group label: Patients undergoing Tadalafil
description: Patients after radical prostatectomy, undergoing Tadalafil 20 mg orally, on alternative days, for more than 6 months
arm group label: Control Group
description: Healthy controls without previous surgery of radical prostatectomy.
intervention type: Drug
intervention name: Tadalafil 20 MG
description: To study retinal and choriocapillary features in patients undergoing Tadalafil 20 mg orally, on alternate days, for more than 6 months.
arm group label: Patients undergoing Tadalafil
other name: Cialis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 45 Years
maximum age: 70 Years
healthy volunteers: No
last name: Gilda Cennamo
role: Principal Investigator
affiliation: Federico II University
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Federico II University
investigator full name: Gilda Cennamo
investigator title: Principal Investigator
mesh term: Erectile Dysfunction
mesh term: Tadalafil