<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/NCT04425954</url>
  </required_header>
  <id_info>
    <org_study_id>PT 2006/20</org_study_id>
    <nct_id>NCT04425954</nct_id>
  </id_info>
  <brief_title>Evaluation of Early Retinal Vascular Modifications After Endoscopic Endonasal Pituitary Surgery</brief_title>
  <official_title>Early Retinal Vascular Modifications After Endoscopic Endonasal Pituitary Surgery: The Role of OCT- Angiography</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>
    <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 vascular features using optical coherence tomography&#xD;
      angiography in patients that received endoscopic endonasal approach for the removal of an&#xD;
      intra-suprasellar pituitary adenoma compressing the optic nerve.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To investigate the potential role of optical coherence tomography angiography in predicting&#xD;
      the postoperative recovery of retinal vascular network of the optic disc in patients before&#xD;
      and at 3 months after Endoscopic Endonasal Approach for the removal of an intra-suprasellar&#xD;
      pituitary adenoma compressing the optic nerve.&#xD;
&#xD;
      The optical coherence tomography angiography represents a novel and non-invasive diagnostic&#xD;
      technique that allows a detailed analysis of retinal vascular features.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Study of vessel density of the optic disc in patients underwent Endoscopic Endonasal Pituitary Surgery for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.</measure>
    <time_frame>48 hours</time_frame>
    <description>To evaluate the role of optical coherence tomography angiography in predicting the recovery of the vessel density of the optic disc after surgery, using optical coherence tomography angiography (OCTA). The parameter analyzed by OCTA was the vessel density of the optic disc (percent)</description>
  </primary_outcome>
  <enrollment type="Actual">14</enrollment>
  <condition>Pituitary Adenoma</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic Endonasal Pituitary Surgery</intervention_name>
    <description>Surgical treatment consisted of an endoscopic endonasal approach using a rigid 0-degree endoscope, 18 cm in length and 4 mm in diameter.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The participans were older than 45 years with pituitary adenoma. They did not present other&#xD;
        ophthalmological and neurological diseases.&#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 pituitary adenoma&#xD;
&#xD;
          -  treatment-naïve with Endoscopic Endonasal Pituitary Surgery&#xD;
&#xD;
          -  absence of other neurological diseases&#xD;
&#xD;
          -  absence of vitreoretinal and vascular retinal diseases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age younger than 45 years&#xD;
&#xD;
          -  No diagnosis of pituitary adenoma&#xD;
&#xD;
          -  previous treatments with Endoscopic Endonasal Pituitary Surgery&#xD;
&#xD;
          -  presence of neurological diseases&#xD;
&#xD;
          -  presence of vitreoretinal and vascular retinal diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 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>Adenoma</mesh_term>
    <mesh_term>Pituitary Neoplasms</mesh_term>
    <mesh_term>Pituitary Diseases</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/NCT04425954
org study id: PT 2006/20
nct id: NCT04425954
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study evaluates the retinal vascular features using optical coherence tomography
      angiography in patients that received endoscopic endonasal approach for the removal of an
      intra-suprasellar pituitary adenoma compressing the optic nerve.
To investigate the potential role of optical coherence tomography angiography in predicting
      the postoperative recovery of retinal vascular network of the optic disc in patients before
      and at 3 months after Endoscopic Endonasal Approach for the removal of an intra-suprasellar
      pituitary adenoma compressing the optic nerve.

      The optical coherence tomography angiography represents a novel and non-invasive diagnostic
      technique that allows a detailed analysis of retinal vascular features.
observational model: Cohort
time perspective: Retrospective
measure: Study of vessel density of the optic disc in patients underwent Endoscopic Endonasal Pituitary Surgery for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.
time frame: 48 hours
description: To evaluate the role of optical coherence tomography angiography in predicting the recovery of the vessel density of the optic disc after surgery, using optical coherence tomography angiography (OCTA). The parameter analyzed by OCTA was the vessel density of the optic disc (percent)
intervention type: Procedure
intervention name: Endoscopic Endonasal Pituitary Surgery
description: Surgical treatment consisted of an endoscopic endonasal approach using a rigid 0-degree endoscope, 18 cm in length and 4 mm in diameter.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
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: Adenoma
mesh term: Pituitary Neoplasms
mesh term: Pituitary Diseases