xml: <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/NCT05969418</url>
    </required_header>
    <id_info>
      <org_study_id>05809850</org_study_id>
      <nct_id>NCT05969418</nct_id>
    </id_info>
    <brief_title>Deep Learning OCT and OCTA in NVC</brief_title>
    <official_title>Deep Learning OCT and OCTA Quantification in Neovascular Age Related Macular Degeneration</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>
        To evaluate the activity of neovascular macula degeneretion as assessed by SD-OCTand OCT-A&#xD;
        using a split-person study design and deep-learning quantification.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Exudative neovascular macular degeneration is the primarily an age-related retinal condition&#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 in order to choose the best therapy .&#xD;
  &#xD;
        The study evaluates the changes in structural optical coherence tomography and optical&#xD;
        coherence tomography angiography features in neovascular macular degeration patients&#xD;
        undergoing ANTI-VEGF treatments using artificial intelligence.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">December 21, 2023</completion_date>
    <primary_completion_date type="Actual">July 20, 2023</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 with macular degeneration complicated by nvc</measure>
      <time_frame>more than sixmonths</time_frame>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Macular Degeneration Choroidal Neovascularization</condition>
    <arm_group>
      <arm_group_label>Patients with neovascular macular degeneration</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>healty patients matched age and sex without any ocular disease</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter</intervention_name>
      <description>Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter before and after ANTI-VEGF treatment</description>
      <arm_group_label>Patients with neovascular macular degeneration</arm_group_label>
      <arm_group_label>healty patients matched age and sex without any ocular disease</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The participans were older than 50 years with diagnosis of neovascular macular&#xD;
          degeneration. They did not present other ophthalmological disease&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria: age older than 50 years&#xD;
  &#xD;
            -  diagnosis of neovascular macular degeneration&#xD;
  &#xD;
            -  absence of previous retinal 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:• age younger than 50 years&#xD;
  &#xD;
            -  previous retinal 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>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ciro Costagliola, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Federico II University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gilda Cennamo, MD</last_name>
      <phone>00390817462394</phone>
      <email>xgilda@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Federico II University</name>
        <address>
          <city>Naples</city>
          <zip>80121</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gilda Cennamo, MD</last_name>
        <phone>00390817462394</phone>
        <email>xgilda@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</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>Doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Macular Degeneration</mesh_term>
      <mesh_term>Choroidal Neovascularization</mesh_term>
      <mesh_term>Neovascularization, Pathologic</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05969418
  org study id: 05809850
  nct id: NCT05969418
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the activity of neovascular macula degeneretion as assessed by SD-OCTand OCT-A
        using a split-person study design and deep-learning quantification.
  Exudative neovascular macular degeneration is the primarily an age-related retinal condition
        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 in order to choose the best therapy .
  
        The study evaluates the changes in structural optical coherence tomography and optical
        coherence tomography angiography features in neovascular macular degeration patients
        undergoing ANTI-VEGF treatments using artificial intelligence.
  observational model: Cohort
  time perspective: Prospective
  measure: The measurements of retinal and choriocapillary vessel density in patients with macular degeneration complicated by nvc
  time frame: more than sixmonths
  arm group label: Patients with neovascular macular degeneration
  arm group label: healty patients matched age and sex without any ocular disease
  intervention type: Diagnostic Test
  intervention name: Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter
  description: Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter before and after ANTI-VEGF treatment
  arm group label: Patients with neovascular macular degeneration
  arm group label: healty patients matched age and sex without any ocular disease
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 90 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ciro Costagliola, MD
  role: Study Chair
  affiliation: Federico II University
  last name: Gilda Cennamo, MD
  phone: 00390817462394
  email: xgilda@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: Federico II University
  investigator full name: Gilda Cennamo
  investigator title: Doctor
  mesh term: Macular Degeneration
  mesh term: Choroidal Neovascularization
  mesh term: Neovascularization, Pathologic