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/NCT06031350</url>
    </required_header>
    <id_info>
      <org_study_id>EOM64</org_study_id>
      <nct_id>NCT06031350</nct_id>
    </id_info>
    <brief_title>Peripapillary and Macular Vascular Changes of Unilateral Anterior Ischemic Optic Neuropathy: An Optical Coherence Tomography Angiography Study</brief_title>
    <official_title>Peripapillary and Macular Vascular Changes of Unilateral Anterior Ischemic Optic Neuropathy: An Optical Coherence Tomography Angiography Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Omar Said</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fayoum University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This series aims at studying the peripapillary and macular vascular changes in subjects with&#xD;
        unilateral anterior ischemic optic neuropathy via Optical Coherence Tomography Angiography&#xD;
        (OCTA).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After approval of the local institutional ethics committee and local institutional review&#xD;
        board, This study was conducted upon 30 patients diagnosed with acute NAION attending at&#xD;
        Ophthalmology outpatient clinic in Fayoum University Hospitals. The participants were&#xD;
        informed about the objectives of the study, the examination, investigations and the&#xD;
        confidentiality of their information and their right not to participate in the study. OCT and&#xD;
        OCTA was done for all subjects and control group with Optovue, Inc., Fremont, CA, USA.&#xD;
        Patients were examined on presentation, after 6 weeks and lastly after 3 months. OCT was used&#xD;
        for evaluation of Central macular thickness (CMT), nerve fiber layer thickness (NFLT) and&#xD;
        ganglion cell complex (GCC). OCTA was done for quantitative evaluation of vessel density in&#xD;
        the following: optic nerve head and peripapillary area, macular superficial vessel density,&#xD;
        macular deep vessel density and foveal avascular zone. Vessel density was reported as the&#xD;
        percentage of the total area that was occupied by blood vessels. All parameters were&#xD;
        calculated automatically by the machine software. Poor quality scans and those with motion&#xD;
        artifacts were excluded. Statistical analysis was performed using SPSS software (version 22;&#xD;
        SPSS, Chicago, IL, USA). The data were presented as the mean ± SD values. P-value &lt;0.05 was&#xD;
        considered significant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 1, 2021</start_date>
    <completion_date type="Actual">June 30, 2022</completion_date>
    <primary_completion_date type="Actual">May 31, 2022</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>3 Months</target_duration>
    <primary_outcome>
      <measure>Peripapillary and macular vascular changes</measure>
      <time_frame>3 months (0,6,12 weeks)</time_frame>
      <description>comparing vessel density in different areas and sectors of diseased and fellow eyes</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Thickness of different retinal layers</measure>
      <time_frame>3 months (0,6,12 weeks)</time_frame>
      <description>comparing thickness of Central macular thickness (CMT), nerve fiber layer thickness (NFLT) and ganglion cell complex (GCC)</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">30</enrollment>
    <condition>Non-arteritic Ischemic Optic Neuropathy</condition>
    <arm_group>
      <arm_group_label>Diseased eyes</arm_group_label>
      <description>The 30 diseased eyes of the patients were considered the case group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Fellow eyes</arm_group_label>
      <description>The 30 fellow eyes of the patients were considered the control group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Optical Coherence Tomography Angiography</intervention_name>
      <description>Optovue, Inc., Fremont, CA, USA</description>
      <arm_group_label>Diseased eyes</arm_group_label>
      <arm_group_label>Fellow eyes</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients presenting to the outpatient clinic of the department of Ophthalmology in Fayoum&#xD;
          university hospitals with unilateral acute NAION. 30 patients (60 eyes) divided into 2&#xD;
          groups: 30 NAION eyes as the case group, and 30 fellow eyes as a control group.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients diagnosed with unilateral NAION and acute or sudden painless drop of vision.&#xD;
  &#xD;
            -  A normal fellow eye.&#xD;
  &#xD;
            -  Age ≥ 40 years old.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Arteritic type of AION.&#xD;
  &#xD;
            -  NAION patients in chronic phase.&#xD;
  &#xD;
            -  Acute phase NAION patients with any other optic neuropathy in the other eye.&#xD;
  &#xD;
            -  Eyes with opaque media.&#xD;
  &#xD;
            -  Elevated intraocular pressure (&gt;22 mmHg).&#xD;
  &#xD;
            -  Refractive errors greater than 6 diopters of spherical equivalent.&#xD;
  &#xD;
            -  Poor cooperation with fixation or the OCTA examination.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Omar Said, MD</last_name>
      <role>Study Director</role>
      <affiliation>Assistant professor of Ophthalmology</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Faculty of Medicine, Fayoum University</name>
        <address>
          <city>Fayoum</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Fayoum University</investigator_affiliation>
      <investigator_full_name>Omar Said</investigator_full_name>
      <investigator_title>Assistant professor of Ophthalmology</investigator_title>
    </responsible_party>
    <keyword>OCTA AION NAION</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Optic Nerve Diseases</mesh_term>
      <mesh_term>Optic Neuropathy, Ischemic</mesh_term>
      <mesh_term>Ischemia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06031350
  org study id: EOM64
  nct id: NCT06031350
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  This series aims at studying the peripapillary and macular vascular changes in subjects with
        unilateral anterior ischemic optic neuropathy via Optical Coherence Tomography Angiography
        (OCTA).
  After approval of the local institutional ethics committee and local institutional review
        board, This study was conducted upon 30 patients diagnosed with acute NAION attending at
        Ophthalmology outpatient clinic in Fayoum University Hospitals. The participants were
        informed about the objectives of the study, the examination, investigations and the
        confidentiality of their information and their right not to participate in the study. OCT and
        OCTA was done for all subjects and control group with Optovue, Inc., Fremont, CA, USA.
        Patients were examined on presentation, after 6 weeks and lastly after 3 months. OCT was used
        for evaluation of Central macular thickness (CMT), nerve fiber layer thickness (NFLT) and
        ganglion cell complex (GCC). OCTA was done for quantitative evaluation of vessel density in
        the following: optic nerve head and peripapillary area, macular superficial vessel density,
        macular deep vessel density and foveal avascular zone. Vessel density was reported as the
        percentage of the total area that was occupied by blood vessels. All parameters were
        calculated automatically by the machine software. Poor quality scans and those with motion
        artifacts were excluded. Statistical analysis was performed using SPSS software (version 22;
        SPSS, Chicago, IL, USA). The data were presented as the mean ± SD values. P-value <0.05 was
        considered significant.
  observational model: Case-Control
  time perspective: Prospective
  measure: Peripapillary and macular vascular changes
  time frame: 3 months (0,6,12 weeks)
  description: comparing vessel density in different areas and sectors of diseased and fellow eyes
  measure: Thickness of different retinal layers
  time frame: 3 months (0,6,12 weeks)
  description: comparing thickness of Central macular thickness (CMT), nerve fiber layer thickness (NFLT) and ganglion cell complex (GCC)
  arm group label: Diseased eyes
  description: The 30 diseased eyes of the patients were considered the case group.
  arm group label: Fellow eyes
  description: The 30 fellow eyes of the patients were considered the control group.
  intervention type: Diagnostic Test
  intervention name: Optical Coherence Tomography Angiography
  description: Optovue, Inc., Fremont, CA, USA
  arm group label: Diseased eyes
  arm group label: Fellow eyes
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 40 Years
  healthy volunteers: No
  last name: Omar Said, MD
  role: Study Director
  affiliation: Assistant professor of Ophthalmology
  facility: 
  country: Egypt
  responsible party type: Sponsor-Investigator
  investigator affiliation: Fayoum University
  investigator full name: Omar Said
  investigator title: Assistant professor of Ophthalmology
  mesh term: Optic Nerve Diseases
  mesh term: Optic Neuropathy, Ischemic
  mesh term: Ischemia
  sharing ipd: Undecided