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/NCT06000176</url>
    </required_header>
    <id_info>
      <org_study_id>M557</org_study_id>
      <nct_id>NCT06000176</nct_id>
    </id_info>
    <brief_title>Comparison of Optical Coherence Tomography Angiography Microvascular Changes in Primary Open Angle and Primary Angle Closure Glaucoma</brief_title>
    <official_title>Comparison of Optical Coherence Tomography Angiography Microvascular Changes in Primary Open Angle and Primary Angle Closure Glaucoma</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 work aims to study the peripapillary and macular microvascular changes in primary open&#xD;
        angle and primary angle closure glaucoma using 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, all patients presenting to the outpatient clinic of the department of Ophthalmology in&#xD;
        the universities has been subjected to routine ophthalmological examination including: best&#xD;
        corrected visual acuity (BCVA), Slit-lamp evaluation of anterior segment, IOP by Goldmann&#xD;
        applanation tonometer, Gonioscopy using gonio contact lens, Fundus examination by indirect&#xD;
        opthalmoscope with history taking focusing on positive family history of glaucoma after a&#xD;
        detailed informed consent was signed by eligible patients and investigated by OCTA of the&#xD;
        Peripapillary and Macular vascular density on presentation using AngiVue (Optovue, Inc.,&#xD;
        Fremont, CA, USA).&#xD;
  &#xD;
        Data analysis performed using the Statistical Package of Social Science (SPSS) software&#xD;
        version 22 in windows 7 (SPSS Inc., Chicago, IL, USA) Simple descriptive statistical analysis&#xD;
        in the form of numbers and percentages of qualitative data, and arithmetic means as central&#xD;
        tendency measurement, standard deviations as a measure of dispersion of quantitative&#xD;
        parametric data.&#xD;
  &#xD;
        For quantitative parametric data: Independent samples test was used to compare quantitative&#xD;
        measures between two independent groups, One-way analysis of variance ANOVA test used to&#xD;
        compare quantitative measures between more than two independent groups of quantitative data&#xD;
        with the benferroni Post-HOC to test the significance between each two groups, Paired t-test&#xD;
        used to compare two dependent quantitative data.&#xD;
  &#xD;
        For qualitative data Chi square test used to compare between two or more than two qualitative&#xD;
        groups.&#xD;
  &#xD;
        Bivariate Pearson correlation test to test the association between variables The probability&#xD;
        value (P-value) &lt; 0.05 was considered as statistical significant&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 5, 2022</start_date>
    <completion_date type="Actual">July 20, 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>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>OCTA macula and ONH</measure>
      <time_frame>We will recruit patient that include the inclusion criteria from april2022 to july 2023</time_frame>
      <description>macular 6*6,3*3 and peripapillary vessel density</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">120</enrollment>
    <condition>Glaucoma,Primary Open-Angle ,Primary Angle Closure</condition>
    <arm_group>
      <arm_group_label>interventional details : diagnostic test OCTA macula and ONH</arm_group_label>
      <description>interventional details : diagnostic test OCTA macula and ONH in the 3 groups</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Optical coherence tomography angiography</intervention_name>
      <description>diagnostic test OCTA macula and ONH</description>
      <arm_group_label>interventional details : diagnostic test OCTA macula and ONH</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with primary open angle ,primary angle closure glaucoma and control patients&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years old.&#xD;
  &#xD;
            -  Fulfilling Diagnostic criteria of PACG patients :occluded angle by gonioscopy in which&#xD;
               &gt; 180˚ of trabecular meshwork cannot be seen , IOP&gt;21, Optic disc and RNFL damage due&#xD;
               to glaucoma&#xD;
  &#xD;
            -  Diagnosed POAG patient: open anterior chamber angle ,IOP&gt;21 ,Optic disc and RNFL&#xD;
               damage due to glaucoma&#xD;
  &#xD;
            -  Healthy patient: normal anterior chamber, open angle and normal fundus.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of other causes of optic neuropathy.&#xD;
  &#xD;
            -  History of systemic diseases. (HTN, DM, Cardiac).&#xD;
  &#xD;
            -  Previous ocular surgeries or Laser iridotomy.&#xD;
  &#xD;
            -  Poor quality of OCTA image less than 4/10.&#xD;
  &#xD;
            -  Refractive errors &gt; 6 diopters sphere, &gt;3 diopter cylinder&#xD;
  &#xD;
            -  Poor cooperation or fixation with the OCTA examination.&#xD;
  &#xD;
            -  Secondary causes of glaucoma&#xD;
  &#xD;
            -  Media opacity that interfere with quality of image (dense cataract,corneal opacity,…)&#xD;
  &#xD;
            -  Previous acute attack of ACG&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Athar Mohamed Mohamed Makhlouf</name>
        <address>
          <city>Fayoum</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 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>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glaucoma</mesh_term>
      <mesh_term>Glaucoma, Angle-Closure</mesh_term>
      <mesh_term>Glaucoma, Open-Angle</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/NCT06000176
  org study id: M557
  nct id: NCT06000176
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  This work aims to study the peripapillary and macular microvascular changes in primary open
        angle and primary angle closure glaucoma using Optical Coherence Tomography Angiography
        (OCTA).
  After approval of the local institutional ethics committee and local institutional review
        board, all patients presenting to the outpatient clinic of the department of Ophthalmology in
        the universities has been subjected to routine ophthalmological examination including: best
        corrected visual acuity (BCVA), Slit-lamp evaluation of anterior segment, IOP by Goldmann
        applanation tonometer, Gonioscopy using gonio contact lens, Fundus examination by indirect
        opthalmoscope with history taking focusing on positive family history of glaucoma after a
        detailed informed consent was signed by eligible patients and investigated by OCTA of the
        Peripapillary and Macular vascular density on presentation using AngiVue (Optovue, Inc.,
        Fremont, CA, USA).
  
        Data analysis performed using the Statistical Package of Social Science (SPSS) software
        version 22 in windows 7 (SPSS Inc., Chicago, IL, USA) Simple descriptive statistical analysis
        in the form of numbers and percentages of qualitative data, and arithmetic means as central
        tendency measurement, standard deviations as a measure of dispersion of quantitative
        parametric data.
  
        For quantitative parametric data: Independent samples test was used to compare quantitative
        measures between two independent groups, One-way analysis of variance ANOVA test used to
        compare quantitative measures between more than two independent groups of quantitative data
        with the benferroni Post-HOC to test the significance between each two groups, Paired t-test
        used to compare two dependent quantitative data.
  
        For qualitative data Chi square test used to compare between two or more than two qualitative
        groups.
  
        Bivariate Pearson correlation test to test the association between variables The probability
        value (P-value) < 0.05 was considered as statistical significant
  observational model: Case-Control
  time perspective: Prospective
  measure: OCTA macula and ONH
  time frame: We will recruit patient that include the inclusion criteria from april2022 to july 2023
  description: macular 6*6,3*3 and peripapillary vessel density
  arm group label: interventional details : diagnostic test OCTA macula and ONH
  description: interventional details : diagnostic test OCTA macula and ONH in the 3 groups
  intervention type: Device
  intervention name: Optical coherence tomography angiography
  description: diagnostic test OCTA macula and ONH
  arm group label: interventional details : diagnostic test OCTA macula and ONH
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  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: Glaucoma
  mesh term: Glaucoma, Angle-Closure
  mesh term: Glaucoma, Open-Angle
  sharing ipd: Undecided