<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/NCT03264391</url>
  </required_header>
  <id_info>
    <org_study_id>17100296</org_study_id>
    <nct_id>NCT03264391</nct_id>
  </id_info>
  <brief_title>Evaluation of Macular Vascular Changes in Behcet's Disease Using Optical Coherence Tomography Angiography</brief_title>
  <official_title>Evaluation of Macular Vascular Changes in Behcet's Disease Using Optical Coherence Tomography Angiography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      Behcet's disease is an important cause of retinal vasculitis and vision loss in Egypt.&#xD;
      Fluorescein angiography is the standard method of diagnosis of retinal vasculitis. OCT&#xD;
      angiography (OCT-A) is a recently developed method that can be used in the evaluation of&#xD;
      retinal circulation. In this study, we will test the utility of OCT-A in diagnosis and follow&#xD;
      up of retinal vascular changes in cases diagnosed with Behcet's disease that visit the&#xD;
      outpatient uveitis clinic of Assiut University hospital, a major tertiary center in southern&#xD;
      Egypt, over a one year duration. Also, correlation of OCT-A changes with visual acuity and&#xD;
      hence prognosis will be described.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim of the research To describe macular retinal vascular changes in patient with retinal&#xD;
      vasculitis secondary to Behcet's disease both qualitatively and quantitatively.&#xD;
&#xD;
      Research design Type of the study: cross sectional analytical study Study Setting: Assuit&#xD;
      University Hospital (Ophthalmology Department)&#xD;
&#xD;
      Study subjects:&#xD;
&#xD;
        1. Inclusion criteria:&#xD;
&#xD;
           • Patients diagnosed with Behcet's disease with or without active uveitis&#xD;
&#xD;
        2. Exclusion criteria:&#xD;
&#xD;
             -  Patients less than 18 years old&#xD;
&#xD;
             -  Hazy media precluding clear fundus view.&#xD;
&#xD;
             -  Patients with very poor fixation.&#xD;
&#xD;
        3. Sample Size Calculation:&#xD;
&#xD;
      We will aim at recruiting all patients diagnosed with Behcet's disease in outpatient clinic&#xD;
      who will meet the inclusion criteria within one year from the start of our project.&#xD;
&#xD;
      Methods Subject recruitment and obtaining consent Study subjects (Behcet's patients) will be&#xD;
      recruited from patients attending uveitis and retina clinic of the ophthalmology Department,&#xD;
      Faculty of Medicine, Assiut University. Written informed consent form will be obtained from&#xD;
      each patient.&#xD;
&#xD;
      Baseline evaluation:&#xD;
&#xD;
        1. Full ocular examination including slit lamp and dilated fundus examinations. Also,&#xD;
           measurement of the best corrected visual acuity (BCVA) using Snellen's chart will be&#xD;
           done.&#xD;
&#xD;
        2. Thorough clinical history and review of other systems involvement as well as full drug&#xD;
           history including use of topical and systemic medications.&#xD;
&#xD;
        3. Retinal vasculitis will be diagnosed by fundus examination. Additionally, fluorescein&#xD;
           angiography may be done according to the discretion of the investigators to confirm the&#xD;
           diagnosis.&#xD;
&#xD;
      Optical coherence tomography angiography imaging OCT imaging will be performed after&#xD;
      pupillary dilatation using Topcon DRI OCT Triton platform which utilizes invisible 1050 nm&#xD;
      light and obtains images at a speed of 100,000 A scans/sec.&#xD;
&#xD;
      First, B scans of the macula will be obtained and anatomical alterations of retinal&#xD;
      architecture will be noted. Next, OCT angiography scans in a 4.5x 4.5 mm circle centered on&#xD;
      the fovea will be then obtained. Analysis and interpretation of the enface images of the&#xD;
      superficial and deep retinal capillary plexus as well as choriocapillaries will be performed.&#xD;
      Areas of capillary dropout, abnormalities of retinal capillaries and vessels such as looping,&#xD;
      dilated segments, microaneurysms as well as FAZ area will be documented.&#xD;
&#xD;
      Research outcome measures:&#xD;
&#xD;
      A. Primary (main):&#xD;
&#xD;
      1- Qualitative description of the retinal capillary plexus changes in the macular area&#xD;
&#xD;
      B. Secondary:&#xD;
&#xD;
        1. Quantification of the extent of macular ischemia by measuring the area of foveal&#xD;
           avascular zone (FAZ).&#xD;
&#xD;
        2. Correlation between extent of macular vascular changes and visual acuity&#xD;
&#xD;
      Data management and analysis:&#xD;
&#xD;
      Data collection data will be recorded in the form of excel spreadsheets Computer software&#xD;
      SPSS and Prism graphpad Statistical tests chi square test and Pearson correlation coefficient&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Qualitative description of the retinal capillary plexus changes in the macular area</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between extent of macular vascular changes and visual acuity</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Retinal Vasculitis</condition>
  <condition>Behcet Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with Behcet's disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Patients diagnosed with Behcet's disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Patients less than 18 years old&#xD;
&#xD;
               -  Hazy media precluding clear fundus view.&#xD;
&#xD;
               -  Patients with very poor fixation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of medicine</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=Ocular+Manifestations%2C+Conventional+Fundus+Fluorescein+Angiographic+Findings%2C+and+Relationship+between+Angiographic+Findings+and+Visual+Acuity+in+Beh%C3%A7et%E2%80%99s+Disease</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/?term=Phase-contrast+OCT+imaging+of+transverse+flows+in+the+mouse+retina+and+choroid</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/?term=Real-time++measurement+of+in+vitro+flow+by+Fourier-domain+color+Doppler+optical+coherence+tomography.</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Bazvand F, Zarei M, Ebrahimiadib N, Karkhaneh R, Davoudi S, Soleimanzadeh M, Sharifian E, Roohipoor R, Modjtahedi BS. Ocular Manifestations, Conventional Fundus Fluorescein Angiographic Findings, and Relationship Between Angiographic Findings and Visual Acuity in Behcet's Disease. Semin Ophthalmol. 2017;32(6):764-771. doi: 10.1080/08820538.2016.1178310. Epub 2016 Aug 10.</citation>
    <PMID>27715380</PMID>
  </reference>
  <reference>
    <citation>Fingler J, Readhead C, Schwartz DM, Fraser SE. Phase-contrast OCT imaging of transverse flows in the mouse retina and choroid. Invest Ophthalmol Vis Sci. 2008 Nov;49(11):5055-9. doi: 10.1167/iovs.07-1627. Epub 2008 Jun 19.</citation>
    <PMID>18566457</PMID>
  </reference>
  <reference>
    <citation>Leitgeb RA, Schmetterer L, Hitzenberger CK, Fercher AF, Berisha F, Wojtkowski M, Bajraszewski T. Real-time measurement of in vitro flow by Fourier-domain color Doppler optical coherence tomography. Opt Lett. 2004 Jan 15;29(2):171-3. doi: 10.1364/ol.29.000171.</citation>
    <PMID>14744000</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>January 12, 2021</last_update_submitted>
  <last_update_submitted_qc>January 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Menatallah Saleh</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>OCT-A</keyword>
  <keyword>Retinal vasculitis</keyword>
  <keyword>Behcet's disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Behcet Syndrome</mesh_term>
    <mesh_term>Retinal Vasculitis</mesh_term>
    <mesh_term>Vasculitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03264391
org study id: 17100296
nct id: NCT03264391
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Behcet's disease is an important cause of retinal vasculitis and vision loss in Egypt.
      Fluorescein angiography is the standard method of diagnosis of retinal vasculitis. OCT
      angiography (OCT-A) is a recently developed method that can be used in the evaluation of
      retinal circulation. In this study, we will test the utility of OCT-A in diagnosis and follow
      up of retinal vascular changes in cases diagnosed with Behcet's disease that visit the
      outpatient uveitis clinic of Assiut University hospital, a major tertiary center in southern
      Egypt, over a one year duration. Also, correlation of OCT-A changes with visual acuity and
      hence prognosis will be described.
Aim of the research To describe macular retinal vascular changes in patient with retinal
      vasculitis secondary to Behcet's disease both qualitatively and quantitatively.

      Research design Type of the study: cross sectional analytical study Study Setting: Assuit
      University Hospital (Ophthalmology Department)

      Study subjects:

        1. Inclusion criteria:

           • Patients diagnosed with Behcet's disease with or without active uveitis

        2. Exclusion criteria:

             -  Patients less than 18 years old

             -  Hazy media precluding clear fundus view.

             -  Patients with very poor fixation.

        3. Sample Size Calculation:

      We will aim at recruiting all patients diagnosed with Behcet's disease in outpatient clinic
      who will meet the inclusion criteria within one year from the start of our project.

      Methods Subject recruitment and obtaining consent Study subjects (Behcet's patients) will be
      recruited from patients attending uveitis and retina clinic of the ophthalmology Department,
      Faculty of Medicine, Assiut University. Written informed consent form will be obtained from
      each patient.

      Baseline evaluation:

        1. Full ocular examination including slit lamp and dilated fundus examinations. Also,
           measurement of the best corrected visual acuity (BCVA) using Snellen's chart will be
           done.

        2. Thorough clinical history and review of other systems involvement as well as full drug
           history including use of topical and systemic medications.

        3. Retinal vasculitis will be diagnosed by fundus examination. Additionally, fluorescein
           angiography may be done according to the discretion of the investigators to confirm the
           diagnosis.

      Optical coherence tomography angiography imaging OCT imaging will be performed after
      pupillary dilatation using Topcon DRI OCT Triton platform which utilizes invisible 1050 nm
      light and obtains images at a speed of 100,000 A scans/sec.

      First, B scans of the macula will be obtained and anatomical alterations of retinal
      architecture will be noted. Next, OCT angiography scans in a 4.5x 4.5 mm circle centered on
      the fovea will be then obtained. Analysis and interpretation of the enface images of the
      superficial and deep retinal capillary plexus as well as choriocapillaries will be performed.
      Areas of capillary dropout, abnormalities of retinal capillaries and vessels such as looping,
      dilated segments, microaneurysms as well as FAZ area will be documented.

      Research outcome measures:

      A. Primary (main):

      1- Qualitative description of the retinal capillary plexus changes in the macular area

      B. Secondary:

        1. Quantification of the extent of macular ischemia by measuring the area of foveal
           avascular zone (FAZ).

        2. Correlation between extent of macular vascular changes and visual acuity

      Data management and analysis:

      Data collection data will be recorded in the form of excel spreadsheets Computer software
      SPSS and Prism graphpad Statistical tests chi square test and Pearson correlation coefficient
observational model: Case-Only
time perspective: Cross-Sectional
measure: Qualitative description of the retinal capillary plexus changes in the macular area
time frame: 1 year
measure: Correlation between extent of macular vascular changes and visual acuity
time frame: 1 year
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Egypt
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=Ocular+Manifestations%2C+Conventional+Fundus+Fluorescein+Angiographic+Findings%2C+and+Relationship+between+Angiographic+Findings+and+Visual+Acuity+in+Beh%C3%A7et%E2%80%99s+Disease
description: Related Info
url: http://www.ncbi.nlm.nih.gov/pubmed/?term=Phase-contrast+OCT+imaging+of+transverse+flows+in+the+mouse+retina+and+choroid
description: Related Info
url: http://www.ncbi.nlm.nih.gov/pubmed/?term=Real-time++measurement+of+in+vitro+flow+by+Fourier-domain+color+Doppler+optical+coherence+tomography.
description: Related Info
citation: Bazvand F, Zarei M, Ebrahimiadib N, Karkhaneh R, Davoudi S, Soleimanzadeh M, Sharifian E, Roohipoor R, Modjtahedi BS. Ocular Manifestations, Conventional Fundus Fluorescein Angiographic Findings, and Relationship Between Angiographic Findings and Visual Acuity in Behcet's Disease. Semin Ophthalmol. 2017;32(6):764-771. doi: 10.1080/08820538.2016.1178310. Epub 2016 Aug 10.
PMID: 27715380
citation: Fingler J, Readhead C, Schwartz DM, Fraser SE. Phase-contrast OCT imaging of transverse flows in the mouse retina and choroid. Invest Ophthalmol Vis Sci. 2008 Nov;49(11):5055-9. doi: 10.1167/iovs.07-1627. Epub 2008 Jun 19.
PMID: 18566457
citation: Leitgeb RA, Schmetterer L, Hitzenberger CK, Fercher AF, Berisha F, Wojtkowski M, Bajraszewski T. Real-time measurement of in vitro flow by Fourier-domain color Doppler optical coherence tomography. Opt Lett. 2004 Jan 15;29(2):171-3. doi: 10.1364/ol.29.000171.
PMID: 14744000
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Menatallah Saleh
investigator title: Principal Investigator
mesh term: Behcet Syndrome
mesh term: Retinal Vasculitis
mesh term: Vasculitis
sharing ipd: Undecided