<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/NCT03257020</url>
  </required_header>
  <id_info>
    <org_study_id>1510-001-034</org_study_id>
    <nct_id>NCT03257020</nct_id>
  </id_info>
  <brief_title>The Diagnostic Performance of BMO-MRW and RNFL Thickness and Their Combinational Index Using Artificial Neural Network</brief_title>
  <official_title>The Comparison of Bruch's Membrane Opening-minimum Rim Width and Retinal Nerve Fiber Layer Thickness and Their Combinational Index Using Artificial Neural Network</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pusan National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pusan National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the relationship between BMO-MRW and RNFL thickness measured by OCT.&#xD;
      SD-OCT exam will be performed to all patients in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      spectral domain optical coherence tomography, SD-OCT, (Heidelberg Engineering, Heidelberg,&#xD;
      Germany) is a widely used commercial device in ophthalmology field. For a long time, retinal&#xD;
      nerve fiber layer (RNFL) thickness was measured with OCT to detect and follow up glaucoma&#xD;
      patients. Bruch's membrane opening - minimum rim width (BMO-MRW) is relatively new parameter&#xD;
      which measures the minimum distance between Bruch's membrane opening to internal limiting&#xD;
      membrane (ILM). BMO-MRW,a new parameter, is known to have better diagnostic performance than&#xD;
      RNFL thickness and recently, many researches has been performed on this new parameter. SD-OCT&#xD;
      can measure RNFL thickness and BMO-MRW at the same time. The test procedure is not different&#xD;
      from RNFL thickness measurement but only software implemented in OCT device calculates&#xD;
      BMO-MRW as well as RNFL thickness. The investigators are going to compare these two&#xD;
      parameters and find out the relationship between two parameters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2015</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Bruch's membrane opening - minimum rim width (BMO-MRW)</measure>
    <time_frame>5~10 minutes</time_frame>
    <description>SD-OCT will be performed to the patients to measure BMO-MRW by trained glaucoma specialist.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Retinal nerve fiber layer (RNFL) thickness</measure>
    <time_frame>5~10 minutes</time_frame>
    <description>SD-OCT will be performed to the patients to measure RNFL thickness. This is measured at the same time as BMO-MRW, not separately.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">402</enrollment>
  <condition>Glaucoma</condition>
  <condition>Tomography, Optical Coherence</condition>
  <arm_group>
    <arm_group_label>Normal subject</arm_group_label>
    <description>Measure BMO-MRW and RNFL with SD-OCT. If the BMO-MRW and RNFL is within the normal range and those with no history of ocular disease, an intraocular pressure &lt; 21 mmHg, an absence of glaucomatous optic disc appearance, and a normal visual field, they will be classified into normal group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glaucoma patients</arm_group_label>
    <description>Measure BMO-MRW and RNFL with SD-OCT. If the BMO-MRW and RNFL is below the normal range and those with glaucomatous optic disc and two consecutive abnormal visual field test results with open angles on gonioscopy, glaucomatous optic neuropathy, RNFL defects congruent with visual field defects, they will be classified into glaucoma patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>SD-OCT</intervention_name>
    <description>SD-OCT was performed to all subjects to measure BMO-MRW and RNFL thickness by trained glaucoma specialist. It takes about 5 to 10 minutes. The foveal location was manually detected with a live B-scan, followed by defining BMO center. A radial pattern containing 24 angular, equidistant, high-resolution 15° B-scans centered on the BMO was used to compute the neuroretinal rim parameters. The BMO points and ILM were identified and marked in each B-scan with automated software (Glaucoma Module Premium Edition, version 6.0; Heidelberg Engineering). After radial scan completed, 3 consecutive circumpapillary B-scans were followed to measure RNFL thickness at diameter of 3.5, 4.1 and 4.7mm. BMO-MRW and RNFL thickness was automatically computed globally and sectorally.</description>
    <arm_group_label>Glaucoma patients</arm_group_label>
    <arm_group_label>Normal subject</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients who visited Pusan National University Hospital glaucoma clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years with a clear cornea and clear ocular media&#xD;
&#xD;
          -  BCVA ≥ 20/40&#xD;
&#xD;
          -  Refractive error within ± 6.0 diopters (D) of 0 and astigmatism ± 3.0 D of 0&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  uveitis&#xD;
&#xD;
          -  secondary glaucoma&#xD;
&#xD;
          -  corneal abnormalities&#xD;
&#xD;
          -  non-glaucomatous optic neuropathies&#xD;
&#xD;
          -  previous trauma&#xD;
&#xD;
          -  ocular surgery or laser treatment&#xD;
&#xD;
          -  any other eye disease except glaucoma.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Jiwoong Lee, M.D., Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Research Institute, Pusan National University Hospital, Busan, Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Busan</city>
        <zip>49214</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>OCT</keyword>
  <keyword>RNFL</keyword>
  <keyword>BMO-MRW</keyword>
  <keyword>Glaucoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participants data for all primary and secondary outcome measures will be shared.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data will be available within 12 months after study published.</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by an external independent review panel (PNUH IRB) and if they approve, data will be provided.</ipd_access_criteria>
  </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/NCT03257020
org study id: 1510-001-034
nct id: NCT03257020
lead sponsor: 
has dmc: Yes
is fda regulated device: Yes
is us export: No
This study evaluates the relationship between BMO-MRW and RNFL thickness measured by OCT.
      SD-OCT exam will be performed to all patients in this study.
spectral domain optical coherence tomography, SD-OCT, (Heidelberg Engineering, Heidelberg,
      Germany) is a widely used commercial device in ophthalmology field. For a long time, retinal
      nerve fiber layer (RNFL) thickness was measured with OCT to detect and follow up glaucoma
      patients. Bruch's membrane opening - minimum rim width (BMO-MRW) is relatively new parameter
      which measures the minimum distance between Bruch's membrane opening to internal limiting
      membrane (ILM). BMO-MRW,a new parameter, is known to have better diagnostic performance than
      RNFL thickness and recently, many researches has been performed on this new parameter. SD-OCT
      can measure RNFL thickness and BMO-MRW at the same time. The test procedure is not different
      from RNFL thickness measurement but only software implemented in OCT device calculates
      BMO-MRW as well as RNFL thickness. The investigators are going to compare these two
      parameters and find out the relationship between two parameters.
observational model: Case-Control
time perspective: Retrospective
measure: Bruch's membrane opening - minimum rim width (BMO-MRW)
time frame: 5~10 minutes
description: SD-OCT will be performed to the patients to measure BMO-MRW by trained glaucoma specialist.
measure: Retinal nerve fiber layer (RNFL) thickness
time frame: 5~10 minutes
description: SD-OCT will be performed to the patients to measure RNFL thickness. This is measured at the same time as BMO-MRW, not separately.
arm group label: Normal subject
description: Measure BMO-MRW and RNFL with SD-OCT. If the BMO-MRW and RNFL is within the normal range and those with no history of ocular disease, an intraocular pressure < 21 mmHg, an absence of glaucomatous optic disc appearance, and a normal visual field, they will be classified into normal group.
arm group label: Glaucoma patients
description: Measure BMO-MRW and RNFL with SD-OCT. If the BMO-MRW and RNFL is below the normal range and those with glaucomatous optic disc and two consecutive abnormal visual field test results with open angles on gonioscopy, glaucomatous optic neuropathy, RNFL defects congruent with visual field defects, they will be classified into glaucoma patients.
intervention type: Diagnostic Test
intervention name: SD-OCT
description: SD-OCT was performed to all subjects to measure BMO-MRW and RNFL thickness by trained glaucoma specialist. It takes about 5 to 10 minutes. The foveal location was manually detected with a live B-scan, followed by defining BMO center. A radial pattern containing 24 angular, equidistant, high-resolution 15° B-scans centered on the BMO was used to compute the neuroretinal rim parameters. The BMO points and ILM were identified and marked in each B-scan with automated software (Glaucoma Module Premium Edition, version 6.0; Heidelberg Engineering). After radial scan completed, 3 consecutive circumpapillary B-scans were followed to measure RNFL thickness at diameter of 3.5, 4.1 and 4.7mm. BMO-MRW and RNFL thickness was automatically computed globally and sectorally.
arm group label: Glaucoma patients
arm group label: Normal subject
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
last name: Jiwoong Lee, M.D., Ph.D
role: Principal Investigator
affiliation: Medical Research Institute, Pusan National University Hospital, Busan, Korea
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Glaucoma
sharing ipd: Yes
ipd description: De-identified individual participants data for all primary and secondary outcome measures will be shared.
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data will be available within 12 months after study published.
ipd access criteria: Data access requests will be reviewed by an external independent review panel (PNUH IRB) and if they approve, data will be provided.