<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/NCT02247284</url>
  </required_header>
  <id_info>
    <org_study_id>Glaucoma-Premium-OCT</org_study_id>
    <nct_id>NCT02247284</nct_id>
  </id_info>
  <brief_title>Reproducibility of RNFL and ONH Measurements in OAG With Heidelberg Spectralis SD-OCT Glaucoma Module Premium Edition</brief_title>
  <official_title>Study to Investigate Reproducibility of the New Heidelberg Spectralis SD-OCT Glaucoma Module Premium Edition (Software Version 6.0) in Comparison to Reproducibility of RNFL Scans.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess and compare the repeatability of SD-OCT (Spectralis™&#xD;
      OCT, Version 6.0, Heidelberg Engineering, Germany) RNFL thickness measurements with a new&#xD;
      software (glaucoma premium module) with the well established peripapillary RNFL thickness&#xD;
      measurements in patients with primary open angle glaucoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to assess and compare the repeatability of SD-OCT (Spectralis™&#xD;
      OCT, Version 6.0, Heidelberg Engineering, Germany) RNFL thickness measurements with the new&#xD;
      software (method B) and with the previous method of measurement (method A) in patients with&#xD;
      glaucoma.&#xD;
&#xD;
      It is a prospective, not blinded, not randomised, monocentric study. Inclusion of 50 patients&#xD;
      with a diagnosis of primary open angle glaucoma (POAG), that will be recruited from the&#xD;
      ophthalmology outpatient department of the UniversityHospital Zurich, Switzerland. All&#xD;
      patients will undergo a full ophthalmic examination including measurement of refraction, best&#xD;
      corrected visual acuity, examination of anterior and posterior compartment and measurement of&#xD;
      the intraocular pressure. On the same day they will have 3 OCT examinations with a new method&#xD;
      of measurement (method B).On the same day the first 10 patients will undergo also 3 OCT&#xD;
      examinations with the previous method (method A) and they will get an other 3 OCT&#xD;
      examinations with method B by a second observer. For this 10 patients the next consultation&#xD;
      (3 months +/- 1 month) the 3 OCT examinations with method B will be repeated by the first&#xD;
      observer.&#xD;
&#xD;
      Primary objectives are coefficient of variations (COV) of method A and B;&#xD;
      Intra-class-correlations (ICC) of method A and B.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2015</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Retinal nerve fiber layer thickness (RNFL)</measure>
    <time_frame>baseline and 3 months +/- 1 month</time_frame>
    <description>Retinal nerve fiber layer thickness (RNFL) measured with Spectralis OCT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bruch's membrane opening-based minimum rim width (BMO-MRW)</measure>
    <time_frame>baseline and 3 months +/- 1 month</time_frame>
    <description>Bruch's membrane opening-based minimum rim width (BMO-MRW) measured with Spectralis OCT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Coefficient of variations (COV) of RNFL and BMO-MRW</measure>
    <time_frame>baseline and 3 months +/- 1 month</time_frame>
    <description>Coefficient of variations (COV) of RNFL and BMO-MRW</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-class-correlations (ICC) of RNFL and BMO-MRW</measure>
    <time_frame>baseline and 3 months +/- 1 month</time_frame>
    <description>Intra-class-correlations (ICC) of RNFL and BMO-MRW</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Primary Open Angle Glaucoma</condition>
  <arm_group>
    <arm_group_label>group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patient with a diagnosis of primary open angle glaucoma will undergo 'RNFL and BMO-MRW SD-OCT' measurements with Heidelberg Spectralis SD-OCT old protocoll and Glaucoma Premium Module (new) protocoll, which in addition to RNFL measurements include measurement of Bruch's Membrane Opening-based minimum rim width (BMO-MRW).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RNFL and BMO-MRW SD-OCT</intervention_name>
    <description>Masurement of peripapillary RNFL measurements with Heidelberg Spectralis SD-OCT (Heidelberg Engeneering GmbH, Heidelberg, Germany) old protocoll and in addition with the new Glaucoma Premium Module (software version 6.0) tocoll, which in addition to RNFL measurements include measurement of Bruch's Membrane Opening-based minimum rim width (BMO-MRW).</description>
    <arm_group_label>group 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of POAG glaucoma&#xD;
&#xD;
          -  male and female patients aged 18 years or older, no upper limit&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  visual acuity of more or equal to 0.5 Snellen&#xD;
&#xD;
          -  refractive error between + /- 6.00 D spheric and under or equal than 2.00 D&#xD;
             cylindrical&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of surgery other than uncomplicated cataract surgery&#xD;
&#xD;
          -  disease affecting cornea, anterior compartment, lens, vitreous body&#xD;
&#xD;
          -  history of severe ocular disease, particularly diseases affecting the optic nerve,&#xD;
             other than glaucoma&#xD;
&#xD;
          -  history of ocular trauma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jens Funk, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UniversityHospital Zurich, Zurich, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UniversityHospital Zurich</name>
      <address>
        <city>Zurich</city>
        <state>ZH</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>March 24, 2020</last_update_submitted>
  <last_update_submitted_qc>March 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02247284
org study id: Glaucoma-Premium-OCT
nct id: NCT02247284
lead sponsor: 
has dmc: No
The purpose of this study is to assess and compare the repeatability of SD-OCT (Spectralis™
      OCT, Version 6.0, Heidelberg Engineering, Germany) RNFL thickness measurements with a new
      software (glaucoma premium module) with the well established peripapillary RNFL thickness
      measurements in patients with primary open angle glaucoma.
The purpose of this study is to assess and compare the repeatability of SD-OCT (Spectralis™
      OCT, Version 6.0, Heidelberg Engineering, Germany) RNFL thickness measurements with the new
      software (method B) and with the previous method of measurement (method A) in patients with
      glaucoma.

      It is a prospective, not blinded, not randomised, monocentric study. Inclusion of 50 patients
      with a diagnosis of primary open angle glaucoma (POAG), that will be recruited from the
      ophthalmology outpatient department of the UniversityHospital Zurich, Switzerland. All
      patients will undergo a full ophthalmic examination including measurement of refraction, best
      corrected visual acuity, examination of anterior and posterior compartment and measurement of
      the intraocular pressure. On the same day they will have 3 OCT examinations with a new method
      of measurement (method B).On the same day the first 10 patients will undergo also 3 OCT
      examinations with the previous method (method A) and they will get an other 3 OCT
      examinations with method B by a second observer. For this 10 patients the next consultation
      (3 months +/- 1 month) the 3 OCT examinations with method B will be repeated by the first
      observer.

      Primary objectives are coefficient of variations (COV) of method A and B;
      Intra-class-correlations (ICC) of method A and B.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Retinal nerve fiber layer thickness (RNFL)
time frame: baseline and 3 months +/- 1 month
description: Retinal nerve fiber layer thickness (RNFL) measured with Spectralis OCT
measure: Bruch's membrane opening-based minimum rim width (BMO-MRW)
time frame: baseline and 3 months +/- 1 month
description: Bruch's membrane opening-based minimum rim width (BMO-MRW) measured with Spectralis OCT
measure: Coefficient of variations (COV) of RNFL and BMO-MRW
time frame: baseline and 3 months +/- 1 month
description: Coefficient of variations (COV) of RNFL and BMO-MRW
measure: Intra-class-correlations (ICC) of RNFL and BMO-MRW
time frame: baseline and 3 months +/- 1 month
description: Intra-class-correlations (ICC) of RNFL and BMO-MRW
arm group label: group 1
arm group type: Experimental
description: patient with a diagnosis of primary open angle glaucoma will undergo 'RNFL and BMO-MRW SD-OCT' measurements with Heidelberg Spectralis SD-OCT old protocoll and Glaucoma Premium Module (new) protocoll, which in addition to RNFL measurements include measurement of Bruch's Membrane Opening-based minimum rim width (BMO-MRW).
intervention type: Device
intervention name: RNFL and BMO-MRW SD-OCT
description: Masurement of peripapillary RNFL measurements with Heidelberg Spectralis SD-OCT (Heidelberg Engeneering GmbH, Heidelberg, Germany) old protocoll and in addition with the new Glaucoma Premium Module (software version 6.0) tocoll, which in addition to RNFL measurements include measurement of Bruch's Membrane Opening-based minimum rim width (BMO-MRW).
arm group label: group 1
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jens Funk, MD, PhD
role: Principal Investigator
affiliation: UniversityHospital Zurich, Zurich, Switzerland
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
sharing ipd: No