<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/NCT02209077</url>
  </required_header>
  <id_info>
    <org_study_id>S-2013-1 Study (REPRO)</org_study_id>
    <nct_id>NCT02209077</nct_id>
  </id_info>
  <brief_title>Spectralis OCT Repeatability and Reproducibility Study</brief_title>
  <acronym>S-2013-1</acronym>
  <official_title>Repeatability and Reproducibility of Optic Nerve Head (ONH), Retinal Nerve Fiber Layer (RNFL), and Macula Parameters With the Heidelberg Spectralis OCT.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heidelberg Engineering GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heidelberg Engineering GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This single-center, prospective, interventional clinical study is conducted to evaluate the&#xD;
      repeatability and reproducibility of structural parameters of the optic nerve head, the&#xD;
      peripapillary retinal nerve fiber layer, and the macula using the Heidelberg Spectralis OCT&#xD;
      (Optical Coherence Tomography) device. Data obtained from healthy volunteers in this study&#xD;
      are compared to those from a previous, larger healthy volunteer study that was conducted in&#xD;
      the United States and Europe (S-2012-1), and data from glaucoma patients are compared to&#xD;
      those from the healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will include approximately 15 normal subjects and approximately 15 subjects who&#xD;
      have glaucoma of varying degree. All subjects will undergo Spectralis OCT imaging and other&#xD;
      study procedures in one single visit. All examinations performed on the subjects are&#xD;
      non-significant risk procedures because the medical devices are cleared for marketing in&#xD;
      Europe and in the U.S. Total study duration is anticipated to not exceed 4 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reproducibility and repeatability of multiple parameters (measured with OCT in the back of the eye) between different studies and different subject types</measure>
    <time_frame>one day</time_frame>
    <description>This study is designed to determine optic nerve head structural values such as ONH rim thickness, RNFL thickness values, and macula structural values such as total retinal or ganglion cell layer thickness, as measured using the Spectralis device in a population of either subjects that are determined to be clinically &quot;normal&quot; or &quot;glaucomatous&quot;. The expected reproducibility and repeatability are approximately 5% or less of the respective means (coefficients of variation, cov). This study shall result in a 95% confidence interval of the cov estimate not larger than ±1% when all data is pooled (normal and glaucoma cases). Statistical analysis of the measurement values will consist of the computation of mean and standard deviation in repeated examinations with the SPECTRALIS OCT in the normal and glaucomatous population.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OCT performed to collect data from the back of the eye</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glaucoma group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OCT performed to collect data from the back of the eye</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OCT performed to collect data from the back of the eye</intervention_name>
    <description>comparative retinal parameters with Spectralis OCT</description>
    <arm_group_label>Glaucoma group</arm_group_label>
    <arm_group_label>Healthy Volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is not an employee of the eye clinic.&#xD;
&#xD;
          -  Age ≥18&#xD;
&#xD;
          -  Able and willing to undergo the test procedures, give consent, and to follow&#xD;
             instructions.&#xD;
&#xD;
          -  For &quot;normal subjects&quot;: Healthy eye without prior intraocular surgery (except cataract&#xD;
             surgery and Lasik - laser-assisted refractive surgery) and without clinically&#xD;
             significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease&#xD;
             of the optic nerve.&#xD;
&#xD;
          -  For &quot;glaucoma subjects&quot;: Early to advanced glaucoma according to existing medical&#xD;
             charts.&#xD;
&#xD;
          -  Refraction between +6 and -6 diopters and astigmatism ≤ 2 diopters.&#xD;
&#xD;
          -  When both eyes are eligible, one randomly selected eye will enter the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Insufficient quality of Spectralis OCT images (this is not determined until after&#xD;
        Spectralis OCT examination, and is an unusual circumstance). Minimum requirements are:&#xD;
&#xD;
          -  Retina completely included in image frame,&#xD;
&#xD;
          -  Quality Score ≥ 20 in the stored ART mean images&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Balwantray C Chauhan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Ophthalmology and Visual Sciences, Dalhousie University, Halifax, Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Ophthalmology and Visual Sciences, Dalhousie University</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 12, 2013</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 1, 2014</last_update_submitted>
  <last_update_submitted_qc>August 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2014</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>
  </condition_browse>
  <!-- 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/NCT02209077
org study id: S-2013-1 Study (REPRO)
nct id: NCT02209077
lead sponsor: 
has dmc: No
This single-center, prospective, interventional clinical study is conducted to evaluate the
      repeatability and reproducibility of structural parameters of the optic nerve head, the
      peripapillary retinal nerve fiber layer, and the macula using the Heidelberg Spectralis OCT
      (Optical Coherence Tomography) device. Data obtained from healthy volunteers in this study
      are compared to those from a previous, larger healthy volunteer study that was conducted in
      the United States and Europe (S-2012-1), and data from glaucoma patients are compared to
      those from the healthy volunteers.
The study will include approximately 15 normal subjects and approximately 15 subjects who
      have glaucoma of varying degree. All subjects will undergo Spectralis OCT imaging and other
      study procedures in one single visit. All examinations performed on the subjects are
      non-significant risk procedures because the medical devices are cleared for marketing in
      Europe and in the U.S. Total study duration is anticipated to not exceed 4 weeks.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Reproducibility and repeatability of multiple parameters (measured with OCT in the back of the eye) between different studies and different subject types
time frame: one day
description: This study is designed to determine optic nerve head structural values such as ONH rim thickness, RNFL thickness values, and macula structural values such as total retinal or ganglion cell layer thickness, as measured using the Spectralis device in a population of either subjects that are determined to be clinically "normal" or "glaucomatous". The expected reproducibility and repeatability are approximately 5% or less of the respective means (coefficients of variation, cov). This study shall result in a 95% confidence interval of the cov estimate not larger than ±1% when all data is pooled (normal and glaucoma cases). Statistical analysis of the measurement values will consist of the computation of mean and standard deviation in repeated examinations with the SPECTRALIS OCT in the normal and glaucomatous population.
arm group label: Healthy Volunteers
arm group type: Experimental
description: OCT performed to collect data from the back of the eye
arm group label: Glaucoma group
arm group type: Experimental
description: OCT performed to collect data from the back of the eye
intervention type: Device
intervention name: OCT performed to collect data from the back of the eye
description: comparative retinal parameters with Spectralis OCT
arm group label: Glaucoma group
arm group label: Healthy Volunteers
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Balwantray C Chauhan, PhD
role: Principal Investigator
affiliation: Department of Ophthalmology and Visual Sciences, Dalhousie University, Halifax, Canada
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Glaucoma