<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/NCT04437082</url>
  </required_header>
  <id_info>
    <org_study_id>200-54611</org_study_id>
    <nct_id>NCT04437082</nct_id>
  </id_info>
  <brief_title>Performance Evaluation of OCT and OCT Angiography-based Ocular Measurements (Optical Coherence Tomography)</brief_title>
  <acronym>OCT</acronym>
  <official_title>Performance Evaluation of OCT and OCTA-based Ocular Measurements</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Optovue</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Optovue</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_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess performance of measurements of anatomical and vascular&#xD;
      structures of the eye based on OCT and OCTA scans in normal subjects and eyes with pathology.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2021</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Standard Deviation</measure>
    <time_frame>Day 1</time_frame>
    <description>measure of variance</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">143</enrollment>
  <condition>Normal Eyes and Ocular Pathology</condition>
  <arm_group>
    <arm_group_label>Normal</arm_group_label>
    <description>no pre-existing conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glaucoma</arm_group_label>
    <description>diagnosis of glaucoma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Retina</arm_group_label>
    <description>diagnosis of retina pathology</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cornea</arm_group_label>
    <description>diagnosis of corneal condition</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>optical coherence tomography</intervention_name>
    <description>imaging structural and vascular features of the eye</description>
    <arm_group_label>Cornea</arm_group_label>
    <arm_group_label>Glaucoma</arm_group_label>
    <arm_group_label>Normal</arm_group_label>
    <arm_group_label>Retina</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Seeing eye doctor for routine or follow-up care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal - No pre-existing conditions.&#xD;
&#xD;
          -  Glaucoma - Diagnosis of glaucoma.&#xD;
&#xD;
          -  Retina - Diagnosis of retinal pathology&#xD;
&#xD;
          -  Cornea - Diagnosis of clinic condition.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Unable to complete required exams.&#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>Oklahoma College of Optometry, Northeastern State University</name>
      <address>
        <city>Tahlequah</city>
        <state>Oklahoma</state>
        <zip>74464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>September 13, 2021</last_update_submitted>
  <last_update_submitted_qc>September 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04437082
org study id: 200-54611
nct id: NCT04437082
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The purpose of this study is to assess performance of measurements of anatomical and vascular
      structures of the eye based on OCT and OCTA scans in normal subjects and eyes with pathology.
observational model: Cohort
time perspective: Prospective
measure: Standard Deviation
time frame: Day 1
description: measure of variance
arm group label: Normal
description: no pre-existing conditions
arm group label: Glaucoma
description: diagnosis of glaucoma
arm group label: Retina
description: diagnosis of retina pathology
arm group label: Cornea
description: diagnosis of corneal condition
intervention type: Device
intervention name: optical coherence tomography
description: imaging structural and vascular features of the eye
arm group label: Cornea
arm group label: Glaucoma
arm group label: Normal
arm group label: Retina
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No