<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/NCT04486976</url>
  </required_header>
  <id_info>
    <org_study_id>TomeyCASIA2-001</org_study_id>
    <nct_id>NCT04486976</nct_id>
  </id_info>
  <brief_title>Comparative Study of the Cornea/Anterior Segment OCT CASIA2 and the RTVue XR OCT Avanti With AngioVue Software</brief_title>
  <official_title>Comparative Study of the Cornea/Anterior Segment OCT CASIA2 and the RTVue XR OCT Avanti With AngioVue Software</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tomey Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tomey Corporation</source>
  <oversight_info>
    <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>
      This study is a prospective comparative, randomized, single center study to gather agreement&#xD;
      and precision data in all subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 27, 2020</start_date>
  <completion_date type="Actual">March 5, 2021</completion_date>
  <primary_completion_date type="Actual">March 5, 2021</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>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Agreement of Corneal thickness (μm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Thickness of Cornea</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Agreement of Angle-Opening Distance (mm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Angle-Opening Distance Angle-Opening Distance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Agreement of Trabecular-Iris Space Area measurement (mm²) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Trabecular-Iris Space Area</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Agreement of OCT image quality for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT and evaluation of visibility of predefined anatomical structures</measure>
    <time_frame>Up to 30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Precision of the Corneal thickness (μm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Corneal thickness</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Precision of the Angle-Opening Distance (mm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Angle-Opening Distance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Precision of the Trabecular-Iris Space Area measurement (mm²) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Trabecular-Iris Space Area</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Precision of the Anterior Corneal Depth measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Anterior Corneal Depth</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Precision of the Anterior Corneal Width measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Anterior Corneal Width</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Precision of the Pupil Diameter measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Pupil Diameter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Precision of the Ks (steep meridian) measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Ks (steep meridian)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Precision of the Kf (flat meridian) measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Kf (flat meridian)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Precision of the Corneal Cylinder measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Corneal Cylinder</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Precision of the Average Keratometry measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Average Keratometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Precision of the Angle Recess Area measurement (mm²) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Angle Recess Area</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Precision of the Trabecular-Iris Angle measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Trabecular-Iris Angle</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational device but not necessarily related to the investigational device.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">134</enrollment>
  <condition>Glaucoma</condition>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Normal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Glaucoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cataract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cornea/Anterior Segment OCT CASIA2</intervention_name>
    <description>Cornea/Anterior Segment OCT CASIA2 The Tomey Cornea/Anterior Segment OCT CASIA2 is a non-contact, high resolution tomographic and biomicroscopic device indicated for the in vivo imaging and measurement of ocular structures in the anterior segment, such as corneal thickness. The Tomey Cornea/Anterior Segment OCT CASIA2 is indicated as an aid in the visualization of anterior segment findings.</description>
    <arm_group_label>Cataract</arm_group_label>
    <arm_group_label>Glaucoma</arm_group_label>
    <arm_group_label>Normal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Optovue RTVue XR Avanti</intervention_name>
    <description>Optovue RTVue XR Avanti The Avanti is an optical coherence tomography system indicated for the in vivo imaging,axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures.</description>
    <arm_group_label>Cataract</arm_group_label>
    <arm_group_label>Glaucoma</arm_group_label>
    <arm_group_label>Normal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria - Normal Group:&#xD;
&#xD;
          1. Male or female subjects 22 years of age or older who have full legal capacity to&#xD;
             volunteer on the date the informed consent is signed;&#xD;
&#xD;
          2. Subjects who can follow the instructions by the clinical staff at the clinical site,&#xD;
             and can attend examinations on the scheduled examination date;&#xD;
&#xD;
          3. Subjects who agree to participate in the study;&#xD;
&#xD;
        Exclusion Criteria - Normal Group:&#xD;
&#xD;
          1. Subjects unable to tolerate ophthalmic imaging;&#xD;
&#xD;
          2. Subjects with any current ocular pathology, as determined by self-report and confirmed&#xD;
             by the investigator assessment and/or confirmed by the investigator assessment at the&#xD;
             study visit;&#xD;
&#xD;
          3. Subjects that present with an active ocular infection in either eye;&#xD;
&#xD;
          4. Subjects who have a history of ocular surgery, including laser therapy/surgery;&#xD;
&#xD;
          5. Subjects with a condition or in a situation which the investigator feels may put the&#xD;
             subject at significant risk, may confound the study results, or may interfere&#xD;
             significantly with the subject's participation in the study.&#xD;
&#xD;
        Inclusion Criteria - Cataract Group:&#xD;
&#xD;
          1. Male or female subjects 22 years of age or older who have full legal capacity to&#xD;
             volunteer on the date the informed consent is signed;&#xD;
&#xD;
          2. Subjects who can follow the instructions by the clinical staff at the clinical site,&#xD;
             and can attend examinations on the scheduled examination date;&#xD;
&#xD;
          3. Subjects who agree to participate in the study;&#xD;
&#xD;
          4. Subjects diagnosed with cataract classified per the LOCS III scale;&#xD;
&#xD;
        Exclusion Criteria - Cataract Group:&#xD;
&#xD;
          1. Subjects unable to tolerate ophthalmic imaging;&#xD;
&#xD;
          2. Subjects with corneal or conjunctival abnormalities that may affect adequate&#xD;
             assessment of the anterior chamber in either eye;&#xD;
&#xD;
          3. Subjects that present with an active ocular infection in either eye;&#xD;
&#xD;
          4. Subjects who have a history of ocular surgery, including laser therapy/surgery;&#xD;
&#xD;
          5. Subjects with a condition or in a situation which the investigator feels may put the&#xD;
             subject at significant risk, may confound the study results, or may interfere&#xD;
             significantly with the subject's participation in the study&#xD;
&#xD;
        Inclusion Criteria - Glaucoma Group:&#xD;
&#xD;
          1. Male or female subjects 22 years of age or older who have full legal capacity to&#xD;
             volunteer on the date the informed consent is signed;&#xD;
&#xD;
          2. Subjects who can follow the instructions by the clinical staff at the clinical site,&#xD;
             and can attend examinations on the scheduled examination date;&#xD;
&#xD;
          3. Subjects who agree to participate in the study;&#xD;
&#xD;
          4. Subjects with glaucomatous optic nerve damage as evidenced by any of the following&#xD;
             optic disc or retinal nerve fiber layer structural abnormalities:&#xD;
&#xD;
               1. Diffuse thinning, focal narrowing, or notching of the neuroretinal rim,&#xD;
                  especially at the inferior or superior poles with or without disc hemorrhage;&#xD;
&#xD;
               2. Optic disc neural rim asymmetry of the two eyes consistent with loss of neural&#xD;
                  tissue&#xD;
&#xD;
          5. History of Visual field defects within the previous six (6) months from the study&#xD;
             visit or measured the day of the study visit consistent with glaucomatous optic nerve&#xD;
             damage with at least one of the following two findings:&#xD;
&#xD;
               1. On pattern deviation (PD), there exists a cluster of 3 or more points in an&#xD;
                  expected location of the visual field depressed below the 5% level, at least 1 of&#xD;
                  which is depressed below the 1% level;&#xD;
&#xD;
               2. Glaucoma hemi-field test &quot;outside normal limits.&quot;&#xD;
&#xD;
        Exclusion Criteria - Glaucoma Group:&#xD;
&#xD;
          1. Subjects unable to tolerate ophthalmic imaging;&#xD;
&#xD;
          2. Subjects with corneal or conjunctival abnormalities that may affect adequate&#xD;
             assessment of the anterior chamber in either eye;&#xD;
&#xD;
          3. Subjects that present with an active ocular infection in either eye;&#xD;
&#xD;
          4. No reliable Humphrey Field Analyzer (HFA) visual field (24-2 Sita Standard, white on&#xD;
             white) result within 6 months of the study visit, defined as fixation losses &gt; 33% or&#xD;
             false positives &gt; 33%, or false negatives &gt; 33% in the study eye;&#xD;
&#xD;
          5. Subjects with a condition or in a situation which the investigator feels may put the&#xD;
             subject at significant risk, may confound the study results, or may interfere&#xD;
             significantly with the subject's participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Andover Eye Associates</name>
      <address>
        <city>Andover</city>
        <state>Massachusetts</state>
        <zip>01810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>August 26, 2021</last_update_submitted>
  <last_update_submitted_qc>August 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2021</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>Cataract</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/NCT04486976
org study id: TomeyCASIA2-001
nct id: NCT04486976
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This study is a prospective comparative, randomized, single center study to gather agreement
      and precision data in all subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Agreement of Corneal thickness (μm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
time frame: Up to 30 days
description: Thickness of Cornea
measure: Agreement of Angle-Opening Distance (mm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
time frame: Up to 30 days
description: Angle-Opening Distance Angle-Opening Distance
measure: Agreement of Trabecular-Iris Space Area measurement (mm²) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
time frame: Up to 30 days
description: Trabecular-Iris Space Area
measure: Agreement of OCT image quality for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT and evaluation of visibility of predefined anatomical structures
time frame: Up to 30 days
measure: Precision of the Corneal thickness (μm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
time frame: Up to 30 days
description: Corneal thickness
measure: Precision of the Angle-Opening Distance (mm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
time frame: Up to 30 days
description: Angle-Opening Distance
measure: Precision of the Trabecular-Iris Space Area measurement (mm²) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
time frame: Up to 30 days
description: Trabecular-Iris Space Area
measure: Precision of the Anterior Corneal Depth measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
time frame: Up to 30 days
description: Anterior Corneal Depth
measure: Precision of the Anterior Corneal Width measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
time frame: Up to 30 days
description: Anterior Corneal Width
measure: Precision of the Pupil Diameter measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
time frame: Up to 30 days
description: Pupil Diameter
measure: Precision of the Ks (steep meridian) measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
time frame: Up to 30 days
description: Ks (steep meridian)
measure: Precision of the Kf (flat meridian) measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
time frame: Up to 30 days
description: Kf (flat meridian)
measure: Precision of the Corneal Cylinder measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
time frame: Up to 30 days
description: Corneal Cylinder
measure: Precision of the Average Keratometry measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
time frame: Up to 30 days
description: Average Keratometry
measure: Precision of the Angle Recess Area measurement (mm²) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
time frame: Up to 30 days
description: Angle Recess Area
measure: Precision of the Trabecular-Iris Angle measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
time frame: Up to 30 days
description: Trabecular-Iris Angle
measure: Adverse Events
time frame: Up to 30 days
description: An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational device but not necessarily related to the investigational device.
arm group label: Normal
arm group type: Experimental
arm group label: Glaucoma
arm group type: Experimental
arm group label: Cataract
arm group type: Experimental
intervention type: Device
intervention name: Cornea/Anterior Segment OCT CASIA2
description: Cornea/Anterior Segment OCT CASIA2 The Tomey Cornea/Anterior Segment OCT CASIA2 is a non-contact, high resolution tomographic and biomicroscopic device indicated for the in vivo imaging and measurement of ocular structures in the anterior segment, such as corneal thickness. The Tomey Cornea/Anterior Segment OCT CASIA2 is indicated as an aid in the visualization of anterior segment findings.
arm group label: Cataract
arm group label: Glaucoma
arm group label: Normal
intervention type: Device
intervention name: Optovue RTVue XR Avanti
description: Optovue RTVue XR Avanti The Avanti is an optical coherence tomography system indicated for the in vivo imaging,axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures.
arm group label: Cataract
arm group label: Glaucoma
arm group label: Normal
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cataract
sharing ipd: No