<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/NCT04428242</url>
  </required_header>
  <id_info>
    <org_study_id>SCT-202</org_study_id>
    <nct_id>NCT04428242</nct_id>
  </id_info>
  <brief_title>Study Evaluating Retinal Health Monitoring System Thickness Module</brief_title>
  <official_title>Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in Subjects With Normal Macular Thickness and Subjects With Center-involving Macular Edema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kubota Vision Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kubota Vision Inc.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the ability and accuracy of the Retinal Health Monitoring System - Retinal Thickness&#xD;
      Module (RHMS - RTM).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in subjects&#xD;
      with normal macular thickness and subjects with center-involving macular edema.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    COVD-19&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 2020</start_date>
  <completion_date type="Anticipated">July 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the RHMS-RTM retinal thickness measurements</measure>
    <time_frame>1 day</time_frame>
    <description>To evaluate the ability of the RHMS-RTM device to measure retinal thickness</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RHMS-RTM repeatability</measure>
    <time_frame>1 day</time_frame>
    <description>To assess repeatability of the RHMS-RTM device</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of retinal thickness measurements between the RHMS-RTM and the SD-OCT</measure>
    <time_frame>1 month</time_frame>
    <description>To evaluate the agreement of measurements by the RHMS-RTM and SD-OCT</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Macular Edema</condition>
  <condition>Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Subjects with normal macular thickness in one or both eyes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Subjects with center-involving macular edema due to w/AMD in one or both eyes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>Subjects with center-involving macular edema due to DR or RVO in one or both eyes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RHMS-RTM</intervention_name>
    <description>Assessment of retinal thickness.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
    <other_name>Handheld swept source (SS) optical coherence tomography (OCT)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>SD-OCT</intervention_name>
    <description>Assessment of retinal structure.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects aged ≥ 18 years old with normal macular thickness, center-involving macular edema&#xD;
        due to wAMD, diabetic retinopathy or retinal vein occlusion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Corrected visual acuity (VA) of 20/100 or better, in the study eye(s)&#xD;
&#xD;
          2. Media clarity, undilated pupil size, OCT-B scans, axial length measurements in the&#xD;
             study eye(s)&#xD;
&#xD;
          3. Able to perform self-testing of retinal thickness with the RHMS-RTM after training&#xD;
&#xD;
          4. Able and willing to give informed consent&#xD;
&#xD;
          5. Group 1:&#xD;
&#xD;
               1. Macula with normal thickness [central subfield thickness (CST) below 305 microns&#xD;
                  as measured by SD-OCT] in at least one eye&#xD;
&#xD;
               2. Patients with dry AMD are eligible for enrollment into Group 1&#xD;
&#xD;
               3. No history of wet AMD, DR, or RVO in either eye&#xD;
&#xD;
          6. Group 2 and Group 3 (in at least one or the same eye):&#xD;
&#xD;
               1. History of center-involving macular edema due to wet AMD (Group 2); or DR or RVO&#xD;
                  (Group 3)&#xD;
&#xD;
               2. Macular edema on SD-OCT with CST ≥ 305 microns&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of corneal refractive surgery, photorefractive keratectomy, radial keratotomy,&#xD;
             in the study eye&#xD;
&#xD;
          2. History of epiretinal membrane, vitreomacular traction, or macular hole in the study&#xD;
             eye(s)&#xD;
&#xD;
          3. Participation in any study using an investigational drug within 30 days or screening&#xD;
             or investigational device within 60 days of screening&#xD;
&#xD;
          4. Refractive error: spherical equivalent of &gt; 3 diopters of hyperopia or &gt; 6 diopters of&#xD;
             myopia, or &gt; 2 diopters cylinder in the study eye(s)&#xD;
&#xD;
          5. History of photocoagulation laser scar or other retinal scar in the central 3 mm of&#xD;
             the macula, in the study eye(s)&#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>
  <overall_official>
    <last_name>Jeff Gregory, MD</last_name>
    <role>Study Director</role>
    <affiliation>Kubota Vision Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Retinal Consultants Medical Group, Inc</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95819</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 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>February 18, 2021</last_update_submitted>
  <last_update_submitted_qc>February 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Macular Edema, Wet AMD</keyword>
  <keyword>Retinal Thickness</keyword>
  <keyword>Diabetic Retinopathy, Retinal Vein Occlusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Macular Edema</mesh_term>
    <mesh_term>Edema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04428242
org study id: SCT-202
nct id: NCT04428242
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
Evaluate the ability and accuracy of the Retinal Health Monitoring System - Retinal Thickness
      Module (RHMS - RTM).
Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in subjects
      with normal macular thickness and subjects with center-involving macular edema.
observational model: Other
time perspective: Prospective
measure: Evaluation of the RHMS-RTM retinal thickness measurements
time frame: 1 day
description: To evaluate the ability of the RHMS-RTM device to measure retinal thickness
measure: RHMS-RTM repeatability
time frame: 1 day
description: To assess repeatability of the RHMS-RTM device
measure: Comparison of retinal thickness measurements between the RHMS-RTM and the SD-OCT
time frame: 1 month
description: To evaluate the agreement of measurements by the RHMS-RTM and SD-OCT
arm group label: Group 1
description: Subjects with normal macular thickness in one or both eyes.
arm group label: Group 2
description: Subjects with center-involving macular edema due to w/AMD in one or both eyes.
arm group label: Group 3
description: Subjects with center-involving macular edema due to DR or RVO in one or both eyes.
intervention type: Device
intervention name: RHMS-RTM
description: Assessment of retinal thickness.
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
other name: Handheld swept source (SS) optical coherence tomography (OCT)
intervention type: Diagnostic Test
intervention name: SD-OCT
description: Assessment of retinal structure.
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jeff Gregory, MD
role: Study Director
affiliation: Kubota Vision Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Macular Edema
mesh term: Edema
sharing ipd: Undecided