<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/NCT03828890</url>
  </required_header>
  <id_info>
    <org_study_id>18-009449</org_study_id>
    <nct_id>NCT03828890</nct_id>
  </id_info>
  <brief_title>Assess Screening for Diabetic Retinopathy Using Retinal Camera in Family Medicine Clinic</brief_title>
  <official_title>A Pilot Study to Assess Screening for Diabetic Retinopathy Using Retinal Camera in Family Medicine Clinic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The long-term goal for this study is to improve compliance of screening for diabetic&#xD;
      retinopathy among subjects with diabetes. Researchers are also doing this research to&#xD;
      determine the ability of appropriately trained family physicians to screen for and identify&#xD;
      Diabetic Retinopathy using a retinal camera in addition to determining an overall patient&#xD;
      perspective of the convenience and cost-effectiveness of retinal imaging within a primary&#xD;
      care setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2019</start_date>
  <completion_date type="Actual">March 15, 2020</completion_date>
  <primary_completion_date type="Actual">March 15, 2020</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Family Physicians Screening for Diabetic Retinopathy - Number of photographs that are interpreted accurately by the family physicians when compared to the retinal specialist</measure>
    <time_frame>6 months.</time_frame>
    <description>Number of photographs that are interpreted accurately by the family physicians when compared to the retinal specialist. These photographs are obtained using retinal imaging and after the initial read by the family physicians trained to interpret the images, the images will be reviewed by the retinal specialist to determine if the interpreted results are accurate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Screening Impact - Percentage increase in the screening rates for Diabetic Retinopathy using retinal imaging.</measure>
    <time_frame>6 months</time_frame>
    <description>Percentage increase in the screening rates for Diabetic Retinopathy using retinal imaging using OPTOS when compared with the traditional dilated eye exam.The current screening rate is around 55%.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>6 months</time_frame>
    <description>Percentage change in patient satisfaction and how much are patients willing to pay out of pocket to screen for Diabetic Retinopathy using retinal imaging. Each patient will be surveyed and these questions will help determine patient satisfaction and their willingness to pay for this versus usual care. We will ask the following questions:&#xD;
Did you find the Retinal Imaging an easy/efficient way of screening for eye disease as a result of having diabetes? Yes/No&#xD;
If you had to pay for this out-of-pocket what is the maximum amount you would be willing to pay?&#xD;
$25&#xD;
$50&#xD;
$75&#xD;
$100&#xD;
&gt;$100 This will help us determine the patient's level of satisfaction and their willingness to pay out of pocket for the service.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Single Arm Trial</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Intervention includes screening eye exam using Optos technology</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Screening eye exam using Optos technology</intervention_name>
    <description>Retinal imaging using Optos technology to identify Diabetic Retinopathy</description>
    <arm_group_label>Single Arm Trial</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient ≥ 18 years of age&#xD;
&#xD;
          -  Diabetes Mellitus Type I or II&#xD;
&#xD;
          -  Patient is willing and able to provide informed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Known Diabetic Retinopathy&#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>Bryan Farford, D.O.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>November 30, 2020</last_update_submitted>
  <last_update_submitted_qc>November 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Bryan Farford</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Retinopathy</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/NCT03828890
org study id: 18-009449
nct id: NCT03828890
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The long-term goal for this study is to improve compliance of screening for diabetic
      retinopathy among subjects with diabetes. Researchers are also doing this research to
      determine the ability of appropriately trained family physicians to screen for and identify
      Diabetic Retinopathy using a retinal camera in addition to determining an overall patient
      perspective of the convenience and cost-effectiveness of retinal imaging within a primary
      care setting.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Family Physicians Screening for Diabetic Retinopathy - Number of photographs that are interpreted accurately by the family physicians when compared to the retinal specialist
time frame: 6 months.
description: Number of photographs that are interpreted accurately by the family physicians when compared to the retinal specialist. These photographs are obtained using retinal imaging and after the initial read by the family physicians trained to interpret the images, the images will be reviewed by the retinal specialist to determine if the interpreted results are accurate.
measure: Screening Impact - Percentage increase in the screening rates for Diabetic Retinopathy using retinal imaging.
time frame: 6 months
description: Percentage increase in the screening rates for Diabetic Retinopathy using retinal imaging using OPTOS when compared with the traditional dilated eye exam.The current screening rate is around 55%.
measure: Patient Satisfaction
time frame: 6 months
description: Percentage change in patient satisfaction and how much are patients willing to pay out of pocket to screen for Diabetic Retinopathy using retinal imaging. Each patient will be surveyed and these questions will help determine patient satisfaction and their willingness to pay for this versus usual care. We will ask the following questions:
Did you find the Retinal Imaging an easy/efficient way of screening for eye disease as a result of having diabetes? Yes/No
If you had to pay for this out-of-pocket what is the maximum amount you would be willing to pay?
$25
$50
$75
$100
>$100 This will help us determine the patient's level of satisfaction and their willingness to pay out of pocket for the service.
arm group label: Single Arm Trial
arm group type: Other
description: Intervention includes screening eye exam using Optos technology
intervention type: Other
intervention name: Screening eye exam using Optos technology
description: Retinal imaging using Optos technology to identify Diabetic Retinopathy
arm group label: Single Arm Trial
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bryan Farford, D.O.
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Bryan Farford
investigator title: Principal Investigator
mesh term: Diabetic Retinopathy
sharing ipd: No