<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/NCT01728883</url>
  </required_header>
  <id_info>
    <org_study_id>2R44EY020016-03</org_study_id>
    <secondary_id>2R44EY020016</secondary_id>
    <nct_id>NCT01728883</nct_id>
  </id_info>
  <brief_title>Diabetic Retinopathy And the Myvisiontrack® (DRAMA) Study</brief_title>
  <acronym>DRAMA</acronym>
  <official_title>Evaluation of New Self-Test Visual Function Assessment System for Diabetic Retinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vital Art and Science Incorporated</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Eye Institute (NEI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Retina Foundation of the Southwest</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Texas Retina Associates</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vital Art and Science Incorporated</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effect of enhancements to the myVisionTrack® in&#xD;
      regards to patient compliance and test-retest variability. Additionally, the ability of&#xD;
      myVisionTrack® to detect changes in vision function will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The results of this study will provide the basis for patient self-monitoring of visual&#xD;
      function with the myVisionTrack®, and for reporting, storage, and maintenance of collected&#xD;
      data. The myVisionTrack® is intended to be used remotely by patients to monitor their&#xD;
      disease. In the case of significant changes, patients will be prompted to visit their&#xD;
      ophthalmologist. It is hypothesized that this can lead to earlier detection of disease&#xD;
      progression, which, in turn, can lead to earlier treatment and better prevention against&#xD;
      vision loss due to diabetic retinopathy (DR).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Test efficacy of the test algorithm improvements</measure>
    <time_frame>Twelve months</time_frame>
    <description>To test the efficacy of test algorithm improvements and usability enhancements on the overall rate of patient compliance and on test-retest variability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Refine the decision rule</measure>
    <time_frame>Twelve months</time_frame>
    <description>To refine the decision rule so as to select optimal cutoff values to achieve desired sensitivity and specificity of self-test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Can improved testing algorithm minimize test time?</measure>
    <time_frame>Twelve months</time_frame>
    <description>To determine if the improved testing algorithm can minimize the length of testing while maintaining or improving accuracy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess patient satisfaction with the test</measure>
    <time_frame>Twelve months</time_frame>
    <description>To assess patient satisfaction regarding the use of myVisionTrack™</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Diabetic Retinopathy</condition>
  <condition>Diabetic Macular Edema</condition>
  <arm_group>
    <arm_group_label>Diagnosed DR/DME requiring treatment</arm_group_label>
    <description>Patients diagnosed as diabetic retinopathy(DR) and/or diabetic macular edema (DME) and requiring treatment at the time they are recruited into the Study. Patients will be home vision monitoring using myVisionTrack®.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Home vision monitoring using myVisionTrack®</intervention_name>
    <description>Patients will be asked to test their vision at home twice per week using myVisionTrack® during the study period.</description>
    <arm_group_label>Diagnosed DR/DME requiring treatment</arm_group_label>
    <other_name>myVisionTrack® Model 0004</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with diabetic retinopathy requiring treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  DR or AMD requiring treatment at time of study initiation&#xD;
&#xD;
          -  Macular edema involving the central subfield based on clinical judgment&#xD;
&#xD;
          -  No noticeable central subfield atrophy&#xD;
&#xD;
          -  Patients willing and able to comply with all study and follow-up procedures (including&#xD;
             the handling of the myVisionTrack™ device)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any ocular pathology other than DR or AMD&#xD;
&#xD;
          -  Any other concurrent systemic illness affecting the retina and visual function&#xD;
&#xD;
          -  Dementia or other neurological or psychological limitation that would prevent patients&#xD;
             from performing self-testing of visual function&#xD;
&#xD;
          -  Past (within the prior 6 months) or current use of, or likely need for, systemic&#xD;
             medications that are known to be toxic to the lens, retina, or optic nerve&#xD;
&#xD;
          -  Use of investigational drugs at the time of screening, or within 60 days (excluding&#xD;
             vitamins and minerals)&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yi-Zhong Wang, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Retina Foundation of the Southwest</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Retina Foundation of the Southwest</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75284</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>May 11, 2017</last_update_submitted>
  <last_update_submitted_qc>May 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetic Retinopathy</keyword>
  <keyword>Diabetic Macular Edema</keyword>
  <keyword>Macular Edema</keyword>
  <keyword>Maculopathy</keyword>
  <keyword>home monitoring</keyword>
  <keyword>shape discrimination hyperacuity</keyword>
  <keyword>Psychophysical Testing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Edema</mesh_term>
    <mesh_term>Retinal Diseases</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>DME Monitoring Results presented at ARVO on May 2, 2016. Additional results planned.</ipd_description>
  </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/NCT01728883
org study id: 2R44EY020016-03
secondary id: 2R44EY020016
nct id: NCT01728883
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine the effect of enhancements to the myVisionTrack® in
      regards to patient compliance and test-retest variability. Additionally, the ability of
      myVisionTrack® to detect changes in vision function will be evaluated.
The results of this study will provide the basis for patient self-monitoring of visual
      function with the myVisionTrack®, and for reporting, storage, and maintenance of collected
      data. The myVisionTrack® is intended to be used remotely by patients to monitor their
      disease. In the case of significant changes, patients will be prompted to visit their
      ophthalmologist. It is hypothesized that this can lead to earlier detection of disease
      progression, which, in turn, can lead to earlier treatment and better prevention against
      vision loss due to diabetic retinopathy (DR).
observational model: Case-Only
time perspective: Prospective
measure: Test efficacy of the test algorithm improvements
time frame: Twelve months
description: To test the efficacy of test algorithm improvements and usability enhancements on the overall rate of patient compliance and on test-retest variability.
measure: Refine the decision rule
time frame: Twelve months
description: To refine the decision rule so as to select optimal cutoff values to achieve desired sensitivity and specificity of self-test
measure: Can improved testing algorithm minimize test time?
time frame: Twelve months
description: To determine if the improved testing algorithm can minimize the length of testing while maintaining or improving accuracy
measure: Assess patient satisfaction with the test
time frame: Twelve months
description: To assess patient satisfaction regarding the use of myVisionTrack™
arm group label: Diagnosed DR/DME requiring treatment
description: Patients diagnosed as diabetic retinopathy(DR) and/or diabetic macular edema (DME) and requiring treatment at the time they are recruited into the Study. Patients will be home vision monitoring using myVisionTrack®.
intervention type: Device
intervention name: Home vision monitoring using myVisionTrack®
description: Patients will be asked to test their vision at home twice per week using myVisionTrack® during the study period.
arm group label: Diagnosed DR/DME requiring treatment
other name: myVisionTrack® Model 0004
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Yi-Zhong Wang, PhD
role: Study Chair
affiliation: Retina Foundation of the Southwest
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Macular Edema
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
sharing ipd: Yes
ipd description: DME Monitoring Results presented at ARVO on May 2, 2016. Additional results planned.