Diabetic Retinopathy And the Myvisiontrack® (DRAMA) Study (DRAMA)

May 11, 2017 updated by: Vital Art and Science Incorporated

Evaluation of New Self-Test Visual Function Assessment System for Diabetic Retinopathy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75231
        • Retina Foundation of the Southwest
      • Dallas, Texas, United States, 75284
        • UT Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with diabetic retinopathy requiring treatment

Description

Inclusion Criteria:

  • DR or AMD requiring treatment at time of study initiation
  • Macular edema involving the central subfield based on clinical judgment
  • No noticeable central subfield atrophy
  • Patients willing and able to comply with all study and follow-up procedures (including the handling of the myVisionTrack™ device)

Exclusion Criteria:

  • Any ocular pathology other than DR or AMD
  • Any other concurrent systemic illness affecting the retina and visual function
  • Dementia or other neurological or psychological limitation that would prevent patients from performing self-testing of visual function
  • Past (within the prior 6 months) or current use of, or likely need for, systemic medications that are known to be toxic to the lens, retina, or optic nerve
  • Use of investigational drugs at the time of screening, or within 60 days (excluding vitamins and minerals)
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diagnosed DR/DME requiring treatment
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®.
Device: Home vision monitoring using myVisionTrack®
Patients will be asked to test their vision at home twice per week using myVisionTrack® during the study period.
Other Names:
  • myVisionTrack® Model 0004

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test efficacy of the test algorithm improvements
Time Frame: Twelve months
To test the efficacy of test algorithm improvements and usability enhancements on the overall rate of patient compliance and on test-retest variability.
Twelve months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Refine the decision rule
Time Frame: Twelve months
To refine the decision rule so as to select optimal cutoff values to achieve desired sensitivity and specificity of self-test
Twelve months
Can improved testing algorithm minimize test time?
Time Frame: Twelve months
To determine if the improved testing algorithm can minimize the length of testing while maintaining or improving accuracy
Twelve months
Assess patient satisfaction with the test
Time Frame: Twelve months
To assess patient satisfaction regarding the use of myVisionTrack™
Twelve months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vital Art and Science Incorporated

Collaborators

National Eye Institute (NEI)
University of Texas Southwestern Medical Center
Retina Foundation of the Southwest
Texas Retina Associates

Investigators

  • Study Chair: Yi-Zhong Wang, PhD, Retina Foundation of the Southwest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

November 13, 2012

First Submitted That Met QC Criteria

November 13, 2012

First Posted (Estimate)

November 20, 2012

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 11, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2R44EY020016-03 (U.S. NIH Grant/Contract)
  • 2R44EY020016 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

DME Monitoring Results presented at ARVO on May 2, 2016. Additional results planned.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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