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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01728883
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : May 12, 2017
National Eye Institute (NEI)
Retina Foundation of the Southwest
University of Texas Southwestern Medical Center
Texas Retina Associates
Information provided by (Responsible Party):
Vital Art and Science Incorporated

Brief Summary:
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.

Condition or disease Intervention/treatment
Diabetic Retinopathy Diabetic Macular Edema Device: Home vision monitoring using myVisionTrack®

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).

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of New Self-Test Visual Function Assessment System for Diabetic Retinopathy
Study Start Date : April 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

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 Name: myVisionTrack® Model 0004

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. 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

  3. Assess patient satisfaction with the test [ Time Frame: Twelve months ]
    To assess patient satisfaction regarding the use of myVisionTrack™

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with diabetic retinopathy requiring treatment

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01728883

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United States, Texas
Retina Foundation of the Southwest
Dallas, Texas, United States, 75231
UT Southwestern Medical Center
Dallas, Texas, United States, 75284
Sponsors and Collaborators
Vital Art and Science Incorporated
National Eye Institute (NEI)
Retina Foundation of the Southwest
University of Texas Southwestern Medical Center
Texas Retina Associates
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Study Chair: Yi-Zhong Wang, PhD Retina Foundation of the Southwest

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Responsible Party: Vital Art and Science Incorporated Identifier: NCT01728883     History of Changes
Other Study ID Numbers: 2R44EY020016-03 ( U.S. NIH Grant/Contract )
2R44EY020016 ( U.S. NIH Grant/Contract )
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: DME Monitoring Results presented at ARVO on May 2, 2016. Additional results planned.

Keywords provided by Vital Art and Science Incorporated:
Diabetic Retinopathy
Diabetic Macular Edema
Macular Edema
home monitoring
shape discrimination hyperacuity
Psychophysical Testing

Additional relevant MeSH terms:
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Macular Edema
Retinal Diseases
Diabetic Retinopathy
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases