Diabetic Retinopathy And the Myvisiontrack® (DRAMA) Study
NCT ID: NCT01728883
Last Updated: 2017-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2013-04-30
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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®.
Home vision monitoring using myVisionTrack®
Patients will be asked to test their vision at home twice per week using myVisionTrack® during the study period.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
40 Years
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
Retina Foundation of the Southwest
OTHER
University of Texas Southwestern Medical Center
OTHER
Texas Retina Associates
OTHER
Vital Art and Science Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Yi-Zhong Wang, PhD
Role: STUDY_CHAIR
Retina Foundation of the Southwest
Locations
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Retina Foundation of the Southwest
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Countries
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Other Identifiers
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