Diabetic Retinopathy And the Myvisiontrack® (DRAMA) Study

Completed

Conditions studied: Diabetic Retinopathy, Diabetic Macular Edema

In brief

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.

Key facts

Study ID

NCT01728883

Run by

Vital Art and Science Incorporated

People needed

60

Starts

2013-04-01

Expected to finish

2017-03-01

Last updated by the study team

2017-05-12

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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