Diabetic Retinopathy And the Myvisiontrack® (DRAMA) Study
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Ocular, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology, Ophthalmology |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 5/13/2017 |
| Start Date: | April 2013 |
| End Date: | March 2017 |
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.
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).
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).
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
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