Diabetic Macular Edema, Diabetic Retinopathy
Conditions
Keywords
Diabetic Retinopathy, Diabetic Macular Edema, Macular Edema, Maculopathy, home monitoring, shape discrimination hyperacuity, Psychophysical Testing
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.
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).
Interventions
DEVICEHome vision monitoring using myVisionTrack®
Patients will be asked to test their vision at home twice per week using myVisionTrack® during the study period.
Sponsors
National Eye Institute (NEI)
Retina Foundation of the Southwest
University of Texas Southwestern Medical Center
Texas Retina Associates
Vital Art and Science Incorporated
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Test efficacy of the test algorithm improvements | 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
| Measure | Time frame | Description |
|---|---|---|
| Refine the decision rule | Twelve months | To refine the decision rule so as to select optimal cutoff values to achieve desired sensitivity and specificity of self-test |
| Can improved testing algorithm minimize test time? | Twelve months | To determine if the improved testing algorithm can minimize the length of testing while maintaining or improving accuracy |
| Assess patient satisfaction with the test | Twelve months | To assess patient satisfaction regarding the use of myVisionTrack™ |
Countries
United States
Outcome results
None listed