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| ID | Type | Description | Link |
|---|---|---|---|
| 2R44EY020016 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
| Retina Foundation of the Southwest | OTHER |
| University of Texas Southwestern Medical Center | OTHER |
| Texas Retina Associates |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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®. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home vision monitoring using myVisionTrack® | Device | Patients will be asked to test their vision at home twice per week using myVisionTrack® during the study period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Test efficacy of the test algorithm improvements | To test the efficacy of test algorithm improvements and usability enhancements on the overall rate of patient compliance and on test-retest variability. | Twelve months |
| Measure | Description | Time Frame |
|---|---|---|
| Refine the decision rule | To refine the decision rule so as to select optimal cutoff values to achieve desired sensitivity and specificity of self-test | Twelve months |
| Can improved testing algorithm minimize test time? |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with diabetic retinopathy requiring treatment
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| Name | Affiliation | Role |
|---|---|---|
| Yi-Zhong Wang, PhD | Retina Foundation of the Southwest | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Foundation of the Southwest | Dallas | Texas | 75231 | United States | ||
| UT Southwestern Medical Center |
DME Monitoring Results presented at ARVO on May 2, 2016. Additional results planned.
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D008269 | Macular Edema |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| OTHER |
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To determine if the improved testing algorithm can minimize the length of testing while maintaining or improving accuracy
| Twelve months |
| Assess patient satisfaction with the test | To assess patient satisfaction regarding the use of myVisionTrack™ | Twelve months |
| Dallas |
| Texas |
| 75284 |
| United States |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D012162 | Retinal Degeneration |