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| ID | Type | Description | Link |
|---|---|---|---|
| 9SB1EY027241 | U.S. NIH Grant/Contract | View source | |
| 2R44EY026864 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or diabetic eye disease (DED), the leading cause of vision loss and blindness in working-age adults. Annual eye screening is recommended for all diabetic patients since vision loss can be prevented with laser photocoagulation and anti-VEGF injections if DR is diagnosed in its early stages. Currently, the number of clinical personnel trained for DR screening is orders of magnitude smaller than that needed to screen the large, growing diabetic population. Therefore, to meet this large unmet need for DR screening, a fully-automated computerized DR screening system is necessary. This study is designed to assess the performance of EyeArt, an automated DR screening tool.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Color fundus photography | Procedure | Subjects will undergo fundus photography before and after administration of mydriatic agent. | ||
| Mydriatic Agent | Drug | Subjects will be administered mydriatic medication to dilate their pupils. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects whose EyeArt results match the reading center grading for identifying referable diabetic eye disease (moderate NPDR or higher on the ICDR scale or surrogate markers for CSME). | The performance of EyeArt will be evaluated using overall accuracy, sensitivity, and specificity measures. | 1 visit |
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Inclusion Criteria:
Exclusion Criteria:
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The study subjects will be enrolled at a primary care center
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LAC+USC Medical Center | Los Angeles | California | 90033 | United States |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D009184 | Mydriatics |
| ID | Term |
|---|---|
| D001337 | Autonomic Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D020164 | Chemical Actions and Uses |