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| Name | Class |
|---|---|
| VisionQuest Biomedical LLC | INDUSTRY |
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In this clinical trial, we plan to evaluate the usefulness of artificial intelligence (AI) software paired with a handheld retinal camera to compare diabetic retinopathy status in Bolivian patients as read by retina specialists versus the AI software.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Picture of the retina with a handheld retinal camera | Other | Patient with diabetes will have their undilated and dilated images taken, with the images being centered on the macula and on the optic disc. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects where the image readout by retina specialists match the readouts by EyeStar AI system for identifying diabetic eye disease | To quantify image analysis performance of the EyeStar AI system paired with Pictor Plus cameras for the detection of referable Diabetic Retinopathy (DR), defined as severe non-proliferative diabetic retinopathy (NPDR), proliferative diabetic retinopathy (PDR), or diabetic macular edema (DME) against adjudicated reads of retinal images by retina specialists | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with gradable images taken by the hand held camera | Pictures taken by the handheld retinal camera will be graded by the retina specialists for the quality of image for readouts | 3 months |
| Number of subjects with ocular diseases other than diabetic retinopathy between the readout by the EyeStar AI system and those by the retina specialists |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are known diabetics in the hospital, or seeking help from the eye clinics or from associated specialties, e.g. endocrinology, will be included in the study as subjects. The Investigators will also recruit subjects who are evaluated in organized outreach visits in the community.
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| Name | Affiliation | Role |
|---|---|---|
| Rajat Agrawal, MD MS | Retina Global | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Medico Kolping | Santa Cruz de la Sierra | Bolivia | ||||
| Clinica Incor |
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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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To assess the performance of the system in detection of other ocular diseases such as macular degeneration and glaucoma |
| 3 months |
| Santa Cruz de la Sierra |
| Bolivia |
| Hospital Universitario Japones | Santa Cruz de la Sierra | Bolivia |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |