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The study evaluates image quality between two devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultra widefield image capture | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P200TxE | Device | The P200TxE ophthalmoscope provides widefield scanning laser ophthalmascope (SLO) fundus imaging. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Image assessment | Results from a qualitative assessment of the clinical utility and image quality of the images from both devices will be assessed from a clinician questionnaire and three independent masked and qualified graders using a four point scale (0-3). | 6 months |
| Safety Assessment from Adverse Events | Analysis of safety will be assessed through adverse events reported by the site and documented on each subject's case report form. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
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| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| P200DTx | Device | The P200DTx ophthalmoscope provides widefield scanning laser ophthalmascope (SLO) fundus imaging. |
|