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| Name | Class |
|---|---|
| Duke University | OTHER |
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This is a prospective clinical study conducted at one clinical site in the United States.
The conducted study is an observational study for an imaging device used in the aid of ophthalmology diagnosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult Normal Eyes | see Inclusion/Exclusion criteria; imaged with OCT and/or OCTA |
| |
| Adult Pathology Eyes | see Inclusion/Exclusion criteria; imaged with OCT and/or OCTA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPECTRALIS | Device | ophthalmic imaging device with head and chinrest |
|
| Measure | Description | Time Frame |
|---|---|---|
| The image quality grade of the acquired images as determined by an independent reading center | OCT, OCTA and IR cSLO - graded Good (2)/Average (1)/Poor (0) | through study completion, average of 1 day |
| Agreement in identification of abnormalities of the acquired Standard OCT images between the devices | based on pre-specified abnormalities | through study completion, average of 1 day |
| Agreement in identification of abnormalities of the acquired OCTA images between the devices | based on pre-specified abnormalities | through study completion, average of 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | All AEs | through study completion, average of 1 day |
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Adult Normal Eyes Population (AN)
Inclusion Criteria for AN Population
Exclusion Criteria for AN Population
Adult Posterior Segment Abnormality Eye Population (AD)
Inclusion Criteria for AD Population
Exclusion Criteria for AD Population
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Adults with healthy eyes (AN), and adults with structural and vascular retinal abnormalities (AD)
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| Name | Affiliation | Role |
|---|---|---|
| Lejla Vajzovic, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Eye Center | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| SPECTRALIS with Flex Module | Device | ophthalmic imaging device on mobile instrumentation stand |
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