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Comparisons for vascular structure visualization in the retina and choroid.
Evaluate the clinical performance of the Maestro2 OCTA for the visualization of the vascular structures of the retina and choroid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects presenting with Normal Eyes | Subjects with no known ocular diseases will be imaged on the Maestro2 OCT, Zeiss Cirrus HD-OCT 5000, and TRC-50DX |
| |
| Subjects with retinal pathology present in the eye | Subjects with no known ocular diseases will be imaged on the Maestro2 OCT, Zeiss Cirrus HD-OCT 5000, and TRC-50DX |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maestro2 OCTA | Device | The Maestro2 OCTA with SS-OCT Angio software is an OCT with a fundus camera used for diagnostic purposes |
|
| Measure | Description | Time Frame |
|---|---|---|
| OCTA image quality | The OCTA image quality comparison between Maestro2 and Cirrus | Day 1 |
| Visibility of key anatomical vascular features | The OCTA visibility comparison between Maestro2 and Cirrus | Day 1 |
| Identification of key pathological vascular features | the agreement rate is calculated based on the match outcome is the same between OCTA and FA/ICGA | Day 1 |
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Pathology Population Inclusion Criteria
22 years of age or older on the date of informed consent
Able to understand the written informed consent and willing to participate by signing the informed consent
Current diagnosis of one or more of the following pathologies in the study eye in two subgroups:
1. Subjects previously enrolled in Maestro2 OCTA feasibility study 2. Subjects who are pregnant or lactating* 3. Unable to complete the required clinical examinations 4. Contraindication to pupil dilation 6. Known allergy or other contradictions to fluorescein and/or to indocyanine green or iodides
Normal Population Inclusion Criteria
1. Subjects previously enrolled in Maestro2 OCTA feasibility study 2. Subjects who are pregnant or lactating* 3. Unable to complete the required clinical examinations 4. Clinically significant findings in the study eye in clinical examination 5. Contraindication to pupil dilation 7. Known allergy or contradictions to fluorescein and/or to indocyanine green or iodides
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Population with normal eye or eyes with pathology
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| Name | Affiliation | Role |
|---|---|---|
| Mayra Tafreshi | CPAD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Retina Medical Group | Santa Ana | California | 92705 | United States | ||
| Southeast Retina Center |
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| Cirrus HD-OCT 5000 | Device | The Zeiss Cirrus HD-OCT 5000 is an OCT used for diagnostic purposes |
|
| TRC-50DX | Device | The TRC-50DX retinal camera images the fundus used for diagnostic purposes |
|
| Augusta |
| Georgia |
| 30909 |
| United States |