OCT Angiography Software Evaluation Study

Study Overview
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Brief Summary
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Comparisons for vascular structure visualization in the retina and choroid.

Detailed Description
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Evaluate the clinical performance of the Maestro2 OCTA for the visualization of the vascular structures of the retina and choroid.

Official Title
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Topcon Maestro2 OCT Angiography Software Evaluation Study

Conditions
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Retina Condition Followed by Fluorescein Angiography Imaging

Intervention / Treatment
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* Device: Maestro2 OCTA
* Device: Cirrus HD-OCT 5000
* Device: TRC-50DX


Participation Criteria
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Eligibility Criteria
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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: Vascular pathologies primarily visualized in Superficial and Deep en face OCTA slabs, including but not limited to Diabetic Retinopathy (DR), Branch Retinal Vein Occlusion (BRVO), Central Retinal Vein Occlusion (CRVO), Central Retinal Arterial Occlusion (CRAO), Macular Telangiectasia (MacTel), Sickle Cell Retinopathy (SCR) Vascular pathologies primarily visualized in Outer Retina and Choriocapillaris en face OCTA slabs, including but not limited to Neovascular Age-Related Macular Degeneration (wet AMD) and Polypoidal Choroidal Vasculopathy (PCV) Exclusion 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. Contraindication to pupil dilation 6. Known allergy or other contradictions to fluorescein and/or to indocyanine green or iodides Normal 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 BCVA 20/40 or better in the study eye Exclusion 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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects presenting with Normal Eyes<br>Subjects with no known ocular diseases will be imaged on the Maestro2 OCT, Zeiss Cirrus HD-OCT 5000, and TRC-50DX | Device: Maestro2 OCTA<br>* The Maestro2 OCTA with SS-OCT Angio software is an OCT with a fundus camera used for diagnostic purposes<br>Device: Cirrus HD-OCT 5000<br>* The Zeiss Cirrus HD-OCT 5000 is an OCT used for diagnostic purposes<br>Device: TRC-50DX<br>* The TRC-50DX retinal camera images the fundus used for diagnostic purposes<br>|
| Subjects with retinal pathology present in the eye<br>Subjects with no known ocular diseases will be imaged on the Maestro2 OCT, Zeiss Cirrus HD-OCT 5000, and TRC-50DX | Device: Maestro2 OCTA<br>* The Maestro2 OCTA with SS-OCT Angio software is an OCT with a fundus camera used for diagnostic purposes<br>Device: Cirrus HD-OCT 5000<br>* The Zeiss Cirrus HD-OCT 5000 is an OCT used for diagnostic purposes<br>Device: TRC-50DX<br>* The TRC-50DX retinal camera images the fundus used for diagnostic purposes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |