Retina Condition Followed by Fluorescein Angiography Imaging
Conditions
Brief summary
Comparisons for vascular structure visualization in the retina and choroid.
Detailed description
Evaluate the clinical performance of the Maestro2 OCTA for the visualization of the vascular structures of the retina and choroid.
Interventions
DEVICEMaestro2 OCTA
The Maestro2 OCTA with SS-OCT Angio software is an OCT with a fundus camera used for diagnostic purposes
DEVICECirrus HD-OCT 5000
The Zeiss Cirrus HD-OCT 5000 is an OCT used for diagnostic purposes
DEVICETRC-50DX
The TRC-50DX retinal camera images the fundus used for diagnostic purposes
Sponsors
Topcon Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Pathology Population Inclusion Criteria 1. 22 years of age or older on the date of informed consent 2. Able to understand the written informed consent and willing to participate by signing the informed consent 3. Current diagnosis of one or more of the following pathologies in the study eye in two subgroups: 1. 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) 2. 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 1. 22 years of age or older on the date of informed consent 2. Able to understand the written informed consent and willing to participate by signing the informed consent 3. BCVA 20/40 or better in the study eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OCTA image quality | Day 1 | The OCTA image quality comparison between Maestro2 and Cirrus |
| Visibility of key anatomical vascular features | Day 1 | The OCTA visibility comparison between Maestro2 and Cirrus |
| Identification of key pathological vascular features | Day 1 | the agreement rate is calculated based on the match outcome is the same between OCTA and FA/ICGA |
Countries
United States
Outcome results
None listed