OCT Angiography Software Evaluation Study

Topcon

Status: Completed

Conditions: Retina Condition Followed by Fluorescein Angiography Imaging

Treatments: Device: Cirrus HD-OCT 5000; Device: Maestro2 OCTA; Device: TRC-50DX

Study type: Observational

Funder types: Industry

Identifiers

NCT04701931

THS-TPCN-2020-003

Details and patient eligibility

About

Comparisons for vascular structure visualization in the retina and choroid.

Full description

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

Enrollment: 135 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

4. 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 Exclusion Criteria

4. 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

Trial design

135 participants in 2 patient groups

Subjects presenting with Normal Eyes

Description:

Subjects with no known ocular diseases will be imaged on the Maestro2 OCT, Zeiss Cirrus HD-OCT 5000, and TRC-50DX

Treatment:

Device: Cirrus HD-OCT 5000

Device: Maestro2 OCTA

Device: TRC-50DX

Subjects with retinal pathology present in the eye

Description:

Subjects with no known ocular diseases will be imaged on the Maestro2 OCT, Zeiss Cirrus HD-OCT 5000, and TRC-50DX

Treatment:

Device: Cirrus HD-OCT 5000

Device: Maestro2 OCTA

Device: TRC-50DX