Clinical trial NCT04701931: OCT Angiography Software Evaluation Study
Official title: Topcon Maestro2 OCT Angiography Software Evaluation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retina Condition Followed by Fluorescein Angiography Imaging
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2021-01-08
Enrollment: 135
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population with normal eye or eyes with pathology

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.

Eligibility 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 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

Primary outcomes:
measure: OCTA image quality
timeFrame: Day 1
measure: Visibility of key anatomical vascular features
timeFrame: Day 1
measure: Identification of key pathological vascular features
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Ana
country: United States
facility: Orange County Retina Medical Group
state: California
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
Study officials:
affiliation: CPAD
name: Mayra Tafreshi
role: STUDY_DIRECTOR
References: