Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
135 participants
OBSERVATIONAL
2021-01-07
2023-06-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Maestro2 OCTA
The Maestro2 OCTA with SS-OCT Angio software is an OCT with a fundus camera used for diagnostic purposes
Cirrus HD-OCT 5000
The Zeiss Cirrus HD-OCT 5000 is an OCT used for diagnostic purposes
TRC-50DX
The TRC-50DX retinal camera images the fundus used for diagnostic purposes
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
Maestro2 OCTA
The Maestro2 OCTA with SS-OCT Angio software is an OCT with a fundus camera used for diagnostic purposes
Cirrus HD-OCT 5000
The Zeiss Cirrus HD-OCT 5000 is an OCT used for diagnostic purposes
TRC-50DX
The TRC-50DX retinal camera images the fundus used for diagnostic purposes
Interventions
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Maestro2 OCTA
The Maestro2 OCTA with SS-OCT Angio software is an OCT with a fundus camera used for diagnostic purposes
Cirrus HD-OCT 5000
The Zeiss Cirrus HD-OCT 5000 is an OCT used for diagnostic purposes
TRC-50DX
The TRC-50DX retinal camera images the fundus used for diagnostic purposes
Eligibility Criteria
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Inclusion Criteria
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)
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
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
22 Years
ALL
Yes
Sponsors
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Topcon Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Mayra Tafreshi
Role: STUDY_DIRECTOR
CPAD
Locations
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Orange County Retina Medical Group
Santa Ana, California, United States
Southeast Retina Center
Augusta, Georgia, United States
Countries
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Other Identifiers
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THS-TPCN-2020-003
Identifier Type: -
Identifier Source: org_study_id
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