The purpose of this clinical protocol is to perform a comparison of Retinal and Retinal Nerve Fiber Layer (RNFL) thickness measurements between the Topcon 3D-1000 and the identified predicate device. In addition, this protocol performs a comparison of the thickness measurement results from images collected and analyzed with the Zeiss Stratus OCT to images collected with the Zeiss Stratus OCT and imported into the Topcon 3D OCT-1000 StratusViewer for analysis.
Study Type
OBSERVATIONAL
Enrollment
48
Retina Consultations
Bronxville, New York, United States
New York Eye and Ear-Glaucoma Associates of New York
New York, New York, United States
Vitreous-Retina-Macula Consultants of NY
New York, New York, United States
SUNY
New York, New York, United States
Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device
The precision and agreement measures the thickness of RNFL and Full Retinal Thickness of the study device and is compared to the predicate device to show agreement. Keywords, ILM - Internal Limiting Membrane RPE - Retinal Pigment Epithelium RNFL - Retinal Nerve Fiber Layer
Time frame: 30 Minutes
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