Zeiss CIRRUS HD-OCT 500, Руководство пользователя

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CIRRUS HD-OCT User Manual 2660021169012 Rev. A 2017-12
Appendix
B-1
Appendix B: CIRRUS Algorithm Studies
Study 1: Retinal Segmentation and Analysis
Introduction
Zeiss partnered with respected members of the academic and clinical community to study
the accuracy and precision of the CIRRUS retinal segmentation algorithm, and to evaluate
the agreement between CIRRUS HD-OCT and Stratus OCT, which is the standard of care for
diagnosing and managing retinal diseases. The Retinal Segmentation Study Group
consisted of faculty, fellows, and physicians at:
• Medical University of Vienna (MUV)
• Bascom Palmer Eye Institute (BPEI) – University of Miami Miller School of Medicine
• Wilmer Eye Institute (WEI) – Johns Hopkins University School of Medicine
• Northern California Retina–Vitreous Associates (NCRVA)
Preliminary results have been reported at conferences (see References on page B-8 ), and
are summarized in this report. Final results are being submitted for publication.
Purpose
The primary purpose of the “Spectral Domain OCT (SD–OCT) Evaluation Study of Retinal
Segmentation and Analysis” was to: 1) evaluate the accuracy and precision of the CIRRUS
HD-OCT retinal thickness segmentation algorithms, and 2) to evaluate the agreement
between the resulting measurements and similar measurements made on Stratus OCT. A
secondary objective of the study was to evaluate the effectiveness of data registration on
repeatability.
Methods
Data Collection
This was a prospective, non–randomized, multi–center study. Subjects 18 years of age or
older, who were willing and able to give consent, and follow study instructions were
recruited from the clinics of four study sites (WEI, BPEI, MUV, NCRVA) from March 2007 to
October 2007, following an informed consent process including signing of a written
consent form approved by the respective clinic's Institutional Review Board.
Both eyes of the subjects where scanned, with one eye being chosen as the study eye
based on eligibility guidelines. When both eyes were eligible, the Principal Investigator
arbitrarily assigned one eye as the study eye. Subjects were classified into six groups based
on the primary diagnosis causing the most pathologic abnormalities in the study eye as
follows:
Group 1 – Age–related macular degeneration (AMD),
Group 2 – Diabetic retinopathy (DR),
Group 3 – Vitreoretinal interface abnormalities (including macular holes),
Group 4 – Other retinal pathology,