Study 3: Repeatability And Reproducibility Of Macular Retinal Pigment Epithelium Elevation Measurements; Phase 1: Inter-Device Variability; Phase 2: Inter-Operator Variability - Zeiss CIRRUS HD-OCT 500 User Manual

B-12
Study 3: Repeatability and Reproducibility of Macular Retinal Pigment Epithelium
2660021169012 Rev. A 2017-12
Appendix
Elevation Measurements
The objective of this study was to determine the repeatability and reproducibility of the
CIRRUS HD-OCT measurements of macular retinal pigment epithelium (RPE) elevation. A
total of 50 eyes of 44 subjects were qualified for inclusion into the data analysis. There
were 26 qualified eyes for Phase 1 and 24 qualified eyes for Phase 2. Subjects in each
phase of the study underwent a series of CIRRUS HD-OCT scans:
Phase 1: Inter–Device Variability
Subjects assigned to Phase 1 of the study underwent the following series of CIRRUS
HD-OCT scans using the three CIRRUS units. A single operator, Operator A, performed all
scans during Phase 1 of the protocol. The following study measures were acquired:
• Three acceptable Macular Cube 200x200 scans on one eye from three CIRRUS
HD-OCT instruments for a total of 9 scans
• Three acceptable Macular Cube 512x128 scans on the fellow eye from three CIRRUS
HD-OCT instruments for a total of 9 scans
Phase 2: Inter–Operator Variability
Subjects assigned to Phase 2 of the study underwent the following series of CIRRUS
HD-OCT scans using only CIRRUS Unit 1. Three operators acquired the scans on each
subject. the following study measures were acquired:
• Three acceptable Macular Cube 200x200 scans on one eye from one CIRRUS HD-OCT
instrument by three operators for a total of 9 scans
• Three acceptable Macular Cube 512x128 scans on the fellow eye from the same
CIRRUS HD-OCT instrument by three operators for a total of 9 scans
The repeatability and reproducibility SD and limits of the area of RPE elevations are seen in
Table B-12 below. The repeatability limit of area measurements within the 3 mm circle
was higher than that of the 5 mm circle in the 200x200 scans (0.3626 and 0.2834 mm
respectively). The reverse was true for the 512x128 scan (0.2343 and 0.4304 mm
respectively). The reproducibility limit of area measurements within the 3 mm circle was
almost the same as that of the 5 mm circle in the 200x200 scans (0.4389 and 0.4073mm
respectively). For the 512x128 scan, the reproducibility limits for the 5 mm circle was
double that of the 3 mm circle (0.5422 vs. 0.2794 mm
reproducibility limits will affect the ability to determine when measurements have changed
due to a change in pathology as opposed to random variability.
2
2
2
2
). The repeatability and
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