Zeiss CIRRUS HD-OCT 500, Руководство пользователя

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CIRRUS HD-OCT User Manual 2660021169012 Rev. A 2017-12
Appendix
B-21
Comparison to Stratus OCT
3
A study of normal subjects and subjects with glaucoma (N = 130) found that although
there were differences between Stratus and CIRRUS, the Pearson correlation coefficient for
the average RNFL thickness was 0.953, indicating good correlation. However, they also
found a systematic difference between CIRRUS and Stratus RNFL measurements. CIRRUS
measures thicker than Stratus at thinner RNFL values and measures thinner at thicker
(more normal) RNFL values. Measurements from the two systems should not be used
interchangeably.
3. Knight OJ, Chang RT, Feuer WJ, Budenz DL. “Comparison of retinal nerve fiber layer measurements using time domain and
spectral domain optical coherent tomography.” Ophthalmology. 2009 Jul;116(7):1271-7.
Table B-20 Repeatability and Reproducibility of CIRRUS RNFL measurements for seventeen sectors, including the
overall average thickness, four quadrants (temporal, superior, nasal, and inferior), and twelve sectors, labeled by clock
hour, with the 9 o’clock hour most temporal, measured on 32 normal subjects.
Mean
Thickness
( μ m)
Repeatability
SD
( μ m)
Reproducibility
SD
( μ m)
Repeatability
Limit
a
( μ m)
Reproducibility
Limit
b
( μ m)
Average 93.1 1.33 1.35 3.72 3.78
Temporal 64.6 2.03 2.05 5.68 5.74
Superior 118.8 3.42 3.45 9.58 9.66
Nasal 68.6 2.19 2.24 6.13 6.27
Inferior 123.6 3.01 3.14 8.43 8.79
Clock hour 1 113.6 4.84 5.05 13.55 14.14
Clock hour 2 84.3 4.7 4.74 13.16 13.27
Clock hour 3 56.4 2.43 2.56 6.80 7.17
Clock hour 4 63.0 3.25 3.37 9.10 9.44
Clock hour 5 102.5 4.35 4.37 12.18 12.24
Clock hour 6 133.5 4.93 5.21 13.80 14.59
Clock hour 7 134.7 5 5.01 14.00 14.03
Clock hour 8 66.1 3 3 8.40 8.40
Clock hour 9 53.0 1.71 1.78 4.79 4.98
Clock hour 10 76.3 3.53 3.53 9.88 9.88
Clock hour 11 125.2 4.75 4.77 13.30 13.36
Clock hour 12 121.6 6.43 6.51 18.00 18.23
a. Repeatability Limit is the upper 95% limit for the difference between repeated results. Per ISO 5725-1 and ISO 5725-6, Repeatability Limit = 2.8 x Repeatability SD.
b. Reproducibility Limit is the upper 95% limit calculated for the difference between results repeated with different operators on different instruments. Each subject was imaged three times
each during three visits on a single instrument (Phase 1) or twice during a single visit on five instruments (Phase 2). Per the ISO quoted in the main text, Reproducibility limit = 2.8 x
Reproducibility
.