Methods; Data Collection; Scan Selection Criteria - Zeiss CIRRUS HD-OCT 500 User Manual

A-20

Methods

2660021169012 Rev. A 2017-12
Appendix
This section summarizes the data collection methodology (also described in the previous
section) and further describes the analysis and characteristics of the normative limits for
Ganglion Cell Analysis parameters.
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Data Collection

Data collection details are described in
Diversified" on page A-1. In summary, 282 subjects were qualified as normal subjects,
enrolled in the NDB study, and included for the Macular normative database. Data from
the same scans was analyzed and evaluated to determine the normal range of Ganglion
Cell Analysis parameters. The normative database does not have subjects with refractive
errors outside the –12.00 D to +8.00 D range. Therefore, the analysis below should be
applied with caution to subjects with refractive errors outside the –12.00 D to +8.00 D
range.

Scan Selection Criteria

The scans were reviewed for image quality as part of the original study. One best quality
scan for each scan type was chosen for each subject per eye. Scans having the following
characteristics were excluded from the normative database:
• Signal Strength of 5 or lower.
• Large eye motion during image acquisition, resulting in a saccade that was within the
central 80% of the scan area.
• Area of data loss greater than 10% at the edge of the scan area.
• Presence of floater(s) obscuring macular area on Macular cube scans or measurement
circle on Optic Disc cube scans.
"RNFL and Macula Normative Databases:
CIRRUS HD-OCT User Manual