Analysis Protocols
Stratus OCT User Manual PN 2660021134133 A
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bottom of the scan image. These are artifacts of the alignment processing algorithm
and are not clinically meaningful.
Normative Data and Its Applicability
Carl Zeiss Meditec gathered data from several hundred normal eyes acquired at multiple
sites to create normative databases for RNFL thickness and for macular thickness. The
Stratus OCT normative database study was designed to obtain normative data for RNFL
and macular thickness from healthy subjects ages 18 to 86. Reference intervals established
in the normative database study are used by the physician to compare individual patient
measurements to those acquired in a normal population. See Normative Database for
Macula and RNFL Measurements, for a detailed description of how this normative
database was generated, including the
selection criteria employed in the clinical study, a
discussion of data acquisition and analysis, and the establishment of normal limits.
Note: RNFL and Macula Normative Databases are optional features that may not be
activated on all instruments. If you do not have these features and want to purchase
them, contact Carl Zeiss Meditec. In the U.S., call 1-877-486-7473; outside the U.S.,
contact your local Carl Zeiss affiliate or distributor.
Note: Subject ethnicity was self-reported by the patients in the population
comprising the normative database but was NOT used as a variable in constructing
the RNFL and Macula normative databases.
Note: Normative data will not appear for patients under 18 years of age. Normative
data will not appear for patients whose records were imported into the system with
their date of birth obscured.
Disclaimer: Carl Zeiss Meditec does not offer advice or instruction
in the
diagnostic interpretation of OCT images. It is the clinician’s responsibility to
ma
ke diagnostic interpretations of OCT scans.
RNFL Normative Database
The scan protocols Fast RNFL Thickness (3.4) and RNFL Thickness (3.4) (at the
default 512 A-scans) were used to acquire the RNFL thickness normative data. The RNFL
Norm
ative Database is applicable only to scans acquired with the same scan protocols.
Normative data that is age-matched to the patient appears only when you perform the
RNFL Thickness Average protocol on either Fast RNFL Thickness (3.4) scans or a
single RNFL Thickness (3.4) scan at the default 512 A-scans.
• RNFL thickness normative data will not appear when you analyze two or more RNFL
Thickness (3.4) scans that have been averaged, or if you analyze a Fast RNFL
Thickness (3.4) scan from which scans ha
ve been deselected.
When the RNFL Thickness Average protocol is applied to an applicable scan type, the
age-matched normative data appears. It uses a white-green-yellow-red color code, as seen
i
n the legend at left, to indicate the normal distribution percentiles. The color code applies
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