Normative Database for Macula and RNFL Measurements
Stratus OCT User Manual PN 2660021134133 A
C-2
valid, as defined by a false positive rate of 15% or less, and fixation losses as
defined by the Heijl Krakau method of 20% or less. Unreliable visual fields may be
repeated at the discretion of the Investigator.
D. Intraocular surgery in the study eye within one year of enrollment.
E. Best corrected visual acuity in the study eye worse than 20/32 on ETDRS scale
(LogMar
+0.2).
F. Evidence of diabetic retinopathy, diabetic macular edema, or other vitreoretinal
disease in either eye upon dilated examination by an ophthalmologist, or upon
evaluation of retinal photos.
G. Evidence of optic nerve or retinal nerve fiber layer abnormality in either eye upon
dilated examination by an ophthalmologist, or upon evaluation of retinal or optic
nerve photos.
H. History of diabetes.
I. Participation in any study involving an investigational drug within the past month,
or ongoing participation in a study with an investigational device.
J. Current or recent (within the past 14 days) use of an agent with photosensitizing
properties by any route (e.g., Visudyne®, ciprofloxacin, Bactrim®, doxycycline).
Data Collection
After undergoing a thorough ophthalmic examination and qualifying, 260 subjects (aged
18-86 years) had scans of their retinas taken with the Stratus OCT device. The
Fast
Macular Thickness Map (Fast Mac) scan protocol was used to acquire the macular
thickness data. For this scan type, a set of six intersecting scan lines, each consisting of
128 data points, was obtained in a single alignment and capture to evaluate macular
thickness. The Fast RNFL (3.4 mm) scan was used to acquire the peripapillary RNFL
thickness data. For this scan type, a set of three circles, each consisting of 256 data points,
was obtained in a single alignment and capture to evaluate peripapillary RNFL thickness
along a circle of radius 3.46 mm from the center of the optic disc.
Data Analysis and Normalization
This normative database is derived from a healthy population. Currently, any correlation
with a disease state is not known. Although the current database may be of clinical utility,
it is unclear how age is related to macular thickness or RNFL thickness.
Each individual sample data point from the 260 individuals was used to estimate the
distribution of macular thickness in a normal population at that macular scan point
location. Likewise, each individual sample data point from the Fast RNFL scan from the
260 individuals was used to estimate the distribution of RNFL thickness in a normal
population at that circle location. Each data point was normalized by a linear
age-dependent coefficient (see
Age Coefficient on page C-3) that compensated for the
estimated change in thickness with subject age. The combined distribution of the
age-normalized thickness data point values was then used to estimate the variation of
macular thickness data for the population as a whole. It is assumed in this analysis that the
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