Summary

TOPCON 3D OCT Series

Topcon has incorporated a normative database into the Topcon 3D OCT 1000 and 3D OCT 2000
Normative Database
instrument. This age stratified normative database is comprised of several ethnicities all collected in
the United States and passed strict inclusion criteria.

References
1. Resnikoff et al, Bulletin of the World Health Organization, November 2004, p.844-851

2. Yamamoto, et al. The Tajimi Study Report 2 Prevalence of Primary Angle Closure and Secondary
Glaucoma in a Japanese Population. Ophthalmology , Volume 112 , Issue 10 , Pages 1661 - 1669

3. Friedman DS, Wolfs RC, O'Colmain BJ, et al. Prevalence of open-angle glaucoma among adults in
the United States. Arch Ophthalmol 2004;122:532-8.

4. American Academy of Ophthalmology. Preferred Practice Pattern: Diabetic Retinopathy. San

Francisco, Calif: American Academy of Ophthalmology; 1998

5. Kempen, Friedman DS, et el. Prevelance of Diabetic Retinopathy in the United States. Arch
Ophthalmol. 2004;122:552-563

6. Van Leiden, H., Dekker, et el. Risk Factors for Incident Retinopathy in a Diabetic and Non diabetic
Population. Arch Ophthalmol. 2003;121:245-251

7. Klaver CC, Wolfs RC, Vingerling JR, Hofman A, de Jong PT. Age-specific prevalence and causes of
]blindness and visual impairment in an older population: the Rotterdam Study. Arch Ophthalmol.
1998;116:653-658.

8. Friedman DS, Wolfs RC, O'Colmain BJ, et al. Prevalence of Age-Related macular Degeneration in
the United States. Arch Ophthalmol. 2004;122:564-572

C 2011 Topcon Medical Systems, Inc.

111 Bauer Drive, Oakland, NJ 07436
t 800.223.1130 f 201.599.5248
www.topconmedical.com
All trademarks belong to their respective registered owners.

75-1 Hasunuma-cho, Itabashi-ku, Tokyo 174-8580, Japan.

Phone:3-3558-2523/2522 FAx:3-3965-6898 www.topcon.co.jp

2011
Printed in Japan 2011 10-10 NP TMS
Introduction Institutional Setting

Optical coherence tomography (OCT) is a noninvasive
technique for high-resolution, cross-sectional topographic
imaging of tissue by measuring backscattered light.
Glaucoma is a socially critical disease that is a major cause of
blindness internationally across many different ethnic groups
and ages. According to 2002 WHO statistics, glaucoma is the
1
second leading cause of blindness worldwide, and
according to a detailed glaucoma epidemiology survey 2
made in the period of 2000 to 2002, the prevalence of
glaucoma for people of 40 years old or above was an
estimated 5.0 percent, and in some ethnic populations even
higher. Optic nerve and field disorders are basically
progressive and non-reversible. With glaucoma, the disorder
gradually progresses without the subject noticing the disease
symptoms. Inhibition or suppression of progress of the
disorder by the early detection and early therapy is therefore
an important challenge. In the diagnosis of glaucoma,
and follow disease progression and efficacy of the treatment The clinical data of normative database was collected at 6 clinical sites in the U.S. (in alphabetical order).
given by the physician. Topcon provides the OCT with a
normative database for the purpose of comparing retinal Durrie Vision State Univ. of New York（SUNY）
nerve fiber layer (RNFL) and macular thickness of a subject Medical College of Wisconsin（MCW） Univ. of California San Diego（UCSD）
to a known database of normal healthy individuals, and it New York Eye and Ear（NYEE） Vitreous-Retina-Macula Consultants of New York（VRMNY）
serves as a comparison against which measured individual
values fall in which under exactly the same scanning pattern.
The normative database is used to set cut-offs based on the
statistical distribution of normal eyes. The measured value is
considered abnormal or normal according to where the value
falls in standard distribution. The cut-offs used by the
Summary of Database
normative database are the bottom 5% for a classification of
Enrollment numbers incorporated in this normative database are described by scan pattern, age, sex and ethnicity
borderline and 1% for a classification of outside normal limits.
in table 1 and figure 1 below. The total eligible subjects are reduced compared to the initial participants who were
defined as normal subjects due to capture failure.
1. Each subject underwent a complete ophthalmologic
examination. To be classified as a “ Normal Eye ” for
inclusion in the normative database the subject must
have met all of the following criteria: 140 140

Number of participants accepted

Number of participants accepted

detection of the morphological change in the optic disc or
a. BSCVA of 20/40 or better (Snellen) 120 120
retinal nerve fiber layer thickness is quite important. Findings 122
b. MRSE between +3.0 D to -6.0 D 116
of the optic disc or retina nerve fiber layer disorder relates to 100 100
c. Intraocular pressure ≤ 21 mm Hg (Goldmann applanation)
the stage of glaucoma, although such disorder is often
d. Axial length between 22-26 mm (biomicroscopy or biometry) 80 80
detected prior to detection of a visual field loss during an
e. Normal anterior segment on slit lamp examination 60 60
ophthalmology examination. An experienced clinician may 67
f. A peripheral anterior chamber angle ≤ Grade 2 during
effectively observe the fundus oculi of subjects and diagnose 40 40
the study examination
glaucoma; however, evaluation of the fundus oculi differs
g. Normal appearance of the optic disc documented by 20
38 20
between different clinicians, so that a standardized method fundus photo
28
for evaluation and decision is desired. h. Normal visual field examination by completion of SITA 0 0
standard 24-2 visual field examination Caucasian Hispanic African American Male Female
Diabetic retinopathy, a retinal vascular disorder that occurs i. Absence of any of the following conditions or medical history:
Figure 1) Plot ethnicity Figure 2) Plot gender
as a complication of diabetes mellitus (DM), is a leading I. Current history of ocular disease, except cataract
cause of blindness in the United States, often affecting II. Corneal surface disruption that would preclude imaging
4
working-aged adults. Approximately 4.1 million US adults 40 III. Prior ocular surgery except uncomplicated Table 1)
years and older have diabetic retinopathy; 1 of every 12 phacoemulsification or strabismus Area Disc Macula
persons with DM in this age group has advanced, vision IIII. Family history of glaucoma among first generation
5 relatives (parents, siblings, children). Scan Pattern 3D(H) 3D(H)
threatening retinopathy. The Hoorn Study suggests that not
only patients with type 2 DM, but elderly individuals with N 137 164
normal glucose metabolism or an impaired glucose 2. OCT was performed to the above normal subjects an OCT Under 20 2 2
6
metabolism have a substantial risk of developing retinopathy. scan quality level ≥ 70 and free from artifact was required. 20 - 29 31 39
Age-related macular degeneration (AMD) is the leading Image was then automatically segmented and each image 30 - 39 29 33
cause of blindness among European descended people older was verified that no segmentation errors existed prior to
40 - 49 25 33
than 65 years. Age-related macular degeneration affects inclusion in the normative database
50 - 59 25 25
more than 1.75 million individuals in the United States. Owing Age
3. The acquired optical coherence tomography images were
to the rapid aging of the US population, this number 7 will 60 - 69 19 25
analyzed and each layer was measured
8
increase to almost 3 million by 2020. In particular, while Over 70 6 7
4. The data was collected and statistically analyzed
age-related macular degeneration has not conventionally AVG 42.64 42.35
found effective therapeutic measures, Visudyne ™
SD 15.86 15.59
photodynamic therapy and intravitreal drugs such as
Min 19 19
Lucentis ™ are now available for early detection and
treatment options, which in effect will minimize a decline in Max 84 84
visual acuity with early diagnoses. It is conceivable that the Female 92 112
Gender
thickness (or volume) of the retina at the macula can be Male 54 61
utilized for early detection of the disorders such as Eligible number of subjects incorporated in this normative database study (Startified by scan pattern)
age-related macular degeneration and diabetic retinopathy (Age diversity 19-year-old to 84-year-old)
The disc and macula scan patterns were analyzed. by ４, 12, 36 sectors: 90-degree ４sectors of Temporal, Superior, DISC 3D Thickness Mean & Standard Devation (Sector)
Nasal, Inferior; 30-degree 12 sectors of Temporal, Superior, Nasal, Inferior in clock order, and 1/3 division of each one
of 12 sectors for 36 sectors for the disc or peripapilary area, and by the Early Treatment of Diabetic Retinopathy Table 3) 4 sectors
Study (ETDRS) grid. Scan Pattern T S N I
AVG 70.58 116.42 80.55 123.94
3D SD 10.25 12.76 12.85 12.73

CI 95% (two-sided) 40.17 50.00 50.36 49.89

Table 2)
unit:microns〔μm〕
Region Layer Scan Mode Area Area for Average
4 sectors
6 sectors 200.00

RNFL Mean Thickness〔μm〕

Peripapilaly RNFL Disc 3D (H) φ3.4mm
12 sectors
36 sectors 150.00
Macula Whole Retina Macula 3D (H) φ6mm ETDRS grid

100.00

50.00
Terminology RNFL ： Retinal Nerve Fiber Layer Due to the limitation in space, some describes as “NFL”
ETDRS ： Early Treatment of Diabetic Retinopathy Study
0.00
T S N I
Figure 3)
The next page shows some sample data and characteristic of its data. The number in brackets ( ) shows the
Table 3 and Figure 3 present the mean RNFL thickness by four sector analysis.
criteria of the scanning.

Peripapillary RNFL Mean Thickness – 12 Sectors

Table 4) 12 sectors
Scan Pattern T TS ST S SN NS N NI IN I IT TI
AVG 60.29 82.29 118.95 114.84 115.479 95.46 69.97 76.19 107.42 133.67 130.77 69.18

3D SD 8.64 13.67 18.32 20.89 18.46 17.43 12.67 15.09 16.64 19.38 21.77 13.84

CI 95% (two-sided) 33.88 53.58 71.81 81.89 72.37 68.31 49.67 59.16 65.22 75.98 85.33 50.35

unit:microns〔μm〕

200.00

Average RNFL Thickness〔μm〕

150.00

100.00

50.00

0.00
T TS ST S SN NS N NI IN I IT TI

Figure 4)

Table 4 and Figure 4 present the mean RNFL thickness by 12 sector analysis.
Macular 3D Retinal Average Thickness & Standard Deviation(ETDRS) Macular Retinal Mean Thickness ETDRS Grid

Table 5) Center Inner T

Average RNFL Thickness〔μm〕

Scan Pattern Center Inner T Inner S Inner N Inner I Outer T Outer S Outer N Outer I

Retinal Mean Thickness〔μm〕

y=-0.053x + 231.4 R≤ = 0.001 y=-0.295x + 301.8 R≤ =0.091
AVG 233.68 289.64 302.11 304.40 298.36 400.00 400.00
240.14 256.75 274.62 246.91

3D SD 19.71 14.86 15.51 15.36 15.42 13.20 13.69 16.60 15.31 300.00 300.00

CI 95% (two-sided) 77.25 58.24 60.80 60.22 60.43 51.74 53.68 65.06 60.00
200.00 200.00

100.00 100.00

0.00 0.00
0 20 40 60 80 100 0 20 40 60 80 100
Outer-S
Age Age

Inner S Inner N
Inner-S

Average RNFL Thickness〔μm〕

Average RNFL Thickness〔μm〕
y=-0.381 x +317.8 R≤ =0.14 y= -0.322x + 317.7 R≤ =0.102
400.00 400.00
Outer-T Inner-T Center Inner-N Outer-N

300.00 300.00
Inner-I
200.00 200.00

Outer-I 100.00 100.00

※ OD 0.00 0.00
0 20 40 60 80 100 0 20 40 60 80 100
Figure 5)
Age Age

Table 5 and Figure 5 present the mean retinal thickness by ETDRS grid. Inner I Outer T

Average RNFL Thickness〔μm〕

Average RNFL Thickness〔μm〕
y=-0.377x + 313.9 R≤ =0.138 y=-0.265x+251.1 R≤ =0.093
400.00 400.00

Peripapillary RNFL Thickness（the Average RNFL Thickness of 4 Quadrants, 300.00 300.00

φ3.4mm Circle Diameter Centered on the Optic Disc）：Disc 3D(H) Scan 200.00 200.00

The chart shows regression plot of mean RNFL thickness in each sector against age. By referring this linear regression, 100.00 100.00

it produces normal value stratified by the age. Note relationship showing decrease in RNFL thickness of each sector
0.00 0.00
along with age. The deviation of temporal area was the smallest. 0 20 40 60 80 100 0 20 40 60 80 100
Age Age

Temporal Superior Outer S Outer N

Average RNFL Thickness〔μm〕

Average RNFL Thickness〔μm〕
y=-0.254x + 267.2 R≤ =0.079 y=-0.369x + 289.9 R =0.114
RNFL Mean Thickness〔μm〕

RNFL Mean Thickness〔μm〕

y=-0.078x +73.81 R≤ =0.014 y=-0.165x + 123.2 R≤ = 0.041 400.00 400.00

200.00 200.00

150.00 150.00 300.00 300.00

100.00 100.00 200.00 200.00

50.00 50.00 100.00 100.00

0.00 0.00 0.00 0.00

0 20 40 60 80 100 0 20 40 60 80 100 0 20 40 60 80 100 0 20 40 60 80 100
Age Age Age Age

Nasal Inferior Outer I

Average RNFL Thickness〔μm〕

y=-0.140x + 86.31 R≤ = 0.029 y=-0.231x + 133.4 R≤ = 0.080 y=-0.238x +256.7 R≤ =0.056

RNFL Mean Thickness〔μm〕

RNFL Mean Thickness〔μm〕

200.00 200.00 400.00

150.00 150.00 300.00

100.00 100.00 200.00

50.00 50.00 100.00

0.00 0.00 0.00

0 20 40 60 80 100 0 20 40 60 80 100 0 20 40 60 80 100
Age Age
Age