Don’t be Puzzled by Glaucoma – The Comprehensive Solution for Your Practice

Glaucoma is one of the leading causes of blindness. Early glaucoma detection and reliable progression analysis may prevent loss of vision. A serious management of glaucoma is the basis of an individualized therapy and excellent patient care.

The detection and monitoring of glaucoma require a targeted combination of clinical observations and reliable examination results. Clinical expertise is always the key to an accurate glaucoma diagnosis.

Structural and functional examinations with Heidelberg Engineering products provide invaluable information to aide in the diagnosis and treatment of glaucoma.

Advanced glaucoma diagnosis demands advanced technology. A complete picture of glaucoma develops only if the diagnostic information fits together like the pieces of a puzzle.

We provide serious diagnostic power for glaucoma!Comprehensive glaucoma solutions from Heidelberg Engineering.

All Pieces of the Puzzle

The Complete Picture of Glaucoma Diagnosis

Flexible Integration – Efficient Networking

Intelligent Use of Patient Data and Optimized Patient Workflow

Efficient integration of diagnostic equipment in the clinical setting can significantly improve workflow and management of an increasing number of patients while delivering a high quality of care.

The HEYEX software platform provides flexible solutions from a solo practice to a large clinic environment. The integrated patient database facilitates storage and management of image files from all existing Heidelberg Engineering devices, such as HRT, HEP and SPECTRALIS.

Network viewing software allows easy and reliable access to patient image files on any networked computer supporting seamless consultation and diagnosis.

One software platform for all

Heidelberg Engineering devices

Network integration and viewing stations

Data security

DICOM compatibility

Connectivity to many electronic

health records systems

Import of third party image data

Validated DiagnosticsThe excellent diagnostic performance of the Heidelberg Retina Tomograph (HRT) is well established. The HRT has been used worldwide over 20 years for the detection and management of glaucoma. Advanced algorithms like the Moorfields Regression Analysis (MRA) and the Glaucoma Probability Score (GPS) allow an objective assessment of structural glaucomatous damage. Objective structural parameters complement the 3D topographic profile of the optic nerve head and facilitate a comprehensive risk assessment of suspect glaucoma patients.

All relevant anatomic structures at a glance – optic nerve head (ONH) excavation, neuroretinal rim and peripapillary retinal nerve fiber layer

Weinreb 2010: Baseline GPS, MRA, and stereoparameters alone or when combined with baseline clinical and demographic factors can be used to predict the development of POAG end points in OHTS (Ocular Hypertensive Treatment Study) participants and are as effective as stereo photographs for estimating the risk of developing POAG in ocular hypertensive subjects1

Zangwill 2005: HRT MRA is the top predictive factor for glaucoma and can identify those patients at high risk for developing the disease2

Strouthidis 2010: In clinical practice, patients with both an abnormal MRA and an abnormal GPS classification at presentation should be followed closely as they have an increased risk of future visual field or HRT change3

1 Weinreb RN et al; Ophthamol 2010; 117:1674–1683. 2 Zangwill LM. et al.; Arch Ophthalmol 2005;123:1188-1197.3 Strouthidis NG et al.; Glaucoma 2010; 19(5):304-309.

Examination Report – HRT Moorfields Regression Analysis

Heidelberg Retina TomographOU Report

Software Version: 3.2/0www.HeidelbergEngineering.com

Patient: Glaucoma, Outside DOB: 14.Dez.1951 Examination: 24.Sep.2003Pat-ID: Caucasian Gender: male Ethnicity: (Caucasian)

OD OSInitial ReportQuality: Excellent (SD 8 µm)

Focus: -1.00 dpt Operator: dcp

Quality: Excellent (SD 9 µm)Focus: -1.00 dpt Operator: dcp

CUPDisc Size: 2.13 mm² (average) Disc Size: 2.55 mm² (average)

Linear Cup/Disc Ratio [ ]0.76 ¢¢¢¢¢¢¢¢

p = 0.03

Asymmetry0.00

44444444

p = 0.4

0.76 44444444

p = 0.06

Cup Shape Measure [ ]-0.06 ¢¢¢¢¢¢¢¢

p = 0.02

Asymmetry0.00

44444444

p = 0.45

-0.06 ¢¢¢¢¢¢¢¢

p = 0.04

RIM

MRA: Outside normal limits MRA: Outside normal limits

4444

¢¢¢¢

6666

6666

6666

6666

4444

¢¢¢¢

6666

6666

6666

6666

66666666 4444

¢¢¢¢

6666

6666

6666

¢¢¢¢

4444

¢¢¢¢

6666

6666

6666

¢¢¢¢

66666666

Rim Area [mm²]0.91 66666666

p < 0.001

Asymmetry-0.17

44444444

p = 0.24

1.08 66666666

p < 0.001

Rim Volume [mm³]0.16 66666666

p < 0.001

Asymmetry-0.09

44444444

p = 0.16

0.25 ¢¢¢¢¢¢¢¢

p = 0.02

RNFL

0.8

0.6

0.4

0.2

0.0

-0.2

-0.4

36031527022518013590450

T TS NS N NI TI T

RNFL Profile0.8

0.6

0.4

0.2

0.0

-0.2

-0.4

36031527022518013590450

T TS NS N NI TI T

RNFL Profile

Height Variation Contour [mm]0.28 44444444

p = 0.16

Asymmetry-0.13

¢¢¢¢¢¢¢¢

p = 0.02

0.41 44444444

p > 0.5

Mean RNFL Thickness [mm]0.20 44444444

p = 0.28

Asymmetry-0.05

44444444

p = 0.12

0.25 44444444

p > 0.5

Inter-Eye Asymmetry 13 %

0.8

0.6

0.4

0.2

0.0

-0.2

-0.4

36031527022518013590450

T TS NS N NI TI T

Combined RNFL Profile

44444444 Within normal limits p > 0.05

¢¢¢¢¢¢¢¢ Borderline p < 0.05

66666666 Outside normal limits p < 0.001

OD RNFL profileOS RNFL profileRNFL profile median

Comments:

Signature:Date: 29.10.2010

Early Detection and Reliable Progression AnalysisThe Topographic Change Analysis (TCA) of the HRT is the best known and most evidence-based method for glaucoma management4. The Gold Standard for objective comprehensive structural analysis of the ONH is the key to an individualized approach to glaucoma diagnosis and treatment.

ONH and retinal nerve fiber layer change at a glance

Early detection of subtle glaucomatous changes i.e. disease progression

Trend analysis – Volume and area changes indicated

Contour-line and reference plane independent

Follow-up examinations and single scans automatically aligned

4 Chauhan BC. et al.; Invest Ophthalmol Vis Sci 2000; 41:775-782.

Examination Report – HRT Topographic Change Analysis

Heidelberg Retina TomographTCA Overview

Software Version: 3.2.0.5/370Page 1/1

Patient:

Examination:

Glaucoma, Progression TCA 13

Sex: female DOB: 30.Jul.1935 Pat-ID: hemorraghe OS Ethnicity: (Caucasian)

Baseline: 30.Mrz.2005 Last Follow-Up: 23.Feb.2009 Elapsed: 46 months OS

Baseline: 30.Mrz.2005Examination Date

01/06 01/07 01/08 01/09 01/10 01/11 01/12 01/13 01/14 01/15

Total Size Change Total Volume Change

[mm

²]

2.0

1.5

1.0

0.5

0.0

[1/1000 mm

³]

100

75

50

25

0

Follow-Up: #2, 01.Aug.2006 Follow-Up: #3, 26.Sep.2007 Follow-Up: #4, 23.Feb.2009

Heidelberg Retina TomographTCA Übersicht

Software Version: 3.2.0.5/370Seite 1/1

Patient:

Untersuchung:

Glaucoma, Progression TCA 13

Geschlecht: weiblich Geb.: 30.Jul.1935 Pat-ID: hemorraghe OS

Erstunters.: 30.Mrz.2005 Letzte Folgeunters.: 23.Feb.2009 Zeitraum: 46 Monate L

Erstunters.: 30.Mrz.2005Untersuchungsdatum

01/06 01/07 01/08 01/09 01/10 01/11 01/12 01/13 01/14 01/15

Flächenänderung Volumenänderung

[mm

²]

2.0

1.5

1.0

0.5

0.0

[1/1000 mm

³]

100

75

50

25

0

Folgeunters.: #2, 01.Aug.2006 Folgeunters.: #3, 26.Sep.2007 Folgeunters.: #4, 23.Feb.2009

Heidelberg Retina TomographTCA Übersicht

Software Version: 3.2.0.5/370Seite 1/1

Patient:

Untersuchung:

Glaucoma, Progression TCA 13

Geschlecht: weiblich Geb.: 30.Jul.1935 Pat-ID: hemorraghe OS

Erstunters.: 30.Mrz.2005 Letzte Folgeunters.: 23.Feb.2009 Zeitraum: 46 Monate L

Erstunters.: 30.Mrz.2005Untersuchungsdatum

01/06 01/07 01/08 01/09 01/10 01/11 01/12 01/13 01/14 01/15

Flächenänderung Volumenänderung

[mm

²]

2.0

1.5

1.0

0.5

0.0

[1/1000 mm

³]

100

75

50

25

0

Folgeunters.: #2, 01.Aug.2006 Folgeunters.: #3, 26.Sep.2007 Folgeunters.: #4, 23.Feb.2009

One Perimeter – Two MethodsThe visual field examination remains an essential part of glaucoma diagnosis and management, despite rapid developments in imaging technologies5. Heidelberg Engineering complements the Gold Standard of structural glaucoma diagnosis, the Heidelberg Retina Tomograph (HRT) with an innovative and reliable partner, the Heidelberg Edge Perimeter (HEP). The HEP offers two perimetric methods in one device.

Flicker-Defined-Form (FDF) Perimetry for early glaucoma detection in patients at risk and ocular hypertensive patients

The Gold Standard, White-on-White Perimetry (SAP) for continuous care of patients with manifest glaucoma

Unique Legacy Scale for a direct comparison with HFA examination results

The Functional Change Analysis FCA allows monitoring of signifi-cant functional changes over time

5 Terminology and Guidelines for Glaucoma. 3rd Edition (2008). European Glaucoma Society. Image courtesy Dr. Fritz Dannheim, Seevetal-Hittfeld, Germany

Examination Report – HEP Single Exam Report

Heidelberg Edge PerimeterHEP Single Field Report (General)

Patient: FDF 24-2, Bjerrum Scotoma DOB: 01.01.1950 Sex: F ODPatient ID: --- Exam.: 17.07.2009Diagnosis: Comment:

Software Version: 2.1.0.33 www.HeidelbergEngineering.com HEP Single Field Report (General)

Notes:

Date: 25.07.2011 Signature:

Stimulus: FDFPattern: 24-2Strategy: ASTA StandardTest Date: 17.07.2009Test Time: 11:02:19Fovea: OffPresentations: 420Reliability: Good

Pupil Diameter: 3.7 mmTarget Size: 5.0°Sphere: +0.00Cylinder: +0.00Axis: 0Corr. Lens: UnknownIOP: -

Duration: 08:12FP Count: 2 / 420 (0%)FN Count: 0 / 5 (0%)Fixation Losses: 17 / 420 (4%)

MD: -6.93 dB p<0.05%PSD: +7.44 dB p<0.05%GHT: Outside Normal Limits

Sensitivity (dB)

30 30 206

2020

10 12

18

113

11

2 7 12

0 203

000

171820 22 20 19

17 18 20 23

17

19

19

17

14

8

0

00

1

2220

18

21 22

21

1

11

16

18

11

9

19

-

--

-

--- - - -

- - - -

-

-

-

-

--

-

- -

-

- -

0-14

00

-9 -7

-2

-9-17

-9

-17 -12 -6

-17 -15-17-14

-19-20-18

-3-20 1 -1 -1

-2 0 0 3

-1

0

-1

-2

-5

-11

-18

-19-17

-17

20

-2

0 1

1

-18

-9

-5

-2

-8

-1

-

--

-

--- - - -

- - - -

-

-

-

-

--

-

- -

-

- -

0-14

-10

-10 -8

-2

-9-17

-9

-17 -12 -7

-17 -15-18-14

-19-20-19

-3-30 1 -1 -2

-2 -1 0 3

-2

0

-1

-3

-5

-11

-18

-19-18

-17

2-1

-3

0 1

0

-19

-10

-5

-2

-9

-1

30 30

0 dB

5

10

15

20

25

p<5

p<2

p<1

p<=0.5%

0 1 2 3 4 5 6 7 8 9 min

FPFNFL

Grayscale

Pattern Deviation

Pattern DeviationTotal Deviation

Total Deviation

Reliability Parameters

Heidelberg Edge PerimeterFunctional Change Analysis (Overview)

Patient: FDF 24-2, Nasal Inferior Defect DOB: 01.01.1939 Sex: M OSPatient ID: ---Diagnosis: Comment:

Software Version: 2.1.0.33 www.HeidelbergEngineering.com Functional Change Analysis (Overview), Page 1/1

Notes:

Date: 25.07.2011 Signature:

0 5 10 15 20 25 dB p>5 p<5 p<2 p<1 p<=0.5%-

WNL 1x 2x 3x

FDF Units

MD Trend Analysis

Examination Date

dB

10/01 11/01 12/01-25-20-15-10

-505

P>5%P<.05%

Grayscale (dB) Total Deviation Pattern Deviation FCA TD FCA PDDate: 05.06.2009 - 19.02.2010 (2)

Stimulus:FDF - 24-2Baseline

GHT: Outside Normal LimitsPSD: +4.04 dB

MD: -6.35 dB FL: 14.5

FP: 1.0FN: 0.5

----

- --

---

- - -- ---

---

--- - - -- - - -

---

-

-- -

---

- --

-

-

-- --

--

- --

---

- - -- ---

---

--- - - -- - - -

--

--

-

-- -

---

-- -

-

-

-

---

Date: 19.02.2010 - 15:30:27

Stimulus:FDF - 24-2Strategy: ASTA Std.

GHT: Outside Normal LimitsPSD: +4.50 dB p<0.05%

MD: -4.63 dB p<1%FL: 5 / 326 (1%)

FP: 1 / 326 (0%)FN: 0 / 8 (0%)

----

- --

---

- - -- ---

---

--- - -- - -

---

--

-- -

---

--

-

-

-

--

-

----

- --

---

- - -- ---

---

--- - -- - -

--

--

--

-- -

---

--

-

-

-

----

Date: 19.05.2011 - 09:01:57

Stimulus:FDF - 24-2Strategy: ASTA Std.

GHT: Outside Normal LimitsPSD: +4.40 dB p<0.05%

MD: -3.97 dB p<2%FL: 141 / 427 (33%) p<0.05%

FP: 0 / 427 (0%)FN: 1 / 11 (9%)

Examination Report – Functional Change Analysis FCA

HRT + HEPOU Report

Software Version: HRT: 3.2/6133 HEP: 2.1.0.63 HEP NDB Version: 2010-03-17 21:52:51.89

Patient:

Examination:

HRT, HEPSex: female DOB: 01.01.1926 Pat-ID: --- Ethnicity: (Caucasian)HRT Date: 22.04.2009HEP(OD) Date: 30.04.2009HEP(OS) Date: 30.04.2009

OD OS

MRA: Borderline MRA: Outside normal limits

Disc Size: 2.71 mm² (large)

4444

4444

¢¢¢¢

¢¢¢¢

4444

¢¢¢¢

4444

4444

¢¢¢¢

¢¢¢¢

4444

¢¢¢¢

¢¢¢¢¢¢¢¢

Disc Size: 2.30 mm² (average)

4444

4444

4444

4444

4444

6666

4444

4444

4444

4444

4444

6666

44444444

Linear Cup/Disc Ratio44444444 0.67 p = 0.24 44444444 0.57 p = 0.42

Cup Shape Measure44444444 -0.13 p > 0.5 44444444-0.23 p > 0.5

Rim Area [mm²]¢¢¢¢¢¢¢¢ 1.48 p = 0.04 44444444 1.56 p > 0.5

Rim Volume [mm³]44444444 0.31 p = 0.14 44444444 0.38 p > 0.5

Height Variation Contour [mm]44444444 0.40 p > 0.5 44444444 0.55 p > 0.5

Mean RNFL Thickness [mm]44444444 0.21 p > 0.5 44444444 0.22 p > 0.5

44444444 Within normal limits

¢¢¢¢¢¢¢¢ Borderline

66666666 Outside normal limits

Pattern Deviation

GHT: Outside normal limits

Pattern Deviation

GHT: Outside normal limits

Test:24-2 24-2Strategy:ASTA Standard ASTA StandardFP Count:3 3FN Count:3/3 (100.0%) 3/7 (42.9%)

Fixation Losses:3 (0.7%) 0 (0.0%)MD:-7.24 dB p<0.05% -6.50 dB p<1%PSD:+5.66 dB p<0.05% +4.86 dB

p > 5% p < 5% p < 2% p < 1% p < 0.5%

HEP

HRT

Within normal limitsBorderlineOutside normal limits

Comments:

Date: 05.11.2010 Signature:

Structure and FunctionClinically, glaucomatous damage is typically diagnosed by combining structural and functional assess-ments. In particular, anatomical structural damage detected by Confocal Scanning Laser Ophthalmo-scopy (HRT) or Optical Coherence Tomography (OCT) is compared to changes in the visual field (VF) sensitivity as measured by FDF Perimetry or SAP. Heidelberg Engineering combines datasets of HRT, SPECTRALIS and HEP in the common software platform HEYEX, and conjointly displays structure-function results on a single report.

All relevant information on one printout

First real correlation of structural and functional examination results

Reliable clinical diagnosis

Improved patient and time management

HRT & HEP – Unique Structure-Function Map

RNFL & Visual Field Combined OU ReportSPECTRALIS® & HEPPatient: DEMO_SPECTRALIS_HRT_HEP, 7 DOB: 01.Jan.1948 Sex: FPatient ID: ---Diagnosis: --- Comment: ---

Software Version: SPECTRALIS® 5.4.0.11, HEP 2.1.0.31 www.HeidelbergEngineering.com RNFL & Visual Field Combined OU Report

Notes:

Date: 12.07.2011 Signature:

Stimulus: FDF Pattern: 24-2 Strategy: ASTA StandardOD - Visual Field - 18.08.2010 OS - Visual Field - 18.08.2010

OD - RNFL Thickness - 18.08.2010 OS - RNFL Thickness - 18.08.2010

Grayscale(legacy dB)

Grayscale(legacy dB)Total Deviation Total DeviationPattern Deviation Pattern Deviation

35302520151050 dB

p > 5%p < 5%p < 2%p < 1%p <= 0.5%

GHT Classification Outside Normal Limits

Time span bet. RNFL and VF exams: 1 days

Duration: 09:26FP Count: 6 / 496 (1%)FN Count: 2 / 13 (15%)Fixation Losses: 0 / 496 (0%) MD: -5.29 dB p<5%PSD: +7.52 dB p<0.05%Reliability: Good

Duration: 06:54FP Count: 8 / 382 (2%)FN Count: 0 / 14 (0%)Fixation Losses: 30 / 382 (7%) MD: +0.15 dB PSD: +3.19 dB Reliability: Low

GHT Classification Outside Normal Limits

Time span bet. RNFL and VF exams: 1 days

200 µm200 µm

IR 30° ART [HR]

200 µm200 µm

IR 30° ART [HR]

200 µm200 µm

ILMILM

RNFLRNFL

OCT ART (16) Q: 34 [HR]

TMP TMPSUP NAS INF

Thick

ness

[µm

]

300

240

180

120

60

0

Position [°]

36031527022518013590450

73

200 µm200 µm

ILMILM

RNFLRNFL

OCT ART (3) Q: 35 [HR]

TMP TMPSUP NAS INF

Thickness [µm]

300

240

180

120

60

0

Position [°]

36031527022518013590450

147T75

N72

S109

I105

T70

N63

S108

I106

G90

T75

TS132

TI110

N72

NS86

NI100

G87

T70

TS127

TI120

N63

NS90

NI92

Classification Within Normal Limits

Classification Within Normal Limits

Within Normal Limits (p>0.05)

Borderline (p<0.05)

Outside Normal Limits (p<0.01)

TMP TMPSUP NAS INF

Thick

ness

[µm

]

300

240

180

120

60

0

Position [°]

36031527022518013590450

—— OD —— OS

SPECTRALIS & HEP – Combined RNFL & VF ReportImage Courtesy Dr. Fritz Dannheim, Seevetal-Hittfeld, Germany and

Dr. Victor Spears, Toronto, Canada.

PrecisionThe SPECTRALIS enables the precise measurement of the peri-papillary retinal nerve fiber layer thickness. Comparing the measurement to a normative database allows a fast and reliable detection of local nerve fiber defects. The examination results are comprehensively documentedand summarized.

Precise measurement of retinal nerve fiber layer thickness

Evaluation of more than 1,500 data points on a single circle scan around the optic nerve head

Automatic comparison to an age-adjusted normativedatabase to classify a patient as being within or outside normal limits

High sensitivity and specificity with TruTrackTM Active Eye Tracking and Fovea-to-Disc (FoDiTM) alignment

High-quality fundus images even under challenging conditions (e.g. cataract)

Examination Report – RNFL Single Exam Report OU

ReproducibilityThe reliable detection of change is critical and defines glaucoma in suspect patients. With the SPECTRALIS changes in nerve fiber layer and retinal thickness as small as 1 µm can be identified.7,8 Structured reports enable a comprehensive documentation of change over time.

Reliable identification of changes as small as 1µm

AutoRescanTM function for follow-up exams

Color-coding of local changes

Visualization of disease progression for easy interpretation

Comprehensive documentation of change over time

Fast localization of nerve fiber layer changes

7 Wolf-Schnurrbusch et al. Macular thickness measurements in healthy eyes using six different optical coherence tomography instruments. Invest Ophthalmol Vis Sci. 2009; 50:3432-3437.8 Wu et al. Reproducibility of retinal nerve fiber layer thickness measure- ments using spectral domain optical coherence tomography. J Glaucoma. 2010 (Published online ahead of print).

Examination Report – RNFL progression

Innovative ConceptsThe Posterior Pole Asymmetry Analysis combines mapping of retinal thickness over the entireposterior pole with an innovative asymmetry analysis. The full geographic extend of nerve fiber and ganglion cell layer defects can be visualized. The combination of nerve fiber layer thickness and retinal thickness provides an even more robust parameter for glaucoma detection and monitoring of change over time.

Examination Report – RNFL & Asymmetry Analysis

Evaluation of nerve fiber layer and retinal thickness in a single visit

Targeted combination of multiple parameters

High-resolution thickness maps with finely graded color scale

Asymmetry Analysis for early detection of glaucomatous abnormalities

Detailed reports

Excellent Image QualityAnterior Chamber Angle assessment is typically used in a comprehensive glaucoma diagnosis to exclude Angle Closure Glaucoma. The SPECTRALIS Anterior Segment Module offers image acquisition of the Cornea and the Sclera. Moreover, both anterior chamber angles can be visualized in a single SD-OCT scan for an efficient glaucoma diagnosis.

16 mm SD-OCT scan

High-resolution images acquired with TruTrackTM Active Eye Tracking and Heidelberg Noise Reduction

Manual measurement tools for Anterior Chamber Angle assessment

Examination Report – Anterior Segment Module

Software Version 5.4

9918

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Corporate HeadquartersHeidelberg Engineering GmbH · Tiergartenstr. 15 · 69121 Heidelberg · Germany

Tel. +49 6221 6463-0 · Fax +49 6221 646362

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