The Glaucoma Tonometer

CR

The Glaucoma Tonometer

Overview
What sets it apart?
Reicherts 7CR Auto Tonometer + Corneal Response Technology takes corneal biomechanical properties into consideration, providing Corneal Compensated IOP (IOPcc) a pressure measurement that is significantly less affected by the cornea than other methods of tonometry. The 7CR is based on Reicherts patented dynamic bi-directional applanation technology, which is the foundation of the revolutionary Reichert Ocular Response Analyzer (ORA). The ORA is the first instrument capable of measuring corneal bio-mechanical properties and is supported by over 100 peer-reviewed publications in the medical literature. Corneal properties such as elasticity, viscosity, and thickness can affect the accuracy of Goldmann IOP values by as much as 17 mmHg in normal eyes and more than 20 mmHg in eyes with corneal pathology. The ORA, and now 7CR, are the only devices in the world that can account for these properties. IOPcc is patented technology (US 7, 481, 767 B2)

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Overview
What sets it apart?
The 7CR presents you with a tremendous opportunity to sell a unique product that has strong clinical utility and essentially NO COMPETITION. 7CR is THE Glaucoma tonometer. This is not a screening device, as NCTs were perceived to be in the past. 7CR should be positioned as the tonometer of choice for the management of glaucoma for ODs and MDs alike. The 7CR is superior to Goldmann or any other IOP measurement. Reichert 7CR Provides more clinically relevant tonometry measurements in:
Normal Tension Glaucoma patients (subjects who have glaucoma but measure low on Goldmann) Primary Open Angle Glaucoma patients (typical high-pressure glaucoma subjects) Post-LASIK and refractive surgery patients (subjects with biomechanically altered corneas) Patients with Fuchs or Edema (very spongy corneas that measure inaccurately on Goldmann) Keratoconus patients (biomechanically weak corneas that measure inaccurately on Goldmann) Patients with thick, thin, or otherwise biomechanically atypical corneas

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Tonometry
Tonometry is used to measure the Introcular Pressure (IOP), which is a risk factor for Glaucoma. Higher IOP increases the risk for glaucoma.
IOP is the ONLY modifiable risk factor for glaucoma. This means that once a patient has been diagnosed with glaucoma, the only thing doctors can do is try to lower the pressure. Regular monitoring of IOP is essential to determining efficacy of treatment in glaucoma patients.

As such, accurate measurement of IOP is CRITICAL for the proper diagnosis and management of glaucoma.

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Tonometry
The Goldmann Tonometer has long been considered the gold standard for measuring pressure, but its accuracy is widely questioned today.
Goldmann Design Assumptions - Cornea is infinitely thin and perfectly flexible - Tear-film and corneal thickness effect cancel each other out Flaws - Experimentation done on cadaver eyes (not representative of live eyes) - Variations in corneal thickness is significantly greater than assumed - Variations in corneal biomechanical properties unaccounted for Accordingly, Goldmann cannot compensate for differences in thickness, elasticity, and other biomechanical parameters that influence accuracy

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Why CCT-based IOP correction is flawed

Cant we calculate true IOP using pachymetry (CCT)?

NO! Central Corneal Thickness based IOP adjustment algorithms

DO NOT WORK. These formulas have been scientifically discredited and the glaucoma opinion leaders of the world are cautioning clinicians against using them. As such, CCT correction tables and pachymeters and tonometers that provide CCT-based corrected IOP values are OBSOLETE.
Correction nomograms that adjust GAT IOP based solely on CCT are neither valid nor useful in individual patients
- Pg 18. Robert N. Weinreb, James D. Brandt, David Garway-Heath and Felipe Medeiros World Glaucoma Association on Intraocular Pressure; Consensus Series 4; May 5, 2007

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Why CCT-based IOP correction is flawed

OHTS and other recent studies have investigated the relationship between central corneal thickness (CCT) and IOP values. They have found a relationship between CCT and GAT measured IOP.

Thicker corneas tend to measure higher on GAT and Thinner corneas tend to measure lower.

However, the relationship between CCT and measured IOP is only valid when observing large data sets. When applied to individual patients, corneal thickness IOP correction formulas present a 40% chance of adjusting the IOP in the WRONG DIRECTION!

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Why CCT-based IOP correction is flawed

Very thick corneas tend to measure high IOP

Very thin corneas tend to measure low IOP

Data courtesy New England College of Optometry

But SCATTER in the data makes accurate mathematical adjustment of IOP impossible for individuals!

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Why CCT-based IOP correction is flawed

Corneal Resistance to bending is not dependant thickness, but on material properties

Thick and thin is WRONG. Think weak and strong

The Glaucoma Tonometer

The 7CR IOPcc measurement is not based on the overly-simplistic Corneal Thickness correction approach.
7CR quantifies the corneas biomechanical properties, and then reduces the effect of these on the IOP measurement process

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The Glaucoma Tonometer

Dynamic Bi-Directional Applanation

Goldmann and other tonometers only determine one number, but they are affected by two things: IOP and cornea.

You cant measure two things with one number!

The 7CR makes a dynamic measurement, monitoring the in/out movement of the cornea in response to a rapid air impulse. The Bi-Directional Applanation results in two IOP measurements in rapid succession (one as the cornea moves in, and one as the cornea moves out). This permits determination of corneal properties, enabling the 7CR to provide a more accurate IOP measurement.

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Dynamic Bi-Directional Applanation

Auto alignment is achieved. instrument is ready to measure
IR Light Emitter

IR Light Detector Undisturbed Cornea

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Dynamic Bi-Directional Applanation

Air pulse is delivered, inward applanation is recorded IR Signal Peak

Air-Jet

Applanated Cornea

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Dynamic Bi-Directional Applanation

Cornea passes through applanation into mild concavity

Air-Jet

Corneal Concavity

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Dynamic Bi-Directional Applanation

Air pulse reduces, cornea returns, outward applanation is recorded IR Signal Peak Peak IR Signal

Air-Jet

Applanated Cornea

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Dynamic Bi-Directional Applanation

Measurement process complete IR Light Emitter Air tube

IR Light Detector Undisturbed Cornea

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Applanation Signal Plot 7CR Measurement Signal

Inward Applanation

Corneal Hysteresis

Outward Applanation

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Hysteresis
Hysteresis
A property of materials or systems that do not instantly follow forces applied to them, but react slowly, or do not return completely to their original state. The phenomenon was identified by Sir James Alfred Ewing in 1890. This term is commonly used to describe material properties in engineering and architecture.

Corneal Hysteresis (CH)

A characterization of the corneas biomechanical tissue properties. It is a result of visco-elastic damping (energy absorption) as the cornea moves rapidly in and out. This is what enables the 7CR to quantify and minimize the corneas influence on IOP measurement.
Discovered by Dr. David Luce of Reichert Inc

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Hysteresis
Many common visco-elastic materials and systems exhibit hysteresis. - Automotive struts - Foam mattresses - Viscous fluids like honey and oil - Door dampers (closers)

The Cornea is visco-elastic like these examples

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IOPcc
Corneal-Compensated Intraocular Pressure
7CR utilizes the information provided in the Corneal Hysteresis measurement to determine IOPcc, which is less affected by corneal properties than other methods of tonometery, such as Goldmann (GAT). 7CR also provides IOPg which is similar to an actual Goldmann measurement. Seeing these values simultaneously gives clinicians a better understanding of patient tonometry values.
IOPcc is patented technology (US 7, 481, 767 B2)

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IOPcc
Corneal-Compensated Intraocular Pressure
IOPcc is still a Goldmann correlated IOP measurement. It agrees with Goldmann on average, but is not influenced by the cornea in the same way as Goldmann and other tonometers are.

Therefore IOPcc has the same scale as a Goldmann measurement, but is more clinically relevant because it is not contaminated by corneal artifacts.
Note: The PASCAL DCT, which claims independence from corneal properties is NOT Goldmann correlated. As such, the clinical relevance of the DCT IOP measurement is questionable.

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7CR IOPCC vs CCT 184 Normals

IOPcc is not influenced by the thickness of the cornea

Data courtesy New England College of Optometry

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28 eyes Pre/Post LASIK IOPCC

IOP appears to be lower after LASIK with Goldmann

IOPcc ignores the change in corneal properties cause by LASIK and provides similar IOP measurements in pre and post refractive surgery subjects
Data courtesy Dr. David Castellano, MD / Dr. Jay Pepose, MD

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Is IOPcc Better than GAT?

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Clinical Publications
IOPg, IOPcc correlation with Goldmann and CCT
GAT

Conclusions: IOPg agrees with Goldmann very well. IOPcc seems to provide an estimate of IOP that is less influenced by corneal properties than those provided by GAT
Evaluation of the Influence of Corneal Biomechanical Properties on Intraocular Pressure Measurements Using the Ocular Response Analyzer. Felipe A. Medeiros, MD and Robert N. Weinreb, MD J Glaucoma 2006;15:364370.

IOPcc

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Clinical Publications
IOPcc differentiates Glaucomatous Eyes

In Glaucomatous eyes IOPcc was significantly higher than GAT. This relationship was also true in Glaucoma suspects. However, in normal eyes and OHT eyes, IOPcc, IOPg, and GAT were all similar. This indicates that IOPcc is a better indicator of glaucoma presence
Ocular Response Analyzer in Subjects with and without Glaucoma. Sullivan-Mee M, Billingsley SC, Patel AD, Halverson KD, Alldredge BR, Qualls C. J Optom Vis Sci. 2008 Jun;85(6):463-70.

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Clinical Publications
IOPcc can differentiate NTG eyes from normal eyes
True normal eyes and eyes with NTG (normal tension glaucoma) were measured with GAT, DCT, IOPg, and IOPcc

Conclusions: Only IOPcc was able to distinguish the NTG eyes from the true normal eyes.
Intraocular pressure measured by dynamic contour tonometer and ocular response analyzer in normal tension glaucoma Tetsuya Morita & Nobuyuki Shoji & Kazutaka Kamiya & Mana Hagishima & Fusako Fujimura & Kimiya Shimizu Graefes Arch Clin Exp Ophthalmol DOI 10.1007/s00417-009-1169-4

The Glaucoma Tonometer

Summary of IOPcc advantages

IOPcc correlates strongly with GAT on the average

HOWEVER, IOPcc has the following advantages over GAT

Not affected by CCT Not affected by corneal biomechanical properties (rigidity) As such, it is more accurate in KC, Fuchs, OHT, NTG eyes In addition, it has less measured IOP reduction post-LASIK No operator bias

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Important Service Note:

7 CR cannot be calibrated using rubber eyes like previous generation Reichert tonometers. A device called a TCT (Tonometer Calibration Tool) must be used. Service and calibration training will be provided at another time