Improving Lifestyle Vision

with Small Aperture Optics

 The Small Aperture Premium Lens Solution

The IC-8™ small aperture intraocular lens (IOL) is a revolutionary lens

that extends depth of focus by combining small aperture technology
with a monofocal lens. Clinical studies demonstrate that the IC-8 IOL
produces unparalleled visual outcomes that deliver1:

• A continuous and uninterrupted range of vision

• Excellent image quality across the entire range of vision

• Good quality night vision with less symptoms like glare or halos

• A new standard in outcomes:

– Good near and intermediate vision without compromising far vision

– A highly forgiving lens when target refractive endpoints are missed

– Compensates to the effects of astigmatism up to 1.5 diopters

of astigmatism

Over the next few pages you will discover how this first of a kind small
aperture IOL is revolutionizing the premium cataract clinic. You will
see clinical and bench testing data that proves the IC-8 IOL is the lens
that can help your patients achieve higher image quality and greater
visual freedom. We invite you to learn more.

_
one
_
Releasing the Power of the IC-8™ IOL

Delivering a Continuous and Uninterrupted Range of Vision

Applying the same small-aperture principle optics as the KAMRA™ inlay,
the IC-8 IOL incorporates a non-diffractive 3.23 mm diameter opaque mask
with a 1.36 mm central aperture embedded within a 6.0 mm one-piece
hydrophobic acrylic lens. The mask creates a pinhole effect, which
delivers nearly 3.0 diopters of extended depth of focus by blocking
unfocused peripheral light rays and isolating more focused central and
paracentral rays through the central aperture2.

The strength of the IC-8 IOL lies in its ability to extend depth of focus.
As a result, the lens provides excellent image quality at all distances,
and less trouble with glare and halos than lenses with two or three
focal points.

Before the IC-8 IOL: The natural lens is unable to focus light.

Light Aberrations

Lens cannot focus

After the IC-8 IOL Implantation: The mask of the IC-8 IOL
is able to focus light to provide a continuous range of vision.

IC-8 Lens
TM

Well-established optical principles have shown

that placing the IC-8 IOL in the non-dominant
eye creates the same positive effect as bilateral
implantation of two premium lenses.
_
two
_
 Providing Excellent Image Quality Near to Far

As shown in the Air Force Target images on the opposite page,

the IC-8 IOL delivers excellent image resolution across a broader
TM

range of vision compared to other premium lenses.

Method for Measuring Optical Performance

The standardized method of measuring IOL optical performance
is with a technique called “through-focus”. With this method,
different IOL designs are optically bench tested under the exact
same conditions. For through-focus testing, optical image data
is measured from +1.00 diopter to -2.50 diopters in 0.50 diopter
increments to establish depth of focus. The best focus position is at
0.00 diopters or the plano position. A standardized Air Force image
target is used to obtain test results. The image data presented on the
next page clearly demonstrate the IC-8 IOL delivers excellent image
resolution across a broader continuous through-focus range of vision
compared to other premium lenses. The testing conditions used for
the optical test comparison test are described as follows:

• ISO Model Eye, ISO 11979-2, In Aqueous, Halogen

White Light (440 – 755 nm) with a 3.0 mm aperture

• MTF data measured at 50 lp/mm

• Through-focus image data measured at 0.50 diopter
increment steps

• Optical Metrology system use was highly accurate
Effective Focal Length (EFL) method

97% of patients would

choose the IC-8 small
aperture lens again.

_
three
_
IC-8TM IOL: Provides a full range of vision without resulting in a loss of far
vision when the target refraction is achieved.A

+1.00 D +0.50 D +0.00 Plano -0.75 D -1.00 D -1.50 D -2.00 D -2.50 D

Far Vision Target Near Vision

Monofocal IOL: Air Force Targets demonstrate excellent image quality

at best focus position (plano) but greatly reduced depth of focus, which
results in poor image quality at intermediate and near distance.

+1.00 D +0.50 D +0.00 Plano -0.75 D -1.00 D -1.50 D -2.00 D -2.50 D

Far Vision Near Vision

Diffractive Multifocal IOL: Air Force Targets demonstrate both

a decrease in image contrast and ghosting. Ghosting is created by an
in-focus image superimposed on top of an out-of-focus image.

+1.00 D +0.50 D +0.00 Plano -0.75 D -1.00 D -1.50 D -2.00 D -2.50 D

Far Vision Near Vision

Trifocal IOL: Air Force Targets demonstrate both a decrease in

image contrast and ghosting. Ghosting is created by an in-focus image
superimposed on top of an out-of-focus image.

+1.00 D +0.50 D +0.00 Plano -0.75 D -1.00 D -1.50 D -2.00 D -2.50 D

Far Vision Near Vision

Summary: The IC-8 IOL delivers excellent image resolution across

a broader through-focus range of vision with better image contrast and _
without ghosting symptoms as compared to other premium lenses.
four
_
 Raising the Standard in Outcomes

Achieving Excellent Outcomes

In a post-market clinical study conducted by AcuFocus, the average
binocular visual acuities were 1.14 decimal (20/16-) at far, 0.91 decimal
(20/20-) at intermediate and 0.71 decimal (20/25-) at near. By achieving
the refractive targets of -0.75 D in the IC-8 eye and plano in the TM

monofocal eye, visual outcomes can be further optimized.

Binocular UCVA (Mean, SD)A

1.25
1.00
Near
0.80
Decimal Acuity

0.63 Intermediate

0.50
Far
0.40

0.35

0.25
Mon 1 (n=105) Mon 3 (n=100) Mon 6 (n=90)
0.20

Forgiving Presbyopia-Correcting Lens

As the graph below demonstrates, the IC-8 IOL provides an
excellent outcome even if the refractive target is missed. This is the
result of the lens being able to deliver an extended range of vision.

Binocular Depth of FocusA

2.00
1.60 Actual
1.30 Distance-
corrected
1.00
OU (n=91)
0.80
Decimal Acuity

0.60 (20/32 Snellen)

0.50
0.40 Actual
Target-
0.30 corrected*
0.25 IC-8/
0.20 Distance-
1 0 -1 -2 -3 -4 corrected
Defocus (D) mono (n=6)

It is important to note that depth of focus is determined by looking

at the amount of defocus (distance) at which the patient can still
achieve a visual acuity of 0.6 decimal (20/32).
_
*IC-8 eyes corrected to -0.75 D.
five
_
Accepting Up to 1.5 Diopters of Astigmatism
Even with 1.50 D of astigmatism, the visual acuity did not decline
by even one line of BCVA when compared to a monofocal IOL,
which lost 1.5 lines.

Cylinder Defocus Curves

IOL
IC-8TM IOL vs. Monofocal IOLA
0
Change in Visual Acuity (logMAR)

0.05

0.1 One Line of Loss

0.15
IC-8
Monofocal
0.2

0.25

N=10
0.3
0 0.5 1 1.5 2 2.5 3

Cylinder Defocus in Diopters

Targeting The Right Patients

Consider implanting the IC-8 small aperture IOL when you
have a patient with:

• Prior refractive procedure

• Great demands for excellent quality of vision across

the entire range of vision

• Higher order aberrations (i.e. post refractive patients)

and/or ocular trauma

• Previous cataract procedure (first eye treated with a

monofocal) and now desire to have second eye treated
with a premium solution

• Corneal astigmatism of ≤1.50 D

• Desire for good contrast and optimal image quality

• Sensitivity to glare, halos and starburst

_
six
_
IC-8™ Small Aperture IOL Specifications
• IOL Material
– Single-piece hydrophobic acrylic

• Optic Design
– One-piece UV blocking hydrophobic acrylic
– Biconvex, anterior aspheric surface
– 6.00 mm optic diameter
– 12.50 mm overall length
– 360° posterior square edge
– Modified C haptic with 5° angulation

• Mask Design
– Polyvinylidene difluoride (PVDF) and
nano-particles of carbon
– 1.36 mm aperture
– 3.23 mm total diameter
– 3200 microperforations
– 5 microns thick

• A-Constant for Optical Biometry:120.5

• A-Constant for Ultrasound Biometry: 120.15

• Optical Surgeon Factor: 2.64

• Diopter Range: +15.5 D to +27.5 D
(0.50 D steps)

• Single-Use Injector System

AcuFocus recommends that surgeons
personalize their A-constant based on their
surgical techniques, equipment, experience
with the lens model and postoperative results.

IC-8 Procedure Overview

Dominant Eye Non-Dominant Eye
Bilateral Procedure Aspheric monofocal or toric IOL IC-8 IOL
Target Refraction Plano -0.75 D
Incision Size 1.8 to 3.2 mm 3.5 mm

AcuFocus, Inc. • 32 Discovery, Suite 200, Irvine, CA 92618 • +1 949.585.9511 • www.acufocus.com

The IC-8 IOL is not available in the United States.

©2016 AcuFocus, Inc. All rights reserved. AcuFocus, IC-8, the IC-8 logo, and KAMRA are trademarks or registered trademarks of AcuFocus, Inc. Patent information: www.acufocus.com/int/patent
References:
1
Grabner G, Ang RE, Vilupuru S. The Small-Aperture IC-8 Intraocular Lens: A New Concept for Added Depth of Focus in Cataract Patients. Am J Ophthalmol. 2015;160(6):1176-1184
2
Pablo Artal, PhD, “How is Extended Depth of Focus Achieved with a Small-Aperture Lens?” Cataract & Refractive Surgery Today Europe, January 2016.
A
Reference: 029 Study, Data on File at AcuFocus MK-1268 Rev B