Improving Lifestyle Vision. with Small Aperture Optics

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Jeremy Allison
5 years ago
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1 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

$when target refractive endpoints are missed Compensates to the effects of astigmatism up to 1.$

2 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 deliver 1 : 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

$small-aperture principle optics as the KAMRA inlay, the IC-8 IOL incorporates a non-diffractive 3.$ 23 mm diameter opaque mask with a 1.36 mm central aperture embedded within a 6.0 mm one-piece hydrophobic acrylic lens.

23 mm diameter opaque mask with a 1.36 mm central aperture embedded within a 6.0 mm one-piece hydrophobic acrylic lens.

0 diopters of extended depth of focus by blocking unfocused peripheral light rays and isolating more focused central and

The strength of the IC-8 IOL lies in its ability to extend depth of focus.

lenses with two or three focal points. Before the IC-8 IOL: The natural lens is unable to focus light.

3 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 TM IOL delivers excellent image resolution across a broader range of vision

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.

4 Providing Excellent Image Quality Near to Far As shown in the Air Force Target images on the opposite page, the IC-8 TM IOL delivers excellent image resolution across a broader 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 diopter to 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 , In Aqueous, Halogen White Light ( 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

$IC-8 TM IOL: Targeting a refraction of -0.75 D does not result in a loss of distance visual acuity. +1.00 D +0.50 D +0.00 Plano -0.50 D -1.00 D -1.50 D -2.00 D -2.$ $50 D Far Vision Near Vision Diffractive Multifocal IOL: Air Force Targets demonstrate both a decrease in image contrast and ghosting.$ Ghosting is created by an in-focus image superimposed on top of an out-of-focus image as a result of splitting light to two foci. +1.00 D +0.50 D +0.00 Plano -0.50 D -1.00 D -1.

Ghosting is created by an in-focus image superimposed on top of an out-of-focus image as a result of splitting light to two foci. +1.00 D +0.50 D +0.00 Plano -0.50 D -1.00 D -1.

Ghosting is created by an in-focus image superimposed on top of an out-of-focus image as a result of splitting light to three foci. +1.00 D +0.50 D +0.00 Plano -0.50 D -1.00 D -1.

5 IC-8 TM IOL: Targeting a refraction of D does not result in a loss of distance visual acuity D D Plano D D D D D Far Vision 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 D D Plano D D D D 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 as a result of splitting light to two foci D D Plano D D D D 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 as a result of splitting light to three foci D D Plano D D D D 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. The IC-8 IOL also demonstrates a much greater depth of focus as compared to a standard monofocal lens. four

$91 decimal (20/20-) at intermediate and 0.71 decimal (20/25-) at near. By achieving the refractive targets of -0.$

6 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 D in the IC-8 TM eye and plano in the monofocal eye, visual outcomes can be further optimized Binocular UCVA (Mean, SD) Decimal Acuity Near Intermediate Far Mon 1 (n=105) Mon 3 (n=100) Mon 6 (n=90) 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. Decimal Acuity Defocus (D) Actual Distancecorrected OU (n=91) (20/32 Snellen) Actual Targetcorrected* IC-8/ Distancecorrected 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). five *IC-8 eyes corrected to D.

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.

$5-3 Cylinder Defocus One Line of Loss IC-8 Monofocal N=10 Targeting The Right Patients Consider implanting the IC-8 small aperture IOL when you have a patient with: Prior refractive procedure Great$

7 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. 0 Cylinder Defocus Curves IC-8 TM IOL vs. IOL Monofocal IOL Change in Visual Acuity (logmar) Cylinder Defocus One Line of Loss IC-8 Monofocal N=10 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.

8 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 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: Optical Surgeon Factor: 2.64 Diopter Range: D to 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 Bilateral Procedure Aspheric monofocal or toric IOL IC-8 IOL Target Refraction Plano D Incision Size 1.8 to 3.2 mm 3.5 mm Non-Dominant Eye AcuFocus, Inc. 32 Discovery, Suite 200, Irvine, CA The IC-8 IOL is not available in the United States AcuFocus, Inc. All rights reserved. AcuFocus, IC-8, the IC-8 logo, and KAMRA are trademarks or registered trademarks of AcuFocus, Inc. Patent information: 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): Pablo Artal, PhD, How is Extended Depth of Focus Achieved with a Small-Aperture Lens? Cataract & Refractive Surgery Today Europe, January A Reference: 029 Study, Data on File MK-1268 Rev A

Dr. Magda Rau Eye Clinic Cham, Germany

3 and 6 Months clinical Results after Implantation of OptiVis Diffractive-refractive Multifocal IOL Dr. Magda Rau Eye Clinic Cham, Germany Refractive zone of Progressive power for Far to Intermediate