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Dr. Sondra Black

Consultant to: ◦  Acufocus ◦  AMO ◦  Valeant

•  Population Growing

•  Incomes and Education Rising

•  Life Expectancy Increasing

•  Working longer

•  Importance of Near Vision

Presbyopic Population What has changed?

Source: MarketScope 2010

}  More than 50% of boomers exercise regularly

}  72% of boomers plan to keep working in some capacity after retirement

}  66% of boomers send text messages

}  90% of boomers are on the computer

}  65% of seniors (66+) have a cell phone

}  82% of seniors 65+ are on the road, driving

4

What do we know about Presbyopes?

1. Data on file, Bausch & Lomb Incorporated. 2. Hardy. Love to Know website. 2012. 3. Del Webb 2010 Baby Boomer Survey 4. Sauer et al. Deloitte Research. 2012. 5.  Jones. Pew Research Center. 2009.

MORE ACTIVE! }  Onset mid-40’s during height

of career }  Presbyopic population is

growing as baby boomers age

}  They are concerned about their appearance

}  This generation coined the phrase “anti-aging”

◦  BOTOX (onabotulinumtoxinA )

◦  Rogaine (minoxidil topical)

◦  Viagra (sildenafil)

buttbutt

What do we know about Presbyopes? They feel Presbyopia is a Lifestyle Problem

6

Source: 230 KAMRA VISIONTM Clinical Trial Patients 7

}  Loss of near vision interferes with everyday activities◦  Shopping◦  Sending text messages◦  Seeing time on watch◦  Reading a menu

}  Frustration with reading glasses◦  Own multiple pairs◦  Can never find reading glasses

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

Under 18 18 to 44 45 to 64 65 or older

2.6% 0.6%

31.5%

15.1%

Population Growth

The Presbyopic population is growing over 10x faster than the pre-presbyopic population More people over 65 than under 5

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Source: 2012 US Census Bureau for Population/Age & Market Scope Projections

*Projections

Country

*2019 Total

Population (Millions)

*2019

Presbyopes (Millions)

% of Population

Canada 36.1 15.1 41.7 United States 333.9 121.8 36.5 South Korea 49.3 20.5 41.6 Japan 125.9 61.4 48.8 China 1380.9 501.5 36.3 India 1311.6 300.2 22.9 Western Europe

409.6 176.6 43.1

36.5% of Americans will be presbyopic by 2019

Copyright2014MarketScope,LLCPP2016CT0363

0

500

1,000

1,500

2,000

2014 2019

1,59

8

1,75

2

208 28

5

Presbyop

es(m

illions)

WithEconomicMeans

Others

Copyright2014MarketScope,LLC

•  1.8 billion presbyopes worldwide in 2012 •  2 billion presbyopes worldwide by 2019

•  37%growthinpopula1onwitheconomicmeansfrom2014-2019

PP2016CT0363

•  While 42% of presbyopes are also myopic or hyperopic but the rest have likely never seen an OD

Population Age 40 to 64

Presbyopia 71%

What do we know about Presbyopes? 42% of them have a refractive error as well as presbyopia

Source: MarketScope 2010

Why do we concentrate on Myopes?

When we can concentrate on Presbyopes….

•  Aspiring financial independence

•  Image conscious

•  Want reassurance

•  Like finance

•  61% of those considering laser say cost is main concern 2007 VisionWatch survey (Jobson/VCA)

•  23% friends myopic

•  Financially independent

•  Age conscious

•  Want richer information

•  Not interested in finance

•  Health is a priority

•  Want to look & feel younger

•  Most friends are presbyopic

}  Myopes �- will tell 23% of friends

}  Presbyopes �- will tell ALL their friends�- as they ALL need glasses!

! !!!"! !!!"

Myopes Presbyopes with

Cataract/IOLs

Age 66+

Presbyopes with clear lens

Age 45-65

How do we look after these presbyopes?

Presbyopic Decision Tree

CATARACT or CLE?

SPECS CONTACT LENSES SURGERY

NO

YES

MONO-FOCAL

MULTI-FOCAL

ACCOMMO-DATING

IOL TYPE

SV Bifocal Trifocal

PAL

Monovision Bifocal

LASIK-Mono Multifocal Cornea

Corneal Inlay Femto Cornea Sx Femto Lens Sx

Scleral Sx

Tecnis ReStor Mplus

Symfony

Crystalens NuLens

Synchrony Akkomodative 1CU

Tetraflex FlexOptic IOL

Power Vision IOL SmartIOL Groningen

Monovision:Spheric

Aspheric

Mono-vision

IOLs

LASIK

PRK

CK

LTK

RK

Corneal vs Lenticular Monovision & Refractive Sx

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Dom Eye

Non-Dom Eye

Dom Eye

Non-Dom Eye

Some patients cant adapt due to

NO OVERLAP

@ ANY

DISTANCE

Advantage to the inlays:

OVERLAP @

DISTANCE

MonoVision

Inlays

Contact Lens Monovision

AR

C

SE

C

Small Aperture Corneal Inlay

AR

C

SE

C

**

*

* Indicates difference from pre-op is statistically significant

Future of Presbyopia Treatment

.

KAMRA

Flexivue Raindrop

Flexivue (3 mm)

KAMRA (3.8 mm) ICOLENS (3 mm) Raindrop (2 mm)

•  Flexivue •  By Presbia (Amsterdam, Netherlands) •  3.0 mm Diameter / 1.8 mm Central Zone •  0.15 mm Central Hole •  15 – 20 microns thick •  Center Ø Power •  Peripheral ring of + ADD (+1.50 to +3.00) •  Hydrogel

}  A transparent hydrogel implant, placed 280 to 300 microns deep pocket in the cornea of the patient’s non dominant eye

}  Flexivue Microlens received CE Mark in 2009 }  Currently undergoing Phase 2 of clinical trial under the FDA }  Available in over 40 countries across Europe, Latin America,

the Middle East, Africa and South Korea

}  Presbyopic, aged between 40 and 65 years (ideal patient early 50’s so power swap not needed)

}  UCDVA in Dominant Eye, or BCDVA if planning concurrent Laser correction >20/25

}  UVCNA < 20/50 }  Endothelial Cell count >2000 in the non dominant eye }  Minimum 480um }  Monovision tolerance, patients must undergo a contact lens trial, the

lens selection is the MSE based on the refraction - 0.25D }  Photopic Pupil >3mm }  Good LASIK candidate ◦  Stable refraction ◦  Clear lens

Distance vision: the rays pass through the central zone of the implant (blue line) and through the free peripheral corneal tissue (interrupted blue line).

Flexivue Microlens Inlay – Distance Vision

For near vision the rays passing through the refractive peripheral zone (red lines) will be focused on the retina

Flexivue Microlens Inlay - Near Vision

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KAMRA (3.8 mm) InVue (3 mm) Flexivue (3 mm) Raindrop (2mm) •  Raindrop (Formerly Presbylens and Vue+)

•  By Revision Optics (Lake Forest, CA) •  2.0 mm Diameter •  SAME Refractive Index as Cornea •  Changes curvature of cornea (+ lens shape) •  Creates Multifocal Cornea (Dist, Inter, Near) •  Proprietary material

•  Hydrogel Inlay • 2 mm Diameter • ≈ 30 µm Thick • 80% Water Content • Same Refractive Index as the Cornea

•  Allows for Nutrient and Oxygen Flow through the Cornea

•  Mechanism of Action: Profocal Shape Changing Technology * Current Recommendation 1/3 of the Central Corneal

Thickness

}  Inlay Naturally Reshapes the Cornea, Creating a Profocal Cornea with a Smooth Transition from

Near to Intermediate to Distance

KAMRA (3.8 mm) ICOLENS (3 mm)

Flexivue (3 mm) Raindrop (2 mm) •  KAMRA Inlay

•  By AcuFocus (Irvine, CA) •  3.8 mm Diameter / 1.6 mm Aperture •  Made of Polyvinylidene Fluoride (PVDF) •  Small Aperture – Increased Depth of Focus 3.8 mm

1.6 mm

Thickness = 5 µm

Weight = 100 mcg

Material = Polyvinylidene Fluoride PVDF (IOL haptics)

Inlay matches corneal curvature

8,400 micro-perforations

(5-11µ)

Pseudo-random pattern

Maximize

nutrient flow

Minimize visual symptoms

Endothelial Cells Keratocytes Corneal Nerves

}  Images of implanted cornea obtained via confocal microscopy

OCT •  The inlay works like an aperture in

a camera (opening) •  This small opening allows only

focused images in the eye •  Only focused light rays allowed to

reach the retina •  Same principle used in camera

lenses to increase depth-of-focus

Pinhole Principle: “Increased Depth of

Focus”

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Depth of focus and image quality of the non-implanted eye of a 49 Year Old Presbyope

OQAS Depth of Focus (D): 0.25

Subjective assessment with the OQAS device shows this eye has only 0.25D of depth of focus

Optical Quality Analysis System - Visiometrics (Spain)

SLR camera simulation of vision with a 4.0 mm pupil.

Focus @ 7.69 feet, f-stop 5.6 SLR camera simulation of vision

with a 1.6 mm pupil. Focus @ 7.69 feet, f-stop 22

Subjective assessment with the OQAS device shows the eye with the inlay has >2.50D of depth of focus

OQAS Depth of Focus (D): 2.50 Optical Quality Analysis System - Visiometrics (Spain)

Depth of focus and image quality of the implanted eye of a 49 Year Old Presbyope

200-250μm

Pocket

Endothelium

Epithelium

•  Faster Visual Recovery

•  Less Dry Eye •  More Stable Cornea •  Ability to place Inlay

deeper •  Flaps for LASIK

remain at 100 microns

100% Pockets

} 

Not as easy as it looks!

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Cataracts and lens opacities can be easily viewed with a dilated pupil

}  If a cataract develops, there are several options: ◦  Phacoemulsification and

monofocal IOL implantation can be performed with the inlay in situ ◦  Inlay can be removed and

replaced after monofocal IOL implantation ◦  Inlay can be removed and a MF

or Accommodating-IOL implanted

Monofocal IOL is functionally the same as a

non-accommodating crystalline lens

The following ocular assessments are possible with the KAMRA inlay in situ: •  Fundus photography •  OCT •  Visual field assessment •  Intraocular pressure

measurement •  Contrast sensitivity

testing •  Gonioscopy

ImagescourtesyofGüntherGrabner,MD

Op1cNerveandRNFLevalua1on

HRTConfocalImage

}  Results of a contralateral comparative study of 9 patients implanted monocular with the KAMRA inlay showed*: ◦  Reliable standard automatic perimetry

results ◦  No difference between PSD scores for

implanted and non-implanted fellow eyes ◦  No localized constrictions, or scotomas ◦  GHT calculations were not impacted

* Dr. Brooker and Sanchez, ARVO 2012.

Pre-op 3 Year

•  Additive procedure •  Doesn’t restrict future options •  Post-removal vision returns to baseline/LASIK target

within 6 months •  Inlays have been successfully removed out to 4

years post-op •  2% removal rate

EMMETROPES(NorefracGveerror)

AMETROPES(Far-sightedornear-sighted)

Post-LASIK MONOFOCALPSEUDOPHAKES

MRSE UCDVA UCNVA

Over+1 20/20 J-5

0.75to0.99 20/20 J-3

0.5to0.74 20/20 J-5

0.25to0.49 20/16 J-3

0to0.24 20/16 J-2

-0.25to-0.01 20/16 J-1

-0.50to-0.26 20/16 J-1

-0.75to-0.51 20/16 J-1

-1to-0.76 20/20 J-1

Lessthan-1 20/25 J-1

Optimal residual refractive error between -0.01D to -0.75D

31.5% of patients enrolled in the clinical trial had a pre-op MRSE in the optimal range

68.5% of patients enrolled in the clinical trial hand a pre-op MRSE

between 0.00D to 0.50D

KEY LEARNING: Dominant eye: plano

+0.50 20/20 wont be happy Non Dominant eye: -0.75 < 0.50D cyl

}  Dislikes reading glasses }  Views loss of near vision as a disability }  Cosmetic and lifestyle motivated }  Easy going }  Optimistic }  Willing to participate in recovery process }  Financial means

How important are the following activities in your daily life?

Very Important

Somewhat Important

Not Important

•  Reading Text •  Reading Numbers •  Working on a Computer •  Seeing your Mobile Phone •  Performing Detailed Tasks •  Driving at Night

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}  Prior corneal procedures (Except LASIK and PRK) }  Any ocular or systemic disease that is a

contraindication for corneal refractive procedures including: ◦  Keratoconus ◦  Uncontrolled and/or severe dry eye ◦  Cataracts ◦  Macular degeneration ◦  Corneal dystrophy or degeneration ◦  Amblyopia or Strabismus

}  Patients with unrealistic expectations }  Patients with psychological conditions

* Applies to all KAMRA procedures

}  Over a 5 year time period a presbyopic patient on average can expect to lose a line of vision

}  Patients with a KAMRA inlay, over the same time period, do not experience a loss of near vision

10

15

20

25

30

35

40

45

50

55

60

0 10 20 30 40 50 60 70

ETD

RS

lett

ers

Month

IE OE BE

J2

J9

Data courtesy of Günther Grabner, MD

Uncorrected Near Visual Acuity

}  Resume most activities the next day }  Clarity of vision may occur within the first 24 hours,

but generally takes 1-3 months (80% of patients) }  Vision may fluctuate for the first few months }  Magnification or LIGHT may still be needed for ◦  Seeing tiny print, reading in dim light conditions, or performing

a near task for an extended period of time ◦  EASIER TO FIND LIGHT THAN GLASSES

©2011 AcuFocus, Inc. All rights reserved.

1 day! 1 week! 1 month! 3 month! 6 month! 12 month!Months!

Uncorrected Visual Acuity - !Early Recovery (N=667) !

UCNVA!UCDVA!

20/63!

20/50!

20/40!

20/32!

20/25!

20/16!

20/20!

J-2!J-1!

J-5!

}  Takes time and careful management }  Reassure patients regarding the recovery process and their

progress }  Adherence to the therapeutic and dry eye regimen post-

operatively can accelerate the healing process

Data courtesy of Dr. Minoru Tomita

}  Follow-up: ◦  1 day ◦  1 week ◦  1, 3, 6 months ◦  1 year

}  Remember to check IOP’s as patients are on

steroids }  Patients should be seen more frequently for

complications or abnormal post-op findings

}  Pred Forte qh x 48 hours then qid remainder of week

}  Then FML or LOTEMAX o QID x 3 W o BID x 1 MO o QD x 1 MO o At 3 months assess whether to d/c steroid or continue v If your patient is a steroid responder utilize beta blocker

or similar to reduce IOP immediately

}  Ocular Surface Management ◦  Preservative free artificial tears �  Hourly for the first week, then �  6 x/day for a month, �  then PRN ◦  Temporary or permanent punctal plugs in EVERYONE ◦  Omega-3 fatty acids ◦  Topical cyclosporine (if needed)- �  Restasis has been a godsend! ◦  Minimize use of preservatives

}  Instill fluorescein to assess for: ◦  SPK ◦  Dryness ◦  Breaches in the anterior corneal layers ◦  Integrity of tear film

}  Easier in a lit room}  Due to the small aperture design, refractions can

be more challenging in the implanted eye◦  The patient will tolerate a larger range of introduced

lenses without experiencing blur◦  The refraction end points are usually softer◦  Mid-point or red-green is useful

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}  Inspect inlay/cornea closely for: ◦  Areas of irregularity or damage ◦  Stromal inflammation (DLK) ◦  Epithelial ingrowth ◦  Stromal haze ◦  Side-cut misalignment or epithelial defects ◦  Striae **

Actual patient images courtesy of David Allamby, MD, Focus Clinics London

•  The inlay may be visible in light eyes from an oblique angle or when a patient has a pupil smaller than 3.8mm in the non-implanted eye. ABBASI, SHAHLA

6522496808Visiometrics

08/11/2015 15:21

ODManifestRefraction

Sph: Cyl: Axis:

UCVA:BCVA:

0.000 0.000 0

3.8

Predicted VA:Decimal Snellen

20/290.7

Original Image

Image of a baby at 1 meter distance

Retinal Image

Simulation of the image on the patient's retina

Doble-pass Image

AcuTarget HD

0 1 2 3 4 5 > 6

Artificial pupil diameter: 4

Correction:

Notes:Objective spherical refraction:Measurement sph refraction:

-0.500-0.500

Measured pupil diameter: 6.9

An OQAS product by Visiometrics

OSI:

•  Think lens surgery!

PP2016CT0363

The prior IOL Portfolio Single Power

Lenses Accommodating

Lens

• Corrects only distance vision

• Does not accommodate in eye

• Glasses required

• Single focal point • Full range of distance, intermediate & near vision

• Uses eye’s natural focusing mechanism

• BUT doesn’t work for everyone

• Takes time to work

Multifocal Lenses

• Multiple, fixed focal points

• Does not accommodate

• Must find appropriate focal point

• Extensive neurological

adaptation BUT have issues with haloing and glare

33 cm working distance

}  Patients wanted all distances }  What were options for intermediate?

Multifocal Accommodating

PP2015CT1138

PP2015CT1138

71TECNISMulGfocalIOLs|PP2015CT0371Data: DFU, TECNIS® Multifocal 1-Piece IOL, Models ZKB00 and ZLB00, and DFU, TECNIS Multifocal 1-Piece IOL, Model ZMB00. Distances (cm) in the graph are approximate.

Mix and Match to give majority of reading

High Patient Satisfaction §  94% of patients would elect to

have the same IOL again

High Binocular Spectacle Independence §  More than 85% of patients

reported an ability to function comfortably without glasses at near, intermediate and far distances*

§  96% of patients reported an ability to function comfortably without glasses at intermediate and far distances

Excellent Binocular Visual Outcomes §  82% of patients achieved 20/25

(J1) or better uncorrected near VA at 6 months at best distance

§  99% of patients had 20/40 or better near vision without glasses

§  84% of patients reported no difficulty (with glasses if needed) with Night Vision at 6 months

§  69% and 57% patients reported no difficulty (with glasses if needed) with Glare/Flare and Halos, respectively

72

* The AMO sponsored patient questionnaire was not determined to be a psychometrically valid assessment of the concept of spectacle independence.

TECNISMulGfocalIOLs|PP2015CT0371Data: DFU, TECNIS® Multifocal 1-Piece IOL, Models ZKB00 and ZLB00, DFU, TECNIS Multifocal 1-Piece IOL, Model ZMB00 and TECNIS® patient brochure.

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High Patient Satisfaction §  97% of patients would elect to

have the same IOL again

High Binocular Spectacle Independence §  More than 80% of patients

reported an ability to function comfortably without glasses at near, intermediate and far distances*

§  98% of patients reported an ability to function comfortably without glasses at intermediate and far distances

§  95% of patients had 20/40 or better near vision without glasses at 40 cm

Excellent Binocular Visual Outcomes §  75% of patients achieved 20/25

(J1) or better uncorrected near VA at 6 months at best distance

§  91% of patients reported no difficulty (with glasses if needed) with Night Vision at 6 months

§  77% and 69% of patients reported no difficulty (with glasses if needed) with glare/flare and halos, respectively, at 6 months

73

* The AMO sponsored patient questionnaire was not determined to be a psychometrically valid assessment of the concept of spectacle independence.

TECNISMulGfocalIOLs|PP2015CT0371Data: DFU, TECNIS® Multifocal 1-Piece IOL, Models ZKB00 and ZLB00, DFU, TECNIS Multifocal 1-Piece IOL, Model ZMB00 and TECNIS® patient brochure.

74TECNISMulGfocalIOLs|PP2015CT0371Data: DFU, TECNIS® Multifocal 1-Piece IOL, Models ZKB00 and ZLB00, and DFU, TECNIS Multifocal 1-Piece IOL, Model ZMB00.

*Non-directed responses from open-ended questions. First eye results only.

94% none or mild

75TECNISMulGfocalIOLs|PP2015CT0371Data: DFU, TECNIS® Multifocal 1-Piece IOL, Models ZKB00 and ZLB00, and DFU, TECNIS Multifocal 1-Piece IOL, Model ZMB00.

*Non-directed responses from open-ended questions. First eye results only.

99% none or mild

0.0

0.1

0.2

0.3

0.4

0.5

2 3 4 5

Pupil diameter (mm)

MT

F a

t 50c

/mm

TECNISMIOL

ReSTOR Aspheric

DISTANCE VISION

0.0

0.1

0.2

0.3

0.4

0.5

2 3 4 5

Pupil diameter (mm)

MT

F a

t 50

c/m

m TECNISMIOL

ReSTORAspheric

NEAR VISION

Data on File. Advanced Medical Optics, Inc. 76 78

Patient

High-quality, full range of vision

Full range of vision without

contrast loss

Lack of visual disturbances, such as halos and glare

Physician

High patient satisfaction by providing reliable outcomes

Low number of complaints (on refractive outcomes or

halos and glare)

No significant additional chair time

PP2016CT0363

79

The TECNIS® Symfony Extended Range of Vision IOL represents a new segment in presbyopia-correcting IOLs.

Multifocal and Tri-

Focal IOLs

Accommodating IOLs

Extended Range of

Vision IOLs

PP2016CT0363

Caution: TECNIS Symfony Extended Range of Vision 1-Piece Intraocular Lens (IOL) is an Investigational Device limited by Federal (or U.S.) Law to investigational use, and is not currently approved or available for sale within the United States.

PLEASE NOTE, THIS EVENT IS ONLY INTENDED FOR DOCTORS in Canada ONLY AND NOT INTENDED FOR US CUSTOMERS OR DOCTORS

Mechanism of Action

80

Reduces chromatic aberration for

enhanced contrast sensitivity1

Extends the range of

vision1

1. TECNIS® Symfony DFU

TECNIS® Symfony IOL merges two complementary enabling technologies

Proprietary Echelette Design Feature

Proprietary Achromatic Technology

}  A diffraction grating is a collection of diffracting elements1

81

Diffracting element or echelette

Step height

Area

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}  The TECNIS® Symfony IOL incorporates proprietary diffractive echelette technology to distribute light in a way that elongates the focus 1

82

}  Chromatic dispersion: ◦  Material’s Index of Refraction causes different

wavelengths of light to be focused at different points 1

= blurry image

Blue Green

Red

83

= Dispersion

Aberration

}  Reduction of chromatic aberration gives clearer image1

= clear image

Blue Green Red

84

1. 170 Data on File_Symfony_Modulation Transfer Function

85

Contrast is the same as compared to a monofocal lens: While light MTF at 50 c/mm measured in the ACE model eye for a 5 mm pupil1 }  TECNIS® Symfony IOL merges 2 technologies to provide: 1

◦  Continuous full range of vision due to the unique echelette design feature that diffracts light to extend the range of vision

◦  High-quality vision due to achromatic technology designed to reduce chromatic aberration for enhanced contrast sensitivity

}  Contrast performance comparable to TECNIS® 1-Piece Monofocal IOL 2

Reduction in haloing and glare

+ = Echelette design

feature Achromatic technology

TECNIS® Symfony IOL

}  Less glare and halo

}  Natural vision ◦  Good functional intermediate and

near }  Can be used in a post

refractive eye

}  Extended Depth of Focus ◦  The small aperture design only allows focused central

light rays to reach the retina resulting in continuous functional vision without blur zones

KAMRA® Corneal Inlay IC-8™ Small-Aperture IOL

}  IOL Material ◦  Single-piece hydrophobic acrylic

}  Mask ◦  PVDF & nano-particles of carbon ◦  1.36mm aperture ◦  3.23mm total diameter ◦  3200 microperforations ◦  5 microns thick

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-0.1

0.0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0-5-4-3-2-1012345

VisualAcuity

(logMAR

)

Defocus Curve (Original and Adjusted by -0.75D) All AllAdjusted

20/16

20/20 20/25

20/32

3.0-DIOPTER

DEFOCUS RANGE AT

20/32 +

•  Small aperture design provides as much as 3.0 D of functional vision (20/32 or better)

•  Forgiving of small target refractive error misses }  Presbyopes represent the fastest growing global

population segment }  Establishing yourself as a “presbyopic practice”

creates a huge opportunity for business growth }  For your clear lens patient the KAMRA inlay

bridges the existing gap between LASIK-aged patients and cataract patients

}  Baby Boomers are looking for a solution-be the practice that can offer one!!