Advances in Intraocular lenses Answers for Presbyopia Jim Simms, VP Refractive Products, Lenstec

Why Recommend an IOL for Presbyopia? ALL Clear Vision™ Near, Far and in-between

You can help your patients with a new answer … Cataract and High Refractive Presbyopic Patients Juggle Spectacles You can help your patients with a new answer … The Tetraflex™ Freedom from Spectacles

Why We Need Reading Glasses and Develop Cataracts The changes to our eyes usually follow a predictable course … Presbyopia develops in the 40s Cataract formation is noticeable in the 60s

Our Eyes Change As We Age As our eye ages we may notice increased headlight glare when driving at night. The eye becomes less efficient and can no longer make delicate adjustments and we lose the ability to accommodate. As we age we will notice our vision appears dim or blurry, and colors are not as bright or crisp.

What Are Cataracts? Symptoms Cloudy, fuzzy, or filmy vision Changes in the way we see colors Headlights seem too bright when driving at night Glare from lamps or the sun Double vision Progressive condition: natural lens becomes cloudy and eventually opaque Most common cause is the aging process By the age of 60 half the population develops the early stages of cataract Almost everyone over the age of 70 will show some degree of cataract formation Develop slowly in most people, gradual deterioration in vision becomes more noticeable over time

What Is Presbyopia? The inability of the eye to focus sharply on nearby objects

What is The Tetraflex™ and How Can it Help Your Patients? Replacing the natural lens, and allows restoration of near, far, and intermediate vision after cataract surgery, and as an alternative for some patients considering refractive surgery (LASIK) The natural lens is removed from inside the eye and an IOL is put in its place. Lens surgery is a common surgical procedure performed on millions of patients annually Worldwide to treat cataracts More patients and their doctors are choosing Presbyopic IOL’s for Refractive corrections as an alternative to LASIK The Tetraflex™

Freedom from glasses for 95% of daily activities ALL Clear Vision™ Near Close Intermediate Far Freedom from glasses for 95% of daily activities

Presbyopic Market Potential The Aging Eye

Presbyopia is characterized by progressive age related loss of accommodative amplitude Begins early in life and culminates in a complete loss of accommodation by about 50 years of age. Most prevalent of all ocular afflictions eventually affects 100% of the population. Generally results in a need for a near spectacle correction or near addition lenses such as bifocal reading glasses.

Presbyopia: presby (old) + opia (vision) Age AMP of ACCOM 10 11.00 35 6.5 15 10.25 40 5.50 20 9.50 45 3.5 25 8.50 60 1.25 30 7.50 70 1.00 Amplitude less than 5 D   Myopes Hyperopes 38 0% 17% 23% 67% 42 57% 70% 44 75% 92% 82% 100% Point where clear or comfortable vision at the desired nearpoint is not obtainable Amplitude of accommodation is less than 5 D Age of onset is variable, but the majority of patients will need near correction by age 45.

Presbyopic IOL 2 Patient Segments Traditional cataract patients who want more than mono-vision from cataract surgery Refractive lens exchange patients who are too old for LASIK but too young for traditional cataract surgery

Presbyopic IOL Cataract Patient Lifestyle Profile Won’t settle for less Works hard to take advantage of today’s technological advancements: flat-screen plasma TV, home entertainment centers, satellite radio, high speed internet Do not settle for the “norm”; want advancements to reading glasses. Highest earning years Not a question of being able to afford the cost, but rather the perceived value is equal or greater than the fee If properly informed about the potential benefits of Presbyopic IOL’s, these consumers will want them.

Presbyopic IOL Refractive Lens Exchange Patient Profile Middle aged segment of today’s population Too old for LASIK and too young for cataract surgery Looking for a superior alternative to reading glasses or bifocals Want to maintain a higher quality of vision throughout their life, despite their age or refractive error This group has impressive outcomes Need more than correction for presbyopia: myopia, hyperopia, or astigmatism. Have reduced vision due to compromised contrast sensitivity. Quality of vision is greatly improved with refractive lens exchange

SURGICAL OPTIONS FOR PRESBYOPIA Cataract Patients (Premium) & Refractive Surgery Accommodative intraocular lens Multi-focal intraocular lens Scleral expansion procedures Multi-focal Lasik Radio Frequency Corneal Inlays

Optometry Response to Presbyopic Treatment Options Source: Review of Optometry Which of the following surgical modalities do you believe holds the most promise for treating presbyopia? A. Multifocal laser ablations 5% B. Scleral expansion surgery 8% C. Multifocal IOLs 32% D. Accommodating IOLs 50% E. Corneal inlays 0%

Why choose Refractive Lens Surgery? An IOL offers significant advantages over other types of refractive surgery Removal of the natural lens means a cataract will not develop as patient becomes older Magnification is at the natural level Full peripheral (side to side) vision Astigmatism can be addressed Minimal risk of glare and halos Permanent or replaceable solution to freedom from spectacles

Live... with less dependence on glasses... The Tetraflex™ The next generation of IOL, designed to mimic the Natural Lens. THE COMBINED Effect: Liner forward and Back Movement Varies by individual - analogy of a handshake Aggressive readers Radius of curvature changes Subjective abberometor/TRACEY Live... with less dependence on glasses...

The Tetraflex™ Promise The Tetraflex lens is designed to permanently provide excellent distance and intermediate vision along with useful reading vision. Activated by the natural accommodation process of the eye, the lens optimizes the optic for near, intermediate and far vision.

Near Close ALL Clear Vision™ Intermediate Far

Specifications Simple-to-use lens Injectable via a 1.6mm cartridge Optic Size: 5.75mm Optic Type: Equiconvex Length: 11.50mm Haptic Style: Tetraflex Angulation: 5 Degrees Construction: 1 Piece Positioning Holes: 0 Optic Material: Acrylic (26% Water Content) A Constant: 118.0 A/C Depth: 5.10 Diopter Increments: Whole: +30.0 to +36.0 Half: +5.0 to +18.0 +25.0 to +30.0 0.2: +18.0 to +25.0 Simple-to-use lens Injectable via a 1.6mm cartridge No variation in surgeons standard phaco technique Minimal learning curve Does not to require patients adopation of unnatural multi-focal duality  

Michal Janek, MD PLZEN, Czech Republic

“Accommodative Amplitude demonstrate 90% gain 2 to 3 dioptres of accommodation and 50% achieved more than 3D”   Source: Deepak Chitkara

FDA Data 138 Patients 6 months Postoperative

Understanding Natural Accommodation The ciliary muscle enlarges and redistributes its mass posteriorly. The lens increases in thickness and the anterior chamber shallows.

The Mechanism of Accommodation

The Tetraflex™ Applied Theory of Accommodation • Two forces are activated during accommodation: vitreous movement and ciliary muscle swelling. • Both of these forces can move the optic forward and/or backward during accommodation.

Design Applied to Theory Designed with a unique anterior angulations, and patented 5˚ contoured haptic The Tetraflex optic is designed to act as a “sail,” catching the wave of vitreous to provide maximum forward movement for near vision and return to the intended plane in the “flat” position for clear intermediate and distance vision.

Evaluation Of The Tetraflex Presbyopic Accommodative IOL Using the iTrace Aberrometer We would like to describe for you the Refractive effects measured with the Tracey iTrace aberrometer and observed with the Tetraflex and Crystalens Accommodative IOLs. SOURCE: Donald R. Sanders, M.D., PhD., David C. Brown M.D., Deepak Chitkara, M.B., ChB. D.O.

Normal Accommodation 3D Refraction Map (Vertical) NEAR DISTANCE DIFFERENCE The map can be tilted a full 90° so that one can view the map vertically. When this is done it is easier to appreciate the range of refractive error encompassed in each map which may be a reasonable measure of depth of focus of the eye. We will look at each of these maps in greater detail.

Normal Accommodation 3D Refraction Map (Vertical) DISTANCE Hyperopia Mean = +0.4D Here is the vertical 3D map of the patient viewing a distance target. In this view hyperopic corrections are on top of the graph, emmetropic corrections are in the middle and myopic corrections are on the bottom of the graph. In this case the patient has a mean refractive error of +0.40D and a refractive range of 1.2D when viewing a distant target. 1.2D Refractive Range Myopia

Normal Accommodation 3D Refraction Map DIFFERENCE The difference map (near minus distance) looks very similar to the near map showing that the change with accommodation results in induced myopia and an increased refractive range. Mean = -4.75D 2.4D Refractive Range

With Normal Accommodation and Near Focus Refraction shifts to More Myopia Refractive Range Increases Thus with normal accommodation, the refraction map of the eye shifts to more myopia and an increased refractive range.

Monofocal IOL 3D Refraction Map NEAR DISTANCE DIFFERENCE Here is a refraction map focusing on a distance and near target after implantation of a standard monofocal IOL. Note that the distance and near refraction maps look virtually identical with very little difference observed in the difference map.

Monofocal IOL 3D Refraction Map DIFFERENCE No Refractive Difference A close view of the difference map shows essentially no refractive difference and a small 0.6D refractive range. 0.6D Refractive Range

Tetraflex in Other Eye 3D Refraction Map NEAR DISTANCE DIFFERENCE The other eye of this patient with the monofocal IOL had a Tetraflex accommodative IOL implanted. We will go over the maps in detail but what is obvious is that relative to the distance map, the near and difference maps show a larger refractive range, largely due to more myopic refractions.

Tetraflex in Other Eye 3D Refraction Map DISTANCE +2.8D 4.1D Refractive Range Mean = +1.6D Here is the distance refraction map in this case. The mean refraction is +1.6D with a refractive range of 4.1D from the most hyperopic point to the most myopic point in the refraction map. The most myopic point is only -1.3D. -1.3D

Tetraflex in Other Eye 3D Refraction Map NEAR +3.8D Mean = +1.1D 8.6D Refractive Range Here is the near refraction map. The mean refraction is 1.1D, only 0.5D more myopic than the distance refraction. However the refractive range is over twice that of the distance map, and while the most myopic portion of the distance map was -1.3D, it is -4.8D in the near map. -4.8D

Summary The Tetraflex Accommodative IOL is associated with a widened refractive range and more myopia with near fixation, which can explain the enhanced near acuity compared to monofocal IOLs.

Global Users Panel ASCRS2005/Washington, D Global Users Panel ASCRS2005/Washington, D.C Experience with The Tetraflex™ Sunil Shah: “my father has had cataract surgery and this is the lens we put in. He is 20/25 in either eye, and he’s about Jaeger 2 unaided” Deepak Chitkara: “almost 90% 0f patients are getting J3 or better” Jorgé Alio: “all of my patients are around J3 or J4 or better”  Jose Rincon: “I have Jaeger 1 or better 10%; Jaeger 2 or better 20%; Jaeger 3 or better 60%, Jaeger 4 or better, 100%.” Carlos Verges: “very nice distance visual acuity; about 20/25; 20/20. And, the near vision acuity is about 20/40, J3/J4 now defined as near social vision acuity”

Performance Comparison The Tetraflex vs. Multi-focal Deepak Chitkara: “multi-focals have the fundamental issue, that they are an unnatural situation” Jorgé Alio: “with mulit-focals some patients are unhappy even with good near and far vision because probably their neuro-processing is not ready for multi-focality in every case” Carlos Verges: “with multi-focal lenses we have to balance between the effective near vision and the secondary problems due to halos, compromised visual quality, and other related problems”

Multi-focal

Candidates for refractive cataract surgery have high expectations Rosa Braga-Mele, MEd, MD, FRCSC; Hawaiian Eye 2006 “A happy patient is better than achieving an arbitrary Snellen acuity value” Understanding the patient’s personality is far more important that the medicine. Patient success : “10% medicine, 90% personality.” Easygoing patients may be easier to please than those who are demanding and perfection-oriented. When determining IOL for refractive cataract patients: divide common activities into zones of vision. Zone 1 would include the most demanding of up-close activities, such as reading a drug label or a phone book and sewing. Zone 2 includes reading the newspaper or a menu and using the computer. Zone 3 includes activities such as watching TV, cooking and common household tasks. Zone 4 involves vision used during daylight hours, such as playing golf. Zone 5 includes the most demanding of scotopic vision, such as night driving or dim illumination such as candlelight With current technology, can effectively give patients about three continuous zones of vision: zones 1 to 3, zones 2 to 4, or zones 3 to 5. Multifocal IOLs tend to work better for zones 1 to 3, accommodating IOLs tend to work better for zones 2 to 4, and aspheric monofocal IOLs tend to work better in zones 3 to 5. Understanding which zones are most important to your patient is critical to achieve success with refractive cataract surgery.

GLOBAL VISION ADVANTAGE Near, Far and in-between … Clear Vision Carlos Verges: “for me intermediate vision is critical for those people who work with computers, and they have to work with intermediate distance. In this case I think the Tetraflex lens is much better.”  Jorgé Alio: “Tetraflex provides patients a near vision improvement, excellent far vision and intermediate vision, and no visual disturbance.” Sunil Shah: “I feel the Tetraflex is the best presbyopic lens at the moment and I don’t use multi-focal lenses anymore at all.”

Patient Education is KEY Ensure they have new knowledge: Qualities of an ideal candidate Realistic expectations for most patients Recovery times Pain and comfort issues Possible risk and complications Understand entire process from workup thru postoperative recovery

Lenstec support Skills/knowledge transfer to surgeon, staff, and referral network. Patient education materials: high image brochures, office posters, PowerPoint presentations for patient and referral education, web site with directory of global users (in development) – directing patients to you! Professional referral program development: education, high profile speakers at societies, regional symposia

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