Advances in Intraocular lenses

Answers for Presbyopia

Jim Simms, VP Refractive Products, Lenstec

Why Recommendan IOL for Presbyopia?

ALL Clear VisionALL Clear Vision™™Near, Far and in-between

You can help your patients with a new

answer …

The Tetraflex™

Freedom from Spectacles

Cataract and High Refractive Presbyopic Patients Juggle 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 ChangeAs We Age

The eye becomes lessefficient and can no longer make delicate adjustmentsand we lose the ability toaccommodate.

As we age we will notice ourvision appears dim or blurry,and colors are not as brightor crisp.

As our eye ages we may notice increased headlight glare when driving at night.

What Are Cataracts?

• 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

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

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?

The natural lens is removed frominside the eye and an IOL is putin its place.

Lens surgery is a commonsurgical procedure performedon millions of patients annually Worldwide to treat cataracts

More patients and their doctorsare choosing Presbyopic IOL’s forRefractive corrections as analternative to LASIK

The Tetraflex™

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)

Near Close Far

ALL Clear VisionALL Clear Vision™™

Freedom from glasses for 95% of daily activitiesFreedom from glasses for 95% of daily activities

Intermediate

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)

AgeAMP of ACCOM

AgeAMP 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

AgeAmplitude less than 5 D

  Myopes Hyperopes

38 0% 17%

40 23% 67%

42 57% 70%

44 75% 92%

45 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 IOL2 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 IOLCataract 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 IOLRefractive 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 improvedwith refractive lens exchange

SURGICAL OPTIONS FOR

PRESBYOPIA

•Accommodative intraocular lens

•Multi-focal intraocular lens

•Scleral expansion procedures

•Multi-focal Lasik

•Radio Frequency

•Corneal Inlays

Cataract Patients (Premium) & Refractive Surgery

Optometry Response to Presbyopic Treatment

OptionsSource: 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 chooseRefractive Lens Surgery?

An IOL offers significant advantages over othertypes 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

The next generation of IOL, designed tomimic the NaturalLens.

THE COMBINEDEffect:

The Tetraflex™

Live... with less dependence on glasses...

•Liner forward and Back Movement•Varies by individual - analogy of a handshake•Aggressive readers •Radius of curvature changes•Subjective abberometor/TRACEY

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.

NearNear CloseClose

FarFar

ALL Clear VisionALL Clear Vision™™

IntermediateIntermediate

Specifications

• 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” 

3.58 3.48 3.46

0

0.5

1

1.5

2

2.5

3

3.5

4

month 1 month 3 month 6

AA (D)

Amplitude of Accommodation-Binocular

2-10

1.75-5.5 2-8

*

Source: Deepak Chitkara

FDA Data 138 Patients 6 months Postoperative

Distance Corrected Near VisionDistance Corrected Near Vision

26

127

19

38

24

39

56 56

69

88

0

20

40

60

80

100

20/20 or better 20/25 or better 20/30 or better 20/40 or better

1 Month 3 Month 6 Month

%%

Uncorrected Distance VisionUncorrected Distance Vision

62

70 69

86 8694 95 92 94 95 95

100

0

20

40

60

80

100

20/20 or better 20/25 or better 20/30 or better 20/40 or better

1 Month 3 Month 6 Month

%%

Understanding Natural Accommodation

The lens increases in thickness and the anterior chamber shallows.

The ciliary muscle enlarges and redistributes its massposteriorly.

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.

• 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.

Design Applied to Theory

• Designed with a unique anterior angulations, and patented 5˚ contoured haptic

Evaluation Of TheEvaluation Of The Tetraflex Tetraflex Presbyopic Presbyopic Accommodative IOLAccommodative IOL

Using the iTrace AberrometerUsing the iTrace Aberrometer

SOURCE: Donald R. Sanders, M.D., PhD., David C. Brown M.D., Deepak Chitkara, M.B., ChB. D.OSOURCE: Donald R. Sanders, M.D., PhD., David C. Brown M.D., Deepak Chitkara, M.B., ChB. D.O.

Normal Accommodation 3D Refraction Map (Vertical)

DIFFERENCEDIFFERENCE

NEARNEARDISTANCEDISTANCE

Normal Accommodation 3D Refraction Map (Vertical)

DISTANCEDISTANCE

Mean = +0.4DMean = +0.4D

1.2D 1.2D RefractiveRefractive

RangeRange

HyperopiaHyperopia

MyopiaMyopia

Normal Accommodation 3D Refraction Map

DIFFERENCEDIFFERENCE

Mean = -4.75DMean = -4.75D

2.4D Refractive Range2.4D Refractive Range

With Normal Accommodation and Near Focus

- Refraction shifts to More MyopiaRefraction shifts to More Myopia

- Refractive Range IncreasesRefractive Range Increases

Monofocal IOL 3D Refraction Map

DIFFERENCEDIFFERENCE

NEARNEARDISTANCEDISTANCE

Monofocal IOL 3D Refraction Map

DIFFERENCEDIFFERENCE

No Refractive No Refractive DifferenceDifference

0.6D0.6D Refractive Refractive

RangeRange

Tetraflex in Other Eye 3D Refraction Map

DIFFERENCEDIFFERENCE

NEARNEARDISTANCEDISTANCE

Tetraflex in Other Eye 3D Refraction Map

DISTANCEDISTANCE

Mean = +1.6DMean = +1.6D4.1D 4.1D RefractiveRefractive

RangeRange

+2.8D+2.8D

-1.3D-1.3D

Tetraflex in Other Eye 3D Refraction Map

NEARNEAR

Mean = +1.1DMean = +1.1D

8.6D 8.6D Refractive Refractive

RangeRange

+3.8D+3.8D

-4.8D-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.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 ComparisonThe 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 ADVANTAGEGLOBAL VISION ADVANTAGE  Near, Far and in-between … Clear VisionNear, 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

Lets us know how we can help you grow your practice, and better

serve your patients

THANK YOU!