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

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

3. 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

4. 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

5. 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.

6. 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

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

8. 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™

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

10. Presbyopic Market Potential The Aging Eye

11. 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.

12. 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.

13. 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

14. 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.

15. 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

16. 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

17. 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%

18. 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

19. 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...

20. 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.

21. Near
Close
ALL Clear Vision™
Intermediate
Far

22. Specifications Simple-to-use lens Injectable via a 1.6mm cartridge
Optic Size: mm
Optic Type: Equiconvex
Length: mm
Haptic Style: Tetraflex
Angulation: Degrees
Construction: Piece
Positioning Holes: 0
Optic Material: Acrylic
(26% Water Content)
A Constant:
A/C Depth:
Diopter Increments:
Whole: to +36.0
Half: to to +30.0
0.2: 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

23. Michal Janek, MD
PLZEN, Czech Republic

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

25. FDA Data 138 Patients 6 months Postoperative

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

27. The Mechanism of Accommodation

28. 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.

29. 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.

30. 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.

31. 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.

32. 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

33. 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

34. 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.

35. 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.

36. 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

37. 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.

38. 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

39. 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

40. 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.

41. 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”

42. 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”

43. Multi-focal

44. 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.

45. 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.”

46. 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

47. 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

48. Lets us know how we can help you grow your practice, and better serve your patients
THANK YOU!