Download Why Recommend The Tetraflex™?

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
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
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.
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?
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™
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
Age
AMP of ACCOM
Age
Amplitude less than 5 D
10
11.00
35
6.5
15
10.25
40
5.50
38
0%
17%
20
9.50
45
3.5
40
23%
67%
25
8.50
60
1.25
42
57%
70%
30
7.50
70
1.00
44
75%
92%
45
82%
100%
Myopes
Hyperopes
•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
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.
Close
Near
ALL Clear Vision™
Intermediate
Far
Specifications
•
•
•
•
•
•
•
•
• 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
•
•
•
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
Michal Janek, MD
PLZEN, Czech Republic
“Accommodative Amplitude demonstrate 90%
gain 2 to 3 dioptres of accommodation
and 50% achieved more than 3D”
Amplitude of AccommodationBinocular
4
3.5
3.58
2-10
3.48
3.46
1.75-5.5
2-8
3
2.5
2
AA (D)
1.5
1
0.5
0
month 1
month 3
month 6
*
Source: Deepak Chitkara
FDA Data
138 Patients 6 months Postoperative
Uncorrected Distance Vision
Distance Corrected Near Vision
1 Month 3 Month 6 Month
100
94
95 92 94
95 95
1 Month 3 Month 6 Month
100
100
86 86
80
%
88
80
70 69
62
%
60
40
69
56
60
19
20
20
24
12
2
0
39
38
40
56
6
7
0
20/20 or better
20/25 or better
20/30 or better
20/40 or better
20/20 or better
20/25 or better
20/30 or better
20/40 or better
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
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
Normal Accommodation
3D Refraction Map (Vertical)
DISTANCE
Hyperopia
Mean = +0.4D
1.2D
Refractive
Range
Myopia
Normal Accommodation
3D Refraction Map
DIFFERENCE
Mean = -4.75D
2.4D Refractive Range
With Normal Accommodation
and Near Focus
- Refraction shifts to More Myopia
- Refractive Range Increases
Monofocal IOL
3D Refraction Map
NEAR
DISTANCE
DIFFERENCE
Monofocal IOL
3D Refraction Map
DIFFERENCE
No Refractive
Difference
0.6D
Refractive
Range
Tetraflex in Other Eye
3D Refraction Map
NEAR
DISTANCE
DIFFERENCE
Tetraflex in Other Eye
3D Refraction Map
DISTANCE
+2.8D
4.1D
Refractive
Range
Mean = +1.6D
-1.3D
Tetraflex in Other Eye
3D Refraction Map
NEAR
+3.8D
Mean = +1.1D
8.6D
Refractive
Range
-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 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
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“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:
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•
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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!