Delivering on the promise: AcrySof IQ ReSTOR IOL

www.eyeworld.org
What role does advanced
technology play in your
practice?
This Show Daily supplement is sponsored by Alcon.
2012 ASCRS•ASOA Chicago Show Daily Supplement
Delivering on the promise:
AcrySof IQ ReSTOR IOL
by John Davidson, M.D., and Cathleen McCabe, M.D.
Why using this multifocal
lens can increase patient
satisfaction and referrals
ost ophthalmologists
agree that patient
selection will always
be a major factor in
patient satisfaction—
and that’s true in our experiences as
well. As two ophthalmologists practicing on either coast, we’ve found
that while our patient populations
may differ in demographics, they
both demand excellent post-cataract
surgery vision. Patients are usually
happy simply because you’ve
removed their cataract, but of all the
happy patients, patients with multifocal lenses are thrilled with their
M
new vision. It’s this type of patient
satisfaction that leads to more wordof-mouth referrals and a higher
volume practice. Patients may not
know the name of a particular IOL,
but they know their neighbors, colleagues, or family friends don’t need
to use spectacles nearly as often as
some of their other acquaintances—
and those are the lenses patients
want. Our results have mimicked
those of the FDA study data (see
Figure 1).
In clinical studies, the distance
peak of the defocus curve demonstrated that the AcrySof IQ ReSTOR
+3.0 IOL (Alcon, Fort Worth, Texas)
patients achieved a mean distance
visual acuity of 20/20 or better, with
a clear range for near vision from
–2.0 D to –4.5 D (see Figure 2). In
6-month post-op data of patient satisfaction with the SN6AD1 (ReSTOR +3)
John Davidson, M.D., and
Cathleen McCabe, M.D.
Overall
Baseline
0.5
Day vision
Baseline
0.7
Night vision
Bilateral
Bilateral
Baseline
Bilateral
Scale: 0-4 (0=not at all satisfied; 4=completely satisfied)
3.3
3.3
0.6
3.1
Figure 1. Patient satisfaction
This supplement was produced by
EyeWorld and sponsored by Alcon. The
doctors featured in this supplement
received compensation from Alcon for
their contributions to this supplement.
Michelle Dalton, EyeWorld contributing
editor based in Reading, Pa., assisted in
writing this supplement.
Copyright 2012 ASCRS Ophthalmic
Corporation. All rights reserved. The views
expressed here do not necessarily reflect
those of the editor, editorial board, or
the publisher, and in no way imply
endorsement by EyeWorld or ASCRS.
Figure 2. Mean defocus curves of the AcrySof IQ ReSTOR +4 IOL vs. an AcrySof IQ ReSTOR +3 IOL
addition, the mean intermediate
visual acuity of 20/25 or better is an
improvement of 1.5 lines in visual
acuity for patients implanted with
an IQ ReSTOR +3.0 IOL vs. an IQ
ReSTOR +4.0 IOL (AcrySof IQ
ReSTOR 6-month directions for use).
Here, we offer some of our
pearls for ensuring success with the
IQ ReSTOR IOL.
Why choose the ReSTOR IOL
Dr. Davidson: The IQ ReSTOR IOL
gives me confidence that I can meet
or exceed patient expectations for
unaided near vision without compromising far vision. In my practice,
I have found refractive results and
patient satisfaction ratings with the
IQ ReSTOR IOL to be highly predictable. The IQ ReSTOR +3 IOL
delivers near vision consistently. I
have not explanted any of the 1,000
IQ ReSTOR +3 IOLs (SN6AD1) that I
have implanted. The IQ ReSTOR +3
IOL is a significant improvement
over previous ReSTOR IOL generations, possessing an expanded range
of focus. I describe the first generation lens as having a near “sweet
spot” and the IQ ReSTOR +3 IOL as
having a near “sweet zone.”
Dr. McCabe: After implanting
more than 2,000 advanced technology lenses, I have learned that a
detailed conversation with the
patient and careful examination of
the eye are critical to success. As
long as the cornea and the rest of
the eye are healthy, I explain to my
patients the range of options available and that we offer all of the advanced technology lenses. I have
found the IQ ReSTOR IOL will most
reliably provide excellent unaided
vision at all distances, and it is my
preferred advanced technology lens
choice. Two important exceptions to
that rule are those patients with any
amount of early corneal disease or
those with significant dry eye that
cannot be managed.
Dr. Davidson: I recommend the
IQ ReSTOR IOL to cataract patients
with healthy eyes who desire high
quality full-range vision, who are
willing to tolerate a temporary halo
Please refer to page 12 for important safety information about the Alcon surgical products described in this supplement.
continued on page 2
2
EW Chicago 2012
Sunday, April 22, 2012
My practice is booming—
baby booming, that is
by Dan Grossman, M.D.
very day, 10,000 baby
boomers turn 65, and the
number of Americans over
age 65 is expected to double
within 7 years.1 As baby
boomers approach the age of
cataract onset, the rate of cataract
surgery will increase dramatically.
Even if the number of ophthalmology residents were to double tomorrow, there would still not be enough
surgeons to serve this growing need.
As the demand for cataract
surgery continues to surpass the
available workforce of surgeons, I
believe laser refractive cataract
surgery will become the norm.
Technologies such as the LenSx
Laser (Alcon, Fort Worth, Texas)
combined with advanced technol-
E
Dan Grossman, M.D.
is perfect,
“ Nobutlensusing
the IQ
ReSTOR IOL has
required less
chair time, fewer
post-op issues to
address, and yields
significantly more
patients who leave
our offices happy
”
ogy IOLs will play a prominent role
in cataract treatment.
The baby boomer population
presents a unique demographic of
cataract surgery patients—they are
educated, technologically savvy, and
demanding when it comes to their
health. To provide the best treatment for this patient population, I
think options such as the AcrySof IQ
ReSTOR IOL (Alcon) and LenSx Laser
technology are a must heading into
the future.
A rapid shift
At the Eye Center of Southern
Indiana, we adopted the IQ ReSTOR
IOL in September 2010. Prior to this,
we used an accommodative lens
technology as our primary premium
lens. Unfortunately, about 20% of
our accommodative lens patients
were dissatisfied, which necessitated
additional chair time and doing
whatever we could to make the
patients happy and to give them the
best possible vision.
Since adopting the IQ ReSTOR
IOL technology, I’ve implanted
more than 215 lenses. The swing
toward the IQ ReSTOR has been
swift. There is less patient dissatisfaction post-op along with outcomes
that usually give patients independence from glasses—more than 90% of
my patients are doing well and are
satisfied at about 6 weeks post-op.
No lens is perfect, but using the
IQ ReSTOR IOL has required less
chair time, fewer post-op issues to
address, and yields significantly
Davidson/McCabe continued from page 1
effect at night, and who are candidates for excimer laser enhancement, including select chronic
monovision and low myopic
patients. In my practice, residual
refractive error and posterior capsule
opacity are the leading causes of
dissatisfaction post-op. I offer LASIK
or PRK to patients who would benefit from such enhancements, as soon
as the refractive error stabilizes, no
sooner than 3 months post-op, and
after YAG posterior capsulotomy has
been performed if also indicated.
Word of mouth is finally becoming a
prominent factor to the point where
I’m now seeing patients on nearly a
daily basis who are asking for the
lens by name.
Dr. McCabe: One other patient
group that is somewhat difficult to
manage is low myopes. With a
monofocal lens, patients will lose
the ability to read but will gain
distance vision. The loss of unaided
reading vision is a difficult concept
for these patients to understand; I
believe this patient group is usually
much better suited for a multifocal
lens like the IQ ReSTOR IOL.
Dr. Davidson: While showing a
near card to patients, I point to the
20/200 line, and tell them that’s the
unaided near vision they can expect
with a basic lens. Then I show them
the J1-3 lines and tell them that’s
the improved vision they should
expect with the IQ ReSTOR IOL.
Implantation pearls
Dr. McCabe: Ensuring you’ve made
an appropriately sized, shaped, and
centered capsulorhexis will help
provide for the long-term stability of
the IQ ReSTOR IOL. Centration can
sometimes be difficult to assess in a
dilated pupil. However, the Purkinje
images of the microscope light from
the lens surface and cornea can
easily be superimposed on the center
ring of the lens. I’ve found that
making sure the two images are
right in the center of the lens allows
for perfect alignment on the first
post-op day. I spend additional time
in surgery confirming that the lens
is centered correctly. Mastel (Rapid
City, S.D.) recently introduced a rim
light that attaches to the microscope
and allows the patient and surgeon
to see a fixation light that is helpful
in aligning the lens correctly.
Dr. Davidson: I also like to
center the central ring of the IQ
ReSTOR IOL on the first Purkinje
image (the brighter, smaller reflection of the microscope light). I find
that by at first orienting the haptics
along the 6/12 o’clock meridian,
the lens is more likely to remain
centered if nudging nasally is
required for centration. Small,
astigmatically neutral corneal
wounds are important in achieving
predictable outcomes because
surgeons need to avoid inducing
astigmatism as much as possible.
Do not be surprised if minor residual
refractive errors affect patient satisfaction. I’ve had rare patients who
are 20/25, J2 unaided, and desire
enhancement for –0.25+0.50X180,
20/15, J1+, and others who are
20/20, J1 with nearly a diopter of
residual refractive astigmatism. A
general rule of thumb is to leave
the residual refractive error within
0.50 D of myopia, hyperopia, and
astigmatism.
Both surgeons agree no lens can
promise perfection. No patient can
be promised 100% spectacle freedom
100% of the time for 100% of the
patient’s chosen activities, but so far
the IQ ReSTOR IOL comes closest to
achieving those results.
Dr. Davidson is medical director, NVISION
Laser Eye Center, Camarillo, Calif., assistant
clinical professor of ophthalmology, Jules
Stein Eye Center, Los Angeles, and in practice
at Miramar Eye Specialists, Ventura, Calif. Dr.
McCabe is medical director and partner, The
Eye Associates, Sarasota, Fla.
Contact information
Davidson: [email protected]
McCabe: [email protected]
Please refer to page 12 for important safety information about the Alcon surgical products described in this supplement.
What role does advanced technology play in your practice?
EW Chicago 2012
3
more patients who leave our offices
happy. That leads to increased
patient referrals.
Counseling the patient
We’ve found that the name of the
IQ ReSTOR IOL product lends itself
to patient education, particularly
with baby boomers. The concept of
being returned to their more vital
and functional days truly resonates
with this active, young-at-heart population. When we offer this advanced technology IOL, we begin by
explaining the concept of presbyopia. Later in the discussion, we introduce the idea of advanced
technology IOLs, their advantages,
and their impact. We can’t guarantee perfect vision, but this is the best
approach to spectacle independence.
Immediately following surgery,
patients often complain about seeing the rings on the lens itself or
about seeing rings of light when
looking at a light source directly.
For this reason, patient expectations
must be managed post-op as well.
There is a period of time during
which neural adaptation takes place.
Over time patients generally adapt
to the new optical system, and this
effect usually fades.
By creating proper patient
expectations and offering continued
encouragement during the first few
weeks of adaptation, we can achieve
an excellent success rate.
Lens centration and
emmetropic outcome
One of the keys to patient success is
an emmetropic outcome, along with
a well-centered IOL. We spend a lot
of time making sure that the lens is
centered before doing final hydration of the wound and exiting the
wound. For this reason I perform
these surgeries using the LenSx
Laser.2 The LenSx Laser creates a
predictable rhexis, which has given
us more predictable centration and
effective lens position.3 In my
experience, the LenSx Laser and
the IQ ReSTOR IOL products offer
predictable options for my cataract
surgery patients.
Patient awareness strategies
Baby boomers are particularly interested in maintaining their active
lifestyles, and we try to market to
that idea—we also make an effort to
educate our optometry network on
the newest technologies and options. While our patients are technology savvy, they don’t necessarily
understand the nuances of cataract
surgery or the different IOLs available to them. In our patient population, that’s best accomplished by
face-to-face time in the office.
We’ve recently redesigned our
website to include a great deal of
content explaining the technology,
as well as multimedia such as videos
and testimonials. This type of material is a beneficial educational tool
for patients who are technologically
savvy. We are also trying to become
more involved in social media.
In general, we’ve found that the
personality trait that causes baby
boomers to require more extensive
pre-op counseling—their discriminating nature—is the very same trait
that makes them ideal candidates for
the IQ ReSTOR IOL. Baby boomers
want the best technology available,
and no sales tactics or gimmicks will
convince them unless it is a quality
product. We stand behind the technology the IQ ReSTOR IOL offers,
along with our strong reputation for
excellence.
References
1. Love J. AARP Research and Strategic
Analysis, December 2010.
2. Nagy Z, Takacs A, Filkorn T, Sarayba M.
Initial Clinical Evaluation of an Intraocular
Femtosecond Laser in Cataract Surgery,
Journal of Refractive Surgery, 2009;25:10531060.
3. Cionni, R. et al. “Comparison of Effective
Lens Position and Refractive Outcome:
Femtosecond Laser vs. Manual Capsulotomy.”
Presented at the 2011 International Society of
Refractive Surgery meeting (American
Academy of Ophthalmology). Oct. 21-22,
Orlando, Fla.
Dr. Grossman is founder of The Eye Center of
Southern Indiana, Bloomington, Ind.
Contact information
Grossman: [email protected]
EW Chicago 2012
4
Sunday, April 22, 2012
Should toric IOLs become
the standard of care?
by Brad Black, M.D.
oric IOLs offer an efficient
and consistent method of
correcting pre-existing
corneal astigmatism in
cataract patients. A 2010
study published in the Journal of
Cataract & Refractive Surgery1 found
that toric IOL implantation was
more predictable and effective than
limbal relaxing incisions (LRIs) in
correcting refractive astigmatism,
resulting in greater spectacle independence.
The AcrySof IQ Toric IOL
(Alcon, Fort Worth, Texas) offers an
excellent range of visual correction
that gives us the capability to correct
0.75 D to 4.0 D of pre-existing
corneal astigmatism.
In addition to these advantages,
toric IOLs obviate the need for the
additional incisions required with
LRIs. In light of these advantages
and the excellent visual outcomes
achieved, I think the AcrySof IQ
Toric IOL is quickly emerging as the
new standard of care for patients
with cataracts and pre-existing
corneal astigmatism.
T
Brad Black, M.D.
The reason that
“
torics are preferred
by many surgeons in
patients with 0.75 D
of pre-existing
corneal astigmatism
or greater is because
the toric IOL is
more predictable
and consistent
than LRIs
”
Corneal astigmatism:
When to treat?
When treating with a monofocal
IOL, residual astigmatism of even
0.75 D should be considered visually
significant and all of these patients
considered as potential candidates
for the AcrySof IQ Toric IOL. Physicians know that 0.5 D of astigmatism creates a considerable amount
of visual aberration for a patient and
can cause vision to drop to the
20/30 to 20/40 ranges. In monofocal
lens patients who are predicted to
have residual astigmatism of 0.8 D
or 0.9 D, I will consider implanting a
lower power of the AcrySof IQ
Toric IOL, the T3, which will leave
them with 0.1 or 0.2 in the opposite
direction to achieve the best
possible visual outcome. Regarding
the higher levels of astigmatism, we
are now able to address a greater
range of refractive error. However,
I always recommend surgeons
perform topography in these patients to rule out ectasia or any type
of progressive irregular astigmatism.
Incisional LRIs versus toric IOLs
The reason that torics are preferred
by many surgeons in patients with
0.75 D of pre-existing corneal astigmatism or greater is because the
toric IOL is more predictable and
consistent than LRIs2; there is no
risk of regression later on. Larger
LRIs may also induce significant peripheral aberration, which certainly
runs counter to our goal of minimizing, not creating, aberrations.
Surgical pearls
If surgeons have not yet implanted a
toric lens, the AcrySof IQ Toric IOL
is an excellent way to get started.
Surgical technique doesn’t vary
much from monofocal IOL implantation. One small adjustment you
must make is marking the 3, 6, and
9 o’clock axes pre-op before the
patient lays down to avoid
misplacement of the IOL due to
ocular cyclorotation in the supine
position. Once you have mastered
marking the desired axis intraoperatively, it’s just a matter of rotating
the IOL clockwise after insertion to
those marks.
Post-op issues
A question that often arises is,
“What if the toric lens is off by 5
degrees?” In my opinion, when you
check the patient on that first postop day and the vision is good and
the patient is happy, where the lens
ended up is not nearly as important
as you might think. The intended
axis is merely an approximation
based on pre-op K readings. It
cannot provide full knowledge of
where the lens should be placed as
we know there are other factors that
may influence post-op refractive
cylinder. If the patient is happy,
there’s no need to bring him/her
back into the OR. Leave the lens
alone.
Conversely, if a patient is not
happy with his/her vision post-op or
comes in with 20/40 vision, which
rarely happens, and thinks he/she is
happy, the surgeon must dilate that
patient to verify the axis position. If
the lens is misaligned, even by as
little as 10 or 15 degrees, I take the
patient back to the OR and rotate
the lens to the intended axis determined pre-op. Remember, the
patient will not complain of tilted
images, etc.—just blurry vision as
one loses 3% of the cylinder power
for each degree of misalignment.
You can make these patients
happier.
Patient education
Educating the patient about astigmatism and what a toric lens actually
does is equally important. Although
many patients know that they have
astigmatism, their understanding of
it may be very limited. We like to
use visuals when explaining astigmatism to a patient, likening the
shape of their eye to a football
rather than a basketball, or a
teaspoon rather than a soup spoon.
We explain that this irregular shape
interferes with their vision and that
the AcrySof IQ Toric IOL will figuratively correct the shape of their eye.
We then explain to patients that
without correcting this problem,
their vision without glasses will not
be as clear, i.e., it will cause halos
around lights and/or less distinct
vision and reduced contrast. Providing detailed patient education allows
patients to make an informed decision. It is not uncommon for patients to say, “I don’t mind wearing
glasses,” whereupon I will explain
that it’s not simply about spectacle
freedom. It is about quality of
vision. People understand that it’s
optically superior to correct astigmatism inside their eye as opposed to
wearing glasses. Also, I will often ask
patients, especially the high astigmats, how often their glasses had to
be remade in the past when their
astigmatism wasn’t properly
corrected. Then I tell them that with
a toric lens, those days are over.
References
1. Mingo-Botin, D. et al., Comparison of toric
intraocular lenses and peripheral corneal
relaxing incisions to treat astigmatism during
cataract surgery, J Cataract Refract Surg
2010; 36:1700-1708.
2. Data on file, Novartis AG.
Dr. Black is founder of Dr. Brad Black’s Eye
Associates in Jeffersonville, Ind.
Contact information
Black: [email protected]
Please refer to page 12 for important safety information about the Alcon surgical products described in this supplement.
What role does advanced technology play in your practice?
EW Chicago 2012
5
What impact does SIA have on treating preexisting corneal astigmatism with a toric lens?
by Paul Ernest, M.D.
ith about 65% of
older patients presenting with corneal
astigmatism between
0.25 D and 1.25 D,
the need to offer a solution to these
patients will continue to grow. In
my patient population, 35% of
patients have astigmatism of 0.75 D
and above, and I implant an AcrySof
IQ Toric IOL (Alcon, Fort Worth,
Texas) in a significant number of
these patients. Most ophthalmologists agree that 0.5 D of astigmatism
translates to about 0.25 D of spherical error and can negatively impact
high contrast visual acuity. With
that in mind, any reduction in
post-op astigmatism of more than
0.5 D will impact visual acuity. The
AcrySof Toric IOLs have been on the
U.S. market since 2005, with the
lowest IOL cylinder power of 1.50 D,
and I think these lenses should be
W
the primary treatment consideration
for patients with pre-existing corneal
astigmatism and corneal cylinder as
low as 0.75 D. I think it’s equally
crucial that we know what degree
of surgically induced astigmatism
(SIA) we’re introducing during the
procedure.
A personal interest of mine has
always been methods to reduce SIA.
Wound geometry and location
certainly play a role—surgeons will
have lower SIA levels if the wound
geometry is square and placed at the
posterior limbus. My SIA for a square
wound originating at the posterior
limbus is 0.25 D with a standard
deviation (SD) of 0.14 D.
Clear corneal incisions have a
higher SIA and wider SDs. We have
recently shown that 2.2 mm square
posterior limbal incisions induced
significantly less SIA relative to
similar-sized clear corneal incisions.1
More importantly, that same study
showed the SIA was significantly less
variable as well. Furthermore, for
patients with lower levels of
astigmatism (i.e., 0.75 D), the
wound architecture and location
play the most significant role. It is
my opinion that it is difficult to
treat 0.75 D if you fall into the
category of having an SIA of 0.6 D
with an SD of 0.4 D.
For a high level of astigmatism
—3.5 D or 4.0 D—SIA is not a
relevant factor.
I think there’s a tendency for
surgeons who use clear corneal
incisions to avoid using the AcrySof
T3 Toric lens because their outcomes
are less predictable. They may be
unaware that it could be the incision
that’s causing the inconsistent
outcomes and not the lens itself.
I was involved in a study
evaluating the refractive results of
the AcrySof T3 Toric and AcrySof IQ
continued on page 6
Paul Ernest, M.D.
These lenses
“should
be the
primary treatment
consideration for
patients with
pre-existing corneal
astigmatism and
corneal cylinder as
low as 0.75 D
”
Figure 1. Distribution of post-op refractive astigmatism by IOL type
6
EW Chicago 2012
Sunday, April 22, 2012
AcrySof platform provides confidence, con
monofocals and advanced technology lens
by Jason Jones, M.D.
Years of experience have
convinced me this is the
best family of lenses for
the majority of patients
have been a long-time user of
the AcrySof (Alcon, Fort
Worth, Texas) family of lenses,
ever since my residency. In my
hands, the AcrySof IOL
continues to be a very comfortable
and convenient product to use.
One of the benefits of choosing this
family of lenses—from the IQ to the
IQ Toric to the IQ ReSTOR IOL—is
just that: It’s a family of products all
built on the same platform. And that
platform has shown time and time
again to provide patients with
phenomenal visual outcomes.
That, in turn, means I inherently
know how the lens is going to
perform as it’s unfolding, as it’s
being inserted, and as I’m positioning it, regardless of which variation
of the lens I’m using.
There are numerous aspects of
the AcrySof IOL line I appreciate: It
has excellent centration, and it’s
constructed out of optimal material
I
Jason Jones, M.D.
Because the
“
AcrySof is a family of
products, the newer
user can gain a lot of
experience with
monofocal lenses and
have more confidence
when beginning
to use the advanced
technology
platforms
”
for a thin profile and easy delivery.
All of the AcrySof lenses are very
forgiving during the implantation through a cartridge
and into the capsular
bag. One of the more
endearing properties
of the platform’s
ability is that the
lenses are gentle
to the ocular
structures and
have the flexibility to tolerate the
implantation
through a very
small incision in a
reliable fashion. This
allows me to
reduce my wound size,
while still using a reliable
portfolio of advanced
technology IOLs.
As I mentioned earlier, this is
a family of products that goes from
an aspheric monofocal to an aspheric toric to an aspheric multifo-
AcrySof IQ IOL
Ernest continued from page 5
spherical monofocal IOLs. Correcting relatively small amounts of
corneal astigmatism with the lowpowered T3 reduced the post-op
astigmatism by about 0.75 D more
than the spherical lens (bearing in
mind these patients had 0.75 D to
1.38 D of pre-op astigmatism).2
Given the small amount of SIA we
noticed in these patients, the
residual effects were basically
non-existent (see Figure 1).
It’s been my experience that
calculating SIAs is not difficult.
Warren Hill, M.D., has created a
website that allows surgeons to
calculate their SIAs as well as their
SD. The program can be downloaded
off doctorhill.com/physicians/
download.htm. According to Dr.
Hill, the SIA Calculator has been
designed to calculate, by means of
vector analysis, the amount of SIA
created during the cataract surgical
procedure. To gain the most benefit,
I suggest that surgeons use the same
instrument for both pre-op and
post-op K measurements.
If the SDs can be minimized,
using an IOL calculator will give you
great success with toric IOLs. If the
SDs are variable, however, it’s likely
surgeons will be disappointed with
their initial outcomes. For those
who are not consistently calculating
their SIAs, I recommend taking
about 30-50 eyes, measuring the preop and post-op Ks, running a simple
vector analysis, and calculating not
only the SIA but the SDs.
After the first 50 cases or so, I
recommend surgeons revisit wound
construction and architecture. Once
the SIAs are lower and surgeons start
seeing more consistent outcomes, it
becomes much easier to approach
the T3 lens with a high degree of
certainty about visual outcomes.
Like the cataract procedure
itself, every step builds on the one
before it. If surgeons know their
SIAs, they can look at their SDs and
work on getting those deviations as
narrow as possible. Keeping tight
SDs has given me the confidence to
know I can easily treat lower levels
of astigmatism very effectively with
a lens-based procedure.
References
1. Ernest P, Hill W, Potvin R. Minimizing
surgically induced astigmatism at the time of
cataract surgery using a square posterior
limbal incision. J Ophthalmol 2011;
2011:243170.
2. Ernest P, Potvin R. Effects of preoperative
corneal astigmatism orientation on results
with a low-cylinder-power toric intraocular
lens. J Cataract Refract Surg 2011;37(4):
727-32.
Dr. Ernest is in private practice, TLC Michigan.
Contact information
Ernest: [email protected]
Please refer to page 12 for important safety information about the Alcon surgical products described in this supplement.
What role does advanced technology play in your practice?
EW Chicago 2012
7
nsistency in
ses
cal. This is a proven platform that
has seen advances, and we can likely
expect more in the future. The
breadth of the family of lenses is an
attractive element because as
surgeons use them on a routine
basis, they become more accustomed to the handling properties,
and they have a greater ability to
have surgical expectations that are
met and understand how the
products will perform.
The familiarity with the lens
family can be helpful when surgeons
step into a position where a patient
has difficult anatomy or if they’re
using an advanced technology IOL
for the first time. Knowing a new
lens has consistent, proven properties, they have a greater confidence
in their ability to deliver the desired
outcome. It’s a nice element of
the AcrySof—to have a family of lenses that goes
from a very low
diopter to a
very high
AcrySof IQ ReSTOR IOL
diopter power in a single-piece
acrylic.
Material advantages
Being a hydrophobic acrylic lens, all
of the AcrySof lenses are stable, both
short and long term. This platform
has no reported issues with calcification. The acrylic nature gives this
lens a high index of refraction. The
inherent flexibility of the lens allows
it to be implanted through a small
incision. The mechanical properties
allow the material to be soft and
pliable at body temperature, which
makes the lens gentle on ocular
structures as it is being implanted.
Additionally, the element of
material flexibility allows a surgeon
who knows where the visual axis is
to slightly nudge the lens
into place a little more
readily than he/she might
be able to with other platforms. In my hands, I’ve
found lenses with stiff haptics tend
to center on the capsular bag, which
may not coincide with the visual
axis. In many routine cases, visual
axis centration may not make a large
difference, but in the cases that do
benefit from this ability, the individualized centration can have a big
impact (particularly with the IQ
Toric and IQ ReSTOR lenses).
AcrySof IQ Toric IOL
Because the AcrySof is a
family of products, the newer
user—either in residency or a
trained surgeon—can gain a lot of
experience with monofocal lenses
and have more confidence when
beginning to use the advanced
technology platforms.
The AcrySof IQ, a monofocal
lens, is a single-piece lens that feels
more resilient in my hands during
implantation. There’s little risk of
damaged haptics, and it decreases
the potential for intraocular damage
—there’s no appendage that can get
caught or possibly break off during
the implantation procedure. I prefer
the one-piece because of the additional stability. The one-piece design
of the AcrySof platform gives me
that extra element of control. It’s
nice to take that for granted.
I’ve worked with all the iterations of various IOLs, and there can
be some issues—as I tell my patients,
these products are all made by
human beings and as such they are
not perfect. No matter which lens
you’re implanting, I find it helpful
to communicate that a successful
surgery will deliver excellent vision,
but it may not give the patient every
single aspect he or she desires. My
advice to other surgeons is to perform meticulous surgery, analyze
your results, and pay strict attention
to lens power calculations. I regularly look at multiple formulas to
help me decide which power lens to
implant. From my perspective, a real
benefit of the AcrySof family is that
it gives surgeons an IOL platform
across a range of advanced technology that shares the consistency I
look for in a lens.
Dr. Jones is president and medical director,
Jones Eye Clinic, Sioux City, Iowa and Sioux
Falls, S.D.
Contact information
Jones: [email protected]
8
EW Chicago 2012
Sunday, April 22, 2012
Femtosecond laser arcuate incisions:
Delivering accuracy and reproducibility
by Eric D. Donnenfeld, M.D.
here are many steps within
the cataract procedure,
when performed manually,
that contain an inherent
level of variability. These
steps include capsulotomy, making
the primary and secondary incisions, and making arcuate incisions
in the cornea. Many surgeons have
avoided performing similar types of
incisions like manual arcuate incisions during cataract surgery.
Manual arcuate incisions require
significant expertise and produce
some degree of unpredictability. As a
result, manual arcuate incisions are
largely avoided by the great majority
of cataract surgeons due to concerns
about accuracy.
The LenSx Laser (Alcon, Fort
Worth, Texas) utilizes image-guided
surgical planning with 3D visualization for the surgeon. This enables
surgeons to plan and execute the
necessary corneal incisions to address the needs of the patient at the
time of cataract surgery with computer-controlled arcuate incisions of
precise depth, length, and position. The integrated imaging system
ensures incisions of accurate width
and tunnel length and geometric
shape.
My early experiences with the
femtosecond laser for refractive
cataract surgery demonstrate that
the femtosecond laser will provide
another layer of precision by creating reproducible arcuate incisions at
the desired optical zone. Incorporating femtosecond laser arcuate incisions into my armamentarium has
given me the confidence to know
I’m offering the most advanced
technologies on the market today to
my patients.
T
Eric Donnenfeld, M.D.
My early
“
experiences with the
femtosecond laser
for refractive cataract
surgery demonstrate
that the femtosecond
laser will provide
another layer of
precision by creating
reproducible arcuate
incisions at
the desired
optical zone
”
Adjust arcuate incisions
The surgeon’s ability to adjust surgical parameters and thereby titrate
the amount of residual tissue attachments in the incision enables another distinct advantage. Utilizing
this feature, the surgeon can adjust
the arcuate incision width by using a
blunt manual instrument.
These kinds of incisions also
could be likened to a LASIK flap. The
surgeon must lift the flap by hand to
make use of the incision. Likewise,
until the cataract femtosecond
incisions are opened manually, the
The LenSx Laser
Source: Alcon
fenestrations the surgeon has
made with the laser have not been
realized.
A great majority of ophthalmologists aren’t doing any type of manual arcuate incision during cataract
surgery due to fear of cutting deeply
into the cornea and risking perforation. Using the femtosecond laser
allows any ophthalmologist to
perform a quality arcuate incision.
Surgeons can be assured that this is
being done with the accuracy and
precision of a laser that is as good as
any surgeon, even one with years of
experience.
rate and reproducible way of doing
cataract surgery. If I can incorporate
that technology into my cataract
surgery, I will do so at any opportunity. I’m getting better reproducibility with my femtosecond incisions
than I ever got with my manual
incisions. Using the femtosecond
laser to create those incisions is
more reproducible, gives me
adjustable incisions, and provides a
level of accuracy that I cannot
consistently achieve manually.
Accuracy and reproducibility
Contact information
My personal belief is that femtosecond cataract surgery is a more accu-
Donnenfeld: [email protected]
Dr. Donnenfeld is a partner at Ophthalmic
Consultants of Long Island.
Please refer to page 12 for important safety information about the Alcon surgical products described in this supplement.
What role does advanced technology play in your practice?
EW Chicago 2012
9
Optimized outcomes with
advanced optical biometry
by Joseph Sokol, M.D.
ataract surgery has
advanced to the point
where accurate measurements are essential to
achieving the best visual
outcomes. I have found that the
LENSTAR LS 900 optical biometer
(Haag-Streit USA, Mason, Ohio)
gives me the most comprehensive
set of information with reliable and
accurate measurements for planning
cataract surgery with advanced
technology IOLs.
C
The need for optical biometry
In my opinion, if you are performing state-of-the-art cataract surgery,
you should be committed to achieving emmetropia in as many patients
as possible regardless of the lens you
are implanting. It therefore follows
that having reliable and accurate
measurements of the eye pre-operatively is essential. For many years
applanation ultrasound was the
method by which physicians gained
information to calculate lens powers. Immersion ultrasound was a big
step forward but was not uniformly
adopted due to the difficulty in
performing the procedure as well as
the inconvenience to the patient.
Optical biometry has made immersion ultrasound quality measurements available to surgeons and
patients alike in an easier format.
Crucial measurements
Within optical biometry, both the
IOLMaster (Carl Zeiss Meditec,
Dublin, Calif.) and the LENSTAR LS
900 optical biometer deliver excellent results. Like many surgeons,
I began to try to improve my
outcomes by using a version 5
IOLMaster. While this did much to
reduce refractive surprises and speed
up the acquisition of data, I still
struggled with certain cases. A particular source of frustration was the
accuracy of the axis of astigmatism
that the IOLMaster found in patients
as compared to manual or automated keratometry. When implanting toric lenses, this was a concern.
Once I started using the
LENSTAR LS 900 optical biometer,
I began to have consistent, predictable results. I found that the
axial length measured between optical biometers was very consistent,
but the keratometry as determined
by the LENSTAR optical biometer
was improved based upon the additional points of measurement. Each
LENSTAR optical biometer scan
measures the anterior corneal curvature at 32 discrete points divided between two different zones—one at
2.3 mm and the other offset at 1.65
mm. That means that when the instrument acquires five scans, you
have sampled over 600 measurements on the cornea per eye. I
believe that the additional measure-
ments on the cornea provided better
outcomes for my toric IOL patients
or for multifocal or accommodating
lens patients in whom I needed to
do limbal relaxing incisions. In fact,
a recently published study using
simulated outcomes suggested that
overall results for a group of patients
whose toric IOL surgery planning
was performed with the LENSTAR
optical biometer was equivalent to
manual Ks, but with a reduced siteto-site variability.1 With the
IOLMaster, the black box was in
play. You got a set of numbers but
without confidence values and
without the ability to see examples
of the actual scans. If a surgeon’s K
readings produce high standard deviations, either in the values or the
axis, it is often unwise to proceed
with surgery until the cause can be
determined. It may be that the
patient’s ocular surface needs to be
improved or that the tear film needs
to be addressed. My advice is to correct those issues as best you can and
then to repeat the K readings. One
can also get a sense of the problem
by looking at the Placido disc
images. Distorted mires, ectatic
areas, or poor images are all warning
signs that should be heeded.
Quantity plus quality
equals greater efficiency
While the difference between ultrasound and optical biometry is huge,
the difference between the LENSTAR
optical biometer and the IOLMaster
is smaller but meaningful. We all
love to be efficient in what we do. In
one scan, the LENSTAR optical
biometer measures lens thickness,
pachymetry, pupillometry, keratometry, axial length, anterior chamber
depth, and the white-to-white limbal distance. The LENSTAR optical
biometer provides additional parameters—such as the lens thickness—
that are often included in newer
fourth-generation formulas and provide a measured, rather than a calculated, anterior chamber depth. This
increased data along with the use of
the newer, more sophisticated formulas should eliminate some of the
surgeon’s reliance on estimations.
Additionally, the LENSTAR optical
continued on page 10
Joseph Sokol, M.D.
The keratometry
“
as determined by the
LENSTAR optical
biometer was
improved based
upon the
additional points of
measurement
”
10
EW Chicago 2012
Sunday, April 22, 2012
Latest advancements in cataract
surgery for achieving precise outcomes
by Robert J. Cionni, M.D.
ecently my cataract clinic
has begun to resemble a
refractive clinic—the
patients want to know
whether or not they will
still need their glasses after surgery.
The nice thing is if we use the best
technologies, the chance of obtaining the best results is more likely. In
my opinion, that means advanced
technology lenses, optical biometers,
femtosecond lasers, and intraoperative aberrometry.
Fortunately, numerous emerging
technologies hold the promise of
optimizing cataract surgery during
all phases of the procedure. These
innovations have the potential to
provide uniformly superior results in
the hands of any surgeon.
R
Robert J. Cionni, M.D.
“ Numerous
emerging
technologies hold
the promise of
optimizing cataract
surgery during all
phases of the
procedure
”
The LENSTAR LS 900
optical biometer
I recommend measuring keratometric cylinder using multiple methods,
including the LENSTAR LS 900
optical biometer (Haag-Streit USA,
Mason, Ohio), which gives us
various readings other technologies
are not able to provide.
The LENSTAR biometer basically
does what we previously asked the
IOLMaster 500 (Carl Zeiss Meditec,
Sokol continued from page 9
biometer, similar to ultrasound,
allows the surgeon to see what
exactly is being measured. This
ability to see the tracing to confirm
the accuracy of the reading is reassuring. If the operator feels that the
machine has mistakenly located the
anterior or posterior lens surface or
the retinal spike, for example, the
calipers on the scan in question can
be manually moved and realigned to
increase the accuracy of the result.
From a clinician’s standpoint,
the joystick on the LENSTAR optical
biometer is similar to what we’ve
used on a slit lamp. The LENSTAR
optical biometer has been programmed to only capture data on
the visual axis—ensuring that if the
patient has problems maintaining
fixation, the LENSTAR optical
biometer will pause the scanning
portion until the patient fixates
again. One last feature I have found
helpful—the LENSTAR optical
biometer almost obviates the possibility of technician error as data
does not have to be transcribed.
Instead, the LENSTAR optical
biometer automatically inputs the
data it captures into the Holladay II
program. There is a short learning
curve to utilizing this instrument.
As the biometer is being integrated
into the practice, technicians and
surgeons may find the images a bit
tricky to obtain at first. Training
from the Haag-Streit/Alcon team
and confidence and experience from
repetitive use conquered this
problem in a relatively short time.
Measurements equal results
Since I’ve been using the LENSTAR
optical biometer in my practice, I
feel more comfortable that I’m getting accurate information for predictable outcomes. This instrument
gives me peace of mind. I firmly believe to meet out patients’ growing
expectations, we are obligated to
provide excellent results. One way
that we can continue to achieve
those results is to use the best instrumentation available on the market
today. I have come to appreciate
that the LENSTAR optical biometer
occupies that top spot.
Dr. Sokol is founder and owner, CT Eye
Specialists LLC, Shelton, Conn.
Reference
1. Hill W, Osher R, Cooke D, et al. Simulation of
toric intraocular lens results: Manual keratometry versus dual-zone automated keratometry
from an integrated biometer. J Cataract
Refract Surg. 2011;37:2181-2187.
Contact information
Sokol: [email protected]
LENSTAR is a registered trademark of
Haag-Streit.
Please refer to page 12 for important safety information about the Alcon surgical products described in this supplement.
What role does advanced technology play in your practice?
Dublin, Calif.) to do. While they
both provide good axial length
readings, the LENSTAR biometer will
take a little longer to produce those
simply because it’s taking so many
more readings and providing more
information. In my opinion, the
LENSTAR biometer provides the
most reliable keratometry readings,
which include accurate axis and
magnitude of corneal cylinder.
In the past, we relied on a
topographer to determine the axis
and on manual keratometry readings for the magnitude. Now, we can
rely on the LENSTAR instrument to
give us not only the axial length,
but also keratometry and lens thickness, and then input that data into
the LenSx Laser (Alcon, Fort Worth,
Texas). The lens thickness reading is
also important in the newer genera-
EW Chicago 2012
11
tion formulas in order to get the best
implant power.
Our group is working with
Lenstar and Alcon to incorporate the
LENSTAR testing into such innovations as patient identification in the
operating room. We’re using the
LENSTAR biometer to take a picture
and identify sentinel vessels, iris
markers such as nevi, and similar
landmarks. The LENSTAR can use
those phenomena to align the
images in order to identify the
patient’s steep axis once the patient
is in the OR. If there is cyclotorsion
after a patient is in the reclining
position, the LENSTAR biometer
realigns the images so the surgeon
can be assured of acting on the true
astigmatic axis.
In the future, I predict we’ll be
using biometers like the LENSTAR
biometer in conjunction with
phaco machines to ensure the bar
code scanned into the phaco machine matches what the LENSTAR
biometer found as an appropriate
lens. It’ll act as another layer to
ensure surgeons are implanting
the proper lens power.
To further test the accuracy of
the LenSx Laser over manual methods, we implanted an additional 23
patients with the IQ ReSTOR IOL
(Alcon) and 28 patients with the
AcrySof IQ Toric IOL (Alcon). In the
IQ ReSTOR IOL group, 12 underwent capsulotomy with the LenSx
Laser and 11 via manual procedures.
The toric group was split equally. In
all cases, the accuracy to within 0.25
D of the target was significantly better with the LenSx Laser. In my
hands, the worst outcomes were in
the toric group with manual methods, where 21% were within 0.25 D.
At 1 month post-op, 100% of the
patients implanted with the IQ
ReSTOR IOL/LenSx Laser had 20/25
or better, compared to 36% with the
manual procedure. Likewise, 82% of
the SN60WF/LenSx Laser and 71%
of the AcrySof IQ Toric IOL/LenSx
Laser patients reached 20/25 or
better at month 1 post-op compared
to 54% and 36%, respectively, in the
manual keratometry group.
The LenSx Laser
As the cataract surgery market continues to grow, new technologies are
being developed to meet this need.
Devices such as the LENSTAR optical
biometer, the LenSx Laser, and the
Wavetec ORA (WaveTec Vision,
Aliso Viejo, Calif.)—as well as the
advanced implants and phaco
machines we already have—enable
us to confidently tell patients that
they are more likely to end up with
the results they are demanding we
provide.
We’ve been incredibly lucky to be
among the first groups to incorporate the LenSx Laser for refractive
cataract surgery. In a study I presented at the 2011 International
Society of Refractive Surgery (ISRS)
meeting,1 I compared the femtosecond laser with manual capsulotomy
in terms of effective lens position
(ELP) and refractive outcomes.
In the study, I looked at 26
patients who underwent surgery
with manual capsulotomy and 22
patients who had surgery with
femtosecond incisions (both groups
implanted with the SN60WF lens
[Alcon]). The two study groups were
comparable in terms of demographics and axial lengths, keratometry,
and anterior chamber depth. We
didn’t perform any astigmatic limbal
relaxing incisions; we were looking
only at the spherical outcome. We
found that 59% more of those in the
femtosecond group reached 20/20
uncorrected vision.
Advanced technologies,
predictable results
Reference
1. Cionni, R. et al. Comparison of Effective
Lens Position and Refractive Outcome:
Femtosecond Laser vs. Manual Capsulotomy.
Presented at the 2011 International Society of
Refractive Surgery meeting (American
Academy of Ophthalmology). Oct. 21-22,
Orlando, Fla.
Dr. Cionni is medical director, The Eye Institute
of Utah, Salt Lake City.
Contact information
Cionni: [email protected]
Lenstar is a registered trademark of
Haag-Streit.
12
EW Chicago 2012
Sunday, April 22, 2012
Important safety information
AcrySof IQ intraocular lenses
Caution: Federal (U.S.) law restricts this device to sale by or on the order of a
physician.
Indications: The AcrySof IQ posterior chamber intraocular lens is intended for the
replacement of the human lens to achieve visual correction of aphakia in adult patients
following cataract surgery. This lens is intended for placement in the capsular bag.
Warning/precaution: Careful pre-operative evaluation and sound clinical judgment should
be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient
with any of the conditions described in the Directions for Use labeling. Caution should be
used prior to lens encapsulation to avoid lens decentrations or dislocations.
Studies have shown that color vision discrimination is not adversely affected in
individuals with the AcrySof Natural IOL and normal color vision. The effect on vision of the
AcrySof Natural IOL in subjects with hereditary color vision defects and acquired color
vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic
uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize;
do not store over 45 degrees C; use only sterile irrigating solutions such as BSS or BSS
PLUS Sterile Intraocular Irrigating Solutions.
Attention: Reference the Directions for Use labeling for a complete listing of
indications, warnings, and precautions.
AcrySof IQ ReSTOR intraocular lenses
Caution: Federal (U.S.) law restricts this device to sale by or on the order of a
physician.
Indications: The AcrySof IQ ReSTOR posterior chamber intraocular lens (IOL) is
intended for primary implantation for the visual correction of aphakia secondary to removal
of a cataractous lens in adult patients with and without presbyopia, who desire near,
intermediate, and distance vision with increased spectacle independence. The lens is
intended to be placed in the capsular bag.
Warning/precaution: Careful pre-op evaluation and sound clinical judgment should be
used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with
any of the conditions described in the Directions for Use labeling. Physicians should target
emmetropia and ensure that IOL centration is achieved. Care should be taken to
remove viscoelastic from the eye at the close of surgery.
Some patients may experience visual disturbances and/or discomfort due to multifocality,
especially under dim light conditions. Clinical studies with the AcrySof ReSTOR lens indicated that posterior capsule opacification (PCO), when present, developed earlier into clinically significant PCO. Prior to surgery, physicians should provide prospective patients with a
copy of the Patient Information Brochure available from Alcon for this product informing
them of possible risks and benefits associated with the AcrySof IQ ReSTOR IOLs.
Studies have shown that color vision discrimination is not adversely affected in
individuals with the AcrySof Natural IOL and normal color vision. The effect on vision of the
AcrySof Natural IOL in subjects with hereditary color vision defects and acquired color
vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic
uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize;
do not store over 45 degrees C; use only sterile irrigating solutions such as BSS or BSS
PLUS Sterile Intraocular Irrigating Solutions.
Attention: Reference the Directions for Use labeling for a complete listing of
indications, warnings, and precautions.
AcrySof IQ Toric intraocular lenses
Caution: Federal (U.S.) law restricts this device to sale by or on the order of a
physician.
Indications: The AcrySof IQ Toric posterior chamber intraocular lens is intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and
pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult
patients with or without presbyopia, who desire improved uncorrected distance vision,
reduction of residual refractive cylinder, and increased spectacle independence for distance
vision.
Warning/precaution: Careful pre-operative evaluation and sound clinical judgment should
be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient
with any of the conditions described in the Directions for Use labeling. Toric IOLs should not
be implanted if the posterior capsule is ruptured, if the zonules are damaged, or if a primary
posterior capsulotomy is planned. Rotation can reduce astigmatic correction; if necessary,
lens repositioning should occur as early as possible prior to lens encapsulation. All viscoelastics should be removed from both the anterior and posterior sides of the lens; residual viscoelastics may allow the lens to rotate.
Optical theory suggests that high astigmatic patients (i.e. >2.5 D) may experience
spatial distortions. Possible toric IOL related factors may include residual cylindrical error or
axis misalignments. Prior to surgery, physicians should provide prospective patients with a
copy of the Patient Information Brochure available from Alcon for this product informing
them of possible risks and benefits associated with the AcrySof IQ Toric Cylinder Power
IOLs.
Studies have shown that color vision discrimination is not adversely affected in
individuals with the AcrySof Natural IOL and normal color vision. The effect on vision of the
AcrySof Natural IOL in subjects with hereditary color vision defects and acquired color
vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic
uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize;
do not store over 45 degrees C; use only sterile irrigating solutions such as BSS or BSS
PLUS Sterile Intraocular Irrigating Solutions.
Attention: Reference the Directions for Use labeling for a complete listing of
indications, warnings, and precautions.
LENSTAR LS 900 Optical Biometer
The LENSTAR LS 900 Optical Biometer is a non-invasive, non-contact OLCR
(optical low-coherence reflectometry) biometer used for obtaining ocular measurements
and performing calculations to assist in the determination of the appropriate power and type
of IOL for implantation after removal of the natural crystalline lens following cataract
removal. The LENSTAR LS 900 Optical Biometer measures:
• Axial eye length
• Corneal thickness
• Anterior chamber depth
• Lens thickness
• Radii of curvature of flat and steep meridian
• Axis of the flat meridian
• White to white distance
• Pupil diameter
LenSx Laser
Caution: Federal (U.S.) law restricts this device to sale by or on the order of a
physician.
Indication: The LenSx Laser is indicated for use in patients undergoing cataract surgery
for removal of the crystalline lens. Intended uses in cataract surgery include anterior
capsulotomy, phacofragmentation, and the creation of single-plane and multi-plane arc
cuts/incisions in the cornea, each of which may be performed either individually or
consecutively during the same procedure.
Restrictions:
• Patients must be able to lie flat and motionless in a supine position.
• Patient must be able to understand and give an informed consent.
• Patients must be able to tolerate local or topical anesthesia.
• Patients with elevated IOP should use topical steroids only under close medical
supervision.
Contraindications:
• Corneal disease that precludes applanation of the cornea or transmission of laser light at
1030 nm wavelength
• Descemetocele with impending corneal rupture
• Presence of blood or other material in the anterior chamber
• Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the
capsulotomy
• Conditions that would cause inadequate clearance between the intended capsulotomy
depth and the endothelium (applicable to capsulotomy only)
• Previous corneal incisions that might provide a potential space into which the gas
produced by the procedure can escape
• Corneal thickness requirements that are beyond the range of the system
• Corneal opacity that would interfere with the laser beam
• Hypotony, glaucoma, or the presence of a corneal implant
• Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for
example, recurrent corneal erosion, severe basement membrane disease)
• This device is not intended for use in pediatric surgery
• A history of lens with zonular instability
• Any contraindication to cataract or keratoplasty surgery
Attention: Reference the Directions for Use labeling for a complete listing of
indications, warnings, and precautions.
Warnings: The LenSx Laser system should only be operated by a physician trained in its
use. The LenSx Laser delivery system employs one sterile disposable LenSx Laser
Patient Interface consisting of an applanation lens and suction ring. The Patient Interface is
intended for single use only. The disposables used in conjunction with Alcon instrument
products constitute a complete surgical system. Use of disposables other than those
manufactured by Alcon may affect system performance and create potential hazards. The
physician should base patient selection criteria on professional experience, published
literature, and educational courses. Adult patients should be scheduled to undergo cataract
extraction.
Precautions:
• Do not use cell phones or pagers of any kind in the same room as the LenSx Laser.
• Discard used Patient Interfaces as medical waste.
AEs/Complications:
• Capsulotomy, phacofragmentation, or cut or incision decentration
• Incomplete or interrupted capsulotomy, fragmentation, or corneal incision procedure
• Capsular tear
• Corneal abrasion or defect
• Pain
• Infection
• Bleeding
• Damage to intraocular structures
• Anterior chamber fluid leakage, anterior chamber collapse
• Elevated pressure to the eye
MIX12044SOV