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New technologies
enhancing patient outcomes
2012 ASCRS•ASOA Chicago Show Daily Supplement This Show Daily supplement is sponsored by Alcon.
Two new innovations Injector (Alcon). AutoSert is an auto- technique (so to speak). In the three-
mated IOL injector handpiece that handed technique, one hand is on
expand options in cataract enables me to control advancement the MONARCH injector, one hand is
surgery: AutoSert IOL of the IOL with the INFINITI system on the second instrument in the
foot pedal. This frees my other hand side port, and a surgical technician’s
Injector and to stabilize the eye with a second in- hand advances the MONARCH
ULTRACHOPPER tip strument, which can also be used to plunger and IOL. However, not
adjust the position of the IOL as it is everyone is willing to execute a
AutoSert IOL Injector entering the capsular bag. three-handed delivery. Perhaps a
When I use MONARCH delivery more controlled velocity is going to
OL insertion isn’t a simple
I
systems (Alcon), I don’t have this make a difference in the integrity of
“push” and it’s in. That’s a
same ability. I need both hands on the incision.
good thing, because investing a
the MONARCH insertion device to In my experience, the INTREPID
little time to understand IOL
hold the injector and advance the AutoSert IOL Injector allows for a
insertion—especially what is plunger. Therefore I don’t have a higher level of control in IOL deliv-
currently at the cusp of innovation convenient way to stabilize the eye. ery. In addition to the foot pedal
Donald Serafano, M.D. —should help deliver superior In that scenario, if the patient starts control of the IOL advance, the
outcomes for cataract patients. to move, I must press the cartridge INFINITI system software has three
The newest addition to my against the incision to keep the IOL parameter settings the surgeon can
surgical portfolio on the INFINITI from being delivered outside the eye. control to meet his/her unique
Vision System (Alcon, Fort Worth, Other surgeons have used a one- requirements. These parameters are:
“ In mytheexperience,
INTREPID
Texas) is the INTREPID AutoSert IOL handed injector or a three-handed initial velocity, pause time, and final
velocity. Based on my experience
with hundreds of procedures with
the AutoSert IOL Injector—from ini-
AutoSert IOL tial tests on cadaver eyes to clinical
procedures on human eyes—these
Injector allows for a parameter settings offer advantages
over using a manual injector.
higher level of With the AutoSert IOL Injector,
the software will advance the IOL,
control in using the initial velocity down the
IOL delivery ” cartridge to the ready-to-insert posi-
tion. Then when the surgeon presses
the foot pedal, the AutoSert IOL
Injector will advance the IOL to the
end of the cartridge, where the
software will pause the plunger
advancement for a period of time.
This pause time, set by the surgeon
on the INFINITI system console,
This supplement was produced by
allows the IOL time to form in the
EyeWorld and sponsored by Alcon.
tip of the cartridge and, in my expe-
The doctors featured in this supplement rience, allows me time to prepare for
received compensation from Alcon for insertion.
their contributions to this supplement. After the pause time elapses, and
with my foot still depressed on the
Matt Young, EyeWorld contributing editor foot pedal, the AutoSert IOL Injector
based in Singapore, assisted in writing this will begin to move the IOL out of
supplement. the cartridge at the final velocity.
The surgeon can set this final veloc-
Copyright 2012 ASCRS Ophthalmic ity to be fixed or linear. Linear veloc-
ity is like an accelerator you use
Corporation. All rights reserved. The views
when driving a car. As I push down
expressed here do not necessarily reflect
on the foot pedal, it increases the ve-
those of the editor, editorial board, or locity of insertion. If I want to slow
the publisher, and in no way imply down, I come off the foot pedal a bit.
endorsement by EyeWorld or ASCRS.
Dr. Serafano injects an IOL using the AutoSert IOL Injector handpiece on the INFINITI Vision System
Please refer to pages 10-12 for important safety information about the Alcon surgical products described in this supplement.
continued on page 2
2 EW Chicago 2012 Monday, April 23, 2012
Redefining control in
single-hand IOL injection
by Robert H. Osher, M.D.
Insertion moves from ficial in small incision implantation. the cartridge. That uncontrolled
Surgeons require one hand to turn movement can cause some signifi-
one-handed devices— the screw on a screw-type injector. cant repercussions. To avoid that,
and even nurse-assisted The other hand stabilizes the device. some surgeons prefer a C cartridge,
Yet there is no countertraction. In rather than a D cartridge, which has
methods—to foot pedals, some cases, nurses also have helped a greater internal surface area to
and for good reason turn the screw to inject the lens, but reduce potential energy.
three hands are required to achieve However, if we are trying to go
n today’s age of refractive countertraction. through smaller incisions, we want
“Injector
The AutoSert IOL
handpiece
injector cartridge into the eye seems
contrary to our goal of achieving the
a one-handed injector, myself in-
cluded. This permits countertraction
with an instrument held in the left
nal incision is slightly smaller than
the internal opening. That’s my way
of inserting the lens with a one-
smallest possible incision.
Surgeons have tried to use the hand through the side port while handed injector. Still, I knew that
gives a reproducible, incision tunnel as an extension of the right hand is used to inject. This there was room for improvement.
the cartridge. The problem is when is very effective. Then Alcon (Fort Worth, Texas)
consistent way of we do that, several things can hap- But there is the issue of poten- developed the footswitch-driven
End velocity settings may be set This is a natural step in the and less stress on the zonules. From
in linear or fixed modes. I prefer a evolution of IOL insertion. Now this point on, I divide the nucleus
linear end velocity, but by no means surgeons can have an automated and remove each fragment in my
is my preference absolutely stan- delivery and have their second hand normal manner.
dard. Each surgeon will find his/her where they want it. After removal of the nucleus
own preferential settings as he/she and cortex, I polish the capsule and
gains personal experience with the ULTRACHOPPER tip then use the AutoSert IOL Injector
instrument. to insert the IOL into the proper
The second addition to my surgical
The directions for use detail that position.
portfolio is the ULTRACHOPPER tip
the AutoSert IOL Injector has been On a dense cataract case, my
(Alcon). I use this new ultrasound tip
validated using the driving console order of the procedure is: CCC,
to prepare the nucleus for pre-chop
default setting (1.7 mm/sec, 3 hydrodissection, ULTRACHOPPER
and/or ultrasound division of the nu-
seconds, and 1.7 mm/sec for initial tip, ultrasound, I/A, AutoSert IOL
cleus. I ask for the ULTRACHOPPER
velocity, pause, and final velocity, Injector, and then OVD removal.
tip if the patient has a dense nucleus
respectively) at 18 degrees C. Using a Both the ULTRACHOPPER tip and
or pseudoexfoliation.
higher velocity and shorter pause, AutoSert IOL Injector have been key
After the capsulorhexis
especially with high diopter lenses, additions to my surgical armamen-
and hydrodissection, I use the
could induce damage to the IOL tarium, and they continue to help
ULTRACHOPPER tip with torsional
and/or the IOL cartridge, affecting make cataract surgery a state-of-the-
ultrasound with 60% power as the
successful IOL implantation. art procedure.
maximum. I score the nucleus into
While there are many insertion
four to six segments. Next I use my
devices available today based on in- Dr. Serafano is in private practice, Complete
normal ultrasound tip to sculpt into
cision size and surgeon preference, I Eye Care Associates, Los Alamitos, Calif.,
the scored areas. Some surgeons may
believe the AutoSert IOL Injector and is associate clinical professor of ophthal-
use a pre-chopper at this point to
reduces risk variables because of its mology, University of Southern California.
help separate the segments. My
controlled and programmable veloc-
ULTRACHOPPER tip approach
ity profile, and it frees my second Contact information
allows me to penetrate a dense
hand. Serafano: serafano@gte.net
nucleus with less ultrasound power
Please refer to pages 10-12 for important safety information about the Alcon surgical products described in this supplement.
New technologies enhancing patient outcomes EW Chicago 2012 3
With fewer post-op visits he EX-PRESS Glaucoma trabeculectomy while avoiding the
needed and faster return to
baseline visual acuity, the
EX-PRESS device provides
a viable surgical option for
certain patient groups
T Filtration Device, which is
non-valved and made of
medical grade 316L stain-
less steel, has been utilized
as an alternative to standard tra-
beculectomy for several years. Use of
the EX-PRESS device has increased
need for a surgical sclerectomy and
iridectomy.
My own clinical observations
have revealed that the EX-PRESS
device does have its advantages.
While IOP reduction has been
demonstrated to be similar between
steadily since its introduction be- EX-PRESS device procedures and
cause of perceived improvements in trabeculectomy, I have found a
the reproducibility of aqueous filtra- decrease in vascularity of blebs with
tion when compared with
continued on page 4
“ Use of the
EX-PRESS device has
increased steadily
since its introduction
because of perceived
improvements in the
reproducibility of
aqueous filtration
when compared with
The EX-PRESS device in the eye
Please refer to pages 10-12 for important safety information about the Alcon surgical products described in this supplement.
New technologies enhancing patient outcomes EW Chicago 2012 5
The WaveLight FS200 laser go. Early or hard OBL can block Biomechanics of the FS200 laser
subsequent pulses and lead to uncut are improved in other ways as well.
has a different path for gas or poorly cut tissue, making flap lifts There is a Beam Control Check,
bubbles, management that more difficult.” for example, which takes only 10
In late OBL, gases produced seconds. This measures the variance
has a positive effect on travel into intralamellar spaces and of the PI glass and change in hydra-
corneal biomechanics, and can make flap lifts difficult, they tion and temperature that could lead
reported. to changes in flap thickness.
smooth integration in an Ella G. Faktorovich, M.D., in Making sure there is a relatively
all-laser LASIK workspace Femtodynamics: A Guide to Laser thin flap of uniform thickness will
Setting and Procedure Techniques to ensure few biomechanical effects on
paque bubble layer
O
Optimize Outcomes with Femtosecond the cornea. The Beam Control
(OBL)—the collection Lasers, further explained that OBL, Check might make a difference in
of gas bubbles in the which can interfere with excimer the accuracy of flap creation, and
intralamellar space after laser tracking and iris registration, today that can be measured by
femtosecond application may take as long as 30-45 minutes doing OCT and other types of
to clear—quite a long time consider- measurements. Ronald Krueger, M.D.
—can interfere with pupil tracking,
iris registration, and other LASIK- ing the speed at which LASIK is In 2007, my colleagues and I
related procedures. The WaveLight performed nowadays. published research observing wave-
FS200 femtosecond laser (Alcon, With the FS200 laser bubble front aberrations created after flaps
Fort Worth, Texas) evacuates such management system a surgeon can that were made with femtosecond
potentially have a bubble-free flap if lasers versus microkeratomes.
bubbles in an ingenious way.
The mechanism by which the
bubbles are evacuated by the eye is
the canal is the right length.
In using the FS200 laser, a
Because of the uniformity of the
femtosecond laser flaps, there were
“ Withlaser
the FS200
bubble
different from the IntraLase (Abbott slightly longer canal allows for opti- fewer aberrations created with these
Medical Optics, Santa Ana, Calif.). mal release. Also, when centering in comparison to two of the most
The IntraLase recommends creation the suction ring on the eye, it’s good popular microkeratomes. management system
to leave more sclera showing superi- I look forward to publishing
of a pocket and incarcerating these
orly where the hinge is so there is new research on the FS200 laser a surgeon can
bubbles deep into the tissue. The
more room to release these bubbles. comparing it to other femtosecond
FS200 laser makes use of a canal that
It is advisable to make the lasers. Currently I am collecting data
potentially have a
comes out to the surface of the eye,
so bubbles can be evacuated out of
the eye.
In their book Management of
length of the canal come right up to
the edge of where the applanation is
(typically this is around where the
and plan to release results after one
more year.
In the meantime, I am pleased
bubble-free flap ”
Complications in Refractive Surgery, limbal vessels are located). by the convenience of the FS200
editors Jorge L. Alio, M.D., and OBL can still occur despite the laser.
Dimitri T. Azar, M.D., explained use of the canal, but when this It’s nice to have the excimer
that early or hard OBL occurs when happens, surgeons should evaluate if laser directly coupled with the fem-
femtosecond pulses “initially placed they are taking the canal length out tosecond laser with the same bed.
in the cornea have no space avail- to the edge of the limbus and appla- When I finish with the flaps, the bed
able, and water vapor and carbon nation meniscus. It’s a little bit of an automatically moves over to the
dioxide produced have nowhere to art and a science. When it is done excimer laser where I lift the flaps
properly, the and go. This saves a step, and in the
surgeon should see future, the two lasers will actually
bubbles moving “talk” to each other in terms of
through the canal. information to further integrate the
That’s the ideal two components.
situation. I especially look forward to
Surgeons also when topographic and wavefront
can easily program analysis can be linked up with laser
the channel length outcomes to get better nomograms
with the FS200 laser. and better outcomes. That is the
The only goal for the future.
issue is, how long
should they make it? Dr. Krueger is medical director, Department of
Although it’s hard to Refractive Surgery, Cole Eye Institute, and
say exactly, take it at professor of ophthalmology, Cleveland Clinic
least out to the sclera Lerner College of Medicine of Case Western
vessels and where Reserve University, Cleveland, Ohio.
the edge of the
Figure 1: The appearance of the FS200 flap with the canal and hinge meniscus ends. Contact information
rotated to an oblique axis, which can be set at any orientation Krueger: Krueger@ccf.org
Source: Ronald Krueger, M.D.
6 EW Chicago 2012 Monday, April 23, 2012
“ Upgrading to the
new WaveLight FS200
WaveLight FS200 femtosecond laser
(Alcon, Fort Worth, Texas) was as
simple as swimming laps. You just
need to dive into the water from the
starting block and apply steady ef-
femtosecond laser fort and good turns to perform well.
was as simple as I have performed about 300
cases since the installation of the
swimming laps ” FS200 laser in the summer of 2011,
and I can say it’s not only a nice
addition to the practice, but my
anxiety level has been substantially
reduced using it compared to other
flap-cutting devices. I don’t get
nervous about what it’s going to do.
It accomplishes fast, safe, and
precise flaps.
Suction is acquired gently and
gradually, and it is not high so
there’s no pain, intense pressure, or
momentary complete loss of vision.
Figure 2. Gas is exiting the superior canal vent through the conjunctiva during 9.0 mm flap creation
The laser only takes about 6 seconds
in a hyperope. The edge of the active applanation can be seen peripherally
to create the flap and then the
suction is gently released.
Many patients feel like they
have experienced almost nothing—
many feel like they expected more
to happen and they’re delighted to
find out that it’s over. That being
said, because this is surgery, flap
complications are always a possibil-
ity, and I make sure my patients un-
derstand that. I used to say that the
hard part is done and the easy part
(the excimer laser) is coming. Now I
just say we are done with this
(femtosecond) part and the next
part is coming. Many patients
remark something to the effect of,
“Oh, that’s interesting, I hardly
knew anything happened.” For
them, this is a non-event—no sense
Figure 3. Dr. Davison’s foot is pressing on the left footswitch to activate the laser. He had used the
right one to activate suction
Please refer to pages 10-12 for important safety information about the Alcon surgical products described in this supplement.
New technologies enhancing patient outcomes EW Chicago 2012 7
Figure 6. The identification of the edge of a perfectly centered flap is made easier with the excimer’s
integrated slit lamp
8 EW Chicago 2012 Monday, April 23, 2012
Speed, convenience, get up and walk across the hall and Wave Eye-Q lasers makes for extraor-
can’t see well, it could be problem- dinary outcomes.
customization—the list atic. Now all the patient has to do is Notably, we are also having
goes on for why integrated lay there during the transfer. good experiences performing pene-
The FS200 laser has many trating keratoplasty (PK), anterior
lasers work so well advantages. It’s fast, for one. A flap lamellar keratoplasty (ALK), and
is made in just 6 seconds. This is deep anterior lamellar keratoplasty
hen we first started
W
helpful not only for speed purposes, (DALK) using the FS200 laser. We are
doing LASIK years but also because it means there is very happy with these procedures.
ago, we used a broad less time for suction to become For example, a patient was treated
beam laser. Treat- dislocated. recently with a corneal scar from a
ments were long be- Second, the pressure is not high previous infection and an irregular
cause of the speed of the laser. The enough for patients to have a flat cornea as a result. We performed
broad beam laser had the potential complete temporary loss of vision. ALK. We turned the donor lamella
to create hot spots, or central is- The culmination of the speed and that was created with the FS200 laser
lands, in the center of the treatment. minimal pressure can potentially upside down and did a steepening
William Culbertson, M.D. These central islands, which are ele- enhance the overall procedure. treatment on the backside of it. We
vations in the central treatment The FS200 laser is capable of then transplanted that into the
zone of the cornea if the laser does making a large LASIK flap up to 10 recipient, hoping to steepen the
not remove enough tissue here, can mm long. This is nice for doing large cornea to a more normal configura-
interfere with vision. ablations, such as ones for hyperopic tion as opposed to what she had. So
treatments. It has the ability to both the Allegretto Wave Eye-Q and
“theThefemtosecond
combination of
and
Today this has all changed. We
have been using the WaveLight
Allegretto Wave Eye-Q laser (Alcon,
customize a flap in any way you
want. For example, it can make an
the FS200 lasers had roles to play in
facilitating this lamellar corneal
Fort Worth, Texas), which is a flying oval flap, move the hinge around, transplantation. It is interesting that
spot laser. We don’t get the central change the size of the hinge, etc. we did the transplantation under
excimer lasers works islands that we would with a broad You can modify flaps for other prob- the WaveLight optics, because they
beam laser. The speed is extremely lems going on in the cornea, such as are so good. The fact that the
extremely well fast, which means that patients have pterygium being present. You can surgeon can see so well is helpful in
less chance to move their eyes dur- optimize the thickness of the flap— this type of procedure. Without the
together. They were ing treatment and the corneas have depending upon the starting optics, surgeons should ask if they
thickness of the cornea versus the know what they are missing.
built to match each less chance to dry out—both of
which could affect outcomes. planned ablation. You can customize There’s no doubt in my mind
other, so they work The tracker today is wonderful, flap shape based on the excimer that from LASIK to keratoplasty, the
as are the optics of the laser. treatment that will be carried out. If integration of femtosecond and
in an integrated We also now have the option of an excimer treatment pattern is excimer systems help provide
doing a wavefront-guided or a more or less oblong or oval, for excellent outcomes.
surgical way ” Wavefront Optimized (Alcon)
treatment with the Allegretto Wave
Laser.
example, then a flap can be made to
that same shape. You’re not making
the flap any larger than it needs to
Dr. Culbertson is the Lou Higgins
Distinguished Chair in Ophthalmology, Bascom
We added the WaveLight FS200 be. These all are ways you can Palmer Eye Institute, University of Miami.
femtosecond laser (Alcon) about a customize the procedure for the pa-
year ago. The combination of the tient and for the surgical technique. Contact information
femtosecond and excimer lasers All in all, I think the integration Culbertson: 305-243-2020,
works extremely well together. They of the FS200 and the Allegretto wculbertson@med.miami.edu
were built to match each other, so
they work in an integrated surgical
way. The flow and operation is sim-
ple.
We begin the procedure under
the FS200 laser for flap creation.
Then the table swings from the
FS200 laser to the Allegretto Wave
Eye-Q excimer laser without the
patient having to get up. This makes
the refractive surgery quick, and it’s
a benefit not having to walk a pa-
tient from one machine to the next.
This is especially true for sedated pa-
tients. After all, when you have just
made a flap and the patient has to
Please refer to pages 10-12 for important safety information about the Alcon surgical products described in this supplement.
New technologies enhancing patient outcomes EW Chicago 2012 9
Femtosecond surgeon and cleus can therefore be fragmented in period depending upon the
order to create either four or six seg- surgeon’s discretion.
phacoemulsification ments, and these segments can be
surgeon team up to get the further divided utilizing cylindrical References
laser application of various diame- 1. Cionni, R. Presented at AAO 2011 Refractive
most out of laser cataract ters. After femtosecond treatment of Subspecialty Day, “Comparison of Effective
surgery the nucleus, the completion of nu- Lens Position and Refractive Outcome:
clear division can usually be accom- Femtosecond Laser vs. Manual Capsulotomy.”
fficient utilization of plished without significant sculpting
Transient Light Sensitivity Syndrome (TLSS): Transient Light Sensitivity Syndrome is Long-term risks of LASIK for myopia with and without astigmatism beyond 12 months have
characterized by symptoms of mild to severe light sensitivity, which manifests between 2 not been studied.
and 6 weeks post-operatively. Patients experience no decrease in uncorrected or best Clinical data hyperopia: The WaveLight ALLEGRETTO WAVE/ALLEGRETTO WAVE
spectacle-corrected visual acuity. The incidence of this sensitivity was observed in approxi- Eye-Q Excimer Laser System has been studied in clinical trials in the United States with
mately 1% of patients who undergo flap creation with a femtosecond laser.3 Patients re- 290 eyes treated, of which 100 of 290 eligible eyes were followed for 12 months.
spond to the use of hourly topical steroids such as Pred Forte (Allergan), and most report Accountability at 3 months was 95.2%, at 6 months was 93.9%, and at 12 months was
improvement within 1 week of treatment. 69.9%. The studies found that of the 212 eyes eligible for the UCVA analysis of effective-
Peripheral Light Spectrum (PLS): Peripheral Light Spectrum is a temporary phenomenon ness at the 6-month stability time point, 95.3% were corrected to 20/40 or better, and 67.5%
whereby patients report the perception of a spoke-like spectrum of light in the periphery of were corrected to 20/20 or better without spectacles or contact lenses.
their vision. PLS has no clinical examination findings and no effect on visual acuity; how- The study showed that the following subjective patient adverse events were reported as
ever the potential diffractive effects may be bothersome to some patients. Reported in only much worse by at least 1% of the subjects (in order of increasing frequency) at 6 months
a small amount of cases, the onset of symptoms occurs during the immediate post-opera- post final treatment: glare from bright lights (3.0%); night driving glare (4.2%); light sensitiv-
tive period and typically resolves within 3 months but may be slightly persistent in rare ity (4.9%); visual fluctuations (6.1%); and halos (6.4%). Long-term risks of LASIK for hyper-
cases. The visual impact of PLS is clinically inconsequential for the vast majority of opia with and without astigmatism beyond 12 months have not been studied.
patients. Clinical data mixed astigmatism: The WaveLight ALLEGRETTO WAVE/ALLEGRETTO
Attention: Reference the Directions for Use labeling for a complete listing of indications WAVE Eye-Q Excimer Laser System has been studied in clinical trials in the United States
and precautions. with 162 eyes treated, of which 111 were eligible to be followed at 6 months. Accountability
at 1 month was 99.4%, at 3 months was 96.0%, and at 6 months was 100.0%.
1. Accutane is a registered trademark of Hoffmann-La Roche Inc. The studies found that of the 142 eyes eligible for the UCVA analysis of effectiveness at the
2. Cordarone is a registered trademark of Sanofi. 3-month stability time point, 95.8% achieved acuity of 20/40 or better, and 67.6% achieved
3. FDA Database Research Results Feb. 5, 2009. acuity of 20/20 or better without spectacles or contact lenses.
The clinical trials showed that the following subjective patient adverse events were reported
The WaveLight ALLEGRETTO WAVE/ as moderate to severe at a level at least 1% higher than baseline of the subjects at 3
months post-treatment: sensitivity to light (43.3% at baseline versus 52.9% at 3 months);
visual fluctuations (32.1% at baseline versus 43.0% at 3 months); and halos (37.0% at
ALLEGRETTO WAVE Eye-Q Excimer Laser System
Caution: Federal (U.S.) law restricts this device to sale by or on the order of a
baseline versus 42.3% at 3 months). Long-term risks of LASIK for mixed astigmatism
physician.
beyond 6 months have not been studied.
Statements regarding the potential benefits of wavefront-guided and Wavefront Optimized
Clinical data wavefront-guided treatment of myopia: The WaveLight ALLEGRETTO
laser-assisted in-situ keratomileusis (LASIK) are based upon the results of clinical trials.
WAVE/ALLEGRETTO WAVE Eye-Q Excimer Laser System used in conjuction with the
These results are indicative of not only the WaveLight ALLEGRETTO WAVE/ALLEGRETTO
WaveLight ALLEGRETTO device was studied in a randomized clinical trial in the United
WAVE Eye-Q Excimer Laser System treatment but also the care of the clinical physicians,
States with 374 eyes treated, 188 with wavefront-guided LASIK (Study Cohort) and 186
the control of the surgical environment by those physicians, the clinical trials’ treatment pa-
with Wavefront Optimized LASIK (Control Cohort). 178 of the Study Cohort and 180 of the
rameters, and the clinical trials’ patient inclusion and exclusion criteria. Although many clini-
Control Cohort were eligible to be followed at 6 months. In the Study Cohort, accountability
cal trial patients after the wavefront-guided and Wavefront Optimized procedure saw 20/20
at 1 month was 96.8%, at 3 months was 96.8%, and at 6 months was 93.3%. In the Control
or better and/or had or reported having better vision during the day and at night, compared
Cohort, accountability at 1 month was 94.6%, at 3 months was 94.6%, and at 6 months was
to their vision with glasses or contact lenses before the procedure, individual results may
92.2%.
vary. You can find information about the clinical trials below and in the Procedure Manuals
The studies found that of the 180 eyes eligible for the UCVA analysis of effectiveness at the
for the WaveLight ALLEGRETTO WAVE/ALLEGRETTO WAVE Eye-Q Excimer Laser Sys-
6-month stability time point in the Study Cohort, 99.4% were corrected to 20/40 or better,
tem. As with any surgical procedure, there are risks associated with the wavefront-guided
and 93.4% were corrected to 20/20 or better without spectacles or contact lenses. In the
and Wavefront Optimized treatment. Before treating patients with these procedures, you
Control Cohort, of the 176 eyes eligible for the UCVA analysis of effectiveness at the 6-
should carefully review the Procedure Manuals, complete the Physician WaveLight System
month stability time point, 99.4% were corrected to 20/40 or better, and 92.8% were cor-
Certification Course, provide your patients with the Patient Information Booklet, and discuss
rected to 20/20 or better without spectacles or contact lenses.
the risks associated with this procedure and questions about the procedure with your
The clinical trials showed that the following subjective patient adverse events were reported
patients.
as moderate to severe at a level at least 1% higher than baseline of the subjects at 3
Indications: The WaveLight ALLEGRETTO WAVE/ALLEGRETTO WAVE Eye-Q Excimer
months post-treatment in the Study Cohort: light sensitivity (37.2% at baseline versus
Laser System is indicated to perform LASIK treatments in patients with documented evidence
47.8% at 3 months) and visual fluctuations (13.8% at baseline versus 20.0% at 3 months).
of a stable manifest refraction defined as less than or equal to 0.50 diopters (D) of pre-opera-
In the Control Cohort: halos (36.6% at baseline versus 45.4% at 3 months) and visual fluc-
tive spherical equivalent shift over one year prior to surgery, exclusive of changes due to un-
tuations (18.3% at baseline versus 21.9% at 3 months). Long-term risks of wavefront-
masking latent hyperopia in patients 18 years of age or older: for the reduction or elimination
guided LASIK for myopia with and without astigmatism beyond 6 months have not been
of myopic refractive errors up to –12.0 D of sphere with and without astigmatic refractive er-
studied.
rors up to –6.0 D; for the reduction or elimination of hyperopic refractive errors up to +6.0 D of
Contraindications: LASIK treatments using the WaveLight ALLEGRETTO WAVE/
sphere with and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a
ALLEGRETTO WAVE Eye-Q Excimer Laser System are contraindicated if any of the
maximum manifest refraction spherical equivalent (MRSE) of +6.0 D; in conjunction with the
following conditions exist. Potential contraindications are not limited to those included in this
WaveLight ALLEGRO Analyzer device for the reduction or elimination of up to –7.0 D of
list: pregnant or nursing women; patients with a diagnosed collagen vascular, autoimmune,
spherical equivalent myopia or myopia with astigmatism, with up to –7.0 D of spherical com-
or immunodeficiency disease; patients with diagnosed keratoconus or any clinical pictures
ponent and up to 3.0 D of astigmatic component at the spectacle plane; and in patients 21
suggestive of keratoconus; and patients who are taking one or both of the following
years of age or older for the reduction or elimination of naturally occurring mixed astigmatism
medications: isotretinoin (Accutane1) and amiodarone hydrochloride (Cordarone2).
of up to 6.0 D at the spectacle plane. LASIK is an elective procedure with the alternatives in-
Warnings: Any LASIK treatment with the WaveLight ALLEGRETTO WAVE/ALLEGRETTO
cluding but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), and
WAVE Eye-Q Excimer Laser System is not recommended in patients who have: systemic
other refractive surgeries. Only practitioners who are experienced in the medical manage-
diseases likely to affect wound healing, such as connective tissue disease, insulin depend-
ment and surgical treatment of the cornea, who have been trained in laser refractive surgery
ent diabetes, severe atopic disease or an immunocompromised status; a history of Herpes
including laser system calibration and operation, may use the device as approved. Prospec-
simplex or Herpes zoster keratitis; significant dry eye that is unresponsive to treatment;
tive patients, as soon as they express an interest in an indicated LASIK procedure and prior
severe allergies; and unreliable pre-operative wavefront examination that precludes
to undergoing surgery, must be given the WaveLight System Patient Information Booklet and
wavefront-guided treatment. The wavefront-guided LASIK procedure requires accurate
must be informed of the alternatives for refractive correction including eyeglasses, contact
and reliable data from the wavefront examination. Every step of every wavefront measure-
lenses, PRK, and other refractive surgeries.
ment that may be used as the basis for a wavefront-guided LASIK procedure must be
Clinical data myopia: The WaveLight ALLEGRETTO WAVE/ALLEGRETTO WAVE Eye-Q
validated by the user. Inaccurate or unreliable data from the wavefront examination will lead
Excimer Laser System was studied in clinical trials in the United States with 901 eyes
to an inaccurate treatment.
treated, of which 813 of 866 eligible eyes were followed for 12 months. Accountability at 3
Precautions: Safety and effectiveness of the WaveLight ALLEGRETTO WAVE/
months was 93.8%, at 6 months was 91.9%, and at 12 months was 93.9%.
ALLEGRETTO WAVE Eye-Q Excimer Laser System have not been established for patients
The studies found that of the 844 eyes eligible for the uncorrected visual acuity (UCVA)
with: progressive myopia, hyperopia, astigmatism and/or mixed astigmatism; ocular dis-
analysis of effectiveness at the 3-month stability time point, 98.0% were corrected to 20/40
ease; previous corneal or intraocular surgery, or trauma in the ablation zone; corneal abnor-
or better, and 84.4% were corrected to 20/20 or better without spectacles or contact lenses.
malities including, but not limited to, scars, irregular astigmatism, and corneal warpage;
The clinical trials showed that the following subjective patient adverse events were reported
residual corneal thickness after ablation of less than 250 microns increasing the risk for
as moderate to severe at a level at least 1% higher than baseline of the subjects at 3
corneal ectasia; pupil size below 7.0 mm after mydriatics where applied for wavefront-
months post-treatment: visual fluctuations (12.8% at baseline versus 28.6% at 3 months).
12 EW Chicago 2012 Monday April 23, 2012
guided ablation planning; history of glaucoma or ocular hypertension of >23 mm Hg; taking Adverse events and complications for wavefront-guided myopia: Certain adverse
the medication sumatriptan succinate (Imitrex3); under 18 years (21 years for mixed astig- events and complications occurred after the wavefront-guided LASIK surgery. No adverse
matism) of age; over the long term (more than 12 months after surgery); corneal, lens, event occurred during wavefront-guided treatments during this clinical study.
and/or vitreous opacities including, but not limited to, cataract; iris problems including, but The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treat-
not limited to, coloboma and previous iris surgery compromising proper eyetracking; taking ment; lost, misplaced, or misaligned flap or any flap/cap problems requiring surgical inter-
medications likely to affect wound healing including, but not limited to, antimetabolites; vention beyond 1 month; corneal edema at 1 month or later visible in the slit lamp exam;
treatments with an optical zone below 6.0 mm or above 6.5 mm in diameter; treatment tar- any complication leading to intraocular surgery; melting of the flap of >1 mm2; epithelium
gets different from emmetropia (plano) in which the wavefront-calculated defocus (spherical of >1 mm² in the interface with loss of two lines or more of BSCVA; uncontrolled IOP rise
term) has been adjusted; myopia greater than –12.0 D or astigmatism greater than 6 D; with increase of >5 mm Hg or any reading above 25 mm Hg; and decrease in BSCVA of
hyperopia greater than +6.0 D or astigmatism greater than 5.0 D; mixed astigmatism >10 letters not due to irregular astigmatism as shown by hard contact lens refraction.
greater than +6.0 D; and in cylinder amounts >4.0 to <6.0 D. The following complications occurred 3 months after wavefront-guided LASIK during this
Due to the lack of large numbers of patients in the general population, there are few clinical trial: corneal epithelial defect (0.6%); foreign body sensation (0.6%); and pain
subjects with cylinder amounts in this range to be studied. Not all complications, adverse (0.6%).
events, and levels of effectiveness may have been determined. The following complications did NOT occur 3 months following wavefront-guided LASIK in
Pupil sizes should be evaluated under mesopic illumination conditions. Effects of treatment this clinical trial: corneal edema; any epithelium in the interface; ghosting or double
on vision under poor illumination cannot be predicted prior to surgery. Some patients may images; and need for lifting and/or reseating of the flap/cap.
find it more difficult to see in such conditions as very dim light, rain, fog, snow, and glare Attention: The safety and effectiveness of LASIK surgery has ONLY been established
from bright lights. This has been shown to occur more frequently in the presence of residual with an optical zone of 6.0-6.5 mm and an ablation zone of 9.0 mm.
refractive error and perhaps in patients with pupil sizes larger than the optical zone size. Reference the Directions for Use labeling for a complete listing of indications, warnings,
The refraction is determined in the spectacle plane, but treated in the corneal plane. In and precautions.
order to determine the right treatment program to achieve the right correction, assessment
of the vertex distance during refraction testing is recommended. Pre-operative evaluation 1. Accutane is a registered trademark of Hoffmann-La Roche Inc.
for dry eyes should be performed. Patients should be advised of the potential for dry eyes 2. Cordarone is a registered trademark of Sanofi S.A.
post LASIK and post wavefront-guided LASIK surgery. This treatment can only be provided 3. Imitrex is a registered trademark of Glaxo Group Limited.
by a licensed healthcare professional.
Adverse events and complications for myopia: Certain adverse events and complica- LenSx Laser
tions occurred after the LASIK surgery.Two adverse events occurred during the post- Caution: Federal (U.S.) law restricts this device to sale by or on the order of a
operative period of the clinical study: 0.2% (2/876) had a lost, misplaced, or misaligned flap physician.
reported at the 1 month examination. The following adverse events did NOT occur: corneal Indication: The LenSx Laser is indicated for use in patients undergoing cataract surgery
infiltrate or ulcer requiring treatment, corneal edema at 1 month or later visible in the slit for removal of the crystalline lens. Intended uses in cataract surgery include anterior
lamp exam; any complication leading to intraocular surgery; melting of the flap of >1 mm2; capsulotomy, phacofragmentation, and the creation of single-plane and multi-plane arc
epithelium of >1 mm2 in the interface with loss of two lines or more of BSCVA; uncontrolled cuts/incisions in the cornea, each of which may be performed either individually or
IOP rise with increase of >5 mm Hg or any reading above 25 mm Hg; retinal detachment or consecutively during the same procedure.
retinal vascular accident; and decrease in BSCVA of >10 letters not due to irregular Restrictions:
astigmatism as shown by hard contact lens refraction. • Patients must be able to lie flat and motionless in a supine position.
The following complications occurred 3 months after LASIK during this clinical trial: 0.8% • Patient must be able to understand and give an informed consent.
(7/844) of eyes had a corneal epithelial defect; 0.1% (1/844) had any epithelium in the • Patients must be able to tolerate local or topical anesthesia.
• Patients with elevated IOP should use topical steroids only under close medical
interface; 0.1% (1/844) had foreign body sensation; 0.2% (2/844) had pain; and 0.7%
supervision.
(6/844) had ghosting or double images in the operative eye.
Contraindications:
The following complications did NOT occur 3 months following LASIK in this clinical trial: • Corneal disease that precludes applanation of the cornea or transmission of laser light
corneal edema and need for lifting and/or reseating the flap/cap. at 1030 nm wavelength
Adverse events and complications for hyperopia: Certain adverse events and complica- • Descemetocele with impending corneal rupture
tions occurred after the LASIK surgery. Only one adverse event occurred during the clinical • Presence of blood or other material in the anterior chamber
study: one eye (0.4%) had a retinal detachment or retinal vascular accident reported at the • Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the
3-month examination. capsulotomy
The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; • Conditions that would cause inadequate clearance between the intended capsulotomy
lost, misplaced, or misaligned flap, or any flap/cap problems requiring surgical intervention depth and the endothelium (applicable to capsulotomy only)
beyond 1 month; corneal edema at 1 month or later visible in the slit lamp exam; any com- • Previous corneal incisions that might provide a potential space into which the gas
plication leading to intraocular surgery; melting of the flap of >1 mm2; epithelium of >1 mm2 produced by the procedure can escape
in the interface with loss of two lines or more of BSCVA; uncontrolled IOP rise with increase • Corneal thickness requirements that are beyond the range of the system
of >5 mm Hg or any reading above 25 mm Hg and decrease in BSCVA of >10 letters not • Corneal opacity that would interfere with the laser beam
• Hypotony, glaucoma, or the presence of a corneal implant
due to irregular astigmatism as shown by hard contact lens refraction.
• Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality
The following complications occurred 6 months after LASIK during this clinical trial: 0.8% (for example, recurrent corneal erosion, severe basement membrane disease)
(2/262) of eyes had a corneal epithelial defect and 0.8% (2/262) had any epithelium in the • This device is not intended for use in pediatric surgery
interface. • A history of lens with zonular instability
The following complications did NOT occur 6 months following LASIK in this clinical trial: • Any contraindication to cataract or keratoplasty surgery
corneal edema; foreign body sensation; pain, ghosting or double images; and need for Attention: Reference the Directions for Use labeling for a complete listing of
lifting and/or reseating of the flap/cap. indications, warnings, and precautions.
Adverse events and complications for mixed astigmatism: Certain adverse events and Warnings: The LenSx Laser system should only be operated by a physician trained in its
complications occurred after the LASIK surgery. No protocol-defined adverse events use. The LenSx Laser delivery system employs one sterile disposable LenSx Laser
occurred during the clinical study. However, two events occurred that were reported to the Patient Interface consisting of an applanation lens and suction ring. The Patient Interface
FDA as Adverse Events. is intended for single use only. The disposables used in conjunction with Alcon instrument
The first event involved a patient who post-operatively was subject to blunt trauma to the products constitute a complete surgical system. Use of disposables other than those
treatment eye 6 days after surgery. The patient was found to have an intact globe with no manufactured by Alcon may affect system performance and create potential hazards. The
physician should base patient selection criteria on professional experience, published
rupture, inflammation, or any dislodgement of the flap. The second event involved the
literature, and educational courses. Adult patients should be scheduled to undergo
treatment of an incorrect axis of astigmatism, which required retreatment.
cataract extraction.
The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; Precautions:
corneal epithelial defect involving the keratectomy at 1 month or later; corneal edema at • Do not use cell phones or pagers of any kind in the same room as the LenSx Laser.
1 month or later visible in the slit lamp exam; epithelium of >1 mm2 in the interface with loss • Discard used Patient Interfaces as medical waste.
of two lines or more of BSCVA; lost, misplaced, or misaligned flap, or any flap/cap problems AEs/Complications:
requiring surgical intervention beyond 1 month; decrease in BSCVA of >10 letters not due • Capsulotomy, phacofragmentation, or cut or incision decentration
to irregular astigmatism as shown by hard contact lens refraction; any complication leading • Incomplete or interrupted capsulotomy, fragmentation, or corneal incision procedure
to intraocular surgery; melting of the flap of >1 mm2; uncontrolled IOP rise and retinal • Capsular tear
detachment or retinal vascular accident. • Corneal abrasion or defect
None of the following complications occurred at 3 months after LASIK during this clinical • Pain
trial: corneal edema; corneal epithelial defect; any epithelium in the interface; foreign body • Infection
sensation, pain, ghosting or double images; and need for lifting and/or reseating of the • Bleeding
• Damage to intraocular structures
flap/cap.
• Anterior chamber fluid leakage, anterior chamber collapse
Subjects were asked to complete a patient questionnaire pre-operatively and at 3 months, 6
• Elevated pressure to the eye
months, and 1 year post-operatively.
MIX12045SOV