What to Consider When Choosing a Femtosecond Laser

Transcription

What to Consider When Choosing a Femtosecond Laser
THINKING
AHEAD
What to Consider When Choosing
a Femtosecond Laser for ReLACS
By Kerry Assil, MD
THINKING
AHEAD
Why I Adopted Femtosecond
Laser Technology for
Refractive Cataract Surgery
The LENSAR Laser System reigns supreme
When choosing whether or not to use femtosecond laser technology
in refractive cataract surgery, an improvement in accuracy is often
the topic of discussion. However, as one of the first eye surgeons in
the world to evaluate lasers for cataract surgery, I counter that the
true benefit of femtosecond lasers, and the reason why I adopted
the technology, is improved patient safety.
Superluminescent diode (SLD) illumination and
variable-rate scanning produce high-resolution,
high-contrast images of the anterior segment
through all cataract densities.
My early beginnings in ReLACS
Kerry Assil, MD, is a board certified ophthalmologist
specializing in refractive procedures. He completed
his residency training at University of California, San
Diego and his fellowship in St. Louis, Missouri at the
Imaging Is the “Holy Grail”
of Patient Safety
“Until LENSAR, femtosecond
LENSAR clearly defines the relevant anterior anatomy for
all grades
lasers weren’t ready to supplant
surgeon worldwide. During his more than 20 years in
Despite my early involvement and evaluation of lasers for use
in cataract surgery, I was hesitant to adopt a laser for my cataract
practice. Manual cataract surgery was successful and patient
outcomes were desirable. I didn’t see the need to change my
approach unless a technology came along that would make
the procedure safer for my patients.
practice, he has authored more than 100 textbooks,
Why the LENSAR Laser System
changed that with its ability
Currently available femtosecond lasers for use in cataract
surgery offer a wide range of imaging capabilities and rely
on different types of imaging technologies to produce an
image or rendering of the eye. When choosing a femtosecond
laser for your cataract practice, you must consider how these
capabilities impact patient safety and ultimately your
treatment approach and outcomes.
Bethesda Eye Institute. He is the founder of Assil Eye
Institute in Beverly Hills, CA.
Dr. Assil has trained more than 14,000 physicians in
refractive and cataract surgery, more than any other
textbook chapters, and articles on refractive and
cataract surgery.
He has also served as editor and reviewer of
multiple scientific journals and is on the medical
and scientific advisory boards of numerous
ophthalmic companies. Additionally, Dr. Assil has
served as the Distinguished Professor lecturer at a
host of prestigious universities including Harvard,
Johns Hopkins, Duke, Baylor, Tokyo, and UCLA.
Kerry Assil, MD, is a paid consultant for LENSAR, Inc.
1
My experience with lasers for use in cataract surgery dates
back to the late 1980s and early 1990s during my residency at
University of California, San Diego (UCSD) and fellowship at
Bethesda Eye Institute in St. Louis, Missouri. At UCSD, I was
first introduced to the ISL laser. Then at Bethesda, I was fortunate
to work in a program where we treated 10 patients with one of
the earliest lasers for lens fragmentation and cataract softening
prior to cataract surgery. I was also involved in testing for some
of the major laser developers.
Finally, a couple of years ago, I was introduced to the LENSAR
Laser System during a research trip to Peru. The LENSAR Laser
blew away my expectations for what a femtosecond laser could
mean for refractive cataract surgery. What stood out about the
LENSAR Laser and what was the deciding factor for me was its
attention to patient safety.
Based upon its unique capabilities, including imaging, efficient
laser delivery, lack of corneal distortion, and its ability to
properly define the anatomy of the nucleus irrespective of
density and scarring in the cornea, I knew with this laser I
could safely remove even the most dense, brunescent and white
cataracts. Until LENSAR, femtosecond lasers weren’t ready to
supplant the manual approach to cataract surgery. The LENSAR
Laser changed that with its ability to deliver on the promise of
increased safety.
the manual approach to cataract
surgery. The LENSAR Laser
to deliver on the promise of
increased safety.”
– Dr. Assil
Superior imaging
When LENSAR realized that existing lasers were unable
to image from the cornea to the lens with high enough
resolution using OCT technology, they responded by creating
their proprietary imaging system. This system relies on a
collection of imaging technologies including confocal
structured illumination, Scheimpflug, and variable scanning
to produce a high resolution image of the relevant ocular
structures from the anterior cornea to posterior lens capsule
in a single capture. This image sharply defines the anatomy
of the nucleus irrespective of density and any corneal scarring
that may exist.
(continued on page 3)
2
Lens tilt detection
and compensation
reduce the chance
of tags and/or
capsular breakage
by showing the
treatment pattern
(represented by
the dark area within
the lens) within
the 3-D model
of the eye.
THINKING
AHEAD
True 3-D modeling
“The 3-D image that is
produced reveals lens tilt
and allows you to visualize
your treatment pattern within
the model and adjust your
treatment as necessary. “
– Dr. Assil
The LENSAR Laser System is also the only femtosecond laser
to create a true 3-D reconstruction of the anatomy of the lens
and the anatomy of the entire anterior segment. To do this,
LENSAR’s rotating camera obtains anterior segment imaging
and biometry at up to 8 different axial positions about the center
of the eye, capturing 2 viewing angles at each position. Then
LENSAR’s proprietary Augmented Reality technology utilizes
optical ray-tracing to create the 3-D model. The 3-D image that
is produced reveals lens tilt and allows you to visualize your
treatment pattern within the model and adjust your treatment
as necessary. This unique feature of the LENSAR Laser is
another way that this laser caters to patient safety.
Precise imaging of the posterior capsule
LENSAR’s collection of imaging technologies makes it possible
to precisely image the exact location and contour of the posterior
capsule, which is the ”Holy Grail” for performing safe laserassisted cataract surgery and the ultimate safety net. When this
visibility is combined with the non-applanating liquid patient
interface, and thus the absence of corneal distortion and deformities
in Descemet’s membrane, every laser pulse can land exactly where
intended. Using the LENSAR Laser, I can get within 250 µm of the
pupillary margin and within 250 µm of the posterior capsule, while
avoiding radial capsular tears and vitrectomies. I have been using
the LENSAR Laser clinically for over a year and have not once
performed a vitrectomy, reinforcing the safety aspect of this laser.
LENSAR is the smarter choice for ReLACS
A wide variety of
fragmentation patterns
are available for efficient
nuclear disassembly
3
By addressing patient safety, led by superior imaging, the
LENSAR Laser System inspires the ultimate in surgical
confidence and a more predictable, accurate, and efficient
cataract surgery across all grades. Because of LENSAR’s
imaging, laser pulses can be delivered where intended,
thus allowing for precise corneal incisions, free-floating
capsulorhexsis, and efficient nuclear fragmentation. And I
would argue that this, when combined with the technology
itself, ultimately leads to better patient outcomes.
THINK
EFFICIENCY
“Thanks to LENSAR, I am able to perform cataract
surgery 3 minutes faster than I was prior to
implementing the laser. And with my wonderful
staff, my turnover times are also faster, so I am
experiencing greater efficiencies than ever before.”
– William Soscia, MD
At LENSAR™, we’re always thinking ahead. That’s why we designed
the LENSAR Laser System with your efficiency in mind. Automated
procedure planning based on customizable surgeon preferences,
pre-programmable laser-to-patient positioning, and an easy-to-use
joystick for docking control reduce suction time and improve
efficiency. Combined with thoughtful ergonomics, you can
seamlessly integrate the LENSAR Laser System into your existing
surgical regimen without increasing overall procedure time.
The LENSAR Laser System. Designed for efficiency,
designed for you. Learn more at LENSAR.com
THINK
ENERGY REDUCTION
“With the LENSAR Laser, I’ve experienced a significant
reduction in phaco energy, and in some cases I’ve
needed no ultrasound energy at all. More importantly,
I’ve seen a reduction in infusion volume and surgical
time, resulting in much quieter postoperative eyes.”
– Jonathan Solomon, MD
Surgical Efficiencies
Impact the Bottom Line
At LENSAR™, we’re always thinking ahead. That’s why we
designed the LENSAR Laser System with phaco energy reduction
in mind. By combining superior imaging of the anterior segment,
precise laser placement, and efficient lenticular fragmentation,
the LENSAR Laser allows for a reduction in phaco time and up
to 100% reduction in phaco energy.1 This ultimately provides
patients with a higher level of safety and you with greater
peace of mind.
The LENSAR Laser System. Designed for energy reduction,
designed for you. Learn more at LENSAR.com
“What’s nice about LENSAR is that
the patient doesn’t have to move from
LENSAR’s thoughtful design encourages maximum
efficiency without added time
room, they are then wheeled into the
Seamless integration is paramount when selecting a laser to
join your refractive cataract offering. You likely already have
a system in place and a patient flow that is working well and
that you don’t want to disrupt. When adding a femtosecond
laser, you must consider how well it will integrate into your
existing surgical flow and whether or not it will add to your
overall procedure time.
OR and are immediately ready for
Flexibility
their surgical procedure. “
The LENSAR Laser is extremely versatile. It was designed
with a small footprint (9'x6.5'), so the laser can easily fit in
an OR or separate treatment room. It is also mobile so can
be moved out of the way to free up floor space should it
be needed.
bed to bed, so once a patient has been
prepped, draped, and treated with the
laser in a standard-sized treatment
– Dr. Assil
For me, housing the laser in its own treatment room was the
best fit considering my existing patient flow. What’s nice
about LENSAR is that the patient doesn’t have to move from
bed to bed, so once a patient has been prepped, draped, and
treated with the laser in a standard-sized treatment room, they
are then wheeled into the OR and are immediately ready for
their surgical procedure. Another patient can then be prepped,
draped, and treated with the laser, while the other patient is
having their cataract removed. This process can be repeated
throughout surgery day, making the most efficient use of my
OR time.
Ergonomic engineering
Dr. Assil using the LENSAR Laser System
The LENSAR Laser, specifically engineered with refractive
cataract surgery in mind, fits within your preferred patient
approach rather than making you work around the laser.
The deployable laser head is easily moved in and out of the
surgical field to maximize space, and an intuitive graphic
interface and 3 treatment monitors allow for simple operation
and control of treatment parameters in any laser orientation.
The laser can also be pre-programmed based on your
preferred patient orientation and bed height, as well as
for your surgical preferences regarding incision site and
fragmentation pattern, to save valuable time.
(continued on page 7)
6
THINKING
AHEAD
LENSAR’s docking is both fast and simple thanks to automation
and an easy-to-use joystick. The docking head makes a macro
movement toward the patient based on your pre-programmed
3
setting, and joystick control simplifies the alignment of the laser
onto the eye. Ultimately, this fast and easy docking system
reduces the amount of time that my patients’ eyes are under
pressure. The fastest procedure time that I’ve recorded, including
docking, is 70 seconds. Because of the speed at which treatment
with the laser can be completed, without using a slit lamp, it is
difficult to tell which eye was operated on the previous day
because the impact on the eye is so minimal.
the amount of time that
my patients’ eyes are
under pressure.”
– Dr. Assil
STUDY
58 year-old patient,
post-RK with buttonhole
flap OS
SE (D)
Manifest Refraction
UCVA
2.25
+3.00 – 1.50 x 70
20/150
LENSAR is the efficient choice
IOL
Power
Docking/Laser Time
Astigmatism Mgmt
Because of LENSAR’s thoughtful ergonomics and time-saving
features, LENSAR is easy to integrate and won’t bog down your
surgical flow. At the end of the day, LENSAR enables you to
provide a safe and accurate laser-assisted cataract removal
without additional time. For me, this attention to surgical
efficiencies is added value for the LENSAR Laser making it
an even stronger choice for ReLACS.
Tecnis Multifocal (Abbott)
+25.0 D
2 minutes 23 seconds
ORA-guided LRI
“Ultimately, this fast and
easy docking system reduces
CASE
Simple docking
(WaveTec Vision)
Target MRSE
Post-op MRSE
Deviation from Target
Post-op UCVA
-0.15
-0.13
0.02 D
20/20
As a surgeon performing intraoperative aberrometry, it is critical that I can place my corneal incisions
Peripheral Corneal Incisions
Are Imperative for
Intraoperative Aberrometry
peripherally, without hindering an aberrometer’s line of sight. This is a unique capability of the LENSAR
LENSAR’s incisions do not interfere with aberrometry
my LRIs. The resulting spherical equivalent was within 0.02 D of my intended target. This case in
If intraoperative aberrometry is part of your premium cataract
surgery offering, then you must consider corneal incision
capabilities when choosing a femtosecond laser. If these incisions
are too central to the pupil, then the ability to take intraoperative
measurements may be hindered.
particular demonstrates to me LENSAR’s value for 1) aberrometry, as LENSAR’s corneal incisions do
Laser and one that enables me to ensure the best possible refractive outcomes for my patients.
In one case of a 58 year-old patient with an RK with buttonhole flap in the left eye, I used the LENSAR
Laser System, in conjunction with WaveTec Vision’s ORA System intraoperative aberrometer, to create
not interfere with taking accurate intraoperative measurements, and 2) creating effective LRIs for the
management of astigmatism.
LENSAR allows for true peripheral incisions
The LENSAR Laser System is FDA-approved for full and partial
thickness, single-plane, and multi-plane cuts in the cornea for
the entry site, paracentesis, and arcuate incisions. LENSAR’s
more intelligent approach to imaging coupled with the lack of
corneal applanation allows for clear corneal incisions and limbal
relaxing incisions (LRIs) in the most logical way.
7
8
AHEAD
Indication and Important Safety Information
LENSAR effective in post-LASIK eyes and eyes with
corneal comorbidities
The LENSAR Laser System – fs 3D (LLS-fs 3D) is intended
for use in patients undergoing cataract surgery for removal
of the crystalline lens. Intended uses in cataract surgery
include anterior capsulotomy, laser phacofragmentation, and
the creation of full and partial thickness single-plane and multiplane arc cuts/incisions in the cornea, each of which may be
performed either individually or consecutively during the
same procedure.
It has been suggested that femtosecond cataract surgery is
not well suited for eyes with corneal distortion or mild corneal
opacity. However, I have demonstrated the LENSAR Laser
System’s ability to deliver an optimum treatment in several
of these complex cases without any intra- or postoperative
complications. (See case studies on page 10)
Laser Capsulotomy, laser phacofragmentation and/or corneal
incisions surgery is contraindicated in patients: who are of
pediatric age, whose pupils will not dilate or remain dilated to
a diameter greater than that of the intended treatment and for
capsulotomies and/or laser phacofragmentation with intended
diameters of less than 4 mm or greater than 7 mm, who have
existing corneal implants, who have previous corneal incisions
that might provide a potential space into which the gas
produced by the procedure can escape, who have conditions
that would cause inadequate clearance between the intended
capsulotomy cut and the corneal endothelium, such as:
hypotony, uncontrolled glaucoma, who have corneal disease
or pathology that precludes transmission of light at the laser
wavelength or causes distortion of laser light, such as: corneal
opacities, residual, recurrent, active ocular or uncontrolled
eyelid disease or any corneal abnormalities (including
endothelial dystrophy, guttata, recurrent corneal erosion, etc.)
in the eye to be treated, ophthalmoscopic signs of keratoconus
(or keratoconus suspect) in the eye to be treated, a history of
severe dry eye that has not responded to therapy, a history
of herpes zoster or herpes simplex keratitis.
Potential contraindications are not limited to those included in
the list.
WARNING: The safety and effectiveness of this laser have
NOT been established in patients with diabetic retinopathy,
a history of treated glaucoma, or prior intraocular surgery.
CASE
Using a Femtosecond
Cataract Laser in Eyes
with Pre-existing Corneal
Conditions
LENSAR femtosecond cataract laser holds its own in
complex cases
The LENSAR Laser System affords quick and easy docking
without applanation, superior imaging of the anterior segment,
and intricate treatment patterns that subsequently contribute
to a reduction in phaco energy. It is because of these features
that LENSAR is able to provide surgeons with an easy
system for accurate laser refractive performance despite
corneal comorbidities.
STUDY
In a series of 7 post-refractive eyes treated with the LENSAR Laser
prior to cataract removal, a mean MRSE within 0.14 D of intended
target was achieved.
Patient # Pre-op Post-op Pre-op Post-op
UCVA UCVA logMARlogMAR
1
30 20 0.180
2
30 20 0.180
3
J5 (40) J1+
0.30
0
4 CF202 0
5
20020 1
0
6
15020 0.880
7
12530 0.800.18
Post-refractive Surgical Eyes:
Deviation from Target MRSE at 2 Weeks
MRSE (D) Deviation
THINKING
Post-refractive eyes
p = .01
Pterygium + pseudoexfoliation in a 73 year-old patient
CASE
STUDY
When performing cataract surgery with a femtosecond laser, pseudoexfoliation syndrome
and pterygium pose the potential for difficulties with docking, imaging, and laser delivery.
Using the LENSAR Laser in a 73 year-old cataract patient with both of these conditions, I
was able to obtain a clear image of the anterior segment and perform a free-floating
capsulotomy. By then implanting a Tecnis Monofocal (Abbott) IOL with a power of 24.5 D,
the treated eye achieved post-op UCVA of 20/30, compared to pre-op UCVA 20/200.
© 2013 LENSAR, Inc. All rights reserved. LENSAR, the
LENSAR logo and Augmented Reality are trademarks of
LENSAR, Inc.
50-00054-000 10/30/13
Image of treated eye with pterygium
9
Resulted in free floating capsulotomy
High fidelity scheimpflug scans
despite ocular comorbidities
10
THINK
PATIENT SAFETY
“LENSAR’s collection of imaging technologies
makes it possible to precisely image the exact
location and contour of the posterior capsule, which
is the ‘Holy Grail’ for performing safe ReLACS.”
– Kerry Assil, MD
At LENSAR™, we’re always thinking ahead. That’s why we designed
the LENSAR Laser System with your patients’ safety in mind. LENSAR’s
rotating camera captures up to 16 images from the anterior cornea
to the posterior capsule and reconstructs a 3-D model of the eye.
Because you’ll see exactly where the relevant anatomy is in the eye
for all grades of white or brunescent cataracts, you can feel secure
in designing and executing an optimum treatment that will maximize
outcomes without putting your patients at risk.
The LENSAR Laser System. Designed for patient safety,
designed for you. Learn more at LENSAR.com