Download TECNIS ® 1-Piece IOL Toric Getting Started Guide (PDF

Getting Started
GUIDE
LEAVE A LEGACY OF EXCELLENT
OUTCOMES FOR PATIENTS
WITH ASTIGMATISM.
TECNIS® TORIC 1-PIECE IOL
pg 1
GETTING STARTED WITH THE
TECNIS® TORIC IOL
TECNIS® TORIC IOL
AT A GLANCE
The IOL you leave behind is the quality of vision your patients take with them. Use this guide to support optimal toric
calculation and insertion, and leave a legacy of excellent outcomes for your patients with astigmatism.
Designed for outstanding optical quality, the TECNIS® Toric IOL
delivers the sharpest vision, best low-light performance and
long-term sustainability.
13.0 mm overall
diameter
IN THIS GUIDE
LENS SPECIFICATIONS pg 3
TECNIS® Toric IOL at a Glance
CALCULATION pg 4
Calculate Proper Cylinder Power
SURGERY pg 6
Pearls for Optimizing Toric IOL Outcomes
Anterior cylinder axis marks
denote IOL meridian with
lowest power
TECNIS® IOL
wavefront-designed
toric aspheric surface
Frosted, continuous 360°
posterior square edge
Anterior
Side
Haptics offset for
3 points of fixation
Posterior Side
PATIENT EDUCATION pg 8
Help Your Patients Understand the Benefits and Risks
RESOURCES AND SUPPORT pg 9
Committed to Your Legacy
6.0 mm optic
diameter
TECHNICAL SPECIFICATIONS pg 10
INDICATIONS AND IMPORTANT SAFETY INFORMATION pg 11
pg 2
TECNIS® TORIC 1-PIECE IOL
INDICATIONS: The TECNIS® Toric 1-Piece Posterior Chamber Lens is indicated for the visual correction of aphakia and pre-existing corneal astigmatism
of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire
improved uncorrected distance vision, reduction in residual refractive cylinder, and increased spectacle independence for distance vision. The device is
intended to be placed in the capsular bag. See Important Safety Information on page 11.
TECNIS® TORIC 1-PIECE IOL
pg 3
CALCULATION
Calculate the Proper Cylinder Power for the TECNIS® Toric IOL
TECNIS® TORIC IOL AT A GLANCE
QUESTIONS & ANSWERS
How is the cylinder calculated?
Why is the sphere not displayed in the results section?
The calculator uses the Holladay 1 formula for calculation of
the cylinder. If you prefer to enter another IOL constant, the
system will convert it.
As the sphere is calculated outside of the toric calculator,
please refer to the printout of your biometry device.
Why do I need to enter the axial length?
In contrast to other online calculators, the
TECNIS Toric Calculator uses axial length for high
accuracy of the calculation.1
How does the TECNIS Toric Calculator compare
to other online calculators?
Why are three lens models displayed instead of the
most suitable IOL model only?
The choice of three IOLs should help to select the lens power
that is most suitable for each individual patient. The calculator
will provide options for the amount of residual cylinder based
on your choice for an individualized patient outcome. This may
include a choice of flipping the axis in order to achieve a lower
amount of residual cylinder.
Most toric calculators use an approximation method rather
than the exact solution, using a constant for the ratio of the IOL
toricity to corneal astigmatism. This approximation can cause
errors. Please be aware that the more a patient’s ocular
parameters vary from normal, the more important it is to use
the exact, rather than the approximation, solution used by
other calculators. For instance, if the residual astigmatism does
not change when the calculation is run for 10 D and 22 D IOLs,
then the calculator is using the approximation method.1
How should I calculate SIA?
Choose your preferred
IOL constant and value
Enter the spherical equivalent
(as calculated with your
biometry device)
Reminder: How to print this
page for surgical planning
pg 4
TECNIS® TORIC 1-PIECE IOL
Make sure to select the
correct corneal index
for your keratometer if
you have entered your
K-readings in diopters
Select the IOL model
based on the residual
cylinder and axis
Preselect your preferred units:
Please refer to sia-calculator.com.
NOTE
If you enter the K-readings in mm, the
keratometer index is not used in the calculation;
however, the TECNIS Toric Calculator requires
that you select a value.
If you enter the K-readings in diopters, the
calculator requires and uses the appropriate
keratometer index for the calculation.
Format of date and decimal layout
Select to display results as
plus or minus cylinder
Select K-notation input unit as
diopters or millimeters
PRECAUTIONS: The use of methods other than the TECNIS Toric Calculator to select cylinder power and appropriate axis of implantation were not
assessed in the clinical study and may not yield similar results. Accurate keratometry and biometry in addition to the use of the TECNIS Toric Calculator
(www.TecnisToricCalc.com) are recommended to achieve optimal visual outcomes. The TECNIS Toric Calculator incorporates the surgeon’s estimated
SIA and incision location when providing IOL options.
1.Holladay JT. Improving toric IOL outcomes. Ocular Surgery News. May 25 and June 10, 2011.
TECNIS® TORIC 1-PIECE IOL
pg 5
SURGERY
Clinical Pearls for Optimizing
Toric IOL Outcomes
Provided by Daniel Chang, MD
1. CORNEAL MARKING
Mark the steep corneal axis clearly and accurately
• In order to identify specific iris structures, reference the
measured steep axis to a preoperative pupil image
• Under the guidance of a slit lamp or surgical microscope,
place precise intrastromal arcuate incisions with a laser or
mark the eye with ink
2. OPENING STEPS
Ensure proper wound construction
• Whether using a femtosecond laser or a blade, construct a
triplanar incision that will seal well at the end of a case
• Create a well-centered capsulotomy that can provide 360°
of capsular overlap, which may help limit asymmetric
capsular forces on the IOL postoperatively
3. IOL UNFOLDING AND POSITIONING
Take time for optimal unfolding
• Prime the IOL injection cartridge and inflate the capsular
bag using a cohesive viscoelastic
• Allow ample time for the IOL to unfold — depending on OR
temperature, this may take 30–40 seconds
• Rotate the IOL in the bag several times, even before
unfolding is complete, to ensure the haptics are fully
deployed into the capsular fornix and to help loosen any
remaining cortical material
pg 6
TECNIS® TORIC 1-PIECE IOL
– Rotating the lens while it is unfolding eliminates
the need to warm the IOL and/or OVD to
facilitate faster unfolding, allowing you to utilize
the time for proper positioning instead
– Occasionally, it may be necessary to assist the
haptics in unfolding
• Scrape the posterior aspect of the anterior capsular rim to
remove lens epithelial cells
– Though some surgeons suggest skipping this step
to promote stability through adhesion of the
capsule to the optic, this may result in capsular
fibrosis due to retained lens epithelial cells
•O
nce the IOL has completely unfolded, align the
marks on the IOL with the corneal marks placed on
the steep meridian
• To help with centration and address the problem of
parallax, have the patient fixate on a coaxial light source
4. OVD REMOVAL
Completely remove OVD under the IOL
•T
o help remove the viscoelastic from the poster chamber
and from behind the IOL, rotate the IOL and press slightly
posteriorly while irrigating and aspirating
•A
s an extra step, place the I/A hand piece behind the IOL to
ensure complete OVD removal
5. IOL AND WOUND CHECK
Ensure optimal positioning and pressure
•A
fter the IOL is rotated into position, lightly press it
onto the posterior capsule to help hold it into position
•P
erform initial wound hydration prior to final
IOL positioning
•O
nce the lens in in position, take care not to induce
any IOL movement during subsequent wound
hydrations by applying only mild-to-moderate
pressure when injecting
– To maintain physiologic pressure, meticulously
check the wounds for leakage
– When performing the check, dry the wound to
find any slow leaks and press on the globe to
simulate an eye rub
•W
hen in doubt, do not hesitate to close the wound
with a suture
6. FINAL CHECK OF LENS POSITIONING
Secure IOL position for outstanding outcomes
•T
o minimize intraocular turbulence or hyperinflation,
inject tangentially to the wound
• At the end of the case, check for any IOL movement by
having the patient look up, down, left and right
•B
ring the eye to physiologic pressure, taking care not
to hyperinflate
• After removing the speculum and drape, perform a final
check to ensure the IOL has not moved or shifted, ensuring
the patient leaves the operating room with the IOL in an
optimal position
– Postoperative hypotony likely plays a major role
in IOL rotation
– A hypotonous eye can compress easily with
blinking or eye rubbing, and a gross deformation
of the globe could cause a shift in IOL positions
• Place an eye shield and instruct the patient not to rub his or
her eye after surgery
AMO does not engage in the practice of medicine, and Dr. Chang’s clinical tips are not a substitute for appropriate medical education and training or for the
exercise of independent medical judgment. AMO cannot warrant the accuracy or completeness of information contained within this document. AMO does
not endorse or recommend any particular technique beyond what is contained in the product labeling, and other techniques may be appropriate in a
physician’s medical judgment.
TECNIS® TORIC 1-PIECE IOL
pg 7
PATIENT EDUCATION
RESOURCES AND SUPPORT
Help Your Patients Understand the Benefits
and Risks of a TECNIS® Toric 1-Piece IOL
• Tell your patients about the convenience of one
procedure to both eliminate their cataracts and
correct their astigmatism
• Explain to your patients that careful calculations have
been performed to choose the optimal lens power for
their eye, but:
Committed To Your Legacy
VISIT TECNISIOL.COM FOR
ADDITIONAL RESOURCES
SIMULATED VISION
Cataracts and
astigmatism
create cloudy and
blurred vision.
• Optimizing Toric IOL Outcomes video
with Daniel Chang, MD
• Toric calculator
•V
ision simulator
- They may still need glasses for reading and distance
vision after surgery
• Brochure
- In rare cases, the lens might change its position
after surgery and a second intervention might be
needed for realignment
• Directions for use
- In case of increasing blurred vision after surgery, they
need to contact you or at least let the referring doctor
know that they have received a toric lens
ATTENTION:
Reference the Directions for Use for a complete listing of
indications, warnings, precautions and safety information.
• Spec sheet
Even after the cataract is
removed, the astigmatism
will still cause blurred vision.
•P
romotional tools
For support, contact your Abbott
representative or call 1-800-366-6554.
• Explain the potential risks of cataract surgery and lens
replacement, including worsening of vision, bleeding
or infection
• Let your patients know they should contact you if they
experience itching, redness, pain, “floaters,” flashing
lights, severe headache, light sensitivity or watery eyes
after the surgery
• Tell your patients the side effects specific to the
TECNIS® Toric Lens, including the potential need for
secondary surgical intervention to replace the lens or
repair the eye, macular edema and retinal detachment
pg 8
TECNIS® TORIC 1-PIECE IOL
With the TECNIS® Toric
IOL, you may have less
dependence on glasses
for distance vision.
TECNIS® TORIC 1-PIECE IOL
pg 9
TECHNICAL SPECIFICATIONS
INDICATIONS AND IMPORTANT SAFETY INFORMATION
FOR THE TECNIS® TORIC 1-PIECE IOL
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
TECNIS® Toric Aspheric IOL Specifications
Powers
+5.0 D to +34.0 D in 0.5 diopter increments
Cylinder Powers
1.50 D, 2.25 D, 3.00 D, 4.00 D, 4.50 D, 5.25 D, 6.00 D
Diameter
6.0 mm
Optic Overall Length
13.0 mm
Shape
Biconvex, anterior toric aspheric surface
Material
UV-blocking hydrophobic acrylic
Refractive Index
1.47
INDICATIONS: The TECNIS® Toric 1-Piece Posterior Chamber Lens is indicated for the visual correction of aphakia and pre-existing
corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by
phacoemulsification and who desire improved uncorrected distance vision, reduction in residual refractive cylinder, and increased spectacle
independence for distance vision. The device is intended to be placed in the capsular bag.
WARNINGS: Physicians considering lens implantation should weigh the potential risk/benefit ratio for any circumstances described in the
TECNIS® Toric 1-Piece IOL Directions for Use that could increase complications or impact patient outcomes. The clinical study did not
show evidence of effectiveness for the treatment of preoperative corneal astigmatism of less than one diopter. The TECNIS® Toric 1-Piece
IOL should not be placed in the ciliary sulcus. Rotation of the TECNIS® Toric 1-Piece IOL away from its intended axis can reduce its
astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder.
Edge Design
ProTEC continuous 360° posterior, frosted square edge
Haptic Design
Offset from optic with 3-point fixation
A-constants
119.3* (Optical Biometry)
118.8† (Ultrasound Biometry)
PRECAUTIONS: Accurate keratometry and biometry in addition to the use of the TECNIS Toric Calculator (www.TecnisToricCalc.com)
are recommended to achieve optimal visual outcomes. The safety and effectiveness of the toric intraocular lens have not been
substantiated in patients with certain preexisting ocular conditions and intraoperative complications. Refer to the TECNIS® Toric
1-Piece IOL Directions for Use for a complete description of the preexisting conditions and intraoperative complications. All preoperative
surgical parameters are important when choosing a toric lens for implantation. Variability in any of the preoperative measurements can
influence patient outcomes. All corneal incisions were placed temporally in the clinical study. Do not reuse, resterilize, or autoclave.
*Derived from clinical evaluation results of the TECNIS® 1-Piece Platform.
†
Value theoretically derived for a typical 20.0 D lens. Abbott Medical Optics
recommends that surgeons personalize their A-constant based on their
surgical techniques and equipment, experience with the lens model and
postoperative results.
ADVERSE EVENTS: The most frequently reported cumulative adverse event that occurred during the TECNIS® Toric 1-Piece IOL
clinical trial was surgical re-intervention which occurred at a rate of 3.4% (lens repositioning procedures and retinal repair procedures).
Cylinder Power Options
Lens Model
ZCT150 ZCT225 ZCT300 ZCT400 ZCT450 ZCT525 ZCT600
Cylinder Powers
IOL Plane
1.50 D
2.25 D
3.00 D
4.00 D
4.50 D
5.25 D
6.00 D
Corneal Plane*
1.03 D
1.54 D
2.06 D
2.74 D
3.08 D
3.60 D
4.11 D
Corneal Astigmatism
Correction Range†
(Preop Kcyl+SIA)
0.75 – 1.50 D
1.50 – 2.00 D
2.00 – 2.75 D
2.75 – 3.62 D
3.00 – 3.50 D
3.50 – 4.00 D
4.00 – 4.75 D
*Based on average pseudophakic human eye.
†
Based on a vector sum of preoperative corneal astigmatism (preop Kcyl) and
the predicted effect of surgically induced astigmatism (SIA).
pg 10
TECNIS® TORIC 1-PIECE IOL
TECNIS® TORIC 1-PIECE IOL
pg 11
TECNIS and ProTEC are trademarks owned by or licensed to Abbott Laboratories,
its subsidiaries, or affiliates. All other trademarks and tradenames are the intellectual
property of their respective owners.
©2015 Abbott Medical Optics Inc. | www.AbbottMedicalOptics.com | PP2015CT0789
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