Perché come chirurgo scegliere tecniche SMILE SMAL LENTICULE CORSO_23Feb24 Poliambulanza DrCANALI.pptx

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0155-2440, Rev A, ELITA™ Femtosecond Platform Clinical Procedure Overview - International Limited Market
Release Edition

21/03/2024
CHIRURGIA RIFRATTIVA ‘19-’23

21/03/2024
CHIRURGIA RIFRATTIVA ‘19-’22

PERCHE’ UNA SMILE
è SUPERIORE ??
COME MIGLIORARCI
21/03/2024

ELITA™ Femtosecond Platform
Clinical Procedure Overview – International Limited Market Release
Edition

Objectives for the
Presentation
1
2
3
Understand the ELITA™ Femtosecond Platform and benefits
Know how to conduct the 3-step ELITA™ Femtosecond Platform
Procedure
Be able to recognize common procedural flow
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Indications For Use
FLAP:
• The ELITA™ System is an ophthalmic femtosecond laser indicated in the creation of a corneal flap in patients undergoing LASIK surgery or other
surgery or treatment requiring initial lamellar resection of the cornea.
SILK™ (Smooth Incision Lenticular Keratomileusis) Treatments:
• The ELITA™ System is indicated for corneal refractive lenticule removal in the reduction or elimination of myopia with and without
astigmatism up to -12.00 D sphere, up to -6.00 D cylinder, with the sum of sphere and cylinder between -1.00 D and -12.00 D using
minus cylinder convention.
• The ELITA™ System is indicated for patients who are 18 years of age or older, with documentation of stable manifest refraction over
the past year as demonstrated by a change of ≤ 0.50 D manifest refraction spherical equivalent (MRSE).
ELITA™ System:
• The ELITA™ System is used in conjunction with a sterile disposable Patient Interface, consisting of a pre-sterilized suction ring assembly and pre-
sterilized applanation cone, intended for single-use.
» The ELITA™ Patient Interface is designed for exclusive use with the ELITA™ System and indicated for corneal resection surgery. The Patient Interface is intended
for use on one eye and must not be reused.
WARNING! The ELITA™ System is not indicated for uses other than the indications listed above.
Lenticule transplants and/or other uses with the ELITA™ System have not been clinically studied.
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Contraindications
FLAP:
• Lamellar resection for the creation of a corneal flap using the ELITA™ System is contraindicated if any of the following conditions exist.
Contraindications include the following, but are not limited to:
SILK™ Treatments:
• Lamellar resection for the creation of a corneal lenticule using the ELITA™ System is contraindicated if any of the following
conditions exist. Contraindications include the following, but are not limited to:
• Corneal edema • Existing corneal implant
• Corneal lesions • Corneal Dystrophy
• Hypotony • Unstable Refractive error within the past year prior to treatment
• Glaucoma • Prior refractive surgery
• Keratoconus
• Corneal edema • Existing corneal implant
• Corneal lesions • Corneal Dystrophy
• Hypotony • Unstable Refractive error within the past year prior to treatment
• Glaucoma • Prior refractive surgery
• Keratoconus
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Introduction to ELITA™ Femtosecond Platform
1. System Components
2. Treatment Delivery
3. Flap Procedure
4. SILK™ Procedure
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System Components
Touchscreen
Monitor
Beam Delivery
Device Vacuum
Port
Video
Microscope
Internal
Illumination
Floating
Optics Head
Patient
Interface
Mount
Gantry
Gantry
Joystick
External
Illumination
Knob
Console
System Key
Switch
USB Port
Emergency
STOP Button
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ELITA™
Femtosecond
Platform
Equipped with:
• Simple and intuitive graphical user
interface for treatment selection,
procedure planning and
procedure workflow enabling a
short learning curve.
• Unique cutting technology
combines the shortest pulse
duration, smallest spot size,
and tightest spot placement which
enables a continuous, tissue
bridge-free laser resection for a
smooth corneal surface.
• SILK™ is a generational leap in
refractive surgery with a
consistent, easy lenticule removal,
leading to fast visual recovery and
excellent visual acuity.
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10 mm Overlay
(Treatment
Field)
Ultrafast
Scan Line
(8000
Hz)
The ELITA™ System accurately
cuts corneal tissue with a high
pulse repetition rate (10 MHz)
and ultra-fast scanner (8000 Hz)
to place pulses tightly next to
each other, generating a
continuous cutting surface.
• When the laser is emitted, the
energy delivered to the point of
focus is sufficient to photo-disrupt
tissue in a very small volume.
Treatment Delivery
A monochrome cutting camera with infrared LED
illumination is used to view a 2 mm diameter field of view of
the live eye image during laser surgery. The 2 mm live image
follows the laser cutting pattern.
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Treatment Delivery
• The process of cutting involves
repetitively setting a focus point
and translating the laser cutting line
generated by the resonant scanner.
10 mm Overlay
(Treatment
Field)
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Flap Procedure
Corneal Resection:
• The ELITA™ System creates a resection plane using tightly focused femtosecond laser pulses to create individual micro photodisruptions of
tissue with micron-scale precision. Individual photodisruption locations are controlled by repeatedly moving the laser focus in the cornea at
high speeds under software control. The surgical effect is produced by scanning tightly placed small spots each second.
• All flap incisions are created as a five-part resection with an optional pocket cut in the following order:
1. Pocket (Optional): a horizontal rectangular cut located 100 µm deeper than the user selected flap depth that can be used to manage the
occurrence of Opaque-Bubble-Layer (OBL) formation.
2. Hinge: a low energy resection is created inside the cornea using a raster pattern at the user-selected flap depth.
3. Bed: a horizontal bed resection is created inside the cornea using a raster pattern at the user-selected flap depth.
4. Ring: A horizontal ring resection plane is created inside the cornea using a raster pattern at the user-selected flap depth.
5. Side Cut: A partial cylindrical arc resection is created, which is a vertical resection around the perimeter of the horizontal resection that
extends from the horizontal ring resection plane to the corneal surface. The side cut is comprised of multiple layers/strips. The first
starting just below the user selected flap depth, and additional layers/strips are created at gradual decreasing depths up to the corneal
surface.
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Cut order:
1. Optional Pocket Resection
2. Low Energy Hinge Resection
3. Bed Resection
4. Ring Resection
5. Multilayer Side Cut
Flap Procedure
(Optional)
Pocket
Resection
Low Energy
Hinge Resection
Bed Resection
Ring Resection
10 mm Overlay
(Treatment
Field)
Multilayer
Side Cut
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Treatment Delivery – FLAP
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SILK™ Procedure
Corneal Resection:
• The ELITA™ System creates a resection plane using tightly focused femtosecond laser pulses to create individual micro photodisruptions of
tissue with micron-scale precision. Individual photodisruption locations are controlled by repeatedly moving the laser focus in the cornea at
high speeds under software control. The surgical effect is produced by scanning tightly placed small spots to produce a biconvex shaped
lenticule within the cornea which can be removed through an incision to alter the curvature of the cornea.
• All SILK incisions are created in the following order:
1. Posterior Lens Resection: creates a curved surface and defines half the refractive power of the lenticule. The resection is made by
moving a raster scan line in a radial pattern.
2. Ring Resection: defines the circumferential edge of the lenticule. It is formed by moving the raster scan line vertically starting from a
depth just below the posterior lens resection surface and ending at a depth just above the anterior lens resection surface.
3. Anterior Lens Resection: creates a curved surface that mirrors the curvature of the posterior lens resection and defines the remaining
half of the refractive power of the lenticule. The anterior lens surface contains an additional entry cut extension region beyond the
transition zone edge to help facilitate lenticule removal.
4. Entry Resection: a vertical cylindrical arc resection with a user defined length is made after the lenticule is completed. The entry cut is
comprised of multiple layers/strips, formed similarly to the ring cut. The first layer starts just below the depth of the entry cut extension
and additional layers are created at gradual decreasing depths up to the corneal surface.
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All SILK™ incisions consist of the
following:
• Posterior Lens Resection
• Ring Resection
• Anterior Lens Resection
• Entry Resection
Treatment Delivery – SILK™
10 mm Overlay
(Treatment
Field)
The anterior and posterior lens resections are made by
moving a raster scan line in a radial pattern.
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Treatment Delivery – SILK™
Cut order:
1. Posterior Lens Resection
2. Ring Resection
3. Anterior Lens Resection with Entry
Extension
4. Entry Resection
Half of the refractive power is defined by the posterior
lens resection, and half is defined by the anterior lens
resection.
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– Key Technologies at Every Step
PLAN
Flap and SILK™ treatments
using the intuitive template-
based planning software
TREAT
Using laser cutting technology
which photo-disrupts a very
small volume of tissue
enabling a continuous, tissue
bridge-free laser resection
ENGAGE
Using the 2-piece ELITA™
Patient Interface and system
controls to enable up to 10
mm treatment area
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ELITA™ Femtosecond Platform –
Procedure: Plan
• Operating system designed for template driven
treatment planning
• Surgeon creates the Treatment Planning Template
• Treatment planning for each patient can be performed
prior to the day of surgery
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Procedure: PLAN
PLAN A TREATMENT
» Select the surgeon from the
drop-down menu
» Enter the patient’s name, ID,
date of birth, eye to be
treated, and corneal thickness
» Select the Flap or SILK™
incision
Tip: Enter the scheduled date and time to filter
patients displayed on the Home Screen
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Procedure: PLAN
PLAN A TREATMENT –
Flap
» Select treatment plan from the
pre-planned templates
» Alternatively:
• Select the Hinge Position
• Enter the Diameter, Oversize
percentage, Hinge Angle,
Depth, Side Cut Angle, Side
Cut Energy and Bed Energy
• Select Pocket On or Off
Tip: Templates will have preprogrammed settings.
If desired, you have the ability to modify the plan.
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Procedure: PLAN
Flap
» Review the Plan Summary for
each eye
» Select the Surgical Timeout
button to proceed to the
Surgical Timeout screen and
verify treatment plan before
treating the patient
» Press the New Plan button to
start planning a new patient
for Flap or SILK™ treatment
Tip: Right Eye and Left Eye treatment planning
screens are color coded to assist in confirming eye
to be treated.
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Procedure: PLAN
SILK™
» Enter the patient’s Manifest
Sphere, Cylinder, and Axis
using minus cylinder
convention
» Enter Sphere and Cylinder
Adjustments*
» Enter the patient’s measured
Flat and Steep Keratometry
• Note: The correction will be
converted to optical infinity for
treatment correction based on
the lane length chosen in the
Details Screen.
Tip: Additional parameters such as optical zone,
vertex distance, lane length, pulse energy, entry
width & position can be set in the Details Screen.
* Johnson & Johnson Vision Training staff may be able to
provide additional information on the use of Sphere and
Cylinder Adjustment parameters to create a nomogram.
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Procedure: PLAN
SILK™
» Confirm the treatment for
each eye planned
» Confirm the Optical Zone,
Entry Width/Position, Anterior
Depth, Lenticule Thickness,
and Residual Bed Thickness
Tip: A Treatment Plan Error and a Modifications
Required message will display if the residual bed
thickness is below 250µm.
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Procedure: Engage
• Use the 2-piece ELITA™ Patient Interface and the
system controls during the docking procedure to
prepare the operative eye for the laser
Steps:
1. Set up the Patient Interface
 Patient Interface Cone
 Scan the Patient Interface Cone
 Suction Ring
2. Docking
3. Centration
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Procedure: ENGAGE
SINGLE USE
DISPOSABLE
Suction Ring Assembly
» Suction Ring
» Squeezable Grippers
» Suction Ring connector which
connects to the system Vacuum port
Patient Interface Cap/Cone Assembly
» Cap assist for the installation of the
Cone to the Patient Interface Mount
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Procedure: ENGAGE
ELITA™ Patient Interface
» Install the Patient Interface
» Press the Scan button on the
Docking screen
• The system checks and
determines any tilt or
variation in the cone glass
• The system will automatically
adjust to account for
variation in the glass
If the cone is not seated properly, the scan will be
unsuccessful. Remove and reinstall the cone.
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ENGAGE: Vacuum
» The Suction Ring is used to
fixate the eye
» Center the suction ring around
the patient’s pupil
» The suction ring can be placed
on the patient under the
system, under the Excimer
laser, or outside the system
» Press the Focus button to optimize the focus of the image
on the touchscreen and the Video Monitor
» Press the Vacuum button to apply vacuum
Procedure: ENGAGE
NOTE: The patient’s cornea can be marked to assist in
centering, and cyclotorsion adjustment in SILK™ treatments
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ENGAGE: Dock
» After the Suction Ring is
attached to the eye, it is
docked to the Cone
» The Floating Optics Head is
lowered to the patient
» Keep the Suction Ring parallel
to the floor
TIP: Applanate beyond the 10 mm
white circle overlay to allow for
maximum centering adjustment
Procedure: ENGAGE
» The Floating Head Vertical Position Indicator represents
force being applied to the docked eye
» The indicator must be in the green and the meniscus
must be beyond the treatment area to Lock
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ENGAGE: Flap
Centration
» Make centering adjustments
by dragging the treatment
overlay on the touchscreen or
Video Microscope
Procedure: ENGAGE
» Select centering arrows to make fine adjustments
» Select the micron value to cycle through 10, 25, and
50µm increments for the centering arrows
» After adjustments are complete, confirm no eye
movement is seen and select the Treat button
NOTE: Treatment parameters can be
changed by selecting the Edit button
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NOTE: Automatic centration is
disabled in this software release
ENGAGE: SILK™
Centration
» Make centering and
cyclotorsion adjustments by
dragging the lenticule on the
touchscreen or Video
Microscope
Procedure: ENGAGE
» Select centering or rotation arrows to make fine
adjustments
» After adjustments are complete, confirm no eye
movement is seen and select the Treat button on the
Touchscreen or Video Microscope
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Procedure: Treat
• ELITA™ Femtosecond Platform performs the Flap or
SILK™ incisions based on the approved treatment
plan
Steps:
1. Step on the footswitch
2. Monitor progress of the procedure and patient
status
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TREAT: Flap
» Monitor progress of the Flap
incision
» Monitor the vacuum level and
the Floating Head Vertical
Position indicator
Once leaving the Centration screen no full-field live view is available. Only a 2 mm
diameter circle with live image that follows the laser cutting pattern appears.
Procedure: TREAT
» Once the treatment is complete release the footswitch
and select the Undock button on the touchscreen or
Video Microscope to undock the patient
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TREAT: SILK™
» Monitor progress of the
treatment (posterior lens, ring,
anterior lens, and entry
resections)
» Monitor the vacuum level and
the Floating Head Vertical
Position indicator
Procedure: TREAT
» Once the treatment is complete release the footswitch
and select the Undock button on the touchscreen or
Video Microscope to undock the patient
Once leaving the Centration screen no full-field live view is available. Only a 2 mm
diameter circle with live image that follows the laser cutting pattern appears.
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Procedure: Review
• PLAN
• ENGAGE
• TREAT
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Integrating Femtosecond Flaps into your LASIK procedure
Flap
Consider the following:
• Use your flap lifting instrument, or
select a flat instrument of choice.
• Be mindful of the side cut angle
programmed for correct entry into
the resection plane.
• Avoid the visual axis
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Integrating into your Lenticule procedure
SILK™
Consider the following:
• Marking the 0 & 180-degree axis of the cornea at a slit lamp prior to starting the SILK™ procedure.
• Marking the visual axis or pupil center to assist in centration prior to applying the Suction Ring.
• After the laser treatment is complete focus the eye under a microscope and dissect the entry resection.
• Identify the anterior lens resection by dissecting a band 2 to 3 mm wide parallel to the entry resection.
• Enter the posterior lens resection plane to one side of the entry resection and dissect 1 to 2 mm beyond the anterior dissection. (Do not fully
dissect the posterior lens resection).
• Dissect the full anterior lens resection.
• Dissect the posterior lens resection making sure to enter in the same posterior plane dissected previously.
• After the dissection is complete (ensuring the lenticule is free), grasp the lenticule with forceps to extract.
• Inspect the lenticule and edges to ensure complete removal with no remnants in the stromal pocket.
• Smooth the corneal surface with a wet surgical sponge ensuring both sides of the entry are aligned.
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Integrating into your Lenticule procedure
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LASER SAFETY
• Operators and support personnel are
not at any optical radiation danger
during normal and routine operation of
the laser.
• As with any medical laser system there
are electrical hazards and fire hazards.
Never operate the system in the
presence of flammables or explosives.
Never open the laser console protective
covers.
• Only those who have been certified by
ELITA™ Femtosecond Platform certified
trainers by completing the required
training should operate the laser
system.
If the system becomes unresponsive at any time,
press the Emergency STOP button and turn the
key to the off position
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QUESTIONS
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21/03/2024
PERCHE’ UNA e’ TECNICAMENTE SUPERIORE ??

21/03/2024
PERCHE’ UNA e’ TECNICAMENTE SUPERIORE ??
« MI PERMETTE UNA CRESCITA PERSONALE
E DI SENTIRMI CHIRURGICAMENTE ADEGUATO
PER DARE UNA RISPOSTA TECNICAMETE
SUPERIORE AI MIEI PAZIENTI «

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Perché come chirurgo scegliere tecniche SMILE SMAL LENTICULE CORSO_23Feb24 Poliambulanza DrCANALI.pptx

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