AUTOMATION AND STANDARDIZATION OF EXCIMER REFRACTIVE SURGERY

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AUTOMATION AND STANDARDIZATION OF EXCIMER
REFRACTIVE SURGERY

• Leon C. LaHaye M.D.
• Inventor with Financial Interest

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PURPOSE

• TO DEPICT A NOVEL INSTRUMENT AND SURGICAL METHOD
  TO STANDARDIZE AND AUTOMATE LASIK BY EMPHASIZING
  ON
• THE DYNAMIC NATURE OF STAGE II (FLAP REFLECTION
  TO FLAP CLOSURE) REQUIRES STANDARDIZATION AND
  STRICT ADHERENCE TO SURGICAL PRINCIPLES AND
  TECHNIQUES TO AVOID UNDESIRABLE CONSEQUENCES AND
  RETREATMENT SURGERIES.

INTRODUCTION
Although complications are rare they can and do
occur. The majority of complications and less
than desired outcomes we see today include
infectious keratitis, diffuse lamellar keratitis,
epithelial ingrowth, de-centered ablation,
corneal haze, under-correction and
over-correction. Most can be attributed to
contamination by surgical debris, inconsistent
hydration and dehydration, inconsistent laser
effectiveness due to masking or blocking of the
laser beam by moisture and surgical plume,
inaccurate laser treatment because of fast
saccades, and other factors. Because of these
issues the need for additional surgery and
subsequent treatments can range from 5 to 23.
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INTRODUCTION
Traditional LASIK relies on a variety of single
utility instruments that lack sophistication in
performing essential procedural Stage II
operations (Table 1). Mostly these instruments
have been borrowed from general ophthalmology and
are marginally effective, inefficient, lack
design specificity and extraneous use may be
responsible for added risk. LAHayeSIK utilizes
a single, multifunctional instrument designed and
developed to facilitate, automate, and
standardize Stage II and address all Stage II
suboptimal issues (Table 2). In this work, a
series of computer generated graphics and
clinical photographs are used to compare
LAHayeSIK with traditional techniques and
instrumentation.
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METHODS COMPARISON BETWEEN TRADITIONAL LASIK AND
LAHayeSIK

• Surgical Field Containment.

ILL 1(a) In conventional LASIK, the surgical
field is largely unprotected and often comes in
contact with lashes, conjunctiva, and surgical
secretions---all sources of contamination. ILL
1(b) The outer cone/ring design of the
LAHayeSIK handpiece isolates and establishes
fluid-tight containment of the ablation area
guarding it from contact with lids, conjunctiva,
backwash and other potential sources of
contamination thereby enhancing sterile
technique.
1(a)
1(b)
ILL 2(b) LAHayeSIK s positive eye control
improves laser accuracy by eliminating fast eye
movements, securing axis alignment, and
maintaining beam perpendicularity while avoiding
potential saccadic contact contamination.
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METHODS COMPARISON BETWEEN TRADITIONAL LASIK AND
LAHayeSIK
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METHODS COMPARISON BETWEEN TRADITIONAL LASIK AND
LAHayeSIK

• Plume Evacuation and Beam Masking Abatement.

• ILL 5(a) Example of a LASIK operation performed
  without plume evacuation. Notice the puffs of
  vertical upward traveling beam-masking plume. In
  conventional surgery, smoke abatement systems
  integrated into the various lasers are located
  several inches from the source, really too far
  away from the eye to be effective, and the
  resulting vertically traveling plume can mask the
  laser beam, leading to uneven and inaccurate
  ablation complications that necessitate
  retreatment.
• ILL 5(b) Snapshot of artificially generated
  plume demonstrating random vertical masking
  turbulent vortices carrying toward last optic and
  plume escape of an actual distal plume evacuator.
  
• ILL 5(c) LAHayeSIK's seven-port laminar flow
  evacuation system provides a more efficient and
  standardized method of removal by instantly
  removing beam masking plume just millimeters from
  the target surface. Turbulence and vertical
  travel is avoided while 10 to 15 times less
  volume of room airflow across the surgical field
  is generated as compared to distal evacuators.

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METHODS COMPARISON BETWEEN TRADITIONAL LASIK AND
LAHayeSIK

• Irrigation

ILL 6(a) Traditional LASIK irrigation utilizes
various cannula connected to a squeeze bottle or
syringe. Excessive fluid pools and mixes within
the cul-de-sac and can backwash across the highly
absorbent ablation area and become trapped in the
exposed tissues resulting in complications.. ILL
6(b) Specialized irrigation ports built right
into the handpiece deliver chilled, pulsed
irrigation providing thorough post-ablation
cleansing and rehydration without backwash
problems.

• Removal of Surgical Debris

ILL 7(a) Aspirating lid specula and sponges are
marginally effective-- neither protect against
pooling/backwash. (Note the lower port plugged
and the ineffective height of the open port)
ILL 7(b) LAHayeSIK provides full 360 degrees
of protected aspiration allowing for instant
removal of surgical fluids and debris from the
contained surgical area for cleaner interfaces.
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METHODS COMPARISON BETWEEN TRADITIONAL LASIK AND
LAHAYESIK

• Flap Adherence

ILL 9(a) Flap adherence is traditionally
promoted by numerous, repeated squeegee. The
use of sponges in an uncontained surgical field
may inadvertently smear contaminants across the
corneal tissues and the extraneous manipulations
may cause iatrogenic micro-abrasions or extend
epithelial defects furthering the incidence of
complications.
9(a)
ILL 9(b) Filtered laminar-flow oxygen aeration
via 4-ports designed into the handpiece
accelerates flap adherence. LAHayeSIK
post-ablation cleansing, rehydration, flap
repositioning, and flap adherence is routinely
completed in less than 15 seconds to streamline
and significantly shorten total procedure time.

9(b)
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METHODS AND RESULTS
TECHNOLOGY
PRE OP EYES

• ACS or AMADEUS II
• NIDEK EC5000 (without tracker, conventional
  ablation, standard NIDEK nomograms)
• LAHayeSIK Surgical System

• 567 eyes
• Sphere -14.5 D
• (mean -4.42 D 2.31 D)
• Cylinder 4.00D
• (mean 0.62 D 0.72 D)
• SE -15.00 D
• (mean -4.11 D 2.22 D)

Complication/Retreatment
Incidence
Traditional
Under / Overcorrection 4.9
-15.0 DLK
1.0 - 4.0
Epithelial Ingrowth 0.9 -
2.2 Flap Striae
1.2 Decentered Ablation
lt 1.0 Off-Axis Ablation
1.0 Infectious
Keratitis 0.1 - 0.3 Haze
/ Stromal Scaring
----- Retreatment Totals Min/Max 8.0 -
23.0 0.88
LAHayeSIK 0.71 0.00 0.00 0.17 0.00 0.00 0.0
0 0.00
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RESULTS
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CONCLUSIONS

• LAHayeSIK represents an innovation in laser
  vision surgery technique and technology
  providing automation and allowing for improved
  procedural standardization.
• The LAHayeSIK instrument synergistically
  integrates a multiplicity of essential functions
  into a single handpiece designed and developed to
  provide the surgeon with exquisite,
  single-instrument control over stage II
  suboptimal variables.
• Reduction of complications and retreatment
  surgeries can be achieved by elimination of
  extraneous instrumentation, positive control of
  eye position, improvement of sterile technique
  via. fluid-tight isolation and containment of
  exposed stroma, effective plume evacuation,
  effective target stroma hydration control,
  thorough post-ablation cleansing / rehydration
  using backwash-free irrigation and instant
  surgical fluid aspiration.

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EXECUTIVE SUMMARY
LASIK
TASK
LAHayeSIK

• Surgical Field Isolation Fluid Tight
  Containment
• Fixation
• Flap Protection
• Hydration Management
• Plume Evacuation
• Irrigation
• Aspiration

• None
• Maybe
• None
• Mechanical (sponge, instrument)
• None or distal
• Manual (squeeze bottle or syringe)
• None or uncontained aspiration speculum
• Instrumanipulation

Yes (Improved Sterile Technique) Yes Yes Filte
red, laminar aeration Yes (proximal) Yes
(automated, pulsed, backwash-free) Yes
(instant) Hinged pedestal O2 Aeration
(seconds)