Moria One Use-Plus SBK vs. 60 kHz IntraLase FS SBK

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Moria One Use-Plus SBK vs.60 kHz IntraLase FS
SBK

• Richard J. Duffey, MD

sadly, no financial interests
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Alternate Title

• Do I really need to throw away my microkeratome
  and buy a femtosecond laser to provide
  state-of-the-art SBK thin flap LASIK?

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ONE Use-Plus SBK Sub Bowmans Keratomileusis
The Moria option for SBK
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Reported advantages of SBK compared to
conventional LASIK

• Less weakening of corneal biomechanics, less risk
  of ectasia, better stability
• Faster visual recovery
• Better quality of vision
• Fewer higher order aberrations
• Better contrast sensitivity
• Fewer complications, less glare, fewer halos
• Less incidence of postoperative dry eye
• Reduced loss of corneal sensitivity
• Ability to treat more patients, and higher levels
  of myopia
• Can treat thinner corneas
• Reduced enhancement rate

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The rationale of SBK
Anterior third of the stroma is the strongest
region of cornea
By John Marshall, PhD, UK
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The rationale of SBK
Less disruption in the anterior third of the
stroma causes less weakening of the cornea
By John Marshall, PhD, UK
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The Moria option for SBK or Sub-Bowmans
Keratomileusis
ONE Use-Plus SBK
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Demographics

• Fifty myopic eyes of 25 consecutive patients
• Eleven females, 14 males
• MRSE mean -3.57 /- 2.17 D (-1.13 to -10.00)
• Refractive cylinder mean 0.53 /- 0.56 D (zero
  to 3.00)

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Measurement Parameters

• Preop

• Intraop

• BSCVA
• MR and CR
• Visx Wavescan HOA
• Orbscan II
• US Pach

• Flap thickness (US pachymetry subtraction method)
• Flap diameter
• Hinge length (in degrees)
• Suction time
• Pupil Tracking success
• Iris Registration success
• Flap status
• Stromal bed smoothness
• Epithelium status

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Measurement Parameters

• Postop Day 1

• Postop Month 1

• UCVA
• Flap status
• Epithelium status

• UCVA
• BSCVA
• Visx Wavescan HOA
• Visante OCT flap profile
• Flap status
• Epithelium status

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Materials and Methods

• One surgeon (RJD) using the Moria One Use-Plus
  SBK automated microkeratome to produce a 100
  micron flap
• VISX S4 Smooth Scan Active Trak excimer laser
  with 39 custom ablations and 11 conventional
  ablations
• Follow-up period of one month on all eyes

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Results

• Flap Thickness 103 /- 9 µ (83 to 123)
• Vertical Flap Diameter 9.3 /- 0.3 mm
• Hinge Length 63 /- 18
• Pupil Tracking success 100
• Iris Registration success 81
• No epithelial defects or slides
• Very smooth and dry beds
• No flap striae, microstriae, slipped flaps, free
  caps, buttonholes, DLK, epithelial ingrowth, etc.
  

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Why such epithelial kindness?

• Disposable smooth heads without imperfections and
  irregularities from autoclaving, handling, and
  reusing
• Consistent translation speed relative to old
  manual LSK-One microkeratome

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Accuracy and predictability equivalent to
Femto-SBK
1. Duffey RJ. One Use-Plus SBK Clinical studies.
Presented at Morias speaker forum during the
annual meeting of American Society of Cataract
and Refractive Surgery April 5, 2008 Chicago,
IL, USA. 2. Kerizian G. Will laser microkeratomes
replace conventional ones? Paper presented at the
ISRS/AAO meeting during the annual meeting of
ESCRS in September 2006, London, UK.
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Results

• UCVA _at_ Day 1

• UCVA _at_ Month 1

• 20/15 38
• 20/20 52
• 20/25 10

• 20/15 50
• 20/20 40
• 20/25 8
• 20/30 2
• MRSE -0.09 /- 0.29 D

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Visual recoverywith One Use-Plus SBK
UCVA at Day 1 postop
N50 eyes
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Why Increased UCVA on Day 1?

• Thin flaps (this has been my experience with
  thin flaps for over 5 years, although UCVA has
  been improved even further with the One Use-Plus
  SBK)
• ? Stretched edges with whales tail ?

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Faster visual recoverywith One Use-Plus SBK
UCVA at Day 1 postop
One Use-Plus SBK (Dr Duffey) N50 eyes Intralase
60kHz (Dr Durrie) N50 eyes
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Visual recovery withOne Use-Plus SBK
UCVA at Month 1 postop
N50 eyes
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Faster visual recoverywith One Use-Plus SBK
UCVA at Month 1 postop
One Use-Plus SBK (Dr Duffey) N50 eyes Intralase
60kHz (Dr Durrie) N48 eyes
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Change in HOA (rms) Results at 1 Month

• Total HOA 0.10µ increase
• Coma 0.04µ increase
• SA 0.08µ increase

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Change in HOA between preop and 1 month postop
with One Use-Plus SBK and FS 60kHz
Blue- One Use-Plus n50 Yellow- IntraLase
FS n11
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Change in High Order Aberrations between preop
and 1 month postop
?No clinically significant difference between
customized SBK treatment using IntraLase 60kHz
One Use-Plus SBK both better than PRK data.
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Visante OCT (2.01) Flap Profile Results at 1
Month

• Planar and near planar flap profiles that match
  photos from published IntraLase studies (Stahl,
  Durrie, et al.) and compare equally between One
  Use-Plus SBK and IntraLase FS 60 kHz SBK in this
  study.
• As with all OCT profiles (even with the latest
  2.01 software), it is impossible to consistently
  identify the interface and accurately place the
  cursor on it at the 1 month postop visit, thus
  decreasing the reliability of central,
  paracentral, and peripheral flap thickness
  measurementsboth in the OUP and FS laser cut
  flaps.
• Very subjective endpoints for flap thickness
  measurements with the present state of OCT
  technology

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AAO 2007 Predictability of flap thicknesswith
-1 disposable ring of One Use-Plus

• James Lewis, MD (OCT Visante)
• Zeiss OCT Visante
• 100 /- 9,6 (83-125)
• N 84 eyes

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High resolution corneal scans512 A-scans per
line0.25 sec per line. Four lines total at 45,
90, 135, and 180 degreesall in 1 sec.
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Color One Use-Plus SBK disposable -1 ringflap
with a planar profile at 1 mo.
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Color One Use-Plus SBK disposable -1 ringflap
with a planar profile digitized
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Grayscale One Use-Plus SBK disposable ringflap
with a planar profile and taper edge
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Color Femtosecond SBK at 1 monthflap with a
planar profile and edge scar
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Color Femtosecond SBK digitizedflap with planar
profile and edge scar
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Grayscale Femtosecond SBK flap with digitized
planar profile and edge scar
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Totally masked placement of cursors on OU-P flap
at 1 month postopnot reproducible!!
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Totally masked placement of cursors on FS flap at
1 month postopnot reproducible!!
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OCT of Flap Interfaces

• At present with the best technology available,
  this is a qualitative test only that helps assess
  the planar nature of flaps.
• It is not sensitive enough nor high resolution
  enough to be able to reproducibly assess flap
  thickness quantitatively in all meridia or even
  along one complete meridian.

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Top Moria OU-P -at 1 month- Bottom FS
60kH
This is the best we can doa qualitative
comparison of the planar nature of both the
One Use-Plus and femtosecond laser flaps.
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Why Planar Flaps?

• ? Meniscus shapes are nullified as the
  microkeratome flaps become thinner ?
• or meniscus shape flaps from longitudinal
  translational mechanical microkeratomes were a
  myth to begin with

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Moria manual LSK-One 180 micron flap after
H-LASIK with slow translationits planar!
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Moria One Use-Plus SBK vs.60 kHz IntraLase FS
SBK

• SEM Smoothness Study of the Stromal Beds

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Materials and Methods

• Four cadaveric eyes (2 paired sets) unsuitable
  for corneal transplantation
• Less than 5 days post mortem

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Methods

• Moria One Use-Plus SBK

• Femtosecond 60 kHz SBK

• One eye from each pair, thus 2 eyes total
• 100 micron flap, 9 mm diam., 60 hinge, 7 mm/sec
  automat. translation, 15,000 oscill/min.
• Flap lift and amputate
• Cornea removed and placed in gluteraldehyde
• SEM prep, scans at 20x, 40x, 80x, and 100x

• One eye from each pair, thus 2 eyes total
• 100 micron flap, 9 mm diam., 55 hinge angle,
  raster pattern energy of 1.0 µj, pulse separation
  8x8 µm, side energy cut 1.0 µj at 70, pocket
  enabled
• Flap lift and amputate
• Cornea removed and
• SEM prep, scans at 20x

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Method of Smoothness Scoring

• 10 masked (to technology) observers rated each
  stromal bed photograph for smoothness on a scale
  from zero to four (zero was polished glass
  smooth)
• Photos were evaluated sequentially by
  magnification all 20x photos first, followed by
  all 40x, followed by all 80x, followed by all
  160x photographs
• 3 representative photos (chosen by SEM
  technician) of each of the 4 different
  magnifications were evaluated for each of the 2
  technologies making a total of 12 Moria and 12
  femtosecond laser bed photographs that were
  scored
• A cumulative mean score was tabulated for each of
  the two technologies by combining the 20x, 40x,
  80x, and 160x data scores lumped together

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SEM 20x
OU-P
IntraLase FS
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SEM 40x
UO-P
IntraLase FS
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SEM 80x
UO-P
IntraLase FS
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Representative Scoring Scale at 160x 0
glass1234
1
2
3
4
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Edges
IntraLase FS 20x
OU-P 80x
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Scored Results (Mean)

• Moria One Use-Plus SBK

• 60 kHz IntraLase FS

• 2.24

• 3.78

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Scanning Electron Microscopy Moria One
Use-Plus vs. IntraLase FS 160x
OU-P
FS 60kH
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Why the difference?

• The raster pattern of the femtosecond laser
  produces a velcro like interface that has to be
  peeled open with increased force to break the
  remaining adhesions between the pixel pattern
  bursts of laser energy.

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Moria One Use-Plus SBK vs.60 kHz IntraLase FS
SBK

• Pain Study

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Patients and Methods

• Ten consecutive eyes with myopia underwent SBK
  (thin flap LASIK) with IntraLase FS (60kHz) flaps
  and
• Ten matched consecutive eyes with myopia
  underwent SBK (thin flap LASIK) with the Moria
  One Use-Plus SBK microkeratome
• All eyes operated by same surgeon (RJD) with the
  same excimer laser (VISX Star S4)

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Scoring Method and Intervals

• Scoring

• Time Intervals

• Pain was assessed for each eye by type (FB,
  burning, sharp, pressure), pattern (continuous,
  intermittent), duration (in hours), intensity (on
  a scale of 0 to 10), and use of pain medications

• A Making of flap in OR
• B First 1-5 hours after surgery
• C First night after surgery
• D First full postoperative day following
  surgery

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Pain Survey
During Flap in OR OD OS First 1-5 hours after surgery OD OS First Night of Surgery OD OS Next Day OD OS
Pain Yes/No
Type FB, burning, sharp, pressure, other
Pattern continuous, intermittent, other
Duration number of hours (one, two, three, etc.)
Amount on a number scale of 0 (none) to 10 (max)
Difficulty sleeping Yes/No
Pain Meds Yes/ No yes
Type Tylenol, Motrin, Aleve, prescription, other xanax
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Results

• Moria One Use-Plus SBK

• IntraLase FS SBK

• A 0.6
• B 0.8
• C 0
• D 0
• Cumulative Overall 1.4
• Mean Score 0.35

• A 1.4
• B 4.8
• C 0
• D 0
• Cumulative Overall 6.2
• Mean Score 1.55

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Greater patient comfortwith One Use-Plus SBK
than with Femto-SBK
 The pain occured at a much lower frequency and
intensity with One Use-Plus SBK in the first 1 to
5 hours after surgery than with Intralase
SBK  Richard J. Duffey, MD (Mobile, AL, USA)
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Why the difference in the 1 to 5 hours post
surgery interval?

• CO2 diffusion through corneal tissue from the OBL
  in the stromal bed, flap, and pocket?
• Possibly a similar mechanism of pain produced in
  a SCUBA diver from too rapid decompression and N2
  bubbles diffusing through tissues

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Miscellaneous Observations
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One Use-Plus SBK

• None of the intraoperative reported complications
  of Femto-SBK
• Laser eye tracking difficulties/Iris
  Registration difficulties
• Suction loss
• Strong adhsions, requiring manual cut-downs or
  recuts
• Interface gas bubble escape (opaque bubble layer
  or OBL) into flap, bed and  pocket 
• Vertical gas breakthrough subepithelial or
  anterior chamber gas bubble

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One Use-Plus SBK

• None of the postoperative reported complications
  of Femto-SBK
• Photophobia due to light hypersensitivity or TLS
  Syndrome
• Energy-related Diffuse Lamellar Keratitis (DLK)
• Occasional interface haze requiring retreatment
• Difficulty in lifting the flap atraumatically
  for retreatments
• Post-operative pain 1-5 hours after surgery
  associated with gas diffusion thru corneal tissue

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My Final Report Card
  Moria OUP/SBK 90 vs. 60 kHz Intralase
flap thickness  
flap profile  
flap diameter  
flap centering    
flap hinge/location    
flap edge  
no flap striae/microstriae  
bed smoothness  
epithelial preservation  
fit on small orbits  
suction time  
iris registration    
pupil tracking    
UCVA day 1  
UCVA month 1  
minimal pain post-op    
minimal ingrowth risk  
low DLK risk  
no TLSS    
no OBL or pocket    
loss suction immediate recut    
corneal biomechanics  
time considerations  
space considerations    
cost-capital investment    
no free cap risk    
no button hole or vertical gas breakthrough risk      
really exciting to drive
Final Score 22 19
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Video of surgery
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GMC Yukon XL or Jaguar XJ220?
Practical Reliable Durable and for me Better
especially with lots of college educations
to pay for.
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Thank You