The Pathophysiology of Regression Following LASIK

The Pathophysiology of Regression
Following LASIK
Dan Z Reinstein MD MA(Cantab) FRCSC DABO1,2,3,4
1. London Vision Clinic, London, UK

2. St. Thomas’ Hospital - Kings College, London, UK
3. Weill Medical College of Cornell University, New York,
4. Centre Hospitalier National d’Ophtalmologie, (Pr.Laroche), Paris
©DZ Reinstein 2004

dzr@londonvisionclinic.com
The author acknowledge
a financial interest in
the subject matter of
this presentation.
Many aspects of the Artemis™
technology are patented. Patents are
administered by the Cornell Research
Foundation. This intellectual property
has been licensed by Cornell to
Ultralink, LLC., a company in which
the authors have a financial interest.
Regression following LASIK
“Regression”
1. Not a diagnosis but an observation
2. Produced by unpredicted biomechanical
and/or epithelial changes
©DZ Reinstein 2004

ARVO 2000
The Accuracy of Routine LASIK;

Isolation of Biomechanical and Epithelial Factors
Dan Z Reinstein, MD, MA(Cantab), FRCSC

Sabong Srivannaboon, MD
Ronald H Silverman, PhD
D Jackson Coleman, MD
Weill Medical College of Cornell University, NY, NY

Lasik Vision Corporation, Vancouver Canada
Service V, Centre Hopitalier National d’Ophtalmologie des XV-XV. Paris, France
Mahidol University, Bangkok Thailand
©DZ Reinstein 2004

“Artemis 2” by Ultralink LLC
• 50 MHz Arc-Scan
• Meridional sweep (0.4sec):
– Whole anterior segment
– Whole Cornea
• Scan positional control
– IR video-image of eye
– Corneal light-reflex
– Internal fixation targets
FDA approved 2000 • Exam time: 3-min per eye
www.ArcScan.com
©DZ Reinstein 2004
VHF Digital Ultrasound
• Cornell University prototype

– 50 MHz probe enhanced by digital signal processing
– Pachymetric precision = 1.0 microns
– Meridional scans for 3D data set of individual corneal interfaces
– 3D pachymetric topography
©DZ Reinstein 2004

VHF Digital Ultrasound
©DZ Reinstein 2004

Artemis C12 Display Reinstein et al. Journal of Refractive Surgery
2000 Jul-Aug;16:414-30
Roberts C. The cornea is not a piece of plastic.
©DZ Reinstein 2004

Deformation of the Cornea - Distinction
• Mechanical deformation
– Stable (?) elastic “bulge”
• Ectasia
– Progressive plastic deformity
©DZ Reinstein 2004

• Ectasia
©DZ Reinstein 2004

• Ectasia
©DZ Reinstein 2004

Method
• 52 eyes
• Routine LASIK
Myopia: - 1.00 to -10.25 [ mean (SD) -4.44 (2.32) ]
• Hansatome/Moria LSK One
• Nidek EC5000/Technolas 217
• Pre- and post-operative ≥ 3 months
– Orbscan, (Orbtek/Bausch&Lomb Inc.)
– VHF 3D Digital Ultrasound scanning - Artemis™
©DZ Reinstein 2004

Calculated Total Corneal Power
• Pre-op
– Front
– Bowman’s
– Back Orbscan
Orbscan front +
VHF Ultrasound Thickness
©DZ Reinstein 2004

Calculated Total Corneal Power
• Pre-op
– Front
– Bowman’s
– Back
Calculated Corneal Power

©DZ Reinstein 2004
• Post-LASIK
Orbscan
Orbscan front +
Post-LASIK-epithelial hyperplasia VHF Ultrasound Thickness
Post-LASIK “bowing”
©DZ Reinstein 2004

• Post-LASIK

©DZ Reinstein 2004
• Post-LASIK - no “epithelial” effect
– Use pre-operative epithelium
Post-LASIK-epithelial hyperplasia
©DZ Reinstein 2004

Substitute with pre-epithelium
©DZ Reinstein 2004

Substitute with pre-epithelium

©DZ Reinstein 2004
• Post-LASIK - no “bowing”
– Subtract back surface radius change from all surfaces
Post-LASIK-epithelial hyperplasia
Subtract
“bowing”
©DZ Reinstein 2004

Subtract “bowing”
from all three surfaces
©DZ Reinstein 2004


©DZ Reinstein 2004
• Post-LASIK - no epithelial or “bowing” effects
©DZ Reinstein 2004

©DZ Reinstein 2004

©DZ Reinstein 2004

Substitute pre-op epithelial layer
©DZ Reinstein 2004

©DZ Reinstein 2004


©DZ Reinstein 2004
Methods: Outcome Measures
Outcome Measures
• Magnitude
– Epithelial
– Biomechanical effects
• Proportional effect
Correlation between
1. [manifest achieved effect] vs. [calculated achieved effect – epithelial
effect]
2. [manifest achieved effect] vs. [calculated achieved effect –
biomechanical effect]
3. [manifest achieved effect] vs. [calculated achieved effect – epithelial
effect
– biomechanical effect]
©DZ Reinstein 2004

Magnitude of Post-Operative Epithelial and Biomechanical Changes
Mean Corneal Power Change Pre- to Post-LASIK

The Effect of Removing Biomechanical and Epithelial Changes
7.00 more positive, more flattining (more surgical effect)
*p <0.0005
*
p<0.0005
6.00
5.00
* *
4.00
3.00
2.00
1.00
0.00
Refractive Power Calculated Corneal No Epithelial nor
No Bowing No Epithelial Effect
Change Power Change (CPC) Bowing Effect
Mean Power Change 4.56 4.86 5.60 5.16 5.89

% Change in Corneal Power -6% 0% 15% 5% 20%
©DZ Reinstein 2004

Results - Accuracy of Treatment
• Attempted vs. Achieved (by refraction)
Attempted vs. Achieved (by Refraction)

-11
-10 y = 0.9225x - 0.298
-9 R2 = 0.9472
-8
-7
-6
-5
-4
-3
-2
-1
0
Attempted SphEq/D
©DZ Reinstein 2004

Validation
 Change in Power of the cornea (CPC) Calculation
 Correlation of corneal power change by calculation, with refractive change
observed
Validation of Calculated Power Change in Cornea
14.00
y = -0.9019x + 0.7472
2
12.00 R = 0.671
10.00
8.00
6.00
4.00
2.00
0.00
0.00 -2.00 -4.00 -6.00 -8.00 -10.00 -12.00
Achieved by Refraction
©DZ Reinstein 2004

Removing Epithelial Effect
 Correlation of corneal power change by calculation, with refractive
change observed
  epithelium
  “bowing”
  epithelium  ”bowing”
Removing Epithelial Change from Treatments
14.00
y = -0.9352x + 0.8981
2
12.00 R = 0.6608
10.00
8.00
6.00
4.00
2.00
0.00
0.00 -2.00 -4.00 -6.00 -8.00 -10.00 -12.00
Achieved Refractive Change
©DZ Reinstein 2004

Removing Bowing Effect
change observed
  epithelium
  epithelium  ”bowing”
Removing Bowing from Treatments
14.00
y = -0.9932x + 1.0672
12.00 2
R = 0.4662
10.00
8.00
6.00
4.00
2.00
0.00
-2.00
-4.00
0.00 -2.00 -4.00 -6.00 -8.00 -10.00 -12.00
©DZ Reinstein 2004

Removing Epithelial + Bowing Effects
change observed
  epithelium
  epithelium  “bowing”
Removing Epithelial Changes and Bowing from Treatments
14.00
y = -1.0256x + 1.2145
12.00 2
R = 0.4757
10.00
8.00
6.00
4.00
2.00
0.00
-2.00
0.00 -2.00 -4.00 -6.00 -8.00 -10.00 -12.00
©DZ Reinstein 2004

Impact of Epithelial and Bowing Effects on Accuracy of LASIK
Validation of Calculated Power Change in Cornea Removing Epithelial Change from Treatments
14.00 14.00
y = -0.9019x + 0.7472 y = -0.9352x + 0.8981
2
12.00 R2 = 0.671 12.00 R = 0.6608
10.00 10.00
8.00 8.00
6.00 6.00
4.00 4.00
2.00 2.00
0.00 0.00
0.00 -2.00 -4.00 -6.00 -8.00 -10.00 -12.00 0.00 -2.00 -4.00 -6.00 -8.00 -10.00 -12.00
Achieved by Refraction Achieved Refractive Change
Removing Bowing from Treatments Removing Epithelial Changes and Bowing from Treatments
14.00 14.00
y = -0.9932x + 1.0672 y = -1.0256x + 1.2145
12.00 2 12.00 2
R = 0.4662 R = 0.4757
10.00 10.00
8.00
8.00
6.00
6.00
4.00
4.00
2.00
2.00
0.00
-2.00 0.00
-4.00 -2.00
0.00 -2.00 -4.00 -6.00 -8.00 -10.00 -12.00 0.00 -2.00 -4.00 -6.00 -8.00 -10.00 -12.00
Achieved Refractive Change Achieved Refractive Change
©DZ Reinstein 2004

The Epithelium in LASIK
©DZ Reinstein 2004

ARVO 1999
Effect of Epithelial Changes on Refractive Ou

tcome in LASIK
Sabong Srivannaboon, MD
Dan Z Reinstein, MD, FRCSC
Hugo FS Sutton, MD, FRCSC
Ronald H Silverman,
Simon P Holland, MD, FRCSC
D. J. Coleman, MD, FACS
University of British Columbia, Vancouver, BC Canada
Weill Medical College of Cornell University, New York, NY
©DZ Reinstein 2004

Epithelium: Results
• Change in Power
• Change in Thickness
©DZ Reinstein 2004

Methods
• 3 groups: Low, Moderate, High myopia

• Changes of the epithelial thickness were determined annularly for
the:
– Center
– Anulus at zone diameters of :
• 3,4,5,6 and 7 mm
©DZ Reinstein 2004

Epithelial Power Changes and Postop SE Error
Post-op Error vs. Epithelial Power Change
-2
y = -0.2701x - 0.3189
-1.5 p=0.036
2
R = 0.0851
Epithelial Power Change
-1
-0.5
0
0.5
1
1.5
2
2 1.5 1 0.5 0 -0.5 -1 -1.5 -2
Post-op Spherical Equivalent
©DZ Reinstein 2004

Epithelial Profile Changes
Level of Myopia vs Epith Thickening by Zone
20
central
3mm zone
18
4 mm zone central
5 mm zone y = -0.1059x2 - 2.5228x
16 R2 = 0.4041
6 mm zone
Epithelial Thickening
3 mm
14 y = -0.1082x2 - 2.5378x
R2 = 0.6311
12 4 mm
y = -0.0889x2 - 2.2592x
R2 = 0.6681
10
5 mm
8 y = -0.0789x2 - 1.9901x
R2 = 0.6644
6 6 mm
y = -0.0658x2 - 1.6039x
R2 = 0.4059
4
0
0.00 -2.00 -4.00 -6.00 -8.00 -10.00 -12.00 -14.00
Level of Myopia
©DZ Reinstein 2004

Results
Central 3 mm 4 mm 5 mm 6 mm 7 mm
annulus annulus annulus annulus annulus
Group 1 7.59+4.31 6.56+3.52 5.21+2.93 4.17+2.77 3.18+3.32 3.30+3.03

(<-4D)
Low
Group 2 10.04+3.01 10.07+3.31 9.74+2.90 8.51+2.17 7.15+3.06 3.34+3.16
(4-6)
Moderate
Group 3 11.70+3.64 12.70+2.69 11.53+2.08 10.64+2.08 8.33+2.71 4.46+2.59

(>6D)
High
©DZ Reinstein 2004

Central
Figure 5 and Epithelial Profile Changes
Mean Epithelial Thickening at Center and Annular Zones

According to level of myopia treated
20.00
18.00
16.00
High
14.00 myopia
12.00 mod
10.00 myopia
8.00 low
myopia
6.00
4.00
2.00
0.00
-2.00 Central 3 mm 4 mm 5 mm 6 mm 7 mm
Zone
©DZ Reinstein 2004

Hypothesis: Epithelial Thickening
©DZ Reinstein 2004 End

Epithelial Power Change vs. Myopia Treated
Epithelial Power Change vs. Spherical Equivalent Treated..

-1.00
-0.80
Epithelial Power Change /D
-0.60
-0.40
-0.20
0.00
0.20
0.40
0.00 -2.00 -4.00 -6.00 -8.00 -10.00
Spherical Equivalent
©DZ Reinstein 2004

Epithelial Power Change vs. Myopia Treated
Epithelial Power Change vs. Spherical Equivalent Treated..
-1.00
2
y = a.x + b.x + c
-0.80 p<0.001
2
R = 0.3914
Epithelial Power Change /D
-0.60
-0.40
-0.20
0.00
0.20
0.40
0.00 -2.00 -4.00 -6.00 -8.00 -10.00
Spherical Equivalent
©DZ Reinstein 2004

What do we do about regression nowadays?
• Enhance!
• But we should diagnose regression before
treating
– epithelial or biomechanical?
©DZ Reinstein 2004

Undercorrected LASIK
• 43 yo white female
OD OS
• Pre op refraction -6.00 -0.50 x 115 -6.00 -0.50 x 20
• Corneal thickness
(Orbscan) 542 540
(Sonogage) 537 553
• Flap thickness (Hansatome) 160 160
• Ablation depth (MEL70) 99 99
• Predicted residual bed 278 281
• Post op (3mo) UCVA 20/20 20/25

• Post op (6 mo) UCVA 20/25 20/25
-0.50 -0.50 x 150 -0.75 -0.50 x 145
(20/16) (20/16)
©DZ Reinstein 2004

Undercorrected LASIK : To enhance OD?
• Predicted RST = 278µm
• Ablation depth required = 24µm
• 278 – 24 = 254µm
277μm
©DZ Reinstein 2004

Undercorrected LASIK : To enhance OS?
• Predicted RST = 281µm
• Ablation depth required = 27µm
• 294 – 27 = 254µm
218μm
• Enhancement OD only!
191–µm
©DZ Reinstein 2004

Summary: Pathophysiology of Regression
• “Regression” is not a diagnosis, but an observation.
• Epithelial and biomechanical changes account for
LASIK inaccuracy
• The diagnosis of “regression” can only be made by
layered analysis of the cornea after LASIK
• Given the uncertainty in pre–op corneal thickness and
flap thickness, direct measurement of flap and
residual stromal thickness before enhancement will
maximize safety.
©DZ Reinstein 2004

Summary: caution
Beware of wavefront guided enhancements for
decreasing spherical aberration (“expanding the
optical zone”) - they are very tissue intensive,
and you may have less tissue available than
expected.
©DZ Reinstein 2004

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The Pathophysiology of Regression

Dan Z Reinstein MD MA(Cantab) FRCSC DABO1,2,3,4

1. London Vision Clinic, London, UK

©DZ Reinstein 2004

©DZ Reinstein 2004

The Accuracy of Routine LASIK;

Dan Z Reinstein, MD, MA(Cantab), FRCSC

Weill Medical College of Cornell University, NY, NY

©DZ Reinstein 2004

• Cornell University prototype

©DZ Reinstein 2004

©DZ Reinstein 2004

Roberts C. The cornea is not a piece of plastic.

©DZ Reinstein 2004

©DZ Reinstein 2004

©DZ Reinstein 2004

©DZ Reinstein 2004

©DZ Reinstein 2004

©DZ Reinstein 2004

Calculated Corneal Power

©DZ Reinstein 2004

Calculated Corneal Power

©DZ Reinstein 2004

Substitute with pre-epithelium

©DZ Reinstein 2004

Substitute with pre-epithelium

Calculated Corneal Power

©DZ Reinstein 2004

©DZ Reinstein 2004

Calculated Corneal Power

©DZ Reinstein 2004

©DZ Reinstein 2004

©DZ Reinstein 2004

Substitute pre-op epithelial layer

©DZ Reinstein 2004

Substitute pre-op epithelial layer

©DZ Reinstein 2004

Substitute pre-op epithelial layer

Calculated Corneal Power

©DZ Reinstein 2004

Mean Corneal Power Change Pre- to Post-LASIK

Mean Power Change 4.56 4.86 5.60 5.16 5.89

©DZ Reinstein 2004

Attempted vs. Achieved (by Refraction)

©DZ Reinstein 2004

Validation of Calculated Power Change in Cornea

©DZ Reinstein 2004

Removing Epithelial Change from Treatments

©DZ Reinstein 2004

Removing Bowing from Treatments

©DZ Reinstein 2004

Removing Epithelial Changes and Bowing from Treatments

©DZ Reinstein 2004

©DZ Reinstein 2004

©DZ Reinstein 2004

Effect of Epithelial Changes on Refractive Ou

©DZ Reinstein 2004

©DZ Reinstein 2004

• 3 groups: Low, Moderate, High myopia