ICLs and Inlays - Texas Optometric Association

2/16/2015
Refractive Surgery
Presbyopia
correcting IOLS
Derek N. Cunningham, OD, FAAO
J. Christopher Freeman, OD, FAAO
Kyle Sandberg, OD, FAAO
Derek N. Cunningham, O.D., FAAO
Dell Laser Consultants
Austin, TEXAS
Why Become Involved?
Epidemiology of Cataracts
• 3 million cataract surgeries
each year1
• #1 cause of blindness worldwide
• By 2020 the U.S. population
over 65 will double from
current levels – 12.9% of total
population
• Reversible blindness in 17 million people worldwide
• Tangible vs. Intangible
benefits
• Cataract surgery is the single biggest expense of Medicare
• Projected to reach 40 million by the year 2020
• In the US, cataracts affect 1 out of every 6 people over the
age of 40
• 1.6 million cataract procedures performed on Medicare
beneficiaries in 2000 costing $3.4 billion
1. http://www.allaboutvision.com/conditions/cataracts.htm
Comparison of Advanced Technology IOLs
Tecnis
ReZoom
ReSTOR
CrystaLens
TECNIS Multifocal Family of
IOLs
A full range of outstanding vision;
personalized to each patient’s lifestyle
Distance
Excellent
Good
Excellent
Excellent
Intermediate
Good
Good
Good
Good
Near
Excellent
Good
Excellent
Fair
Effective add
+3.0D
+2.6D
+2.1 and +3.2D
+1.25D
Strengths
Less GSH
Pupil
independent
Good distance
vision
Good near vision
in most lighting
Fewer problems with
GSH
Weakness
Intermediate can
be problematic
Pupil dependent
Halos
Larger pupils may
not get good near
May need reading
glasses for near
tasks
NEW
A full range of
outstanding vision…
for patients favoring near
vision related activities such
as reading or knitting .
A full range of
outstanding vision…
for patients favoring
activities at longer reading
distances such as multimedia work.
Data: DFU, TECNIS® Multifocal 1-Piece IOL, Models ZKB00 and ZLB00, and DFU, TECNIS Multifocal 1-Piece IOL, Model ZMB00.
NEW
A full range of
outstanding vision…
for patients favoring
intermediate vision activities
such as golfing or grocery
shopping.
TECNIS Multifocal IOLs | PP2014CT0439
6
1
2/16/2015
TECNIS Multifocal Family of
IOLs
TECNIS Multifocal IOLs +3.25D
and +2.75D
Clinical
Outcomes
Ability to
Function Comfortably Without Glasses at 6 Months Bilateral Subjects –
High Patient Satisfaction
 >93% of patients reported they
would have the same IOL
implanted again*
ZKB00, ZLB00 and ZM900*
100
90
97.9 97.3
94
97.9 96
90
85.9
85
81
70
60
Percent
>80%
Good Functional Vision
in Mesopic Binocular
Conditions
 TECNIS Low Add IOLs deliver
20/25 (J1) Mean VA Near
Uncorrected
 The Mean Near VA for Distance
Corrected Mesopic was 20/40
at patient's best distance

of patients reported an
ability to function
comfortably without
glasses at all distances
80
Excellent Visual Outcomes
at Near and Binocular
Distance
TECNIS
Low Add IOLs deliver
20/20 Mean VA Distance
Uncorrected
50
40
30
* ZM900 (+4.0D) data are historical from a
separate clinical study using the same test
methodology.
20
10
PRECAUTIONS
The central one millimeter area of the lens creates a far image focus in accordance with the labeled power of the IOL, so patients with abnormally small pupils
(~1 mm) should achieve, at a minimum, the prescribed distance vision under photopic conditions; however because this multifocal design has not been tested
in patients with abnormally small pupils it is unclear whether such patients will derive any near vision benefit.
0
Near
ZKB +2.75D N= 142
Intermediate
ZLB +3.25D
N= 149
Distance
ZM900 +4.0D N= 292
Data: DFU, TECNIS® Multifocal 1-Piece IOL, Models ZKB00 and ZLB00, and DFU, TECNIS Multifocal 1-Piece IOL, Model ZMB00.
TECNIS Multifocal IOLs | PP2014CT0439
7
Data: DFU, TECNIS® Multifocal 1-Piece IOL, Models ZKB00 and ZLB00, and DFU, TECNIS Multifocal 1-Piece IOL, Model ZMB00.
TECNIS Multifocal IOLs | PP2014CT0439
8
How Do These Compare?
Advanced Technology:
The Players
Accessed from www.allaboutvision.com on 4/7/11
What About Astigmatism?
Why Treat Astigmatism?
• Quality of vision
• Pre-surgical aberrations tolerated
• More adapting issues post-surgical
No Astigmatism
1.0 D Astigmatism
2.0 D Astigmatism
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2/16/2015
Toric IOLs
• Differentiate corneal cylinder
from refractive cylinder
• Corneal
• Lenticular
• Mixed
• Accurate / consistent
measurements
• Manual keratometry
• Corneal topography
• IOL Master
• More than 1 D of corneal Cyl
TRULIGN™ Toric IOL
Key Properties
TRULIGN™ Toric IOL
Key Properties
•
•
•
•
•
•
•
•
5.0-mm optic body
Biconvex shape
Rectangular hinged haptics
Approved dioptric power range
from +4.00 to +33.00 D
• Cylinder powers 1.25, 2.00, and
2.75 D
• Round-to-the-right asymmetric
polyimide loops
x
o
5.0-mm optic body
Biconvex shape
Rectangular hinged haptics
Approved dioptric power range
from +4.00 to +33.00 D
• Cylinder powers 1.25, 2.00, and
2.75 D
• Round-to-the-right asymmetric
polyimide loops
o
Where has LASIK Gone
• National rates
x
o
o
New Technology
on the Horizon
• Current technology:
• Conventional, Optimized, WFG
• Available soon:
• Advanced wavefront
• What new level of outcomes can
we achieve?
• What standards are we measuring
against?
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2/16/2015
Next Generation Diagnostic Information:
Ocular Aberrations
Potential Advantages of Advanced WavefrontGuided Ablations
• Current technology proven, with exceptional results
• Technology been available for several years
• Broad range of FDA approved treatments
• Treats entire eye aberrations
• Not just corneal astigmatism
• Diagnostic capabilities take into account entire optical system
• Improved ablation profile based on whole eye optical
aberrations
• Higher quality aberrometer
• Increased dynamic range
• Precise torsional alignment
• Corneal curvature compensation
iDesign LASIK
Low – Moderate Myopia <= 6D
8,905 eyes
(4,721 patients)
Surgery Date Range
Gender
% Male / % Female
5/30/2012 – 8/24/2013
47.6% / 52.4%
• Broad data capture
• Can measure all ocular aberrations – HOAs
• AMO, WaveLight options
Monocular Postop UCVA
100%
Min, Max
33.8 (9.84)
Min, Max
20/25
20/40
84%
80%
17 , 67
Preop Sphere
Mean (STD)
100%
90%
Age
Mean (STD)
99%
95%
70%
-2.80 (1.47)
-6.00 , -0.25
60%
Mean (STD)
-0.81 (0.75)
Min, Max
-5.50 , 0.00
50%
Preop Cylinder
Source: Steve Schallhorn, MD & Optical Express. Presented at ASCRS 2014
20/16
20/20
Source: Steve Schallhorn, MD & Optical Express. Presented at ASCRS 2014
Future of Laser Vision Correction: Advanced
Wavefront
• Unprecedented level of customization
• The future is beyond 20/20:
Small Incision Lenticule Extraction
– Higher-resolution diagnostics can deliver higher-quality
vision
• We need to adapt our technology & measurement
standards to achieve these results
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2/16/2015
Reason #1
•Avoid Flap Risks/Complications
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2/16/2015
Flap Risks/ Complications
Reason #2
5+ fold > Incisional Circumference
•Concern Over Biomechanical Instability
3.5 mm
300 degree
9 mm
diameter
Flap
< 60
degree
7.5
mm
2 mm
diameter
Cap
Greater risk of Striae, Ingrowth or Trauma!
90 μm
160 μm
9%
32%
Better Biomechanically?
LASIK flap
9%
33%
Side cut only
5%
5%
Delamination only
Reason #3
Abhijit Roy, PhD, BJ Dupps, MD, PhD, Cynthia Roberts, PhD
•
J Cataract Refract Surg. June 2014
SMILE Cuts Fewer Anterior Nerves
SMILE
•Advantage in Dry Eyes/Neurotrophic Surface?
LASIK
More Corneal Sensation & Less Dry Eyes
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2/16/2015
Dry Eyes/Neurotrophic Surface
LASIK
SMILE
• 6 months post-op
• Corneal sensation change
Reason #4
•Change in Global Perception
• 0.38 cm
• SMILE: -0.10 cm
• p<0.01
• Greater reduction in corneal
sensation with a flap
Global Perception
Worldwide SMILE Surgeries
2009………………….200
12/2012……………20,000
7/2013……………..50,000
12/2013……………80,000
2/2014……………100,000
Will This Survive/Thrive
• Too soon to tell
• FDA trial. We are considering performing
• Predictability data has been excellent
• LASIK is excellent
• No flap issues
• Some theoretical DES and safety advantages
Reason #5
•One laser instead of two
Some Unknowns
• Best way to enhance
• ASA?
• Retained fragments
• Accuracy and quality vs WFG?
• We are only aware of 2 ectasia cases from our center since 1995,
with none since 1998, and this is lower than the new incidence of
KC in the general population
• Quick recovery
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2/16/2015
FDA Approved Phakic Implants
Don’t touch my lens!!
Verisyse® (AMO)
• Iris Fixed Anterior chamber
lens
• Visible to the naked eye
• FDA approved in 2004
• Treatment from -5.00D to
-20.00D
Phakic Implants and Corneal Inlays
Visian ICL® (STAAR)
• Posterior chamber lens placed in
the sulcus
• Visible only under slit lamp
• FDA approved in 2005
• Treatment from -3.00D to -20.00D
• Available in hyperopic powers and
toric lenses in Europe
Kyle Sandberg, O.D., F.A.A.O.
Chief, Refractive Surgery and Laser Services
Rosenberg School of Optometry
San Antonio, TX
Visian ICL
Visian ICL®
•
•
•
•
Peripheral iridotomies performed prior to implantation
Standard of care is simultaneous bilateral implantation
Requires skilled surgeon – 1.4% risk of anterior subcapsular cataract
Lenses may be removed or replaced (advantage over LASIK even for low
refractive errors)
• Recovery is quick and patients experience great vision immediately
• Superior to LASIK/PRK with high refractive errors, severe DES, Irregular
corneas, Large pupils
• Preop:
< 100 um
< 50
microns
500-600 um
• AC depth (> 3.0)
• UBM
• Stable refraction (<0.5 D within 12 months)
Who can’t have an ICL?
•
•
•
•
•
•
•
•
•
Shallow AC (< 3.0 mm)
Significant corneal/endothelial disease
Narrow angles
Glaucoma
Pseudoexfoliation
h/o significant or recurrent iritis
Cataracts
Caution with highly toric corneas (may combine with LASIK/PRK)
This is not a multifocal lens
ICL Complications
•
•
•
•
•
•
Pupillary block
ASC cataract – 1.4%
Retinal Detachment – 0.6%
Glare/halos
Any complications associated with LASIK/PRK
Check for vault. Ideally ~ 500 microns.
• Approved for 21-45 yo
http://optometrytimes.modernmedicine.com/optometrytimes/content/tags/cornea/identifying-candidates-non-corneal-refractive-surgery?page=full
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Vault
ICL case
• 26yo AM
• 3rd year Optometry student
• Uneventful bilateral implantation of ICLs (~7pm in live surgery event)
• Refraction:
• MRx:
• OD: -10.75-0.50x180 VA 20/15• OS: -11.00-0.50x004 VA 20/15-
• Night of sx: returned to office for ocular pain secondary to increased
IOP. (~35 mmHg)
• Pt was burped and given in-office Diamox and Rxed Alphagan
• The following morning IOP was 12 OD, 16 OS
Images: http://www.sciencedirect.com/science/article/pii/S0002939409000415
1 day p.o. (18 hours post op)
Anterior Crystalline Lens Opacity
OD
OS
36 Hrs Postop
OD
OS
PIOLs Awaiting FDA Approval
AcrySof® Cachet® Phakic Lens (Alcon)
• No PI required
• Angle Supported AC lens
• -6D to -16.5D
Visian® Toric ICL ™
• Up to 4D of astigmatism
Corneal Inlays
Visian® ICL ™ V4c with CentraFLOW ™
• Eliminates need for PI
Images: domedics.ch
www.reviewofophthalmology.com/content/d/refractive_surgery/i/1448/c/27318/
www.alconsurgical.ca/ACRYSOF-Cachet-Phakic-Lens.aspx
article.wn.com
9
2/16/2015
KAMRA (AcuFocus™)
KAMRA (AcuFocus™)
n=417 @ 36M
• 3.8mm diameter with 1.6 mm aperture, 5 µm
thick
• Placed through a corneal pocket created with a
femtosecond laser ~ 200 µm
• ~20/32 mean NVA
• Thousands of holes to facilitate transport of
corneal nutrients
• Placed in non-dominant eye with minimal effect
on distance vision
Data from Ophthalmic Devices Panel Executive Summary. Pg. 59. Pub. May 12, 2014.
RAINDROP® (ReVISION Optics)
RAINDROP® (ReVISION Optics)
• 2 mm diameter clear hydrogel lens (30 microns)
• It changes the curvature of the corneal surface (Profocal
cornea) but has no optical power
• Placed in non-dominant eye
• Small degradation of distance VA
• Placed under 160 micron flap
• Centered over the light constricted
pupil
• Removable
Mean Uncorrected Visual Acuities (Inlay Only)
Corneal Inlays
•
•
•
•
•
Severe Dry Eye
Severe Lid Disease
KCN/PMD
Normal Ocular Health
Still need residual stromal
bed
Complications
Near
• Inflammation near the
inlay
• May be treated with topical
steroids or removed
• Inlay dislocation
• Any complication related to
flap
•
•
•
•
DLK
Epi ingrowth
Infection
Flap slippage/striae
Intermediate
Distance
n=37
55
-0.1
Mean Acuity (logMAR)
Contraindications
• Similar to LASIK
50
0.0
20/20
45
0.1
20/25
0.2
40
20/40
35
0.3
30
0.4
25
0.5
20
0.6
Preoperative
N = 39
1 Week
39
1 Month
39
3 Months
38
6 Months
37
Visual acuities stable at 1 month, mean monocular UVAs for near,
intermediate, and distance (~ 20/25)
Courtesy: Greg Parkhurst, MD
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2/16/2015
Functional Binocular Visual Acuity
Patient Satisfaction: Overall
6 months
Distance
Intermediate
Near
N = 37
How satisfied are you with your vision
correction?
Percentage of Patients
Completely Satisfied
Very Satisfied
300%
250%
97%
100%
Somewhat Satisfied
Somewhat Dissatisfied
200%
150%
92%
100%
100%
100%
N = 37
19%
8%
15%
8%
43%
15%
38%
26%
28%
Very Dissatisfied
Completely Dissatisfied
6M
100%
50%
0%
20/25 (0.8)
100% patient satisfaction
20/32 (0.63)
Binocularly, 92% of patients can see 20/25 or better at all distances
Courtesy: Greg Parkhurst, MD
Courtesy: Greg Parkhurst, MD
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Financial Disclosure
Refractive Technology on
the Horizon
• Full-time employee of nJoy Vision
• No financial interest in any products mentioned
(and some that’s recently available)
J. Christopher Freeman, OD, FAAO
Diplomate, American Board of Optometry
Clinical Director, nJoy Vision OKC
President, Optometric Council on Refractive Technology
Cataract Surgery
…is Refractive Surgery
DROPLESS CATARACT SURGERY
Reproduced from Duke-Elder S. Diseases of the Lens and Vitreous. St Louis: Mosby; 1969
11
2/16/2015
On the rise among cataract
surgeons
•
•
•
•
Singapore 30%
England 55%
Australia 81%
USA ??
Medication
• Imprimis Pharmaceuticals
• Compounded anti-inflammatory and antibiotic
• TriMoxi
• TriMoxiVanc
• Delivered tranzonularly to posterior chamber
• 2007 ASCRS Survey 14%
• 2014 ASCRS Survey 50%
Potential Benefits
• Better reassurance for the doctors
• Less medication variability
• Saves time/money on patient education and follow up care
• Reduced patient confusion/improved compliance
Potential Benefits
• Reduced ocular surface toxicity
• Reduced cost
• Can be up to approx. $400 for typical post op regimen
• Imprimis pharmaceuticals $20-$25 in a single use vial.
• Reduces calls from pharmacy
• Reduces problems with insurance plans
Potential Risks/Considerations
•
•
•
•
Compounded medication
Endophthalmitis
CME – No NSAID in compound
IOP spike
• M. Stewart Galloway Study 1575 eyes (none received
topical abx/steroid)
• 0 cases of endophthalmitis
• 0 cases of IOP spike
• 2% had CME
• Premium IOL recipients and some with high risk of CME were given
topical NSAID
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2/16/2015
Potential Risks/Considerations
• Low likelihood of FDA approval
• Rebound inflammation at 2-3 weeks
• More floaters/blurry vision at 1 day post op
• 51% in Galloway Study had 1 day BCVA of 20/100 or worse
• Reduced partnership benefits from pharmaceutical
companies
• Provide staff education
• Provide samples
New Technology: Surgery… It’s
Here
• Femtosecond laser-assisted cataract surgery
•
•
•
•
LenSx- Alcon
LensAR
Catalys- AMO
Victus- B&L
• Femtosecond Uses
•
•
•
•
Liquefy, soften or “chop” the lens
Create capsulotomy
Create all required Surgical Incisions
Provide a refractive solution to pre-existing astigmatism by creating
relaxing incisions
• Possibly do all above with better accuracy and precision than our
current manual techniques?
Advantages of femtosecond laserassisted cataract surgery
References
• Walter, Keith. Epitropoulos, Alice. “Debating the Merits of Dropless Cataract Surgery.”
http://www.healio.com/ophthalmology/cataract-surgery/news/print/ocular-surgerynews/%7B0e80f7e5-a48c-4da5-ba2b-56c99a4ba6b8%7D/debating-the-merits-ofdropless-cataract-surgery?page=1
• Mangan, Richard. “No Endophthalmitis seen in case series of ‘no-drop’ cataract
surgery.” http://www.healio.com/optometry/cataract-surgery/news/print/primary-careoptometry-news/%7B624c3b23-44a1-4898-b7a0-b48726dbc958%7D/noendophthalmitis-seen-in-case-series-of-no-drop-cataract-surgery
• Krader, Cheryl. “News on cataract surgery medications centers on intraocular
preparations.”
http://ophthalmologytimes.modernmedicine.com/ophthalmologytimes/news/newscataract-surgery-medications-centers-intraocular-preparations?page=full
Femtosecond laser-assisted cataract surgery
• Femtosecond Technology
• Same technology as laser flaps for LASIK
• Now approved and will change the future of
CATARACT SURGERY
•
•
•
•
Incisions
Anterior Capsulorhexis
Lens Fragmentation
Relaxing Incisions – LRI’s/AK’s
Two Week Post-Op OCT
 SAFETY


Incisions – perfect wounds, less chance for endophthalmitis
Lens Fragmentation – softer nucleus, less time and energy

43% decrease in average phaco time

51% decrease in effective phaco power
 ACCURACY

Capsulotomy – precision size & centration, critical for
Refractive IOLs

Manual 329 microns; Laser 27 microns
 OUTCOMES

Relaxing Incisions – for astigmatism, with newer IOL
technology goal is within 0.50D of emmetropia
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2/16/2015
Femtosecond laser-assisted Cataract Surgery
Capsulotomy Results
Capsulorhexis Precision
• Perfect centration
• Precision diameter: < ± 0.25 mm
• No radial tears
• Easy and complete removal of capsule
• No adverse events
Femtosecond laser-assisted
cataract surgery outcomes
New Technology: IOL’s
• Presbyopia Correcting IOL’s
• Crystalens- pseduoaccommodating
94.7%
100.0%
90.0%
83.2%
• Trulign- Toric Crystalens
98.2% 100.0%
• Tecnis Multifocal- diffractive multifocal
• ReSTOR- diffractive multifocal
92.4%
81.9%
80.0%
• +3, +4
70.0%
60.0%
53.1%
50.0%
40.0%
35.4%
• ReZoom- diffractive multifocal
46.7%
LCS
32.4%
MCS
30.0%
20.0%
10.0%
0.0%
0.00D
0.25D
0.50D
0.75D
1.00D
LCS
MCS
Comparison of absolute mean difference (diopters) from the intended correction in laser cataract surgery (LCS) and manual
cataract surgery (MSC) groups.
• Clinical Trials
•
•
•
•
•
•
•
Synchrony
Humanoptics
NuLens
Tetraflex
Medenium Smart IOL
Liquilens
Elenza- electroadaptive optic
Source: Roberts, et al, Clinical and Experimental Ophthalmology 2013; 41: 180–186
New Technology: IOL’s
•
•
•
•
Tecnis Multifocal Toric - AMO
ReSTOR Toric - Alcon
Tecnis Symfony – AMO
Elenza
AMO Symfony
• The proprietary diffractive echelette design feature extends the range of
vision
• The proprietary achromatic technology corrects chromatic aberration for
enhanced contrast sensitivity.
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2/16/2015
ElectroAdaptive Optics
(IOL’s)
AMO Symfony
• Elenza
TECNIS® Monofocal IOL
(next generation IOL)
• NO movement
• Foldable
• <3.5mm incision
• +3.50 Diopters (accommodative amplitude)
• Near – Intermediate – Far Vision: (Depth of
Focus)
• Failsafe optics
TECNIS® Multifocal IOL
TECNIS® Symfony IOL
Example: EA Element Turned ON
Example: EA Element Turned OFF
E/A
Element ON
Low-Index
edge
E/A
Element OFF
• Variable speed of light
causes change in
wavefront shape
• Huygen’s Principle
explains change in
direction of rays
• The result is positive
lens power
Hi-Index
center
Constant
index
center to
edge
• Wavefront emerges
unchanged
• Result is zero add power
Low-Index
edge
Variable
Flat Wavefront Constant Flat Wavefront
Entering speed of Leaving
light
Incoming speed of lightConverging
Wavefront
Wavefront
ELENZA, Inc.
ElectroAdaptive Optics (IOL’s)
ElectroAdaptive Optics
(IOL’s)
Smaller the Aperture, the Larger the
Depth of Focus, the Better Acuity
in the range of 30-100 cm
Mechanism of Action
1.2mm
Central
Optic
(+2.0D)
 Sapphire™ Provides 20/20 Vision at Intermediate (DOF is 1.5D)
 MultiFocal and Accommodative IOLs Only Provide 20/30 Vision at Intermediate
Intermediate
Closed
Shutter
(+1.5D)
20/30
20/20
Near
Near Image
Focused on Retina
+3.5D
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2/16/2015
All Components Have Been Proven &
Tested
ElectroAdaptive Optics
(IOL’s)
Haptics Design
 Sensors
Batterie
 Rechargeable Batteries
 Integrated Circuits
 E-A Liquid Crystal
 Glass-infused Package
 Haptics / Hydrophobic IOL
Displacement
FEM simulation
ElectroAdaptive Optics
(IOL’s)
Corneal Collagen Crosslinking (CXL)
Inductive Charging Solutions
History
• Studied since 1994
• University of Dresden
Eye Mask at Night
• Theo Seiler
• Eberhard Spoerl
• Gregory Wollensak
“Charging Pillow”
Contour
Neck Pillow
Inductive Coil
Corneal Collagen Crosslinking (CXL)
Basics
Sites For Collagen Cross-Linking
1. Riboflavin (vit. B2) + Ultraviolet radiation
OH
O P O
-
H2C
OH
H C OH
H C OH
H C OH
H2C
H3C
N
H3C
N
N
O
NH
O
2. Production of oxygen radicals (ROS)
Cross Linking
O2 3. Induction of collagen cross-links
-CH2-CH2-CH2-CH = NH-CH2-CH2-CH2-CH2-
collagen fibril
collagen fibril
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2/16/2015
Riboflavin/UV Cross-Linking
Pachymetry
Riboflavin 0.1% q2 minutes/30 minutes
Fluorescence in Anterior Chamber
Riboflavin q2 minutes and
Light for 30 minutes
UV Light for __ Minutes
UV
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2/16/2015
Bandage Contact Lens
Corneal Collagen Crosslinking (CXL)
Conclusions
• Halts progression of ectatic corneal diseases
•
•
•
•
Decreases corneal curvature and thickness
Regularizes corneal surface
Improves UCVA and BSCVA
Effect lasts indefinitely
• Offers safe and effective treatment for conditions with no
currently available treatment and may avoid
• 20% of corneal transplants
• Disability, cost, loss of productivity, CTL
What is a Successful Outcome?
• 20/20 ?
• No Complications?
Co-managing the Refractive
Surgery Patient
• DLK, infection…
• Plano Rx?
• 20/Happy?
• Meeting expectations?
J. Christopher Freeman, OD, FAAO
Diplomate, American Board of Optometry
Clinical Director/Residency Director, nJoy Vision OKC
President, Optometric Council on Refractive Technology
• Patients want good vision and safety
• Better than ever now with wavefront science and
blade-free technology.
Is LASIK Safe and Efficacious?
Are Patients Satisfied With the Results of
Their Laser Vision Correction?
• The majority of patients are satisfied with their Laser
Vision Correction.
• LASIK is safe and effective in the
treatment of mild to moderate myopia and
myopic astigmatism.
• 95.4% - 96.5% of LVC patients would recommend LVC
to their friends and family members 1,2.
• More than 94% of LVC patients say LVC improved the
quality of their life1.
1. Steven C. Schallhorn, MD and Jan A. Venter, MD. One-month Outcomes of Wavefront-guided LASIK for Low to
Moderate Myopia With the VISX STAR S4 Laser in 32,569 Eyes Journal of Refractive Surgery Vol. 25 No. 7 July,
Supplement 2009
2. Yuen LH, Chan WK, Koh J, Mehta JS, Tan DT: A 10-year prospective audit of LASIK outcomes for myopia in 37,932
eyes at a single institution in Asia. Ophthalmology. 2010 Jun;117(6):1236-1244.e1. Epub 2010 Feb 13
1.
Mitchell C. Brown, OD; Steven C. Schallhorn, MD; Keith A. Hettinger, MS, MBA and Stephanie E.
Malady, BS. Satisfaction of 13,655 Patients With Laser Vision Correction at 1 Month After Surgery.
Journal of Refractive Surgery Vol. 25 No. 7 July, Supplement 2009
2.
Solomon KD, Fernández de Castro LE, Sandoval HP, Biber JM, Groat B, Neff KD, Ying MS, French
JW, Donnenfeld ED, Lindstrom RL. LASIK world literature review: quality of life and patient
satisfaction. Ophthalmology. 2009 Apr;116(4):691-701.
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2/16/2015
Are Patients Satisfied With the Results of
Their Laser Vision Correction?
• LASIK Quality of Life Collaboration Project
(LQOLCP)
• FDA/NIH/DOD
• PROWL-1
• Military
• PROWL-2
• FDA
• Civilian sites around the country
Patient Screening for LVC
• Patient Expectations are Key!
• Patient Expectations
• Patient Expectations
• Realistic Goals
• Can patients expect to receive what they’re looking for with surgery
• Good candidate psychologically vs. physically
Patient Selection:
Candidacy
• Appropriate/realistic Expectations?
• Is the patient within range to treat?
• Tighter ranges now than before
• We know more now than in the ‘90’s
• Millions of procedures worth of experience/data
• Other options available
• Phakic IOL’s
• Refractive Lens Exchange
• Presbyopic IOL’s
Patient Selection:
Expectations
• Find out what you’re patient wants/goals
• Can you deliver what they want?
• Presbyopia?
• No glasses at all?
• “I want 20/10 vision.”
• What can you deliver and is that OK?
• Careful to make sure they’re really OK with it.
• Monovision- Presbyopia still gets worse!
• Make sure everyone’s on the same page at the end of the
consultation
Which is better LASIK or PRK?
1.
Which is the best Ablation Profile?
• Wavefront Guided LASIK and Wavefront Guided PRK have
similar efficacy, safety, predictability and contrast
sensitivity1,2.
• Conventional Ablation
• Wavefront Guided PRK may induce less High Order
Aberrations1.
• Wavefront Guided Ablation
• Wavefront Optimized Ablation
Moshirfar M, Schliesser JA, Chang JC, Oberg TJ, Mifflin MD, Townley R, Livingston MK, Kurz CJ
Visual outcomes after wavefront-guided photorefractive keratectomy and wavefront-guided laser in
situ keratomileusis: Prospective comparison. J Cataract Refract Surg. 2010 Aug;36(8):1336-43.
2.
Randleman JB, Perez-Straziota CE, Hu MH, White AJ, Loft ES, Stulting RD. Higher-order
aberrations after wavefront-optimized photorefractive keratectomy and laser in situ keratomileusis.
J Cataract Refract Surg. 2009 Feb;35(2):260-4.
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2/16/2015
Which is the best Ablation Profile?
• Custom Wavefront Guided LASIK induces less high order aberrations
as compared to conventional LASIK1,2.
• Custom Wavefront Guided LASIK produces better quality of vision,
contrast sensitivity and less night vision disturbances as compared
to conventional LASIK1,2.
1. Villarrubia A, Palacín E, Bains R, Gersol J. Comparison of custom ablation and conventional laser in
situ keratomileusis for myopia and myopic astigmatism using the Alcon excimer laser Cornea. 2009
Oct;28(9):971-5.
2. Myrowitz EH, Chuck RS. A comparison of wavefront-optimized and wavefront-guided ablations. Curr
Opin Ophthalmol. 2009 Jul;20(4):247-50.
What is Wavefront-Optimized?
• Aspheric Ablation Profile
• More mid-peripheral laser treatment to reduce induced
spherical aberration with LASIK
•
•
•
•
Which is the best Ablation Profile?
• Wavefront-guided LASIK and wavefront-optimized LASIK produced
equivalent visual outcomes and no differences in HOAs1.
1. Perez-Straziota CE, Randleman JB, Stulting RD. Visual acuity and higher-order aberrations with
wavefront-guided and wavefront-optimized laser in situ keratomileusis. J Cataract Refract Surg. 2010
Mar;36(3):437-41.
Aspheric Transition Zones
Allegretto- “PerfectPulse”
Zeiss- “PrecisePulse”
Technolas- “Zyoptix Aspheric”
Alcon-Wavelight Allegretto
Carl Zeiss Meditec
Technolas Perfect Vision*
VISX-in future
A circular beam
Is being projected
On the cornea
Reflection
Normal ablation
• Better than “conventional” treatment
• Results rival custom wavefront-guided ablation
Circular in the center
* Not available in U.S.
Wavefront-guided ablation
Compensates for
induction of
spherical aberration
Reduced Ablation, low
Fluence
Wavefront-guided ablation
• Much more than an optical cross of sphere and cylinder
• Measures optical distortions of entire optical system
• Cornea
• Lens
• Media
-2.00
-4.00
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2/16/2015
Is LASIK the best choice for the
correction of high myopia?
• The upper limit of myopia correction with LASIK is
decreasing1.
• While the FDA recommends 250 microns as the minimal
residual stromal depth, most surgeons leave 275 – 300
microns residual stromal bed1.
Patient Screening for LVC
• Patient Expectations are Key!
• Patient Expectations
• Patient Expectations
• Realistic Goals
• Can patients expect to receive what they’re looking for with
surgery
• Good candidate psychologically vs. physically
• Phakic IOL’s may be safer and more efficacious for
patients with moderate to high myopia as compared to
LASIK2.
1. Duffey R, Leaming D. US Trends in Refractive Surgery. The 2009 ISRS Survey. American Academy of
Ophthalmology Sub-specialty Day.
2. Barsam A, Allan BD. Excimer laser refractive surgery versus phakic intraocular lenses for the
correction of moderate to high myopia Cochrane Database Syst Rev. 2010 May 12;5:CD007679
Patient Screening for LVC
• Corneal Topography Analysis is the most important test when
screening patients for laser vision correction.
• Corneal Topography Analysis is the most important factor in
preventing the keratectasia after laser vision correction1.
Laser Vision Correction- Essentials
• Residual Stromal Bed (RSB)
• FDA says 250mm
• Most surgeons use 300mm
• Blade Flap Thickness
• Around 160mm +/-
• Femtosecond Flap Thickness
• Around 110mm +/-
• Excimer Laser Ablation Depth
• Around 15 microns per diopter (for 6.5mm OZ)
1. Dumitrica DM, Colin J. Indices for the detection of keratoconus Oftalmologia.
2010;54(2):19-29
Refractive Surgery- Pre-Op Exam
• Patient History- Visual demands, CL history (monvision?)
• UCVA/BCVA
• Corneal Tomography
• Pentacam, Orbscan, Topo
•
•
•
•
•
•
•
•
•
•
Wavefront Aberrometry
Binocularity/EOM Testing
Pupils
Dry Refraction
Wet refraction
Keratometry
Tonometry
Slit lamp Biomicroscopy
Dry Eye Testing
Dilated Fundus Exam
Laser Vision Correction:
What’s the short version?
Key message
• Patient selection is most important!
• Patient expectations/goals?
• RX within treatable range
• Pachymetry
• Treatment depth & residual stroma bed (RSB)
• Corneal Mapping
• Rule out ectasia suspicion/risks
• Too steep or too flat
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2/16/2015
Why is Ocular Surface Disease
Important?
Why is Ocular Surface Disease Important?
• Important for pre-op measurements for IOL surgery and
laser vision correction
• “Aggressive treatment of dry eye may be important before
obtaining wavefront measurements that serve as the basis for
planning refractive corneal laser treatments and retreatments.”
•
Huang et al, American Journal of Ophthalmology, January, 2004
• Important for excellent outcomes from IOL surgery and
laser vision correction
• “The risk for refractive regression after LASIK was increased in
patients with chronic dry eye.”
•
LVC: Ocular Surface Disease
• Significant Emphasis on OSD in ocular surgery
• We understand more about OSD
• MGD, Aqueous Def. dry eye, combin. disease
• We understand more about its impact
• Better meds for treatment
• Azasite [off label], Restasis, Omega 3’s
• More awareness among docs & patients
Albietz et al, Journal of Cataract and Refractive Surgery, March, 2004
Patient Selection:
Common Ranges [relative]
• Myopia
• Up to -10.00 with -4.00 cyl
• ICL > -7.50
• Hyperopia
• Up to +2.75-ish with cyl up to point where it becomes mixed
astigmatism
• Mixed Astigmatism
• Up to +3.00-ish with up to -5.00 cyl
• Depends on laser and comfort level
Vision After Cataract or Refractive
Surgery in the Presbyopic Patient
Patient Education is
the Key to Success
• Improve the quality of life of our cataract
patients by increasing their spectacle freedom
through providing a quality range of vision
1. Monofocal at distance (near glasses)
2. Monofocal at near (distance glasses)
3. Monovision (successful with contacts)
4. Toric (monofocal)
5. Multifocal
6. Accommodating
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2/16/2015
Who Are Good Multifocal/Accom
Candidates?
•
•
•
•
•
Visual and functional need for cataract surgery
Motivated not to wear glasses
Younger or Young at Heart patients*
Active lifestyle
Qualify for bilateral implants
•Realistic expectations
Who Are NOT Good Candidates for
Multifocal IOLs?
• Those who want to wear
glasses
• Poor “general alertness”
• Occupational night drivers
• High astigmatism*
• Poor candidates for refinement
• Unrealistic expectations
• Ocular pathology
* Relative Contraindications
Who Are Good Multifocal/Accom
Candidates? Careful Consideration
• Previous refractive surgery*
• Crystalens OK, multifocal not ok
• Previous cataract surgery with a monofocal IOL*
• EBMD, corneal scaring, any AMD, VMT
• Crystalens OK , multifocals not OK
Patient Selection Pearls
• Realistic expectations
• If you suggest a
multifocal for a
perfectionist don’t be
surprised when they
demand perfection
• Multifocals do not fix
crazy patients
Retrieved from http://www.filmcritic.com/reviews/1980/the-shining/ on 2/2/11
Slide Courtesy of Shaun Coombs, OD
Make this an exciting opportunity
for your patients
• This is a great time to have cataract surgery as we
can offer you so much more than several years ago
• This is your one opportunity to select your
intraocular lens
• As your primary care Eye Doctor, I will make a
recommendation and help you make this important
decision
Preparing the
Patient
Kyle Sandberg, O.D., F.A.A.O.
Chief, Refractive Surgery and Laser Services
Rosenberg School of Optometry
San Antonio, TX
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2/16/2015
Consider Their Needs
Co-management
• The degree to which you participate in the care should
be up to you!
• 1 day
• 1 week
• Next year?
• Higher participation leads to higher praise for the OD.
• You may not have done the sx, but you can still get a lot of
credit for the outcome
• Increased respect
• Increased referrals
Technical
Take into account:
• Lifestyle
• Astigmatism (especially for ICL or RLE)
• Pathology/Preexisting ocular conditions, (e.g., dry eye, lid
disease)
Technical
LASIK/PRK
ICL
• Stable refraction within
past 12 months?
• Stable topography?
• CL use?
• Cycloplegic refraction
• If presbyopic… monovision
trial complete?
• Counseling on presbyopia
• Stable refraction within
past 12 months?
• Cycloplegic refraction
• Not a multifocal
• Counseling for prepresbyopes
• Tx lid disease
LASIK/PRK
• Treatment range?
• Up to -12D
• Up to +6D
• Up to 6D of astigmatism
• Pachs/Topo
• Pachs thick enough for tx
• Min 250 stromal bed
• Flap ~100 µm
• ~12-15µm/D
• No evidence of K ectasia
forme fruste KCN
• Tx DES
• Tx lid disease
ICL
• Treatment range?
• -3D to -20.00D
• No hyperopic or toric
lenses in U.S.
•
•
•
•
Topo
AC depth
DFE
UBM
• Complete DFE
Lens Rise
Cyst in Sulcus
740 Micron
Difference!
Rise: 480 µ
STS: 12.3
Courtesy: Greg Parkhurst, MD
Rise: 1,220 µ
STS: 12.3
Courtesy: Greg Parkhurst, MD
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2/16/2015
Contraindications
Counseling the patient
LASIK/PRK
•
•
•
•
•
•
•
•
KCN
Monocular pts
Hx of HSV/HZV
Fuch’s/severe guttata
Glaucoma
EBMD (PRK only)
Keloid formers
Autoimmune or
uncontrolled DM
ICL
• Shallow AC (< 3.0 mm)
• Significant
corneal/endothelial
disease
• Narrow angles
• Glaucoma
• Pseudoexfoliation
• h/o significant or
recurrent iritis
• Cataracts
Counseling the patient
• Main ICL Risks
•
•
•
•
•
•
• Proper counseling is KEY!!!
• A thorough 5-10 minute pre-op discussion = no calls after hours
• Patients should understand R/B/A in YOUR office
• Main LASIK/PRK risks
•
•
•
•
•
Over/undercorrection
Dry Eye
Starburst/Glare/Halos
Infection
Loss of Vision
Counseling the patient
• RLE – Underpromise… overdeliver
• Best Choice for presbyopes that want more independence from
glasses/contacts
• Don’t promise complete freedom
• Same risks as cataract surgery with secondary benefit of avoiding
future sx.
• Still need refractive stability
• Tx DES/lid disease before sx
Over/undercorrection
Increased IOP
Formation of cataract
Retinal Detachment
Infection
Loss of Vision
• biggest cause for post-op problems in diffractive lenses
Patient counseling
RLE Pre-op discussion
• Diffractive Presbyopia Correcting Lenses
• Expect glare/halos which generally improve with time (consider bromonidine)
• Don’t promise complete independence from glasses. May still use cheaters
for dim light or fine print
• Crystalens/Trulign
• Less glare/halos
• May need glasses for near (consider blended vision)
• About 5-10% of people may require “2-step” procedure
• Treat over/undercorrection or residual cylinder with LVC
• Healing differs for individuals – Effective Lens Position
• Adaptation
Hyperopic
Patient counseling
• Vision will be blurry/hazy initially
• Improves steadily over the first week but adaptation may require
1-3 months
• More so with PRK/RLE
• LASIK/ICL tend to offer quicker recovery
• Significant pain or loss of vision (not blurry vision) warrants a call
• Vision will be better after 2nd eye (with RLE)
• Especially near vision with premium lenses
• Need for Yag – especially with premium lenses or significant PSC
• Switch prostaglandin patients to a different med peri-operatively
if possible
Myopic
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2/16/2015
Patient Outcomes
• Post-operative success is directly related to pre-operative
expectations and satisfaction
• Take the time to educate. Patients need to hear it from YOU, not from a
piece of paper.
• Review the pros and cons of all of the lens technologies so they are
prepared for their visit to the surgeon and there are no surprises
• Make sure you and the surgeon are on the same page
• Set realistic expectations, then meet or exceed them
I love my vision and
my eye care
team!!!
26