Tech lecture for SA - · PDF fileTech lecture for SA.pptx Author: DOUGLAS KOCH Created Date:...
Transcript of Tech lecture for SA - · PDF fileTech lecture for SA.pptx Author: DOUGLAS KOCH Created Date:...
7/2/12
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What’s new in IOL technology?
Douglas D. Koch, M.D. Cullen Eye Institute, Baylor College of Medicine, Houston, TX
I have a financial interest with the following
companies: Abbo8 Medical Op<cs Alcon Calhoun Vision Carl Zeiss Meditec NuLens Op<medica Ziemer
Financial Disclosure
Shockingly little
Why????
US Cataract Procedures
0
500
1,000
1,500
2,000
2,500
3,000
3,500
2007 2008 2009 2010 2011 2012*
2,987
3,075
3,167
3,248
3,306
3,452
US Ca
taract Procedu
res (000)
Source: Market Scope EsEmates * Forecast
Many reasons
Excellent results with current technology
FDA and costs of introducing new technology (>$10 million)
Few if any breakthroughs in the key area: Accommodative IOLS
Current IOLs are great.. . . But do we have the ideal IOL? Not even close. . . Problems include:
Unwanted visual symptoms Inability to adjust power No decent accommodating IOLs PCO Etc.!
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So what do we have now?
Monofocal Multifocal Accommodating Toric monofocal
Monofocal: Silicone 3-piece IOLs
Advantages: No cosmetic reflection Little if any dysphotopsia
Disadvantages: A bit harder to insert Require > 2.8 mm incision Occasional early fibrotic PCO ? Not as accurate for IOL power
Monofocal: Hydrophilic acrylic IOLs
Advantages: No cosmetic reflection Little if any dysphotopsia Fairly easy to insert
Monofocal: Hydrophilic acrylic IOLs
Disadvantages: Increased PCO Can become tilted with
XS capsular forces Reports of surface
opacification (calcium)
Monofocal: Hydrophobic acrylic IOLs
Advantages (one-piece): Easy to insert Excellent biocompatibility Tight accuracy for IOL calcs
Monofocal: Hydrophobic acrylic IOLs
Disadvantages: Negative dysphotopsia Cosmetic: reflection with higher
refractive index
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Anything new?
Incisions smaller with better cartridges and injectors
Preloaded injectors But no new materials or designs
Multifocal IOLs Refractive: Rezoom
Issues: Poor near and severe halos
Multifocal IOLs: How much better can they get?
Categories Diffractive Refractive
Diffractive designs
Multiple designs
New refractive model: Lentis Mplus (Oculentis, Netherlands)
Hydrophobic acrylic
Aspheric 3.0 and 1.5 D add
models
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Potential advantages
Distance: Upper ½ and small center Light in transition zones refracted
away from fovea
Accommodating IOLs: Will complete success require a huge technology leap?
sclera ciliary muscle
cornea
lens anterior zonular fibers
UBM image of unaccommodated eye
Credit: Adrian Glasser
UBM image of unaccommodated eye
Credit: Adrian Glasser
UBM image of accommodated eye How do we harness this movement in the pseudophakic eye? Change in optic:
Position Curvature Power
Or combinations of these
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Where do we harness this movement? Capsular bag Ciliary sulcus
Do we even try to harness this movement? Use other accommodative changes:
Pupillary constriction Convergence
Accommodative
Crystalens: Hmm. . .not really Increased depth of focus maybe. .
Crystalens vs. SN60WF
*In SN60WF eyes, AA negatively correlated with pupil size (r= -0.84, p<0.05): Smaller pupil size strongly correlated with increased AA
Criteria Crystalens HD (n=9)
SN60WF (n=8)
BCDVA
20/20 LogMAR -0.01 + 0.08
(-0.12 to 0.10)
20/20 LogMar -0.02 + 0.07
(-0.12 to 0.10)
DCNVA (@40cm)
J5 – J6 LogMAR 0.34 + 0.25
(0.17 to 0.80)
J6 LogMAR 0.42 + 0.27
(0.10 to 0.80)
AA (in D)
1.76 + 0.82 (0.68 to 3.34 D)
*1.58 + 0.80 (0.63 to 2.52 D)
Pupil (mm)
2.97 + 0.52 (2.10 to 4.00)
*2.75 + 0.61 (2.52 to 3.70 mm)
Single optic: Crystalens & Tetraflex How do they work? Does it move?
< 1 mm if at all in most eyes Other proposed mechanism:
IOL flexure with accommodation
“Accommodative arching”
Mechanism:
Optic moves? Optic changes shape?
Anything new?
Several designs in clinical trials Bag fixated Sulcus fixated IOL flexes IOL moves Electro-optical design
Will they reach USA in next 5 years???
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Dual-optic design: Synchrony Two optics connected by
haptics with a spring function
Anterior optic: + 32 D Posterior optic: minus
power individualized
Implantation of Synchrony
Objective Testing All 5 eyes showed dynamic UBM
movement and iTrace refraction change cyclo near
1
cyclo near
2
cyclo near
3
cyclo near
4
cyclo near
5
2.97 D 3.22 D 2.97 D 2.94 D 2.76 D Subjective Accommodation (Push Down)
UB
M
iTra
ce
Nea
r
C
yclo
Mechanism:
Optic moves Optic changes shape?
Dual-optic: AkkoLens Sulcus implantation Optic elements slide over each other Clinical trial in progress
Mechanism:
Optic moves
Optic changes power
NuLens – Neuroadaptive model
Mechanism:
Optic moves
Optic changes shape
Optic designs: Dynamic optic FluidVision Design (PowerVision)
Mechanism:
Optic expands
Optic changes shape
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Elenza Lens: Mechanism of Action
On-‐board Photosensors (10-‐50 μ)
Capable of Sensing Pupillary Constriction and Convergence during Accommodation
Triggers Electro-‐active change in Diffractive Element
Pupillary ContracEon
∅ ∅
Eye Convergence
α
Mechanism:
Optic changes power Independent of
movement of ciliary body and capsule
New accommodative IOLs Not easy!!
Wide-open field Lots of interrelated questions:
How Where What material
Major hurdles
Bag: Need to preserve capsular flexibility
Sulcus: Need to prove long-term biocompatibility
Electro-optical: Component safety and durability
Use of Premium IOLs-‐US Cataract Surgeons
Copyright 2012, Market Scope, LLC
Total Premium, Q4-‐11, 14.5%
PC-‐IOL Total, Q4-‐11, 7.3%
Toric , Q4-‐11, 7.2%
0%
2%
4%
6%
8%
10%
12%
14%
16%
Q1-‐04
Q2-‐04
Q3-‐04
Q4-‐04
Q1-‐05
Q2-‐05
Q3-‐05
Q4-‐05
Q1-‐06
Q2-‐06
Q3-‐06
Q4-‐06
Q1-‐07
Q2-‐07
Q3-‐07
Q4-‐07
Q1-‐08
Q2-‐08
Q3-‐08
Q4-‐08
Q1-‐09
Q2-‐09
Q3-‐09
Q4-‐09
Q1-‐10
Q2-‐10
Q3-‐10
Q4-‐10
Q1-‐11
Q2-‐11
Q3-‐11
Q4-‐11
Percen
t of All US IOL Surgeries
Total Premium PC-‐IOL Total Toric
Source: Market Scope Quarterly Survey of Cataract Surgeons, Q4-‐2011 n=335
Why are multifocal/accommodating volumes flat? Surgeon lack of confidence in
outcomes Multifocal:
Quality of vision Patient complaints
Accommodating Unpredictable accommodative range
Why are multifocal/accommodating volumes flat?
Lack of confidence in surgical precision Precise biometry/astigmatic correction Need to perform PCRIs
Many surgeons are not performing PCRIs Need to perform second refractive
procedure on some Many surgeons are not performing excimer
procedures Avoidance of need for IOL exchange
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Why are multifocal/accommodating volumes flat? Lack of toric models Growth of monovision
Aided by torics
Toric IOLs are growing
Cannibalized the premium IOL market Offer the opportunity to upcharge with
a high likelihood of high patient satisfaction
The toric IOL is less expensive than presbyopia-correcting IOLs
Toric IOLs are growing
And likely to expand. . .somewhat New surgeons
But it is likely that primarily low-volume surgeons are not currently using them
New models Especially toric multifocal and
accommodative
Toric Truly new:
Increased range of powers Devices to aid alignment
ORA SM1 Tracy
Anything else new?
Puzzling cases. . .
Patient #1
Pre-op evaluation for cataract surgery in 41 year-old female
Left eye UCVA: 20/40 MR: -0.50 + 2.00 x 180 = 20/40 Retinoscopic refraction: -1.50 + 1.50 x 180
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OS: Atlas SimK astigmatism: 1.24 D@80° OS: Corneal astigmatism
Atlas SimK 1.24 D @ 80°
Galilei SimK 1.35 D @ 88°
IOLMaster K 1.23 D @ 92°
Lenstar K 1.13 D @ 93°
Galilei TCP 1.02 D @ 87°
OS: Posterior corneal astigmatism
Posterior asEg: -‐0.46 D @ 90°
TCP asEg: 1.02 D @ 87°
Monofocal IOL implanted Post-‐op refracEon: -‐0.50+0.50x100 =20/20
Patient #2: WTR astigmatism
Patient E.H. 77 y.o. male with 3+ NSC OS
Pre-op Biometry: IOL Master: Cyl: 2.01 @ 91˚ Lenstar: AST: 1.66 @ 92˚ Atlas: Astig: 1.73 @ 85˚ OPD Scan II: 1.78 @ 91˚ MR: -1.25 +1.25 x85
Lens Selected
Alcon SN6AT4 21.5D
-Placed in the bag at 91˚ -Typically used to correct 1.50D of anterior corneal astigmatism
-Target intermediate
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Post-op visit
POM #3 Computer vision “fuzzy” MR: -1.50 +0.75 x180 BCVA: 20/15 *Patient’s astigmatism is overcorrected by +0.75 D
and the axis has been flipped
Patient #3: ATR astigmatism
Patient: 71 y.o. female with 3+ NSC OS
Pre-op Biometry: IOL Master: 1.34 @ 176˚ Lenstar: 1.64 @ 173˚ Atlas: 0.95 @ 169˚ OPD Scan II: 1.31 @ 176˚
**MR: -5.75 +2.50 x176
Lens Selected
Alcon SN6AT4 13.5D
-Placed in the bag at 175˚ -To correct 1.50D of corneal astigmatism
Post-op visit
POM #1 UCVA: 20/60 -1 MR: -2.25 +1.00* x165 BCVA: 20/25 +2
*Patient’s astigmatism is undercorrected by 1 D! True for fellow eye also. . .
Galilei Dual-Scheimpflug analyzer
Combined Placido-disk and dual-Scheimpflug corneal analyzer
Total corneal power (TCP) Using Snell’s law Ray tracing through the anterior and posterior
surfaces
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Results: Corneal astigmatism magnitude
Mean ± SD (D) Range (D)
CATCP 1.07 ± 0.71 0.03 to 4.26
CASimK 1.08 ± 0.71 0.02 to 4.40
CAfront 1.20 ± 0.79 0.02 to 4.90
CAback -0.30 ± 0.15 -0.01 to -1.10
Steep meridian on anterior corneal surface
78
67 72
53
37 32
17
7 11
18 21
37 44
61
15 22
10
27 27 24 23
0
10
20
30
40
50
60
70
80
90
100
20-‐29 yrs 30-‐39 yrs 40-‐49 yrs 50-‐59 yrs 60-‐69 yrs 70-‐79 yrs 80-‐89 yrs
% of e
yes
% of eyes with steep meridian verEcal % of eyes with steep meridian horizontal % of eyes with steep meridian oblique
Steep meridian on posterior corneal surface 96
88 80
73
0 1 2 1 3 7 10 8 10 10
3 9
13 18
88 89 92
0
10
20
30
40
50
60
70
80
90
100
20-‐29 yrs 30-‐39 yrs 40-‐49 yrs 50-‐59 yrs 60-‐69 yrs 70-‐79 yrs 80-‐89 yrs
% of e
yes
% of eyes with steep meridian verEcal % of eyes with steep meridian horizontal % of eyes with steep meridian oblique
What is the effect of the posterior cornea being steep vertically?
Creates net plus power along the horizontal meridian
Therefore creates ATR ocular astigmatism
Does a clear-corneal incision make a difference?
Net change: • 0.37 D ATR shift over ten years • Same for unoperated and surgical
corneas
*Hayashi et al. AJO 2011;151:858-65
Corneal astigmatism is not stable
This long-term ATR change with age Despite temporal clear corneal cataract
surgery Must be factored in
To extend the benefit of astigmatic correction for our patients
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Recommendation #1: To account for the ATR shift with age, we need a new target for postop astigmatism*:
0.25 to 0.5 D of WTR astigmatism
(And, no, it won’t create problems if one flips the axis
a small amount!)
Recommendation #2: Account for posterior corneal astigmatism
O.5 D in with-the-rule corneas 0.3 D in against-the-rule corneas
Recommendation #3
Use the Holladay II to account for effect of IOL power and ACD
Factor in your surgically induced astigmatism
Recommendation #4: When feasible, measure. . .
Posterior corneal astigmatism Intraoperatively
Baylor Toric IOL Nomogram WTR Astigmatism
(Target range 0.25 - 0.50 D WTR)
Astigmatism (D) Toric IOL
≤ 1.69 0 (PCRI if >1.00)
1.70 – 2.19 T3
2.20 – 2.69 T4
2.70 – 3.19 T5
0.7 D shift: UP
Baylor Toric IOL Nomogram ATR Astigmatism
(Target range 0.25 - 0.50 D WTR)
Astigmatism (D) Toric IOL
< 0.39 0
0.40* – 0.79 T3
0.80 – 1.29 T4
1.30 – 1.79 T5
*Especially if specs have more ATR
0.7 D shift: DOWN