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

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Conclusion

  Needs more work  Data  Accuracy  Role of refraction as predictive factor  Age   It undoubtedly will change!

Thank you

Thank you for your attention