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Clinical Performance of the Crystalens® AO

Guy M. Kezirian, MD, FACS

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Disclosures • The presenter is

– A paid consultant to Bausch & Lomb – Owner of SurgiVision® Consultants, Inc.

• Provides DataLink IOL Edition for B&L surgeons

• Data in this report are taken from DataLink IOL Edition – An Online IOL Registry - not a study

• Data in this report have not been audited

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Crystalens AO (Aspheric Optic)

3rd IOL in a series of 5.0 mm optics lenses in the Crystalens series

1. Five-O – Square edge design, new haptic configuration

2. HD – Added a 2 mm “Blended bi-spheric” central optic – Net result is mild asphericity to increase near vision

3. AO – Smooth, aspheric optic designed to be less

sensitive to small decentrations – FDA Approved 10-23-2009

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Available Powers:

Crystalens AO

10.0 to 33.0 D in 0.50-D steps

18 - 22 in 0.25-D steps

Crystalens HD

10.0 to 33.0 D in 0.50-D steps

18.0 to 22.75 D in 0.25-D steps

Crystalens Five-O

4.0 to 9.0 D in 1-D steps

10.0 to 16.0 D in 0.50-D steps

16.25 to 26.75 D in 0.25-D steps

27.0 to 33.0 D in 0.50-D stepsCrystalens AO Product Specifications Only:

Diameter: 5.0 mm

Shape: Biconvex

Material: Biosil®

Recommended Starting A Constant: AO 119.1

Recommended Starting ACD: 5.61 mm

Overall length: AT50AO 11.5 mm (17.0 to 33.0 D)

AT52AO 12.0 mm (10.0 to 16.5 D)4/10/2010 Guy M. Kezirian, MD, FACS

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Methods • DataLink IOL Edition is an online registry

available to all Crystalens users • This report evaluates AO outcomes

– Based on single procedure outcomes, only – Operated December, 2009 – September, 2010

• Eligibility Criteria – Excluded eyes with preop pathology, prior LASIK,

extreme axial lengths (<19 or > 28)– Required complete postop data (Distance / Near /

Refraction)– Exam required to be greater than 3 weeks from

surgery – Eyes with reported PCO excluded

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• Overall, 3,250 AO lenses have been reported

into DataLink • 76 surgeons contributed 576 eyes that met all

the eligibility criteria – Most common exclusions were

• Fewer than qualifying 5 eyes per surgeon / n = 1,913 • Incomplete data (esp. intermediate VA), prior conditions / n = 962• Postop exams for early visits, only (e.g., 1 week postop) / n = 273

<5 Eyes: 1913

Incomplete Data: 962

Postop Too Early: 273

Complete Data: 576

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Postop Spheroequivalent Error from Targeted (D)

≤ -2.00 D <-1.50 to -2.00 D

<-1.00 to -1.50 D

<-0.50 to -1.00 D

± 0.50 D >+0.50 to +1.00 D

>+1.00 to +1.50 D

>+1.50 to +2.00 D

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

0.0% 0.7%5.0%

21.0%

64.5%

6.6%1.6% 0.5%

Pe

rce

nt E

yes

Mean -0.16 ± 0.54 DN = 576

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Average Visual OutcomesDistance Targets (Plano to -0.50 D)

Distance Intermediate Near0

10

20

30

40

50

60

70

80

90

100

28.521.9

30.5

Un

corr

ect

ed

Vis

ua

l Acu

ity

20

/

N = 402

Worse B

etter

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UCVA (Rates)Distance Targets (Plano to -0.50 D)

Distance Intermediate Near0%

10%20%30%40%50%60%70%80%90%

100%

32.1%

60.4%

19.9%

56.2%

80.3%

46.5%

75.1%

91.0%

72.9%

20/20 20/25 20/30N = 402

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Comparison to Prior Crystalens Models(Comparison Data: April 2010 ASCRS)

Distance Intermediate Near15.0

20.0

25.0

30.0

35.0

30.6

24.6

32.830.7

22.7

31.0

28.5

21.9

30.5

Crystalens Five-O Crystalens HD Crystalens AO

UC

VA

(2

0/X

)

Worse

Better

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Comparison to Other IOL’s: Rate of 20/30 or Better Standardized Outcomes Comparison (S.E. ± 1 D / ≤ 1 D Cyl)

Distance Intermediate Near0%

10%20%30%40%50%60%70%80%90%

100% 92%

79%

97%91%

70%

98%93%

99%

86%

Restor Plus 3 Tecnis Multifocal Crystalens AO

Pe

rce

nt

Eye

s

N = 2,867 N = 451 N = 3,724

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Distance UCVA v. Cylinder DefocusSpheroequivalent within ± 0.25 D

15

20

25

30

35

40

45

50Cyl ≤0.25 D Cyl >0.25 and ≤ 0.75 D Cyl > 0.75 AND ≤ 1.50 D

UC

VA

:

20/X

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Discussion • This report is based on reliable, complete data sets that met study

criteria

– Can be used to confirm the results in the general registry, which show similar findings

• Findings suggest that results with the AO lens are equal or better than prior crystalens models

• Compared to the ReSTOR Plus 3 and the Tecnis multifocal:

– Intermediate acuities are better with the AO

– Near acuities are not as good

• Surgeons should measure and document intermediate acuities as part of the routine postop visit!

– Use the VA card made for this purpose

• The final refractive outcome is critical to the performance of Presby IOLs!

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Thank You

Guy M. Kezirian, MD, FACS

Guy1000@SurgiVision.net