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1
Clinical Performance of the Crystalens® AO
Guy M. Kezirian, MD, FACS
2
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
3
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
4
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
5
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
6
• 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
7
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
8
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
9
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
10
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
11
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
12
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
13
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!