AcrySof ® ReSTOR ® Aspheric IOL

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AcrySof ® ReSTOR®
Aspheric IOL
AcrySof ® ReSTOR®
Aspheric IOL
AcrySof ® ReSTOR® Aspheric IOL
SN6AD3
SN6AD1
Add Power: +4 D
Spectacle Plane: 3.2 D
Range: +10 D to +34 D
A-Constant: 118.9
Add Power: +3 D
Spectacle Plane: 2.4 D
Range: +10 D to +34 D
A-Constant: 118.9
2
AcrySof ® ReSTOR®
Aspheric IOL
Discussion Topics
• Aspheric (SN6AD3) vs. Spheric (SN60D3)
• Introduction of SN6AD1
• True performance at near, intermediate
and distance
• Comparison between SN6AD1 and SN6AD3
• High resolution image quality
• Minimal visual disturbances
3
AcrySof ® ReSTOR®
Aspheric IOL
Anatomy of the Apodized
Diffractive Technology
Central 3.6 mm
apodized diffractive
structure
Step heights
decrease peripherally
from 1.3 – 0.2 microns
Anterior
aspheric
optic
A +4 D at lens plane
equaling +3.2 at
spectacle plane
Outer refractive zone
4
AcrySof ® ReSTOR®
Aspheric IOL
Anatomy of the Apodized
Diffractive Technology
13.0 mm
Anterior
Apodized
Diffractive Optic
6.0 mm
Symmetric
Biconvex
6.0 mm
Anterior
Aspheric Optic
5
AcrySof ® ReSTOR®
Aspheric IOL
Apodization
• Gradual reduction or blending
of the diffractive step heights.
• Optimally manages light energy
delivered to the retina as it
distributes the appropriate
amount of light to near and
distant focal points, regardless
of the lighting situation.
• Designed to improve image
quality while minimizing visual
disturbances.
1.3 micron
step
6
AcrySof ® ReSTOR®
Aspheric IOL
Technology of the AcrySof ®
ReSTOR® IOL in “Human” Terms
• Thickness of a Human Hair
= 60 microns
• Thickness of a Red Blood Cell
= 7 microns
• Step Height at periphery of
the diffractive portion of the
AcrySof ® ReSTOR® Aspheric
IOL = 0.2 microns
7
AcrySof ® ReSTOR®
Aspheric IOL
Design Objective
• Design considerations for the AcrySof ®
ReSTOR® Aspheric IOL:
– Induce negative Spherical Aberrations with the
lens to compensate for positive corneal Spherical
Aberrations
8
AcrySof ® ReSTOR®
Aspheric IOL
The Problem – Spherical Optics
Marginal Rays
Spherical IOL
Light Rays
Paraxial Rays
Spherical
Aberration
• Spherical aberration occurs when light rays are
over-refracted at the periphery of a lens system,
resulting in a region of defocused light which can
decrease image quality.
9
*Smith,
G., Atchinson D.A., (1997) The Eye and Visual Optical Instruments. Cambridge University Press, Cambridge, United Kingdom, pp. 667.
AcrySof ® ReSTOR®
Aspheric IOL
The Solution – Aspheric Optics
Aspheric IOL
Light Rays
Aspheric
Surface
• Aspheric optics align the light rays to compensate for
positive corneal spherical aberration, resulting in
enhanced image quality.
10
*Smith,
G., Atchinson D.A., (1997) The Eye and Visual Optical Instruments. Cambridge University Press, Cambridge, United Kingdom, pp. 667.
AcrySof ® ReSTOR®
Aspheric IOL
AcrySof ® ReSTOR® Aspheric IOL
(SN6AD3) Specifications
OPTICS
13.0 mm
6.0 mm
Multifocal
Apodized Diffractive Optic
Compensation for Positive
Corneal Spherical Aberration
Aspheric Optic
Optic Type
Proprietary Symmetric Biconvex
Optic Diameter
6.0 mm
Overall Length
13.0 mm
MATERIAL
Optic/Haptic Material
AcrySof® Hydrophobic Acrylic
Light Filtration
UV and High-Energy Blue
DESIGN
IOL Design
Single-Piece
Haptic Design
STABLEFORCE® Modified-L
SPECIFICATIONS
Diopter Range
+10 D – +30 D in 0.5 D increments
+31 D – +34 D in 1.0 D increments
11
Introducing
AcrySof ® ReSTOR®
Aspheric IOL +3 D
AcrySof ® ReSTOR®
Aspheric IOL
Lens Objectives
• Offer an additional choice of add power
• Maintain existing optical design characteristics and
manufacturing processes
• Without affecting visual disturbances or image contrast
13
AcrySof ® ReSTOR®
Aspheric IOL
SN6AD1 Design Characteristics
• Utilizes existing ReSTOR® Aspheric +4 D platform
with identical asphericity, energy distribution profile,
and shape factor
• Modified add power from +4 D to +3 D
– 9 diffractive rings vs. 12 diffractive rings
– Slightly wider ring spacing to modify the add power
14
AcrySof ® ReSTOR®
Aspheric IOL
Physical Comparison
+4 D, 12 zones
+3 D, 9 zones
• Both +4 D and +3 D have 3.6 mm
Apodized Diffractive region
• +4 D central zone diameter = 0.742 mm
• +3 D central zone diameter = 0.856 mm
15
AcrySof ® ReSTOR®
Aspheric IOL
FRACTION OF ENERGY
Physical Comparison
ReSTOR ® Energy Balance
4.0 D add vs. 3.0 D add
1.0
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.0
ReSTOR® Aspheric +3 D Distance
ReSTOR ® +4 D
Add Distance
ReSTOR® Aspheric +4 D Near
ReSTOR® Aspheric +3 D Near
1.0
2.0
3.0
4.0
5.0
6.0
LENS DIAMETER (mm)
• Diffractive step height profile and energy distribution are
identical for +4 D and +3 D ReSTOR® Aspheric IOLs
Data on File. Alcon, Inc.
16
AcrySof ® ReSTOR®
Aspheric IOL
Study Objective
To confirm that the increase in the distance of near
vision for the ReSTOR® Aspheric +3 D IOL does not
negatively impact:
• visual acuity at near, distance, or intermediate
• contrast sensitivity
• halo visual disturbance scores
as compared to the ReSTOR® Aspheric +4 D IOL
17
AcrySof ® ReSTOR®
Aspheric IOL
Study Design
•
•
•
•
•
Prospective
Randomized
Subject masked
6 month duration with FDA submission at 3 months
300 subjects bilaterally implanted with either
– AcrySof ® ReSTOR® Aspheric +3 D IOL Model SN6AD1
– AcrySof ® ReSTOR® Aspheric +4 D IOL Model SN6AD3
• Approximately 20 subjects at each site
18
True VA Performance
• Near • Intermediate • Distance
AcrySof ® ReSTOR®
Aspheric IOL
Mean Distance VA
Uncorrected VA
Best Corrected VA
-0.1
LogMAR
20/20
0
20/25
0.1
20/32
0.2
20/40
0.3
ReSTOR® Aspheric +3 D N=138
ReSTOR® Aspheric +4 D N=131
• Both VAs are less than one letter different
20
Data on File. Alcon, Inc.
AcrySof ® ReSTOR®
Aspheric IOL
Mean Near VA at Best Distance
Uncorrected VA
Best Corrected VA
-0.1
LogMAR
20/20
0
20/25
0.1
20/32
0.2
20/40
0.3
ReSTOR® Aspheric +3 D N=138
ReSTOR® Aspheric +4 D N=131
• Both VAs are less than two letters different and both 20/25
21
Data on File. Alcon, Inc.
AcrySof ® ReSTOR®
Aspheric IOL
Mean Distance of Best Near VA
ReSTOR® Aspheric +3 D N=138
ReSTOR® Aspheric +4 D N=131
Distance in cm
40
38
36
34
32
30
28
Uncorrected in cm
Distance corrected in cm
• ReSTOR® Aspheric +3 D has approximately 6.5 cm (2.6 in)
increase in distance compared to ReSTOR® Aspheric +4 D
Data on File. Alcon, Inc.
22
AcrySof ® ReSTOR®
Aspheric IOL
Mean Uncorrected Intermediate VA
LogMAR
50 cm
60 cm
70 cm
0
20/20
0.1
20/25
0.2
20/32
0.3
20/40
0.4
ReSTOR® Aspheric +3 D N=138
ReSTOR® Aspheric +4 D N=131
• VAs are approximately 1-1.5 line(s) better for ReSTOR®
Aspheric +3 D
Data on File. Alcon, Inc.
23
AcrySof ® ReSTOR®
Aspheric IOL
Mean Distance Corrected
Intermediate VA
LogMAR
50 cm
60 cm
70 cm
0
20/20
0.1
20/25
0.2
20/32
0.3
20/40
0.4
ReSTOR® Aspheric +3 D N=138
ReSTOR® Aspheric +4 D N=131
• VAs are approximately 1.5 lines better for ReSTOR®
Aspheric +3 D
Data on File. Alcon, Inc.
24
AcrySof ® ReSTOR®
Aspheric IOL
Percent of Subjects
Combined VA’s:
Distance, Intermediate, Near
100
80
60
40
20
0
20/20 or 20/25 or 20/32 or 20/40 or
better
better
better
better
ReSTOR® Aspheric +3 D N=138
worse
than
20/40
ReSTOR® Aspheric +4 D N=131
25
Data on File. Alcon, Inc.
AcrySof ® ReSTOR®
Aspheric IOL
Bilateral Defocus Curve
Refraction (D)
2
1.5
1
0.5
0
0.5
-1
-1.5
-2
-2.5
-3
-3.5
-4
-4.5
-5
-0.1
0
20/20
logMAR
0.1
0.2
0.3
20/40
0.4
0.5
0.6
0.7
ReSTOR® Aspheric +3 D
Data on File. Alcon, Inc.
ReSTOR® Aspheric +4 D
26
AcrySof ® ReSTOR®
Aspheric IOL
Clinical Defocus Curve
27
AcrySof ® ReSTOR®
Aspheric IOL
Distance Contrast Sensitivity
Mean Photopic without Glare
Log Units
2.5
2
1.5
1
0.5
0
3 cpd
6 cpd
12 cpd
18 cpd
Spatial Frequency
ReSTOR® Aspheric +3 D N=117
ReSTOR® Aspheric +4 D N=114
28
Data on File. Alcon, Inc.
AcrySof ® ReSTOR®
Aspheric IOL
Distance Contrast Sensitivity
Mean Photopic with Glare
Log Units
2.5
2
1.5
1
0.5
0
3 cpd
6 cpd
12 cpd
18 cpd
Spatial Frequency
ReSTOR® Aspheric +3 D N=117
ReSTOR® Aspheric +4 D N=114
29
Data on File. Alcon, Inc.
AcrySof ® ReSTOR®
Aspheric IOL
Distance Contrast Sensitivity
Mean Mesopic without Glare
Log Units
2.5
2
1.5
1
0.5
0
1.5 cpd
3 cpd
6 cpd
12 cpd
Spatial Frequency
ReSTOR® Aspheric +3 D N=117
ReSTOR® Aspheric +4 D N=114
30
Data on File. Alcon, Inc.
AcrySof ® ReSTOR®
Aspheric IOL
Distance Contrast Sensitivity
Mean Mesopic with Glare
Log Units
2.5
2
1.5
1
0.5
0
1.5 cpd
3 cpd
6 cpd
12 cpd
Spatial Frequency
ReSTOR® Aspheric +3 D N=117
ReSTOR® Aspheric +4 D N=114
31
Data on File. Alcon, Inc.
AcrySof ® ReSTOR®
Aspheric IOL
Distance Image Quality
in Mesopic Conditions
40
30
21
22
20
18
11
10
10
0
5 mm Aperture
ReSTOR® Aspheric +3 D
ReSTOR® Aspheric +4 D
TECNIS* MF IOL
REZOOM* IOL
ACRI.LISA* 366D
MTF measured with model eye at 100 lp/mm.
All IOL powers range from 20.0D to 22.0D
Data on File. Alcon, Inc. *Trademarks are property of their respective owners.
32
Minimal Visual
Disturbances
AcrySof ® ReSTOR®
Aspheric IOL
Mean Visual Disturbances
None
Moderate
Mild
Severe
Problems with Night Vision
Problems with Color Perception
Halos
Glare/Flare
Double Vision
Distorted Near Vision
Distorted Far Vision
Blurred Near Vision
Blurred Far Vision
0
1
2
3
ReSTOR® Aspheric +3 D N=138
Data on File. Alcon, Inc.
4
5
6
ReSTOR® Aspheric +4 D N=131
7
34
AcrySof ® ReSTOR®
Aspheric IOL
Mean Visual Disturbances
ACRI.LISA*
REZOOM*
ReSTOR® Aspheric +4 D
Images provided by Jim Schwiegerling at the University of Arizona
*Trademarks are property of their respective owners.
TECNIS*
ReSTOR® Aspheric +3 D
35
AcrySof ® ReSTOR®
Aspheric IOL
Frequency of Spectacle Wear
(Distance Vision)
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
ReSTOR® Aspheric +3 D N=138
ReSTOR® Aspheric +4 D N=131
Never
Sometimes
Always
How often do you wear glasses?
36
Data on File. Alcon, Inc.
AcrySof ® ReSTOR®
Aspheric IOL
Frequency of Spectacle Wear
(Overall)
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
ReSTOR® Aspheric +3 D N=138
ReSTOR® Aspheric +4 D N=131
Never
Sometimes
Always
How often do you wear glasses?
37
Data on File. Alcon, Inc.
AcrySof ® ReSTOR®
Aspheric IOL
Percent of Subjects
96% of ReSTOR +3 Patients Would
Have the Same Implant Again
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
ReSTOR® Aspheric +3 D N=149
ReSTOR® Aspheric +4 D N=139
No
Yes
Would you have the same implant again?
38
Data on File. Alcon, Inc.
AcrySof ® ReSTOR®
Aspheric IOL
AcrySof ® ReSTOR®
Aspheric IOL Conclusions
• True performance at near, intermediate, and distance
• ReSTOR® Aspheric +3 D IOL provides a range of
near vision
– Best distance approximately 7cm out for ReSTOR®
Aspheric +3 D IOL
•
•
•
•
1 – 1.5 line(s) improvement in intermediate VA
Aspheric optic provides improved image quality
No significant differences in visual disturbances
High rate of patient satisfaction and spectacle
independence
39
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