AcrySof ® ReSTOR ® Aspheric IOL. Aspheric IOL AcrySof ® ReSTOR ® 2 AcrySof ® ReSTOR ® Aspheric IOL SN6AD3 Add Power: +4 D Spectacle Plane: 3.2 D Range:
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AcrySof ® ReSTOR®
Aspheric IOL
Aspheric IOL
AcrySof ® ReSTOR®
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AcrySof ® ReSTOR® Aspheric IOL
SN6AD3Add Power: +4 DSpectacle Plane: 3.2 DRange: +10 D to +34 D A-Constant: 118.9
SN6AD1Add Power: +3 DSpectacle Plane: 2.4 DRange: +10 D to +34 D A-Constant: 118.9
Aspheric IOL
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• 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
Discussion Topics
Aspheric IOL
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Anatomy of the Apodized Diffractive Technology
Central 3.6 mm apodized diffractive structure
Step heights decrease peripherally from 1.3 – 0.2 microns
A +4 D at lens plane equaling +3.2 at spectacle plane
Outer refractive zone
Anterior aspheric optic
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Anatomy of the Apodized Diffractive Technology
13.0 mm
Anterior Apodized Diffractive Optic
6.0 mm6.0 mm
Symmetric Biconvex
Anterior Aspheric Optic
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• 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.
Apodization
1.3 micronstep
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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
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• Design considerations for the AcrySof ®
ReSTOR® Aspheric IOL: – Induce negative Spherical Aberrations with the
lens to compensate for positive corneal Spherical Aberrations
Design Objective
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• 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.
The Problem – Spherical Optics
Spherical Aberration
Marginal Rays
Paraxial Rays
Light Rays
Spherical IOL
*Smith, G., Atchinson D.A., (1997) The Eye and Visual Optical Instruments. Cambridge University Press, Cambridge, United Kingdom, pp. 667.
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Aspheric Surface
• Aspheric optics align the light rays to compensate for positive corneal spherical aberration, resulting in enhanced image quality.
The Solution – Aspheric Optics
*Smith, G., Atchinson D.A., (1997) The Eye and Visual Optical Instruments. Cambridge University Press, Cambridge, United Kingdom, pp. 667.
Light Rays
Aspheric IOL
Aspheric IOL
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AcrySof ® ReSTOR® Aspheric IOL
(SN6AD3) Specifications
13.0 mm
6.0 mm
OPTICSMultifocal 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
Introducing AcrySof
® ReSTOR® Aspheric IOL +3 D
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• Offer an additional choice of add power• Maintain existing optical design characteristics and manufacturing processes• Without affecting visual disturbances or image contrast
Lens Objectives
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• 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
SN6AD1 Design Characteristics
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• 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
Physical Comparison
+4 D, 12 zones
+3 D, 9 zones
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• Diffractive step height profile and energy distribution are identical for +4 D and +3 D ReSTOR® Aspheric IOLs
Physical Comparison
0.00.10.20.30.40.50.60.70.80.91.0
1.0 2.0 3.0 4.0 5.0 6.0LENS DIAM ETER (mm)
FRA
CTI
ON
OF
ENER
GY
ReSTOR ® Energy Balance4.0 D add vs. 3.0 D add
ReSTOR® Aspheric +3 D Distance
ReSTOR ® +4 D Add Distance
ReSTOR® Aspheric +4 D Near
ReSTOR® Aspheric +3 D Near
Data on File. Alcon, Inc.
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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
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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
True VA Performance• Near • Intermediate • Distance
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Mean Distance VA
-0.1
0
0.1
0.2
0.3
Uncorrected VA Best Corrected VA
LogM
AR
ReSTOR® Aspheric +3 D N=138 ReSTOR® Aspheric +4 D N=131
20/20
20/25
• Both VAs are less than one letter different
20/32
20/40
Data on File. Alcon, Inc.
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Mean Near VA at Best Distance
-0.1
0
0.1
0.2
0.3
Uncorrected VA Best Corrected VA
LogM
AR
ReSTOR® Aspheric +3 D N=138 ReSTOR® Aspheric +4 D N=131
20/20
20/25
• Both VAs are less than two letters different and both 20/25
20/32
20/40
Data on File. Alcon, Inc.
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Mean Distance of Best Near VA
• 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.
28
30
32
34
36
38
40
Uncorrected in cm Distance corrected in cm
ReSTOR® Aspheric +3 D N=138ReSTOR® Aspheric +4 D N=131
Dis
tanc
e in
cm
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Mean Uncorrected Intermediate VA
Data on File. Alcon, Inc.
0
0.1
0.2
0.3
0.4
50 cm 60 cm 70 cm
LogM
AR
ReSTOR® Aspheric +3 D N=138 ReSTOR® Aspheric +4 D N=131
20/20
20/25
20/32
20/40
• VAs are approximately 1-1.5 line(s) better for ReSTOR® Aspheric +3 D
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Data on File. Alcon, Inc.
0
0.1
0.2
0.3
0.4
50 cm 60 cm 70 cm
LogM
AR
ReSTOR® Aspheric +3 D N=138 ReSTOR® Aspheric +4 D N=131
20/20
20/25
20/32
20/40
Mean Distance Corrected Intermediate VA
• VAs are approximately 1.5 lines better for ReSTOR® Aspheric +3 D
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Data on File. Alcon, Inc.
Combined VA’s: Distance, Intermediate, Near
020406080
100
20/20 orbetter
20/25 orbetter
20/32 orbetter
20/40 orbetter
worsethan20/40
Perc
ent o
f Sub
ject
s
ReSTOR® Aspheric +3 D N=138 ReSTOR® Aspheric +4 D N=131
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Data on File. Alcon, Inc.
-0.1
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
2 1.5 1 0.5 0 0.5 -1 -1.5 -2 -2.5 -3 -3.5 -4 -4.5 -5
ReSTOR® Aspheric +3 D ReSTOR® Aspheric +4 D
Bilateral Defocus Curvelo
gMA
R
Refraction (D)
20/20
20/40
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Clinical Defocus Curve
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Data on File. Alcon, Inc.
Distance Contrast Sensitivity Mean Photopic without Glare
0
0.5
1
1.5
2
2.5
3 cpd 6 cpd 12 cpd 18 cpd
Spatial Frequency
Log
Uni
ts
ReSTOR® Aspheric +3 D N=117 ReSTOR® Aspheric +4 D N=114
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Data on File. Alcon, Inc.
Distance Contrast Sensitivity Mean Photopic with Glare
0
0.5
1
1.5
2
2.5
3 cpd 6 cpd 12 cpd 18 cpd
Spatial Frequency
Log
Uni
ts
ReSTOR® Aspheric +3 D N=117 ReSTOR® Aspheric +4 D N=114
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Data on File. Alcon, Inc.
Distance Contrast Sensitivity Mean Mesopic without Glare
0
0.5
1
1.5
2
2.5
1.5 cpd 3 cpd 6 cpd 12 cpd
Spatial Frequency
Log
Uni
ts
ReSTOR® Aspheric +3 D N=117 ReSTOR® Aspheric +4 D N=114
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Data on File. Alcon, Inc.
Distance Contrast Sensitivity Mean Mesopic with Glare
0
0.5
1
1.5
2
2.5
1.5 cpd 3 cpd 6 cpd 12 cpd
Spatial Frequency
Log
Uni
ts
ReSTOR® Aspheric +3 D N=117 ReSTOR® Aspheric +4 D N=114
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Data on File. Alcon, Inc. *Trademarks are property of their respective owners.
Distance Image Quality in Mesopic Conditions
21 22
11 1018
0
10
20
30
40
5 mm Aperture
ReSTOR® Aspheric +3 D ReSTOR® Aspheric +4 DTECNIS* MF IOL REZOOM* IOLACRI.LISA* 366D
MTF measured with model eye at 100 lp/mm.All IOL powers range from 20.0D to 22.0D
Minimal Visual Disturbances
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Data on File. Alcon, Inc.
Mean Visual Disturbances
0 1 2 3 4 5 6 7
Blurred Far Vision
Blurred Near Vision
Distorted Far Vision
Distorted Near Vision
Double Vision
Glare/Flare
Halos
Problems with Color Perception
Problems with Night Vision
ReSTOR® Aspheric +3 D N=138 ReSTOR® Aspheric +4 D N=131
Mild Moderate SevereNone
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Mean Visual Disturbances
ACRI.LISA* REZOOM* TECNIS*
ReSTOR® Aspheric +4 D ReSTOR® Aspheric +3 D
*Trademarks are property of their respective owners.Images provided by Jim Schwiegerling at the University of Arizona
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Data on File. Alcon, Inc.
Frequency of Spectacle Wear(Distance Vision)
How often do you wear glasses?
0%10%20%30%40%50%60%70%80%90%
100%
Never Sometimes Always
ReSTOR® Aspheric +3 D N=138
ReSTOR® Aspheric +4 D N=131
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Data on File. Alcon, Inc.
Frequency of Spectacle Wear(Overall)
How often do you wear glasses?
0%10%20%30%40%50%60%70%80%90%
100%
Never Sometimes Always
ReSTOR® Aspheric +3 D N=138
ReSTOR® Aspheric +4 D N=131
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Data on File. Alcon, Inc.
96% of ReSTOR +3 Patients Would Have the Same Implant Again
Would you have the same implant again?
0%10%20%30%40%50%60%70%80%90%
100%
No Yes
ReSTOR® Aspheric +3 D N=149
ReSTOR® Aspheric +4 D N=139
Perc
ent o
f Sub
ject
s
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• 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
AcrySof ® ReSTOR®
Aspheric IOL Conclusions
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