AcrySof ® ReSTOR ® Aspheric IOL. Aspheric IOL AcrySof ® ReSTOR ® 2 AcrySof ® ReSTOR ® Aspheric...

AcrySof ® ReSTOR®

Aspheric IOL

Aspheric IOL

AcrySof ® ReSTOR®

2

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

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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

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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.

Aspheric IOL

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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

Aspheric IOL

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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


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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


20/20

20/25

• Both VAs are less than two letters different and both 20/25

20/32

20/40


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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


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


0

0.1

0.2

0.3

0.4

50 cm 60 cm 70 cm

LogM

AR


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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0

0.1

0.2

0.3

0.4

50 cm 60 cm 70 cm

LogM

AR


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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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


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-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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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


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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


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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


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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


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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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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


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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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


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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



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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



Perc

ent o

f Sub

ject

s

Aspheric IOL

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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

AcrySof ® ReSTOR ® Aspheric IOL. Aspheric IOL AcrySof ® ReSTOR ® 2 AcrySof ® ReSTOR ® Aspheric...

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