AcrySof IQ ReSTOR +3.0 D IOL True Performance at … Performance at All Distances: the consistent...

NearIntermediateDistance

333

AcrySof® IQ ReSTOR® +3.0 D IOL

True Performance at All Distances

The Power of +3

Based on the defocus curve, the AcrySof® IQ ReSTOR® +3.0 D IOL

provides a full spectrum of visual acuity to satisfy patient needs:

• Near

Mean VA is 20/20 at 40 cm (16 in)

• Intermediate

Mean VA is 20/20 at 50 cm (20 in)

• Distance

Mean VA is 20/20 at distance

5 mm Aperture

Distance FocusNear Focus

02 3 4 5 6

10

100

Pupil Size (mm)

Reti

nal I

llum

inan

ce (

Trol

ands

)

Normal Light

Cone Threshold ≈0.01

Dim Light

Binocular Defocus Curve1

20/40

20/50

+6.0 D to +30.0 D in 0.5 D increments+31.0 D to +34.0 D in 1.0 D increments


Apodized, aspheric, biconvex

6.0 mm

13.0 mm

0º

118.9†

UV and blue-light filtering

Model Number

Add Power

Add Power to Spectacle Plane

Number of Steps

Diopter Range

Optic Type

Optic Diameter

Overall Length

Haptic Angulation

Suggested A-Constant

Filtration

SN6AD1

+3.0 D

+2.5 D

9

SN6AD3

+4.0 D

+3.2 D

12

20/32

20/25

20/20

Snel

len

MTF

(%)

Speci�cations

Overall Patient Satisfaction with Vision (Without Glasses)1*

Prior to Cataract Surgery

After Bilateral+3.0 D Surgery

0

1

2

3

3.3

0.5

4

Distance Image Quality in Mesopic Conditions2

0

10

20

30

IQ ReSTOR® IOL

TECNIS† Multifocal IOL

CRYSTALENS†

HD500CRYSTALENS†

Five-OReSTOR®

Spherical +4.0 DREZOOM†

IOLACRI.LISA†

366D


+0.00 -0.50 -1.00 -1.50 -2.00 -2.50 -3.00 -3.50 -4.00

20/40

20/50

20/32

20/25

20/20

Refraction (D)

Snel

len

IQ ReSTOR® IOL +4.0 D (N=114)IQ ReSTOR® IOL +3.0 D (N=117)

Overall Frequency of Spectacle Wear1

Never Sometimes Always0

20

40

60

80

100

Perc

ent o

f Sub

ject

s

Not at AllSatis�ed

CompletelySatis�ed

∞ 70 cm (28 in)

50 cm(20 in)

40 cm(16 in)

33 cm(13 in)

AcrySof® IQ ReSTOR® +3.0 D IOL Amount of Theoretical Light2

Refraction (D)

AcrySof® IQ ReSTOR® +4.0 D IOL (N=114)AcrySof® IQ ReSTOR® +3.0 D IOL (N=116)

∞ 70 cm (28 in)

50 cm(20 in)

40 cm(16 in)

33 cm(13 in)

+0.00 -0.50 -1.00 -1.50 -2.00 -2.50 -3.00 -3.50 -4.00

Mean Binocular Distance-Corrected VA at 6 months1*

Intermediate60 cm (24 in)

20/15

Snel

len

Distance NearIntermediate 50 cm (20 in)


AcrySof® IQ ReSTOR® +3.0 D IOL Theoretical Total Energy Balance2

02 3 4 5 6

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

Pupil Size (mm)

Rela

tive

Ene

rgy

Normal Light Dim Light



20/40

20/50

20/32

20/25

20/20

Comparison of mean defocus curves for AcrySof ® IQ ReSTOR® IOLs 6 months postoperatively after binocular implantation.

1. AcrySof® IQ ReSTOR® IOL Directions for Use.CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.INDICATIONS: The AcrySof ® IQ ReSTOR® Posterior Chamber Intraocular Lens (IOL) is intended for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag.Please refer to the back cover for important safety information for AcrySof ® IQ ReSTOR® IOL.

A Greater Range of Visual Acuity

The next evolution of a proven presbyopia-correcting IOL platform, the AcrySof® IQ ReSTOR® +3.0 D IOL delivers

True Performance at All Distances: the consistent near and far vision you expect, with significantly improved intermediate vision as

compared to AcrySof® IQ ReSTOR® +4.0 D IOL.

5 mm Aperture


02 3 4 5 6

10

100

Pupil Size (mm)

Reti

nal I

llum

inan

ce (

Trol

ands

)

Normal Light


Dim Light


20/40

20/50




6.0 mm

13.0 mm

0º

118.9†


Model Number

Add Power


Number of Steps

Diopter Range

Optic Type

Optic Diameter

Overall Length

Haptic Angulation


Filtration

SN6AD1

+3.0 D

+2.5 D

9

SN6AD3

+4.0 D

+3.2 D

12

20/32

20/25

20/20

Snel

len

MTF

(%)

Speci�cations




0

1

2

3

3.3

0.5

4


0

10

20

30

IQ ReSTOR® IOL


CRYSTALENS†

HD500CRYSTALENS†

Five-OReSTOR®


IOLACRI.LISA†

366D


+0.00 -0.50 -1.00 -1.50 -2.00 -2.50 -3.00 -3.50 -4.00

20/40

20/50

20/32

20/25

20/20

Refraction (D)

Snel

len




20

40

60

80

100

Perc

ent o

f Sub

ject

s



∞ 70 cm (28 in)

50 cm(20 in)

40 cm(16 in)

33 cm(13 in)


Refraction (D)


∞ 70 cm (28 in)

50 cm(20 in)

40 cm(16 in)

33 cm(13 in)

+0.00 -0.50 -1.00 -1.50 -2.00 -2.50 -3.00 -3.50 -4.00



20/15

Snel

len




02 3 4 5 6

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

Pupil Size (mm)

Rela

tive

Ene

rgy




20/40

20/50

20/32

20/25

20/20

* “Near” acuities were adjusted for the working distance – “20/20” letter font size is smaller for patients tested at a “near” distance of ~31-33 cm (patients implanted with Model SN6AD3) than it is for patients tested at a “near” distance of ~37-40 cm (patients implanted with Model SN6AD1). Patients implanted with the + 4.0 add model will generally be able to read smaller font size at “near” than those implanted with the + 3.0 add, due to the different working distance.

A Proven Satisfaction

Patients reported a significant improvement in

vision after bilateral cataract surgery.

5 mm Aperture


02 3 4 5 6

10

100

Pupil Size (mm)

Reti

nal I

llum

inan

ce (

Trol

ands

)

Normal Light


Dim Light


20/40

20/50




6.0 mm

13.0 mm

0º

118.9†


Model Number

Add Power


Number of Steps

Diopter Range

Optic Type

Optic Diameter

Overall Length

Haptic Angulation


Filtration

SN6AD1

+3.0 D

+2.5 D

9

SN6AD3

+4.0 D

+3.2 D

12

20/32

20/25

20/20

Snel

len

MTF

(%)

Speci�cations




0

1

2

3

3.3

0.5

4


0

10

20

30

IQ ReSTOR® IOL


CRYSTALENS†

HD500CRYSTALENS†

Five-OReSTOR®


IOLACRI.LISA†

366D


+0.00 -0.50 -1.00 -1.50 -2.00 -2.50 -3.00 -3.50 -4.00

20/40

20/50

20/32

20/25

20/20

Refraction (D)

Snel

len




20

40

60

80

100

Perc

ent o

f Sub

ject

s



∞ 70 cm (28 in)

50 cm(20 in)

40 cm(16 in)

33 cm(13 in)


Refraction (D)


∞ 70 cm (28 in)

50 cm(20 in)

40 cm(16 in)

33 cm(13 in)

+0.00 -0.50 -1.00 -1.50 -2.00 -2.50 -3.00 -3.50 -4.00



20/15

Snel

len




02 3 4 5 6

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

Pupil Size (mm)

Rela

tive

Ene

rgy




20/40

20/50

20/32

20/25

20/20

Because it delivers True Performance at All Distances,

94% of patients indicated they would have the

AcrySof® IQ ReSTOR® +3.0 D IOL implanted again.1*

Patient-reported spectacle independence was determined using the Cataract TyPE Specification instrument (Javitt, 1997). Spectacle independence rates between the Model SN6AD1 and Model SN6AD3 were similar, with better than 78% of patients in both groups reporting “never” having to use glasses at any time.

1. AcrySof ® IQ ReSTOR® Directions for Use.* Some side effects that patients may experience include glare, halos and blurred vision, and reduction of sensitivity in low lighting conditions.CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.INDICATIONS: The AcrySof ® IQ ReSTOR® Posterior Chamber Intraocular Lens (IOL) is intended for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag.Please refer to the back cover for important safety information for AcrySof ® IQ ReSTOR® IOL.

Better Image Quality by Design1

The AcrySof® IQ ReSTOR® +3.0 D IOL utilizes apodization within

the central 3.6 mm optic zone to control light distribution to

both near and distant focal points. This gradual decrease in

step heights from center to periphery delivers enhanced image

quality by optimally allocating energy to the retina based on all

lighting conditions.

• Precise reduction in step heights from

1.3 to 0.2 microns

• Higher step heights direct more light to

the near focal point

• Light energy is gradually distributed to the

distant focal point as the pupil enlarges

1. AcrySof ® IQ ReSTOR® Directions for Use.

Improved Vision in All Lighting Conditions2

• Sends optimal light to both near and distant focal

points, providing a full range of quality vision

• As the pupil dilates (low-light situations), the

refractive portion sends a greater percentage of

light energy to the distance focal point

• Manages nighttime visual disturbances (halos)

caused by defocused light

• As the pupil dilates to 6 mm, for both distance and near vision

images, the AcrySof® IQ ReSTOR® +3.0 D IOL provides ample

amount of light that is well above the threshold (0.01 Trolands)

for retinal cone receptors to function

5 mm Aperture


02 3 4 5 6

10

100

Pupil Size (mm)Re

tina

l Illu

min

ance

(Tr

olan

ds)

Normal Light


Dim Light


20/40

20/50




6.0 mm

13.0 mm

0º

118.9†


Model Number

Add Power


Number of Steps

Diopter Range

Optic Type

Optic Diameter

Overall Length

Haptic Angulation


Filtration

SN6AD1

+3.0 D

+2.5 D

9

SN6AD3

+4.0 D

+3.2 D

12

20/32

20/25

20/20

Snel

len

MTF

(%)

Speci�cations




0

1

2

3

3.3

0.5

4


0

10

20

30

IQ ReSTOR® IOL


CRYSTALENS†

HD500CRYSTALENS†

Five-OReSTOR®


IOLACRI.LISA†

366D


+0.00 -0.50 -1.00 -1.50 -2.00 -2.50 -3.00 -3.50 -4.00

20/40

20/50

20/32

20/25

20/20

Refraction (D)

Snel

len




20

40

60

80

100

Perc

ent o

f Sub

ject

s



∞ 70 cm (28 in)

50 cm(20 in)

40 cm(16 in)

33 cm(13 in)


Refraction (D)


∞ 70 cm (28 in)

50 cm(20 in)

40 cm(16 in)

33 cm(13 in)

+0.00 -0.50 -1.00 -1.50 -2.00 -2.50 -3.00 -3.50 -4.00



20/15

Snel

len




02 3 4 5 6

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

Pupil Size (mm)

Rela

tive

Ene

rgy




20/40

20/50

20/32

20/25

20/20

5 mm Aperture


02 3 4 5 6

10

100

Pupil Size (mm)

Reti

nal I

llum

inan

ce (

Trol

ands

)

Normal Light


Dim Light


20/40

20/50




6.0 mm

13.0 mm

0º

118.9†


Model Number

Add Power


Number of Steps

Diopter Range

Optic Type

Optic Diameter

Overall Length

Haptic Angulation


Filtration

SN6AD1

+3.0 D

+2.5 D

9

SN6AD3

+4.0 D

+3.2 D

12

20/32

20/25

20/20Sn

elle

n

MTF

(%)

Speci�cations




0

1

2

3

3.3

0.5

4


0

10

20

30

IQ ReSTOR® IOL


CRYSTALENS†

HD500CRYSTALENS†

Five-OReSTOR®


IOLACRI.LISA†

366D


+0.00 -0.50 -1.00 -1.50 -2.00 -2.50 -3.00 -3.50 -4.00

20/40

20/50

20/32

20/25

20/20

Refraction (D)

Snel

len




20

40

60

80

100

Perc

ent o

f Sub

ject

s



∞ 70 cm (28 in)

50 cm(20 in)

40 cm(16 in)

33 cm(13 in)


Refraction (D)


∞ 70 cm (28 in)

50 cm(20 in)

40 cm(16 in)

33 cm(13 in)

+0.00 -0.50 -1.00 -1.50 -2.00 -2.50 -3.00 -3.50 -4.00



20/15

Snel

len




02 3 4 5 6

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

Pupil Size (mm)

Rela

tive

Ene

rgy




20/40

20/50

20/32

20/25

20/20

Note: Some visual effects with AcrySof ® IQ ReSTOR® IOLs may be expected due to the superposition of focused and unfocused multiple images. These may include some perceptions of halos or radial lines around point sources of light under nighttime conditions. A reduction in contrast sensitivity as compared to a monofocal IOL may be experienced by some patients and may be more prevalent in low lighting conditions. Therefore, multifocal patients should exercise caution when driving at night or in poor visibility conditions.Please refer to the back cover for important safety information for AcrySof ® IQ ReSTOR® IOL.

Excellent Biomechanics

• Single-piece design for rotational stability

• Patented STABLEFORCE® haptics for capsular bag stability

Optimal Biomaterials

• High refractive index for thinner IOL profile

• UV and blue-light filtration

Advanced Optics

• Proven aspheric design for image quality

• Thin edge profile

Ease of Implantation1,3

• Consistent design

• Consistent delivery

• Predictably unfolds*

• Easier centration*

Trusted Leadership

• Over 60 million AcrySof® IOL implants2

• Backed by the Alcon® network of support

CONFIDENCE

The Power of a Proven Platform

Built on the proven AcrySof® platform, the AcrySof® IQ ReSTOR® +3.0 D IOL

shares the same benefits of the entire AcrySof ® family:

The AcrySof ® IQ ReSTOR®+3.0 D IOL Delivers

True Performance at All Distances.

5 mm Aperture


02 3 4 5 6

10

100

Pupil Size (mm)Re

tina

l Illu

min

ance

(Tr

olan

ds)

Normal Light

Cone Threshold≈0.01

Dim Light


20/40

20/50

+6.0 D to +30.0 D in 0.5 D increments





6.0 mm

13.0 mm

0º

118.9†

UV and blue-light �ltering

Model Number

Add Power


Number of Steps

Diopter Range

Optic Type

Optic Diameter

Overall Length

Haptic Angulation


Filtration

SN6AD1

+3.0 D

+2.5 D

9

SN6AD3

+4.0 D

+3.2 D

12

20/32

20/25

20/20

Snel

len

MTF

(%

)

Speci�cations

Overall Patient Satisfaction with Vision (Without Glasses)1



0

1

2

3

3.3

0.5

4


0

10

20

30

IQ ReSTOR® IOL


CRYSTALENS†

HD500CRYSTALENS†

Five-OReSTOR®


IOLACRI.LISA†

366D


+0.00 -0.50 -1.00 -1.50 -2.00 -2.50 -3.00 -3.50 -4.00

20/40

20/50

20/32

20/25

20/20

Refraction (D)

Snel

len




20

40

60

80

100

Perc

ent

of S

ubje

cts

Not at AllSatisfied

CompletelySatisfied

∞ 70 cm (28 in)

50 cm(20 in)

40 cm(16 in)

33 cm(13 in)


Refraction (D)


∞ 70 cm (28 in)

50 cm(20 in)

40 cm(16 in)

33 cm(13 in)

+0.00 -0.50 -1.00 -1.50 -2.00 -2.50 -3.00 -3.50 -4.00

Mean Binocular Distance-Corrected VA at 6 months*1


20/15

Snel

len




02 3 4 5 6

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

Pupil Size (mm)

Rela

tive

Ene

rgy




20/40

20/50

20/32

20/25

20/20

†Provided as a guideline only.

Front View Side View

Anterior Apodized Diffractive

Aspheric Surface

PosteriorOptic Surface

13.0 mm

6.0 mm

AcrySof ® IQ ReSTOR® +3.O D IOL* Bench data on file: Monarch® Delivery Systems.Please refer to the back cover for important safety information for AcrySof® IQ IOLs.

1. AcrySof® IQ ReSTOR® IOL Directions for Use.2. Data on file. Alcon® R&D Technical Report. 3. Independent third party research; Data on File, December 2011.

© 2012 Novartis 1/12 RES11092SA AlconSurgical.com

CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.

INDICATIONS: The AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lens (IOL) is intended for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag.

WARNING/PRECAUTION: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Physicians should target emmetropia, and ensure that IOL centration is achieved. Care should be taken to remove viscoelastic from the eye at the close of surgery.

Some patients may experience visual disturbances and/or discomfort due to multifocality, especially under dim light conditions. Clinical studies with the AcrySof® ReSTOR® lens indicated that posterior capsule opacification (PCO), when present, developed earlier into clinically significant PCO. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof® IQ ReSTOR® IOLs.

Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof® Natural IOL and normal color vision. The effect on vision of the AcrySof® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45° C; use only sterile irrigating solutions such as BSS® or BSS PLUS® Sterile Intraocular Irrigating Solutions.

ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions.


INDICATIONS: The AcrySof® IQ Toric posterior chamber intraocular lenses are intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision.

WARNING/PRECAUTION: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Toric IOLs should not be implanted if the posterior capsule is ruptured, if the zonules are damaged, or if a primary posterior capsulotomy is planned. Rotation can reduce astigmatic correction; if necessary lens repositioning should occur as early as possible prior to lens encapsulation. All viscoelastics should be removed from both the anterior and posterior sides of the lens; residual viscoelastics may allow the lens to rotate.

Optical theory suggest, that, high astigmatic patients (i.e. > 2.5 D) may experience spatial distortions. Possible toric IOL related factors may include residual cylindrical error or axis misalignments. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof® IQ Toric Cylinder Power IOLs.




INDICATIONS: The AcrySof® IQ posterior chamber intraocular lens is intended for the replacement of the human lens to achieve visual correction of aphakia in adult patients following cataract surgery. This lens is intended for placement in the capsular bag.

WARNING/PRECAUTION: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Caution should be used prior to lens encapsulation to avoid lens decentrations or dislocations.



AcrySof ® IQ Toric IOL

AcrySof ® IQ IOL

AcrySof ® IQ ReSTOR® IOL

IMPORTANT SAFETY INFORMATION:

AcrySof IQ ReSTOR +3.0 D IOL True Performance at … Performance at All Distances: the consistent...

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