Laser Refractive Cataract Surgerywith the

LenSx® Laser

a Novartis company

LenSx® Laser

LSX12241SK

1

LenSx® Laser Important Safety InformationWarnings:The LenSx® Laser System should only be operated by a physician trained in its use. The LenSx® Laser delivery system employs onesterile disposable LenSx® Laser Patient Interface consisting of an applanation lens and suction ring. The Patient Interface is intended for single use only. The disposables used in conjunction with ALCON® instrument products constitute a complete surgical system. Use of disposables other than those manufactured by Alcon may affect system performance and create potential hazards. The physician should base patient selection criteria on professional experience, published literature, and educational courses. Adult patients should be scheduled to undergo cataract extraction.

Caution:United States Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner.

Indication:The LenSx® Laser is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

Restrictions:• Patients must be able to lie flat and

• Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the capsulotomy

• Conditions which would cause inadequate clearance between the intended capsulotomy depth and the endothelium (applicable to capsulotomyonly)

• Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape

• Corneal thickness requirements that are beyond the range of the system

• Corneal opacity that would interfere with the laser beam

• Hypotony, glaucoma, or the presence of cataract extraction.

Precautions:• Do not use cell phones or pagers of any kind

in the same room as the LenSx® Laser.• Discard used Patient Interfaces as medical

waste.

AEs/Complications:• Capsulotomy, phacofragmentation, or cut or

incision decentration• Incomplete or interrupted capsulotomy,

fragmentation, or corneal incision procedure• Capsular tear• Corneal abrasion or defect• Pain• Infection• Bleeding• Damage to intraocular structures• Anterior chamber fluid leakage, anterior

chamber collapse• Elevated pressure to the eye

• Patients must be able to lie flat and motionless in a supine position.

• Patient must be able to understand and give an informed consent.

• Patients must be able to tolerate local or topical anesthesia.

• Patients with elevated IOP should use topical steroids only under close medical supervision.

Contraindications:• Corneal disease that precludes

applanation of the cornea or transmission of laser light at 1030nm wavelength

• Descemetocele with impending corneal rupture

• Presence of blood or other material in the anterior chamber

• Hypotony, glaucoma, or the presence of a corneal implant

• Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease)

• This device is not intended for use in pediatric surgery

• A history of lens with zonular instability.• Any contraindication to cataract or

keratoplasty surgery.

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

The Changing Face of Cataract Surgery

- Large, rapidly growing demographic

- Educated, financially secure

- Increased life expectancy

- Longer working careers

The Baby Boomer Generation

- Longer working careers

- Demand high quality vision (reading, distance,

night vision)

- New requirement for near vision (computers)

- Unwilling to compromise active lifestyle

- Embracing demand driven healthcare

LSX12241SK

3

The Need for Improvement

LSX12241SK

5

Adapted from FDA Clinical Data: Crystalens* and WaveLight® Trials

*Trademarks are property of their respective owners.

Limitations of Traditional Cataract Surgery

LSX12241SK

6

Improved Refractive Cataract Surgery

• Address Major Requirements for Improved Refractive

Procedure

IOL Position Corneal Early Wow IOL Position Predictability

• Uniform Shape and Size Capsulotomy

Corneal Astigmatism

• Reproducible Corneal Entry and Arcuate Incisions

Early Wow Factor

• Reduced Phaco Power and Corneal Edema

Hill WJ, J Cataract Refract

Surg 2008;34:364–367 Norrby SJ, J Cataract Refract

Surg 2008;34:368–376Devgan U, Current Opinions in

Ophthalmology 2011;18:19–22.

LSX12241SK

7

The LenSx® Laser

A dynamic, platform technology

designed to:

• Deliver the precision of a femtosecondlaser to Refractive Cataract Surgery

• Rapidly advance the evolution of true

image-guided intraocular surgeryimage-guided intraocular surgery

• Advance the development of a more digitized, predictable approach to lens

replacement surgery

LSX12241SK

8

Image-Guided Refractive Cataract Surgery

LSX12241SK

9

Manual Clear Corneal Incisions

Dynamics of wound architecture created with hand-held instruments1:

- imprecise tunnel length and geometry

- frequently require stromal hydration to seal

- may result in cascading intraoperative difficulties (fluid control, anterior chamber

maintenance)

- incisions may be unstable at low IOPs- incisions may be unstable at low IOPs

• Recent literature suggests an increased incidence of post-op infection2

1Behrens A, Stark WJ, Pratzer KA, McDonnell PJ. Dynamics of small-incision clear cornea wounds after phacoemulsification surgery usingoptical coherence tomography in the early postoperative period, J Refract Surg, 2008;24(1):46-9.

2Taban M, Behrens A, Newcomb RL, Nobe MY, Saedi G, Sweet PM, McDonnell PJ. Acute endophthalmitis following cataract surgery: asystematic review of the literature, Arch Ophthalmol. 2005;123(5):613-20.

LSX12241SK

10

LenSx® Laser Corneal Incisions

Customized wound architecture and placement Self-sealing incisions

LSX12241SK

11

Effective Lens Position (ELPo)

• “The key to highly accurate IOL power calculation is being able to correctly

predict ELPo for any given patient and IOL”1

• ELPo for the 5 formulas commonly in use are:

– SRK/T d = A-constant

– Hoffer Q d = pACD

– Holladay 1 d = Surgeon Factor

– Holladay 2 d = ACD

– Haigis d = a0 + (a1 * ACD) + (a2 * AL)

• ELPo is assumed value, from empirical data (A constant and surgeon factor)

• A significant source of IOL power error2 and key to post surgery refraction3

• Size of capsulorhexis effects ELPo4

LSX12241SK

1Haigis W, Lege B, Miller N, Schneider B, Comparison of immersion ultrasound biometry and partial coherence interferometry for IOL calculation according to Haigis, Graefes, Arch Clin Exp Ophthalmol, 2000;238:765-773.

2Norrby S, Sources of error in intraocular lens power calculation,J Cataract Refract Surg, 2008;34:368-376.3Hill WE, Does the Capsulorrhexis Affect Refractive Outcomes? In Chang D, editor: Cataract and Refractive Surgery Today,2009:78.

4Cekiç O, Batman C, The relationship between capsulorhexis size and anterior chamber depth relation. Ophthalmic Surg Lasers,1999;30(3):185-190. Erratum in: Ophthalmic Surg Lasers,1999;30(9):714

12

Factors Affecting IOL Predictability1

If IOL is 0.5 mm posterior to the

assumed plane, a 21 D lens will

produce only 20 D of correction

If IOL is 0.5 mm anterior to the

assumed plane, a 21 D lens

will produce 22 D of correction

HyperopicMyopic

LSX12241SK

1Norrby S, Sources of error in intraocular lens power calculation,J Cataract Refract Surg, 2008;34:368-376.

13

Does Capsulotomy Size Impact ELPo?

Consistent capsulorhexis diameter is critical to

Effective Lens Position1,2

• A 4 mm capsulorhexis results in longer post-operative ELPo than does a 6

mm capsulorhexis for the type of IOL used3

• To ensure that an IOL’s position in the bag matches the anticipated formula used to calculate its power, the capsulorhexis should be round, centered

and smaller than the IOL optic2

1Hill WE. Hitting Emmetropia. Chang D. (ed.) In: Mastering Refractive IOLs – The Art and Science. Slack, Incorporated, 2008.2Hill WE. Does the Capsulorhexis Affect Refractive Outcomes? Chang D. (ed.) In: Cataract Surgery Today, Bryn Mawr Communications,Wayne, Pennsylvania 2009. p. 78.

3Cekiç O, Batman C, The relationship between capsulorhexis size and anterior chamber depth relation. Ophthalmic Surg Lasers,1999;30(3):185-190. Erratum in: Ophthalmic Surg Lasers,1999;30(9):714

LSX12241SK

14

Laser

Fragmentation

Mechanism of

Action

Chop Patterns Cylinder Patterns

LSX12241SK

15

LenSx® Laser Phacofragmentation

• Cylinder pattern, utlilized for the softer lens, enables removal with

I & A only, no phaco power

• Chop pattern efficiently fragments the lens for removal with

reduced phaco power and time1

1.4

Comparison of Effective Phaco Time

30

Comparison of Average Phaco Power

43% reduction51% reduction

1Nagy ZZ, Takacs A, Filkorn T, Sarayba M, Initial Clinical Evaluation of an Intraocular Femtosecond Laser in CataractSurgery, Journal of Refractive Surgery, 2009;25:1053-1060.

LSX12241SK

16

0

0.2

0.4

0.6

0.8

1

1.2

1.4

Eff

ective

Ph

aco

Tim

e (

min

)

Phaco only

Laser plus Phaco

0

5

10

15

20

25

30

Avera

ge P

ow

er

(%)

Phaco only

Laser plus Phaco

Hybrid Fragmentation Pattern*

• Combination of

Cylinder and Chop

Patterns

• Efficient for All Cataract

Grades

• Rapid Lens Removal • Rapid Lens Removal

with Minimal Phaco

Required

• Number of

Cuts/Cylinders Totally

Customizable

*510(k) Premarket Notification to the FDA, LenSx Laser System, K101626, 2010.

LSX12241SK

17

Manual Arcuate Incisions

• Manually executed by “tracing”

corneal marks with handheld diamond knife

• Inconsistent depth control

• Unpredictable effect due to

imprecise wound architecture

and depth

• No image-guided surgical

planning or visualization

LSX12241SK

19

LenSx® Laser Arcuate Incisions

Image-guided surgical planning

with 3D visualization:

• Real time corneal thickness

• Computer programmed incisions- % depth

- incision length and position

- 3D visualization of incision placement- 3D visualization of incision placement

• Predictable incision width, tunnel length

• Titratable incisions- adjustable during surgical procedure

- adjustable post-op at slit lamp

LSX12241SK

510(k) Premarket Notification to the FDA, LenSx Laser System, K101626, 2010.

20

LenSx® Laser Arcuate Incision

• Square edge• Square edge

• Uniform depth (no ripples)

• Precise, reproducible

– Arc shape

– Arc length

– Diameter

Steinert RF, Application of the Femtosecond Laser in Cataract Surgery for the Creation of Multi-Planar, Self-Sealing Incisions, ASCRS 2010, Boston

LSX12241SK

21

LenSx® Laser: Peer Reviewed Publications

Ecsedy M, Miháltz K, Kovács I, Takács A, Filkorn T, Nagy ZZ, Effect of Femtosecond Laser Cataract Surgery on the Macula, Journal of Refractive Surgery, 2011;27:717-722.

Miháltz K, Knorz MC, Alio JL, Takács A, Kránitz K, Kovács I, Nagy ZZ, Internal Aberrations and Optical Quality After Femtosecond Laser Anterior Capsulotomy in Cataract Surgery, Journal of

Refractive Surgery, 2011;27:711-716.

Nagy ZZ, Kránitz K, Takács A, Miháltz K, Kovács I, Knorz MC, Comparison of Intraocular Lens Decentration Parameters After Femtosecond and Manual Capsulotomies, Journal of Refractive

Surgery, 2011;27:565-569.Surgery, 2011;27:565-569.

Kránitz K, Takács A, Miháltz K, Kovács I, Knorz MC, Nagy ZZ, Femtosecond Laser Capsulotomy and Manual Continuous Curvilinear Capsulorrhexis Parameters and Their Effects on Intraocular Lens Centration, Journal of Refractive Surgery, 2011;27:559-563.

Nagy ZZ, Takács A, Filkorn T, Sarayba M, Initial Clinical Evaluation of an Intraocular FemtosecondLaser in Cataract Surgery, Journal of Refractive Surgery, 2009;25:1053-1060

LSX12241SK

23

LenSx® Laser vs Manual CCC, Monofocal IOL*

Analysis:

• Non-randomized, prospective, single site,

single surgeon study

• Single lens type (Alcon SN60WF)

• Manual group (n=26)

- Attempted 5.0mm capsulotomy- Attempted 5.0mm capsulotomy

Mastel 5.75 mm OZ marker to create 5.0 mm CCC

• LenSx® Laser group (n=22)- Femtosecond laser created 5.0 mm capsulotomy

• Accuracy to Target, Actual ELPo (LENSTAR® Optical Biometer – ACD)

• No significant difference in baseline between cohorts

LSX12241SK

LENSTAR is a registered trademark of Haag-Streit

24

*Robert J Cionni MD. Presented AAO 2011 Refractive Sub-Specialty Day, “Comparison of Effective Lens Position and Refractive Outcome:Femtosecond Laser vs Manual Capsulotomy”

LenSx® Laser vs Manual CCCActual vs Predicted ELPo

4.75

5.00

Actual ELP1M PostOP

LenSx® Laser Group (n=22)

95% Confidence

4.75

5.00

Actual ELP1M PostOP

Manual Group (n=26)

R² = 0.709

4.00

4.25

4.50

4.20 4.60 5.00 5.40 5.80 6.20

Predicted ELPo

95% Confidence Intervals

R² = 0.2877

4.00

4.25

4.50

4.20 4.60 5.00 5.40 5.80 6.20

Predicted ELPo

� 71% of the variable’s variance result for the LenSx® Laser group Vs. only 29% for the manual group.

Better ELPo predictability

LSX12241SK

25

Prediction Error Distribution

32%

27%

23%

27%

Frequency Distribution (%) of Eyes

Hyperopic

Mo

re

Myopic

0%

9%

18%

9%

5% 0%0% 0%

15%

12%

15%

4% 4%

≤ -1 -0.75 -0.5 -0.25 0 0.25 0.5 0.75 ≥ 1

Spherical Equivalent Prediction Error (D) = Pred. Ref. - Actual 1M PostOP Ref.

LenSx (n=22)Manual (n=26)

Less

Mo

re

Less

26

LSX12241SK

Where Are We Today?

The LenSx® Laser

• The first femtosecond laser cleared in the US for all indications in cataract surgery:

- Anterior Capsulotomy

- Laser Phacofragmentation- Laser Phacofragmentation

- Cataract Incisions, including Arcuate Incisions

• The only femtosecond laser globally commercialized to date for cataract surgery indication

LSX12241SK

27

Where Are We Today?

The LenSx® Laser

• More than 250 LenSx® Laser installations globally

• More than 60,000 LenSx® Laser procedures globally

• More than 1000 surgeons from 42 countries trained; utilizing LenSx® Laser in

daily practice1daily practice

• Accelerated innovation based upon actual user feedback

• Rapid practice conversion – intuitive benefits of laser refractive cataract surgery validated in clinical practice

• Early results demonstrate that the image-guided, LenSx® Laser capsulotomypositively influences the predictability of effective lens positioning.2

1Alcon LenSx Physician Training Records2Robert J Cionni MD, Comparison of Effective Lens Position and Refractive Outcome: Femtosecond Laser vs Manual Capsulotomy,2011 AAO/ISRS Refractive Subspecialty Day, Orlando, Florida

LSX12241SK

28

Patient Expectations

• The medical milestone of cataract will be increasingly re-defined by lifestyle requirements

• This younger, active patient population will seek a surgical resolution much

earlier than previous generations

LenSx® Laser technology provides the patient:

• Perceived benefits of a laser procedure

- Computer controlled precision

- Procedural predictability

• A comprehensive, advanced technology approach to lens replacement surgery

• An advanced technology, value-added surgical experience

LSX12241SK

29

Opportunity for Eyecare Providers

LenSx® Laser technology provides:

• Known benefits of femtosecond technology

- Improved accuracy of all incisions

- Predictability at every step

• True image-guided intraocular surgery

- Opportunity to create optimal wound architecture

- Precise capsulotomy design for every IOL

• A strong value proposition

- A message that easily resonates with patients and staff

LSX12241SK

30

Thank You

a Novartis company© 2013 Novartis 1/13 LSX12241SK

31