Laser Refractive Cataract Surgery with the LenSx Laser

Transcription

1 Laser Refractive Cataract Surgery with the LenSx Laser a Novartis company 1

2 LenSx Laser Important Safety Information 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 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 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 capsulotomy only) 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 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. Warnings: The LenSx Laser System should only be operated by a physician trained in its use. The LenSx Laser delivery system employs one sterile 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. 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

3 The Changing Face of Cataract Surgery The Baby Boomer Generation - Large, rapidly growing demographic - Educated, financially secure - Increased life expectancy - 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 3

4 The Need for Improvement Adapted from FDA Clinical Data: Crystalens* and WaveLight Trials *Trademarks are property of their respective owners. 5

5 Limitations of Traditional Cataract Surgery 6

6 Improved Refractive Cataract Surgery Address Major Requirements for Improved Refractive Procedure IOL Position Corneal Early Wow Predictability Astigmatism Factor Uniform Shape and Size Capsulotomy Reproducible Corneal Entry and Arcuate Incisions Reduced Phaco Power and Corneal Edema Norrby SJ, J Cataract Refract Surg 2008;34: Hill WJ, J Cataract Refract Surg 2008;34: Devgan U, Current Opinions in Ophthalmology 2011;18:

7 The LenSx Laser A dynamic, platform technology designed to: Deliver the precision of a femtosecond laser to Refractive Cataract Surgery Rapidly advance the evolution of true image-guided intraocular surgery Advance the development of a more digitized, predictable approach to lens replacement surgery 8

8 Image-Guided Refractive Cataract Surgery 9

9 Manual Clear Corneal Incisions Dynamics of wound architecture created with hand-held instruments 1 : - 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 Recent literature suggests an increased incidence of post-op infection 2 1 Behrens A, Stark WJ, Pratzer KA, McDonnell PJ. Dynamics of small-incision clear cornea wounds after phacoemulsification surgery using optical coherence tomography in the early postoperative period, J Refract Surg, 2008;24(1): Taban M, Behrens A, Newcomb RL, Nobe MY, Saedi G, Sweet PM, McDonnell PJ. Acute endophthalmitis following cataract surgery: a systematic review of the literature, Arch Ophthalmol. 2005;123(5):

10 LenSx Laser Corneal Incisions Customized wound architecture and placement Self-sealing incisions 11

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 error 2 and key to post surgery refraction 3 Size of capsulorhexis effects ELPo 4 1 Haigis 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: Norrby S, Sources of error in intraocular lens power calculation,j Cataract Refract Surg, 2008;34: Hill WE, Does the Capsulorrhexis Affect Refractive Outcomes? In Chang D, editor: Cataract and Refractive Surgery Today, 2009:78. 4 Cekiç O, Batman C, The relationship between capsulorhexis size and anterior chamber depth relation. Ophthalmic Surg Lasers, 1999;30(3): Erratum in: Ophthalmic Surg Lasers,1999;30(9):714 12

12 Factors Affecting IOL Predictability 1 If IOL is 0.5 mm posterior to the assumed plane, a 21 D lens will produce only 20 D of correction Hyperopic If IOL is 0.5 mm anterior to the assumed plane, a 21 D lens will produce 22 D of correction Myopic 1 Norrby S, Sources of error in intraocular lens power calculation,j Cataract Refract Surg, 2008;34:

13 Does Capsulotomy Size Impact ELPo? Consistent capsulorhexis diameter is critical to Effective Lens Position 1,2 A 4 mm capsulorhexis results in longer post-operative ELPo than does a 6 mm capsulorhexis for the type of IOL used 3 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 optic 2 1 Hill WE. Hitting Emmetropia. Chang D. (ed.) In: Mastering Refractive IOLs The Art and Science. Slack, Incorporated, Hill WE. Does the Capsulorhexis Affect Refractive Outcomes? Chang D. (ed.) In: Cataract Surgery Today, Bryn Mawr Communications, Wayne, Pennsylvania p Cekiç O, Batman C, The relationship between capsulorhexis size and anterior chamber depth relation. Ophthalmic Surg Lasers, 1999;30(3): Erratum in: Ophthalmic Surg Lasers,1999;30(9):714 14

14 Laser Fragmentation Mechanism of Action Chop Patterns Cylinder Patterns 15

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 time 1 Comparison of Average Phaco Power Comparison of Effective Phaco Time Average Power (%) Phaco only Laser plus Phaco Effective Phaco Time (min) Phaco only Laser plus Phaco % reduction 43% reduction 1 Nagy ZZ, Takacs A, Filkorn T, Sarayba M, Initial Clinical Evaluation of an Intraocular Femtosecond Laser in Cataract Surgery, Journal of Refractive Surgery, 2009;25:

16 Hybrid Fragmentation Pattern * Combination of Cylinder and Chop Patterns Efficient for All Cataract Grades Rapid Lens Removal with Minimal Phaco Required Number of Cuts/Cylinders Totally Customizable *510(k) Premarket Notification to the FDA, LenSx Laser System, K101626,

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 19

18 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 Predictable incision width, tunnel length Titratable incisions - adjustable during surgical procedure - adjustable post-op at slit lamp 510(k) Premarket Notification to the FDA, LenSx Laser System, K101626,

19 LenSx Laser Arcuate Incision 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 21

20 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: 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: 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: 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: Nagy ZZ, Takács A, Filkorn T, Sarayba M, Initial Clinical Evaluation of an Intraocular Femtosecond Laser in Cataract Surgery, Journal of Refractive Surgery, 2009;25:

21 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 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 *Robert J Cionni MD. Presented AAO 2011 Refractive Sub-Specialty Day, Comparison of Effective Lens Position and Refractive Outcome: Femtosecond Laser vs Manual Capsulotomy LENSTAR is a registered trademark of Haag-Streit 24

22 LenSx Laser vs Manual CCC Actual vs Predicted ELPo 5.00 LenSx Laser Group (n=22) 5.00 Manual Group (n=26) Actual ELP 1M PostOP Actual ELP 1M PostOP % Confidence Intervals R² = R² = Predicted ELPo Predicted ELPo Better ELPo predictability 71% of the variable s variance result for the LenSx Laser group Vs. only 29% for the manual group. 25

23 Prediction Error Distribution Hyperopic Frequency Distribution (%) of Eyes 32% Myopic 23% More 27% 27% Less 15% 18% More Less 15% LenSx (n=22) Manual (n=26) 9% 12% 9% 0% 0% 0% 5% 4% 0% 4% Spherical Equivalent Prediction Error (D) = Pred. Ref. - Actual 1M PostOP Ref. 26

24 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 - Cataract Incisions, including Arcuate Incisions The only femtosecond laser globally commercialized to date for cataract surgery indication 27

25 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 practice 1 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 capsulotomy positively influences the predictability of effective lens positioning. 2 1 Alcon LenSx Physician Training Records 2 Robert J Cionni MD, Comparison of Effective Lens Position and Refractive Outcome: Femtosecond Laser vs Manual Capsulotomy, 2011 AAO/ISRS Refractive Subspecialty Day, Orlando, Florida 28

26 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 29

27 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 30

28 Thank You 2013 Novartis 1/13 a Novartis company 31