Laser Cataract Refractive Surgery. Robert Maloney, MD

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1 Laser Cataract Refractive Surgery Robert Maloney, MD

2 Traditional Cataract Surgery!!!! Capsulotomy size directly related to Effective Lens Position1,2 Corneal incisions are manually executed and imprecise High level of phaco power can be associated with post-op complications Cataract surgery complications are 10x that of LASIK3,4 Common Incidence Vision Threatening Incidence Posterior Capsular Opacification 10-30% Retinal Detachment % Cystoid Macular Edema (transient) 2-10% Cystoid Macular Edema (persistent) 1-2% Vitreous Loss 1-5% IOL Malposition 0.3% Corneal Endothelial Cell Loss 4-10% Need for Corneal Transplant 0.3% Endopthalmitis 0.1% 1. Norrby S. Sources of error in intraocular lens power calculation. J Cataract Refract Surg Mar;34(3): Cekiç O, Batman C. The relationship between capsulorhexis size and anterior chamber depth relation. Ophthalmic Surg Lasers Mar;30(3): Pereira et al. JCRS 2006 Oct;32(10): /26/11 4. Park et al. Ophthalmic Surg Lasers Imaging Mar-Apr;41(2):236-41

3 The LenSx Laser The LenSx Laser A dynamic platform technology that will: Deliver true refractive cataract surgery with the precision of a femtosecond laser Establish Laser Refractive Cataract Surgery - a viable new premium category Rapidly advance the evolution of true image-guided intraocular surgery Advance the development of a more digitized, predictable approach to lens replacement surgery

4 Laser Cataract Refractive Surgery Domino Video w/sound already approved.

5 Laser Refractive Cataract Surgery Goal is to Improve Every Procedure, Technology and Surgeon Key Step Current Surgery Impact Safety Impact Corneal Incision Not Optimized Induced Cylinder Infection Capsulorhexis Variable Sized, Variable IOL Position Capsular Tears,! New laser-based standard, Not Centered synonymous & Effective with Lens patient pay Posterior Capsule Power Opacification Lens Excessive Ultrasound Delayed Visual Loss of Endothelial Fragmentation Power Recovery Cells, Capsule Rupture

6 LenSx Laser Integrated OCT Image-guided Laser Refractive Cataract Surgery Intuitive touch screen Graphic User Interface - for easy customization of all surgical parameters Real-time video imaging for 3D visualization - guides the surgeon while docking - for optimal surgeon control True image-guided surgical planning - enables the surgeon to precisely program size, shape, location of each incision

7 Laser Refractive Cataract Surgery Slade Video Case 3a already approved.

8 Traditional Lens Fragmentation! Initial phaco technique divides the nucleus into quadrants (Divide and Conquer) Endothelium effects! Variations on this technique were developed to reduce phaco power Chop, Quick Chop, Stop and Chop, Flip, etc.! Difficult to perform! Lens density dependent

9 Laser Fragmentation Mechanism of Action Chop Patterns Liquefy Patterns

10 LenSx Laser Phacofragmentation Liquefy pattern requires I&A only, no phaco power Chop pattern efficiently fragments the lens for removal with reduced phaco power and time 51% reduction 43% reduction

11 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 May;123(5): 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 Jan;24(1):46-9. Manual Clear Corneal Incisions! Wound architecture limited by hand-held instruments, manual incisions - imprecise tunnel length and geometry! Frequently require stromal hydration to seal! Can result in cascading intraoperative difficulties - fluid control, anterior chamber maintenance Recent literature suggests an increased incidence of post-op infection 1 Incisions may be unstable at low IOPs 2

12 Incision Configurations Single or Multiplane Computerized programming of incision patterns Customizable geometry Angle Depth Width

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

14 Arcuate Incisions Traditional, Handheld Diamond Knife Manually executed by tracing corneal marks Inconsistent depth control Unpredictable effect due to imprecise wound architecture and depth No image-guided surgical planning or visualization

15 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

16 Laser Arcuate Incision Square edge Uniform depth (no ripples) Precise, reproducible Arc shape Arc length Diameter

17 Ideal Capsulorhexis! Reproducible size, shape and well-centered Current Manual Capsulorhexis Too large Too small Irregular shape No capsule-iol overlap IOL tilt Phimosis Difficult phaco maneuver IOL tilt IOL decentration Off center IOL decentration Edge catches visual axis

18 LenSx Laser Capsulorhexis Reproducible, Precise Circular Shape and Diameter Capsulotomy Enables Image-Guided Centration of Capsulotomy

19 LenSx Laser Capsulorhexis Predictably Centered and Highly Reproducible Capsulotomy Diameter Accuracy (Absolute difference between A>empted and Achieved) Laser (n=60) Manual (n=60) Percent of Sample (%) <=0.25 <=0.5 <=0.75 <=1.0 <=1.25 <=1.5 Diameter Error (mm) Only 10% of manual rhexis achieved diameter accuracy of +/ mm 19

20 Effective Lens Position (ELPo) Assumed value, from empirical data (A constant and surgeon factor) A significant source of IOL power error,(norby, 2008) key to post surgery refraction (Hill, 2009) Size of capsulorhexis effects ELPo (Cekic, 1999)

21 Importance of Effective Lens Position (ELPo) The key to highly accurate IOL power calculation is being able to correctly predict ELPo for any give patient and IOL Haigis 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,(norby, 2008) key to post surgery refraction (Hill, 2009) Size of capsulorhexis effects ELPo (Cekic, 1999)

22 Factors Affecting IOL Predictability If IOL is 0.5 mm posterior to the assumed plane, a 21D lens will produce only 20D of correction If IOL is 0.5 mm anterior to the assumed plane, a 21D lens will produce only 22D of correction Hyperopic Myopic

23 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 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 Cekic, Batman. Ophthalmic Surgery and Lasers, March 1999

24 LenSx Laser vs Manual Capsulorhexis Prospective study to determine the effect of capsulotomy method on ELPo variability 4.5 mm LenSx Laser capsulotomy Attempted 4.5 mm manual capsulorhexis ACD and AL measured using LenStar Optical Biometry

25 Results (mm) Effective Lens Position (ELPo) Manual LenSx Laser * F Test P < 0.05 Statistically Significant Difference in Variance Between the Two Groups ACDAL Ratio 1 Month Reduced Variability in Effective Lens Position in LenSx Laser Group Month Manual LenSx Laser

26 Patient Expectation 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 A truly premium, value-added surgical experience

27 Practice Performance LenSx Laser technology provides the surgeon: 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

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