Financial Disclosure. So what s the problem? 7/13/12 FEMTOSECOND LASER CATARACT SURGERY: FAD OR FUTURE? Laser Cataract Surgery: the claim

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1 FEMTOSECOND LASER CATARACT SURGERY: FAD OR FUTURE? Douglas D. Koch, M.D. Cullen Eye Institute Baylor College of Medicine Houston, Texas Financial Disclosure I have a financial interest with the following companies: Abbo8 Medical Op<cs Alcon Calhoun Vision Carl Zeiss Meditec NuLens Op<medica Ziemer Thanks to David Chang for data slides on complications!! Surgical Systems Laser Cataract Surgery: the claim Catalys Precision Laser System- LenSx Laser Replaces some of the least predictable surgical steps and enhances safety profile of Performs four primary incisions: 1. Capsulotomy LensAR Laser System TECHNOLAS femtosecond Workstation 2. Lens Fragmentation 3. Relaxing s 4. Cataract What is laser cataract surgery? Precision So what s the problem? Accuracy Safety 1

2 As good as our current surgery is.... Endophthalmitis: 1/10,000 Wound leak Torn or irregular capsulorhexis Corneal edema Unexpected postoperative effective lens position resulting in postoperative ametropia Postoperative astigmatism > 0.5 D /ELP Arcuate s Leaking wound can cause endophthalmi<s Endophthalmitis Risk Cataract incision Wallin T, Parker J, Jin Y, et al. Cohort Study of 27 cases of endophthalmitis at a single institution. J Cataract Refract Surg 2005;31: Zonular/capsule rupture - 17x No antibiotic day of surg - 5x leak - 44 x Key Finding: Laser system can create multi-planar wounds with better sealability Supporting Results from LenSx¹: 0/42 eyes receiving 2 plane laser incision required stromal hydration to seal. 17/18 eyes receiving manual Langerman incision required stromal hydration to seal. ¹Steinert, R. Application of the femtosecond laser in cataract surgery for the creation of multi-planar self-sealing incisions. Accessed at lensxlasers.com. Arcuate s Incidence of Anterior Capsule Tears Marques FF, Marques DM, Osher RH, Osher JM. Fate of anterior capsule tears during cataract surgery. J Cataract Refract Surg 2006;32: Anterior tear of CCC % 21/2646 eyes CCC (0.5 % ) 48% extended to posterior capsule 19% required vitrectomy 2

3 Author Published % Vitreous loss Study size Desai % 18,454 Martin % 3000 Lundstrom % 2731 Ionides % 1420 Gimbel % 18,470 Tan % 2538 Chan % 8230 Androudi % 543 Hyams % 1364 Ang % 2727 Zaidi % 1000 Mearza % 1614 Agarwal % 6564 Published Vitreous Loss Rates % Clinical Results Recent clinical data from LenSx, LensAR, OptiMedica and Technolas Manual Laser Capsulotomy Clinical Results Recent clinical data from LenSx, LensAR, OptiMedica and Technolas Manual Laser Capsulotomy Arcuate s Corneal Phaco Burn Lens fragmentation with femtosecond laser Clinical results phaco energy For cataracts of all grades, laser pre-treatment of lens resulted in reduced phaco energy For soft lenses (grade 1,2) laser pre-treated lenses often required no phaco energy at all Laser vs. Control OptiMedica LensAR LenSx ³ Technolas4 Control Laser Pre-Treated All Lens Densities Grade 4 Lenses 38% CDE (p=0.028) 40% CDE >35% CDE¹ 41.6% CDE (p=0.052) ² 54% average phaco power No published data ²Fishkind, W MD Alternative fragmentation patterns in femtosecond laser cataract surgery, ESCRS 2010 ³Data courtesy of LensAR Nov 2010 ³Slade, S MD Femtosecond Laser Refractive Cataract Surgery, AAO Technolas company website Studies ongoing Studies ongoing 3

4 Arcuate s Decentered Multifocal IOL Decentere d IOL Arcuate s Decentered Multifocal IOL Decentere d IOL Arcuate s Pre- op Arcuate Pre- op s Post- op Keratometry Database: (Warren Hill) > 0.50 D 72% > 0.75 D 53% > 1.00 D 38% LRI (PCRI) Wang L, Misra M, Koch DD. Peripheral corneal relaxing incisions combined with cataract surgery. J Cataract Refract Surg 2003; 29: D (n = 104) retrospective <0.50 D (1 mo) 20% 4 m0) <1.00 D (1 mo) 58% 4 m0) Relaxing s Surgeon can configure depth at time of based on measured corneal thickness System creates consistent and precise arc length and curvature 4

5 Arcuate incisions: Two strategies 1. Make incisions but do not open them much or at all intraoperatively Titrate opening them over weeks, months, years 2. Key to pricing strategy We can bill for relaxing incisions We CANNOT bill for using a laser to: n Make cataract wounds n n Soften nucleus Are these problems enough: To warrant purchase of $500,000 laser??? Peer-reviewed clinical studies demonstrating benefits of femto laser cataract surgery: Center s choice for system location is dependent on 4 key drivers: # of ORs Avg OR time per case # of surgeons simultaneously operating # of ORs used by each surgeon These are some of the main factors for determining whether system is placed: 1) inside an operating room or 2) in a room outside of the operating room Condensed workflow schematic: Nurse involvement S.T.A.M.P 1. Treatment plan entry 2. Patient check-in 3. System prep 4. Patient preop preparation 8. Patient transfer onto stretcher 7. Conduct treatment 6. Dock patient 5. Patient transfer (in) Surgery Day Nurse Nurse Nurse 9. Into OR for phaco/iol 10. Patient post-op New steps for laser cataract surgery 5

6 Pre- Laser Procedure Dilate patient Apply topical anesthesia Transfer patient to laser room (or operating room) Assist patient in getting positioned under system Assure patient comfort, stability during Laser Procedure Patient set-up under the laser Transfer patient to laser room (or operating room) Assist patient in getting positioned under system Assure patient comfort, stability during Lens Other key factors for placement decision: Proceed with standard, e.g.: Transfer patient to OR Help prepare patient for surgery Assure patient comfort during Room requirements for laser system Facility layout Workflow Scheduling 6

7 Access: scheduling considerations Surgeon preference: S.T.A.M.P Timing considerations Series Laser Phaco/IOL (post Laser) 1. Prep Op Preparation 2. Laser 3. Phaco/IOL Grouped Laser x 2-3 Phaco/IOL x 2-3 (post Laser) Interspersed Manual surgery Laser Manual surgery Phaco/IOL (post Laser) Staffing the laser: looking at existing roles Laser technician: Certified to operate lasers May be familiar with femtosecond lasers already: treatment plan entry, patient interface prep, treatment monitoring, etc Scrub technician: Familiar with the anatomy being treated S.T.A.M.P More likely that this person is already employed by group that purchases the laser system Same individual could support surgeon during laser treatment and lens removal/iol? Other potential duties for laser operator Technical expert on system boot up, admin, troubleshooting, training new hires In charge of ordering/inventory of disposable components Sample Treatment Planning with Catalys Scrub tech activities 1 2 Patient Information Entry 3 4 Lens Fragmentation Template Capsulotomy Template Treatment Plan Summary Post laser, prior to cataract removal: s already created Lens pre-softened Potential Implications? Fewer instruments in kit New phaco machine parameters Reduced OR time, quicker room turnover Quick, template based planning 7

8 Clinic Staff and Patient Education Don t oversell or over educate up front. All staff should be aware of surgeon preferences as they educate the potential surgical patient. Not all surgeons will want to make this change, discuss how this fits in your clinic approach and marketing plan. Why should I care about laser cataract surgery? Potential benefits of Laser Cataract Surgery Is femto gimmic or game changer... Efficacy Gains: More predictable and accurate size, shape, and placement of capsulotomy More consistent of corneal incisions Safety Gains: in ultrasound phaco energy Less risk of capsular tears Surgeon Confidence Gains: Consistent incisions from case to case and from surgeon to surgeon The field of ophthalmology has experienced Paradigm shift from extra cap to phaco Paradigm shift from microkeratome -> femto for LASIK Paradigm shift from phaco to femto phaco??? As it disseminates, it will raise the overall level of cataract surgery Issues to resolve... On the other hand... Can we afford the extra: Time Cost Personnel How will we provide widely in this regulatory environment? Will our patients perceive this to be the best technology and demand it? Will we agree and therefore want to provide it? Manual Surgery: 1 month post op Laser Surgery: 1 month post op 8

9 This discussion is just beginning...or is it? Questions? 9

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