femtosecond laser cataract surgery: … · ¹steinert, r. application of the femtosecond laser in...

7/13/12

1

FEMTOSECOND LASER CATARACT SURGERY: FAD OR FUTURE?

Douglas D. Koch, M.D. Cullen Eye Institute Baylor College of Medicine Houston, Texas

I have a financial interest with the following companies: Abbo8 Medical Op<cs Alcon Calhoun Vision Carl Zeiss Meditec NuLens Op<medica Ziemer

Financial Disclosure

Thanks to David Chang for data slides on complications!!

Surgical Systems

LenSx® Laser

Catalys™ Precision Laser

System-‐ Op@Medica

LensAR Laser System™

TECHNOLAS femtosecond Workstation

Laser Cataract Surgery: the claim

• Replaces some of the least predictable surgical steps and enhances safety profile of procedure

• Performs four primary incisions:

1.  Capsulotomy

2.  Lens Fragmentation

3.  Relaxing Incisions

4.  Cataract Incision

What is laser cataract surgery?

Precision

Accuracy Safety

So what’s the problem?

7/13/12

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

Potential Problems in Contemporary Cataract Surgery:

Steps: Incision

Capsulorhexis Phacoemulsification IOL Centration/ELP Arcuate Incisions

(Astigmatism) Leaking wound can

cause endophthalmi<s

Endophthalmitis – Risk

Wallin T, Parker J, Jin Y, et al. Cohort Study of 27 cases of endophthalmitis at a single institution. J Cataract Refract Surg 2005;31:735-741

¨  Zonular/capsule rupture -

17x ¨  No antibiotic day of surg -

5x

¨  Incision leak - 44 x

Cataract incision

¤ 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.


Steps: Incision Capsulorhexis

Phacoemulsification IOL Centration Arcuate Incisions

(Astigmatism)

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;32:1638-42

§  Anterior tear of CCC - 0.8 %

§  21/2646 eyes §  14@ CCC (0.5 % )

§  48% extended to posterior capsule

§  19% required vitrectomy

7/13/12

3

Published Vitreous

Loss Rates

1999 – 2009

1.1-4.4

%

Author Published % Vitreous loss Study size

Desai 1999 4.4% 18,454

Martin 2000 1.3% 3000

Lundstrom 2001 2.2% 2731

Ionides 2001 2.9% 1420

Gimbel 2001 0.2% 18,470

Tan 2002 3.6% 2538

Chan 2003 1.1% 8230

Androudi 2004 4.0% 543

Hyams 2005 2.0% 1364

Ang 2006 1.1% 2727

Zaidi 2007 1.1% 1000

Mearza 2009 2.7% 1614

Agarwal 2009 1.6% 6564

Recent clinical data from LenSx, LensAR, OptiMedica and Technolas

Clinical Results

Manual Capsulorhexis Laser Capsulotomy

Clinical Results

Manual Capsulorhexis Laser Capsulotomy

Recent clinical data from LenSx, LensAR, OptiMedica and Technolas


Steps: Incision Capsulorhexis Phacoemulsification

IOL Centration Arcuate Incisions

(Astigmatism)

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

Laser Pre-Treated

Control

• For soft lenses (grade 1,2) laser pre-treated lenses often required no phaco energy at all

Laser vs. Control

OptiMedica LensAR LenSx³ Technolas4

All Lens Densities

38% reduction in CDE (p=0.028)

>35% reduction in CDE¹

54% reduction in average phaco power

Studies ongoing

Grade 4 Lenses

40% reduction in CDE

41.6% reduction in CDE (p=0.052)²

No published data

Studies ongoing

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 2010. 4 Technolas company website

7/13/12

4

Steps: Incision Capsulorhexis Phacoemulsification IOL Centration

Arcuate Incisions (Astigmatism)

Decentered IOL

Decentered Multifocal IOL


Steps: Incision Capsulorhexis Phacoemulsification IOL Centration

Arcuate Incisions (Astigmatism)

Decentered IOL

Decentered Multifocal IOL


Steps: Incision Capsulorhexis Phacoemulsification IOL Centration Arcuate Incisions

(Astigmatism)

Pre-‐op Arcuate Incisions


Pre-‐op

Post-‐op

¨  Keratometry Database: (Warren Hill)

> 0.50 D 72% > 0.75 D 53%

> 1.00 D 38%

0.75 – 3.75 D (n = 104) retrospective

<0.50 D (1 mo) 20% (21% @ 4 m0)

<1.00 D (1 mo) 58% (49% @ 4 m0)

LRI (PCRI) Wang L, Misra M, Koch DD. Peripheral corneal

relaxing incisions combined with cataract surgery.

J Cataract Refract Surg 2003; 29:712–722

Relaxing Incisions

¤ Surgeon can configure depth at time of procedure based on measured corneal thickness

¤ System creates consistent and precise arc length and curvature

7/13/12

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 Capsulorhexis n Soften nucleus

To warrant purchase of $500,000 laser???

Are these problems enough:

Peer-reviewed clinical studies demonstrating benefits of femto laser cataract surgery:

¨  . . . . . . . .

# of ORs

# of surgeons simultaneously

operating

Avg OR time per case

# of ORs used by each surgeon

Center’s choice for system location is dependent on 4 key drivers:

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

New steps for laser cataract surgery

S.T.A.M.P

1. Treatment plan entry

2. Patient check-in 3. System prep 4. Patient pre-

op preparation

5. Patient transfer (in) 6. Dock patient 7. Conduct

treatment

8. Patient transfer onto

stretcher

9. Into OR for phaco/IOL

10. Patient post-op

Condensed workflow schematic: Nurse involvement

Activity 1: Pre-procedure

Activity 2: Laser procedure

Activity 3: Lens removal and IOL insertion

Surg

ery

Day

Nurse Nurse Nurse

7/13/12

6

Pre-procedure

¨  Dilate patient ¨  Apply topical anesthesia




Laser Procedure

¨  Transfer patient to laser room (or operating room) ¨  Assist patient in getting positioned under system ¨  Assure patient comfort, stability during procedure




Laser Procedure

¨  Transfer patient to laser room (or operating room) ¨  Assist patient in getting positioned under system

¨  Assure patient comfort, stability during procedure




Patient set-up – under the laser

¨  Proceed with standard procedure, e.g.: ¤ Transfer patient to OR ¤ Help prepare patient for surgery ¤ Assure patient comfort during procedure

Lens removal and IOL insertion




Other key factors for placement decision:

•  Room requirements for laser system •  Facility layout •  Workflow •  Scheduling

7/13/12

7

Access: scheduling considerations

S.T.A.M.P Surgeon preference:

Laser Phaco/IOL (post

Laser)

Laser x 2-3 Phaco/IOL x

2-3 (post Laser)

Manual surgery Laser

Phaco/IOL (post Laser)

Manual surgery

Serie

s G

roup

ed

Inte

rspe

rsed

Timing considerations

1. Prep Op Preparation 2. Laser 3. Phaco/IOL

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 ¤ 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 insertion?

S.T.A.M.P

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

•  Quick, template based planning

1 2

3 4

Lens Fragmentation Template Treatment Plan Summary

Patient Information Entry Capsulotomy Template

Scrub tech activities

¨  Post laser procedure, prior to cataract removal: ¤  Incisions already created ¤ Lens pre-softened

¨  Potential Implications? ¤ Fewer instruments in kit ¤ New phaco machine parameters ¤ Reduced OR time, quicker room

turnover

7/13/12

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

¨  Efficacy Gains: ¤  More predictable and accurate size, shape, and placement of capsulotomy ¤  More consistent construc@on of corneal incisions

¨  Safety Gains: ¤  Reduc@on in ultrasound phaco energy ¤  Less risk of capsular tears

¨  Surgeon Confidence Gains: ¤  Consistent incisions from case to case and from surgeon to surgeon

Is femto gimmic or game changer. . .

¨  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. . .

¨  Can we afford the extra: ¤ Time ¤ Cost ¤ Personnel

¨  How will we provide widely in this regulatory environment?

On the other hand. . .

¨  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

7/13/12

9

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

Questions?

femtosecond laser cataract surgery: … · ¹steinert, r. application of the femtosecond laser in...

Documents