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Controversies in Femtosecond Lasers and Presbyopic IOLs Richard Awdeh, MD Carlos Buznego, Md Mitch Jackson, MD Aylin Kilic, MD Jodi Luchs, MD Parag Majmudar, MD

Neda Shamie, MD William Trattler, MD George Waring IV, MD Robert Weinstock, MD Elizabeth Yeu, MD

OSN NY 2013

Disclosure • We will be discussing off-label use of: – Refractive lens exchange – Laser vision correction – Medications – Femtosecond lasers for cataract surgery

Note: There is no handout – as this is an interactive discussion panel

Disclosure • Course Instructors are consultants, receive research support, and/or are on the speakers Bureaus of all companies with FDA-approved IOLs, Lasers, and Medications

Disclosures • Richard M. Awdeh, MD – Consultant: Abbott Medical Optics; Bausch + Lomb; Cirle; iDoc; RVO – Ownership Interest: Cirle; iDoc • Carlos Buznego, MD – Consultant: Alcon Laboratories, Inc.; Allergan; Bausch + Lomb; Glaukos – Ownership Interest: CXL-USA; Glaukos; RPS • Mitchell A. Jackson, MD – Consultant: ACE Vision Group; Bausch + Lomb – Fees for Non-CME Services: Abbott Medical Optics; Alcon Laboratories, Inc.; Allergan; – Hoya; Marco – Ownership Interest: Paragon Bioteck, Inc.

Disclosures • Aylin Kılıç, MD – No relevant financial relationships to disclose • Jodi Luchs, MD, FACS – Consultant: Allergan; Bausch + Lomb; EyeGate; Nicox; Optimedica – Contracted Research: Alcon Laboratories, Inc.; Allergan; Bausch + Lomb; Insite; SarCode – Fees for Non-CME Services: Allergan; Bausch + Lomb; Nicox; Optimedica – Ownership Interest: CXL Opthalmics • Parag A. Majmudar, MD – Consultant: Alcon Laboratories, Inc.; Bausch + Lomb; TearScience – Investor: CXL Opthalmics; Ojo; Rapid Pathogen Screening

Disclosures • Neda Shamie, MD – Consultant: Allergan; Bausch + Lomb; Nicox • George O. Waring IV, MD – No relevant financial relationships to disclose • Robert J. Weinstock, MD – Consultant: Bausch + Lomb; TruVision; WaveTec – Fees for Non-CME Services: Bausch + Lomb – Contracted Research: Alcon Laboratories, Inc.; Bausch + Lomb; Glaukos – Ownership Interest: TruVision; WaveTec • Elizabeth Yeu, MD – Consultant: Allergan; Bausch + Lomb

Cataract Surgery is becoming more of a Vision Correction Procedure • Patient’s have very high expectations – Rapid Visual Recovery • Minimize amount of corneal swelling on Postop Day 1

– Avoid CME with prophylactic meds – Prevention of Ocular Surface Disease • Very common in cataract surgery patients

• Patients also expect to be on target with good uncorrected vision regardless of IOL choice

Challenging case Cataract Surgery OD in 2011

Returns for Cataract Surgery OS in 2013

Challenging case: 2011 Findings 62 yr old male: prior to phaco/IOL OD

Challenging case: Patient is now 64 with a significant change in Ks over 2 years OS: 2011

OS: Sept 3, 2013

1.5 D Shift in IOL power over 2 years (no surgery)

Challenging Case: Topography Topography OS Oct 2011

Topography OS Sept 2013

Challenging case: Pentacam OS 2013 Consistent with Keratoconus

63 year old female with Keratoconus progression OU over 4 years and 2 months:

Difference

Preoperative Topography: OK for Presbyopic IOL?

Pellucid Pattern Skewed Radial Axis and inferior steepening

Patient selection • 64 year old patient S/P myopic LASIK 10 years ago – Enjoyed monovision LASIK – Wants to be spectacle free if possible following cataract surgery • Approach?

William Trattler, MD

Patient selection • 64 year old patient S/P myopic LASIK 10 years ago

William Trattler, MD

Previous corneal surgery? PRK, LASIK or RK?

Previous RK for myopia

William Trattler, MD

63 year old female with vis sig cataract – would like to reduce need for distance lenses Which approach (if any) would you recommend?

Central Astigmatism Relatively Regular

TORIC IOL placed: T7 at axis 170 • UCVA = 20/20 at postop day 5 – Patient very pleased with quality of vision – No monocular diplopia

Another Pellucid case Toric IOL? LRI?

Avoid Toric IOL or Corneal Incisions Consider Crosslinking….

William Trattler, MD

86 year old Female: Initial Consultation for cataract surgery

William Trattler, MD

2 D shift in IOL power (from 18.5D to 20.5D)

72 yr old asymptomatic female with a cataract After 2 weeks of Pred & cyclosporine

12/19/11

1/4/12

After punctal plug plus more Pred & cyclosporine

1/10/12

26

After 3 weeks of Pred Forte TID, Restasis BID, and lower punctal plug 1/10/12

Note: No EBMD present

What is the value of a Preop OCT? • Do you perform on all cataract surgery patients, or just selected patients? • Can these patients have Multifocals? Crystalens?

Surgery Planning Patient Discussion • When do you recommend a Toric IOL over a Presbyopic IOL? • When do you recommend Femto LRIs over a toric IOL?

Mitchell A Jackson MD Founder/Director, Jacksoneye Lake Villa, IL [email protected]

The Setup  Baseline Exam 1/27/2012  63 y/o WF on alprazolam (Xanax) and temazepam (Restoril) daily  8 incision RK OU 1990 (different surgeon)  Myopic LASIK enhancement OU 2001 (different surgeon)  MRx  

OD +1.00+0.75x25 20/60 OS +1.50+1.50x170 20/60

 2+NSC/2+PSC OU

Preop IOLMaster

Preop Vector Toric IOL Analysis

The Surgery and Outcome  Uncomplicated phaco MICS 1.8 mm incision 2/6/2012  No ORA available at ASC at that time  Acrysof T7 used  Yag Capsulotomy early postop 4/25/2012

 MRx OS -3.25+0.75x100 20/25 5/21/2012  Patient is upset, doesn’t want OD cataract done  Prefers to wear Rx glasses with 4.75D anisometropia

until 2 weeks ago (16 months total)

Corneal Topography OS postop

Why Me?  OD has changed to +3.25+0.75x35 20/60 8/17/2013  Now 6.5D anisometropia which she can’t tolerate  Now she wants cataract surgery done OD  OPTIONS  Take one of her alprazolam (Xanax) and operate and hope to get lucky  Take the same approach as OS and hope the eye ends up symmetrically myopic to OD  Don’t operate on her and send her on all-expense paid trip to Miami to see Bill Trattler  ORA now in our ASC and may add a better comfort zone

How much residual astigmatism is tolerated with a multifocal IOL?

Unhappy Presbyopic IOL patient with residual astigmatism

UCVA OD = 20/60 MR = -0.50 +1.50 X 175 = 20/25

What approach would you take? PRK? LASIK Other?

Femto AKs

Parameters for laser AK Depth = 450 microns Optical zone = 8.5

Unhappy Presbyopic IOL patient with residual astigmatism

UCVA OD = 20/60 MR = -0.50 +1.50 X 175 = 20/25

5 days postop UCVA OD = 20/30 MR = +0.25 +0.50 X 001 = 20/25

Femto-cataract Surgery • What platforms are you using • What steps of the procedure are you using femto for?

If insurance was not an issue when would you recommend femto cataract surgery?

• Please sure conditions where you feel femto truly makes a difference in your surgical outcomes

Patient with Pseudoexfoliation Femto-Cataract? Presbyopic IOL?

A Challenging Case

Robert J. Weinstock, MD The Eye Institute of West Florida

38 yo healthy male presents with 5 year hx of worsening vision. Was told he had “unusual cataracts” by several doctors.

Patient has heard about “advanced” lenses and does not want to wear glasses after cataract surgery.

OD

OS

What would you do?

Options Sewn/glued in monofocals with possible monovision targeting  Sewn/glued in multifocals  ACIOLs with or without monovision  Punt to another cataract surgeon  Punt to retina  Other ideas 

Challenging FCAT Case • 50 year old male • History of bilateral epikeratophakia (by M. McDonald) • Recently underwent CE/IOL in contralateral eye (manual, blade surgery) – Difficult view

• Second eye, attempt at FCAT Richard M. Awdeh, MD

Epikeratophakia, K’s > 50

Treatment planning

OCT Treatment planning

Post-sx surprise Elizabeth Yeu, MD

patient 62 yo healthy female AL: 25.63 K’s 44.92/45.08 Nervous about halos Crystalens AO on June 5, 2013

Patient

June 10, 2013: (POD 10) UCVA 20/20 (Plano) August 5, 2013: (POM 2) UCVA 20/30 MRx: +1.00 + 0.25 x 151

options?

Clear Corneal Incision Neda Shamie • “…there are multiple factors for reducing endophthalmitis and that incision construction and architecture are the primary factors in preventing post-op endophthalmitis” – Howard Fine, MD

The ideal clear corneal incision • Self-sealing & watertight – wound architecture

• Astigmatically neutral – size and limbal position

• Easily accessible – placement and ease of opening

• Challenges with laser assisted CC wounds? • Thoughts as to why? • Solutions?

Before and After I/A

Cortical Removal with Femtosecond Assisted Cataract Surgery George O. Waring IV, MD Director, Refractive Surgery Assistant Clinical Professor of Ophthalmology Medical University of South Carolina, Storm Eye Institute Charleston, SC

Medical Director Magill Vision Center Mt. Pleasant, SC Adjunct Assistant Professor of Bioengineering College of Engineering and Science Clemson University Ocular Surgery News, NYC 2013

Cortex Removal with Femtosecond Laser – Ease/Efficiency • How do you find ease and efficiency of cortical removal compared to manual and what platform do you use? – Easier/more efficient – No difference – More difficult/less efficient

Waring IV, GO

Cortex Removal with Femtosecond Laser – Technique • Have you changed your technique for cortical removal with femto? – No change – “Pneumodissection” – New hydrodissection cannula design – Hydrodissection post nuclear removal – Bimanual – Other Waring IV, GO

Cortex Removal with Femtosecond Laser – Laser Settings • Have you changed your laser settings to improve ease of cortex removal and has this affected your capsulorhexis? – Decreased depth of capsulorhexis cut – Lowered energy for capsulorhexis cut – Changed fragmentation pattern – Lowered energy for fragmentation pattern

Waring IV, GO

Cortex Removal with Femtosecond Laser – Etiologies • Why do you think cortical removal is different with femto assisted cataract surgery? – Lack of fimbrication/tags – Energy changes phyisical property – Plasma gas release changes physical property – Pressure from gas release – Other?

Waring IV, GO

Thank You [email protected] www.georgewaringiv.com

New members?

What would you do for this cataract patient who desires Premium IOL? • Toric IOL • Presbyopic IOL – If so – which one?

Handling the Unhappy Presbyopic IOL Patient

• How do you handle unhappy patients on the one-two week postop visit? – End up off target • 20/30 UCVA or worse • Insufficient reading ability

Handling the Unhappy Presbyopic IOL Patient • How do you handle unhappy patients on the onetwo week postop visit? – Night Vision Complaint at the 1-2 week visit? – Can any interventions help? • Alphagan/pilo? • Yag? • Other options for patient?

• How do you handle the patient that wants to wait for night vision complaints to improve before proceeding with second eye?

Handling the Unhappy Presbyopic IOL Patient

• How soon after cataract surgery will you Yag? – Crystalens vs multifocal?

• Does this take away your option for an IOL exchange?

LASIK Dissatisfaction & UCVA S. Schallhorn MD, Optical Express Data n=22,194 pts, Nov 09 – July 10 86% of eyes attained at least 20/20 UCVA

What % of eyes reached 20/25 or better (TMF)?

Only 50% of eyes are 20/25 or better 100.00%

TMF: UCDVA

91.60%

90.00%

Percent of Eyes

80.00%

76.30%

70.00% 60.00%

49.60%

50.00% 40.00% 30.00%

20.00% 10.00%

12.20%

0.00%

20/20

20/25 or better 20/30 or better 20/40 or better Uncorrected Distance Visual Acuity

Data from Center for Excellence In Eye Care 85 Miami, FL

What % of eyes reached 20/25 or better (Restor D1)?

Only 50% of eyes are 20/25 or better 100.00%

ReSTOR D1: UCDVA

90.00%

87.70%

80.00%

76.90%

Percent of Eyes

70.00% 60.00%

49.20%

50.00%

40.00% 30.00% 20.00%

24.60%

10.00% 0.00%

20/20

20/25 or better

20/30 or better

20/40 or better

Uncorrected Distance Visual Acuity

Data from Center for Excellence In Eye Care

Miami, FL

86

Can Visual Outcomes Improve with Femtosecond Cataract Surgery 

Possible reasons for improvement. 

More uniform Effective lens Position with femto 



Laser anterior capsulotomy : 

Centered



Uniform

More efficient surgery 

2011.02.17-MM3003

Less phaco energy required

87

Percentage within Intended Result Single Surgeon (Harvey Uy, MD) LensAR Laser vs Manual Capsulotomy (IOL = AcrySof SA60AT IOL for both groups) Overall Accuracy 6-months % within

Laser

Manual

0.00 of target

11.6%

4.1%

≤0.25 of target

47.4%

22.0%

≤0.50 of target

78.7%

52.8%

≤1.00 of target

93.2%

90.2%

249

123

n

Recommendations for post-Myopic LASIK (previously -6.00) patient with cataract

Which premium IOL Would you recommend, if any?

ASCRS.org

20.5D TMF placed

Outcome 20/30 UCVA MR: -0.50 +0.75 X 090

Recommendations for post-Hyperopic LASIK (previously +2.00) patient with cataract

Which premium IOL Would you recommend, if any?

Recommendations for post-RK patient with cataract

Which premium IOL Would you recommend, if any?

How would you counsel this patient seeking maximum spectacle independence? • 70-year-old • -12.00D myope • Succesful with monovision RGPs for 30 years – 1.5 cylinder on topography

How would you counsel this patient seeking maximum spectacle independence? • 52-year-old nearly emmetropic stockbroker who loves to play golf. – No cataract – Wants to be spectacle independent at all costs.

Short eye with 4D astigmatism • Axial length <20 • Predicted Alcon Toric IOL power for plano: 36 – Highest IOL power for Toric IOL = 30

• Options

– Toric IOL with LRI and piggyback IOL – Toric IOL with LRI followed by LVC – Monofocal IOL with LRI, followed by LVC – Other options

Preop Dry eye & Blepharitis? • How commonly do these conditions impact your Presbyopic IOL results?

Images courtesy of Jodi Luchs

• Do you implant multifocal IOLs in a patient with mild macular disease such as mild nonproliferative diabetic retinopathy or a few drusen?

WaveTec “ORange™” Intraoperative Aberrometer

IOL Calculation Pearls for Presbyopic IOLs

Prebyopic IOLs in Glacoma

Preop Pupil size? • How does pupil size affect your presbyopic IOL choice?

Surgery Planning Patient Discussion • Do you make a recommendation on a Presbyopic lens type – or give patients multiple options?

Surgery Planning Patient Discussion • Do you make a recommendation on a Presbyopic lens type – or give patients multiple options? • How important are your staff in communicating with patients regarding presbyopic IOL choices?

Conclusions • Femto cataract surgery is an exciting technology which will continue to grow in use in the US • Presbyopic IOLs can provide improved patient satisfaction – but requires careful preoperative planning and potential for more challenging postoperative care

Case # 1 68 year old female, monovision contact lens wear x 30 years, OD near Gradual decrease in both distance and near VA – Pre-op MRX +2.50 +0.50 x 005 +0.25 sphere Slit lamp exam 1-2+ NS OD 3-4+ NS OS

20/30 20/100

OS OD

Rex Hamilton, MD

8

Case #1 • • •

Refractive oriented patient, history of monovision Significant cataract in distance eye Significant epiretinal membrane in near eye

What is your lens of choice?

1. Monofocal with monovision? 2. Monofocal for distance only? 3. Accommodating (Crystalens)? 4. Multifocal? OU? 2011.09.21-ME4047

MAKE A CHOICE

Rex Hamilton, MD

9

11/16/12

• The Centers for Medicare and Medicaid Services today released guidance to clarify when beneficiaries can be billed for non-Medicare-covered services using the femtosecond laser to insert a premium refractive intraocular lens, after cataract surgery. – CMS indicates that it is possible to bill beneficiaries for use of the femtosecond laser for services such as imaging when a premium refractive IOL is implanted, but not when a conventional IOL is used. – The agency specifically does not permit billing for the use of femtosecond laser technology in conjunction with Medicare-covered steps of the cataract surgery, such as the phaco incision, capsulotomy and lens fragmentation

Technologies that can help expand patients visual • Toric IOLs • Presbyopic IOLs • Preoperative testing to identify subtle preop conditions • Technologies to make surgery less risky • Technologies to help patients ende

• “The physician may take into account the additional physician work and resources required for insertion, fitting, and visual acuity testing of the presbyopia-correction IOL” • Allows surgeons to charge for non-covered services – Preoperative testing • Topography • OCT of the macula • Other tests

– Intraoperative testing – Postoperative testing • Topography • Wavefront • Testing of Intermediate and near vision

– Refractive Surgery Enhancements: PRK or LASIK