Refractive Outcomes and Initial Clinical Experiences

Refractive

Outcomes and

Initial Clinical

Experiences

Founder and Attending Surgeon: Minnesota Eye Consultants Adjunct Professor Emeritus:

University of Minnesota, Department of Ophthalmology

Associate Director: Minnesota Lions Eye Bank

Acufocus, Inc. C,I,R, Abbott Medical Optics, Inc. C,I, _{Adoptics C, Advanced}

Refractive Technologies CAlcon Laboratories, Inc. C, AqueSys C,I _{Bausch + Lomb,}

Inc. C,I,R,

Bio Syntrx C,I Calhoun Vision Inc, C,I _{Clarity Ophthalmics} C,I_,

Clear Sight C,I, CoDa Therapeutics C,IConfluence Acquisition Partners I, Inc. I, EBV Partners C,I, EGG Basket Ventures C,I, ELENZA, C_{, Encore} C,I

Evision Photography, C,I, _{Evision Medical Laser ,} I, _{Eyemaginations, Inc.} C,I_{, ForSight,} C_,

Foresight Venture Fund #3, C,I, Fziomed I, Glaukos

Corporation C,I, HEAVEN Fund I, Healthcare Transaction Services I, High Performance Optics C,I,

Hoya Surgical Optics C , _{Improve Your Vision} C,I_{, OcularTherapeutix} C,I, _Lensar C,I

LenSx C,I, , Lifeguard Health, C,I _{, Lumineyes, Inc.} C _{, Minnesota Eye Consultants, P.A.} C,I_,

Nisco, I_{, NuLens} C,I

Ocular Surgery News/Slack,c , Ocular Optics C,I, _{Omega Eye Health,}C,I, _Omeros

Corp., C

OnPoint, I_{, One Focus Ventures,} 1, _{Pixel Optics,} C, I _Quest C,I.R_{, Rainwater Healthcare} I_,

Refractec C,I, MD_{, Revision Optics,}I,

Revital Vision C, I,_{, SarboxNP,} I_{, SARcode Corporation} 1_{, Schroder Life Science Venture}

Fund C,1_,

Seros Medical, LLC C_{, Sight Path,} C,I, MD, _Solbeam, I _{, Surgijet/Visijet,} C, I

3D Vision Systems C,I, TLC Vision C,I, MD, Tearlabs, Inc. C,I_{, Tracey Technologies} C,I_,

Transcend

Medical, Inc,C,I , True Vision, C,I_{, Versant} C _Viradax I_{, Vision Solutions Technologies} C,I,

TriPrima, I_{, Wavefront Systems,} I

*C=Consultant  *I= Investor  * MD= Medical Director *R= Royalty

THIS PRESENTATION MAY CONTAIN DISCUSSION OF OFF LABEL USE OF FDA APPROVED DRUGS AND/OR DEVICES

“This presentation represents the speaker’s professional experience.”

“Products/procedures not approved by the FDA and off label use of FDA approved products/procedures may be discussed.”

THE PROBLEM: RESIDUAL REFRACTIVE

ERROR REDUCES VISUAL PERFORMANCE

0 20 40 60 80 100 -2 -1 0 1 2 HD Five-O ReSTOR SN60D3 ReSTOR Aspheric 3 • Refractive errors result in significant vision loss with all

lenses(Kezirian, 2011) B e t t e r W o r s e

Single Procedure Postop Results @Month 1

Presby-IOL’s only (n=45,678;Kezirian:2011)

57.4% 65.7% 42.4% 0% 20% 40% 60% 80% 100% ± 0.50 D

Spheroequivalent Postop Cyl ≤ 0.50 D "Emmetropia"

(± 0.50 D S.E. with ≤ 0.50 D Cyl )

Sphere Enhancement Results

(MEC=18%) Spherical

Equivalent. (Kezirian,2011)

SA60D3  SN60D3 ReSTOR  ReZOOM  Crystalens Five‐O  Crystalens HD 

Mean Err

Cylinder Enhancement Results (MEC:18%)

(Abs. Postop Cyl)(Kezirian:2011)

Stratified by Correction Amount

0.24  0.22  0.22  _0.11  0.30  _0.13  0.34  ‐0.50  0.00  0.50  1.00  1.50  2.00  2.50  3.00  0.00  ‐0.25  ‐0.50  ‐0.75  ‐1.00  ‐1.25  ‐1.50  Mean / SD Pr edic2on Err or (D)  Pre‐Enhancement As2gma2sm (D)  Interpretation

• Accuracy of cylinder corrections does not significantly decrease throughout the observed range

Kezirian GM, Stonecipher KG. Comparison of the IntraLase femtosecond laser and mechanical keratomes for laser in situ keratomileusis. J Cataract Refract Surg. 2004 Apr;30(4):804-11.

Mean: 0.29 ± 0.41 D

Refractive Cataract Surgery

Tools Utilized

1.  Alcon/LenSx Femtosecond Laser

2.  Wavetec Intraoperative Aberrometer

(Orange/ORA)

Surgical Technique

1.  Mark steeper and flatter meridian with

Mastel or Zeiss Surgical Keratoscope

2.  WaveTec Intraoperative

Aberrometer(Orange/ORA) used to select IOL power and measure

intraoperative astigmatism

3.  Corneal relaxing incisions titrated open

using Mastel Surgical Keratoscope and Wavetec aphakic refraction

Mastel Illuminating Surgical Keratoscope

ISK

Mastel Illuminating Surgical Keratoscope

Innovative Alignment Systems By

Enhanced rendered image representing corneal mires created by the illuminated surgical keratoscope.

Mastel Illuminating Surgical Keratoscope

Innovative Alignment Systems By

Enhanced rendered image representing toricity of the IOL with larger and dimmer mires opposing 90 degrees from those of the cornea.

TORIC

Mastel Illuminating Surgical Keratoscope

Innovative Alignment Systems By

Enhanced rendered image representing corneal and IOL mires aligned with the

concentric rings of the multi– focal IOL.

With the patient fixating on the flashing centration light the visual axis is maintained during the crucial and final alignment.

Corneal and IOL

Mires: Multi-Focal

ORA System™

With New Optiwave™

Technology

Clinically Proven to Increase Accuracy & Improve Outcomes

•  Provides intra-operative refractive

information

•  Enables on-demand course

correction

•  Get it right – right on the table •  Compatible with & attaches to

LenSx Laser

Alcon LenSx, Inc. • Aliso Viejo, CA

•  2008: 1st _{femtosecond laser used}

clinically in EU for Laser Refractive

Cataract Surgery (Nagy, Budapest)

•  1st _{femtosecond laser to receive}

FDA

clearance for cataract surgery (2009) •  Currently three 510(k) clearances: - Anterior Capsulotomy - Corneal Incisions - Laser Phacofragmentation

•  1st _{Laser Refractive Cataract}

Surgery

procedure performed in US on Feb 29, 2010 (Slade, Houston) •  First case MEC: Aug. 22,2011

Materials and Methods

1.  First 25 consecutive cases (Excludes: PK,

DSEK, Fuchs, eyes with greater than 2.0

diopters astigmatism. Includes: 4 Lasik, 1-PXF) a.  Single Surgeon: Richard L. Lindstrom, MD

2.  Manifest refraction (OD, COMT, COT) (Last

pre-op, Last 1-3 mo post op)

3.  IOL’s

a.  Diffractive Multifocal (n=12)

Materials and Methods

4.  On axis incision if astigmatism less than

1.0 diopters

a.  2.8-3.2mm for Diffractive Multifocal (12)

b.  1.8-2.2mm for MICS Aspheric Monofocal

(13)

5.  Corneal relaxing incision and on axis

incision if astigmatism 1.0-2.0 diopter

a.  Lindstrom ARC-T Nomogram – 70 year old

b.  8.0 mm optical zone, 80% depth, 30°,

Defocus Outcomes(n=25):

Preoperative: -8.50 to +2.75 D

Astigmatism Outcomes (n=25):

Preoperative: 0.50-2.00 D.

A.  Range: 0.25 – 0.75D (25)

B.  Mean: 0.39D

C.  0.50 or less : 96%(24 of 25)

* 92% of cases with 0.50D or less defocus and 0.50D or less of astigmatism post

On Axis Incision Reults: (n=13)

Preoperative: 0.50-1.00 D

7.  Astigmatism with on axis incision only

Pre

operative Post operative Change

Range: 0.50-1.00 D 0-0.50 D -0.48D Mean: .77 D 0.29 D

On Axis Incision Results: (n=13)

8.  Mean effect of an on-axis incision

Range Mean

1.8-2.2mm(n=6) 0.25-0.50 D 0.39 D 2.8-3.2mm(n=7) 0.25-1.00 D 0.58 D

On Axis Incision Plus

Femtosecons Laser Corneal

Relaxing Incision: (n=12)

9.  Astigmatism with on axis incision plus

corneal relaxing incision

Preoperative Postoperative

Range: 1.25-2.00 D 0.25-0.75 D Mean: 1.71 D 0.50 D

Results of On Axis Incision and

Corneal Relaxing Incision By

Degree of Arc: 30,45,60

10.  Mean effect of corneal relaxing incision

plus on axis incision (8mm optical zone, 80% depth): (n=12)

Range Mean

30° (n=4) 0.50-1.00 0.75D 45° (n=3) 0.75-1.50 1.19D 60° (n=5) 1.25-2.00 1.55D

Calculated Mean Effect of Femtosecond

Laser Arcuate Corneal Relaxing Incision

at 8.0 mm optical zone and 80% depth

by Degree of Arc: 30,45,60

Femtosecond

CRI Mean Lindstrom ARC-T Diamond Knife 8 mm OZ (600 microns Depth) Nomogram 30° (n=4) 0.27 0.45 45° (n=3) 0.71 0.90 60° (n=5) 1.02 1.35

Current Femtosecond Laser

Astigmatism Correction

Planning Nomogram for 2012

On axis incision: 1-8-2.2mm 0.25 D On axis incision: 2.8 mm-3.2 mm 0.50 D On axis incision Plus: 1 X 30 CRI 0.75 D

On axis incision Plus: 1 X 45 CRI 1.00-1.50 D On axis incision Plus: 1 X 60 CRI 1.50-2.00 D On Axis Incision Plus: 2 X 45 CRI 2.00-2.50 D On Axis Incision Plus: 2 X 60 CRI 2.50-3.00 D

Visual Acuity with Technis

Multifocal IOL

Complications

# %

1 Anterior Capsule Tear 0 0

2 Posterior Capsule Tear 0 0

3 Vitreous Loss 0 0 4 Wound Leak 0 0 5 Lens Subluxation 0 0 6 CME 0 0 7 R.D. 0 0 8 PRK/Lasik Enhancement 0 0 9 Secondary Glaucoma 0 0

10 Uveitis (small retained nuclear clip aspirated at one month)

femtosecond related? 1 4

11 Suction Loss 0 0

12 Unable to achieve suction 1 0

13 Subconjunctival heme 25 100

14 Patient complaint re: pressure 1 4

Ten Femtosecond Laser

Refractive Cataract Surgery

Clinical Pearls

1.  Pre-treat with steroid and NSAID to reduce inflammation and

pupillary miosis

2.  Mark the steeper and flatter corneal meridian with a surgical

keratoscope (Zeiss or Mastel)

3.  No more than 2 drops topical anesthetic prior to Femtosecond

Laser Treatment

4.  Use a Leibowitz solid bladed speculum to isolate lids and

proptose the globe

5.  Pre-treat with lopidine gtts to reduce subconjunctival

Ten Femtosecond Laser

Refractive/Cataract Surgery

Clinical Pearls

7.  Place a drop of topical lubricant on the eye after Femtosecond

laser treatment and tape the eye closed during transportation to the OR.

8.  Inject Leiter’s phenylephrine solution or equivalent into the eye

prior to cataract removal to re-dilate the pupil

9.  Protect the ocular surface and endothelium with a dispersive

Viscoelastic (do not overinflate anterior chamber, rinse off the surfacewhen measuring the intraoperative aberrometry and when using the Mastel or Zeiss keratoscope).

10.  Measure the aphakic refraction with the Wavetec Intraoperatiive

Aberrometer. Use this for IOL power selection. Titrate the corneal relaxing incision open with a Sinskey hook using the Mastel or Zeiss keratoscope and WaveTec Intraoperative Aberrometer until the mire is round: Over inflate the eye with a cohesive viscoelastic to create a firm globe prior to measurements.

Economics of Femtosecond

Laser Refractive Cataract

Surgery

1 Fixed Cost (LenSx, Wavetec ORA, Mastel Keratoscope) 5 years pay off

$8,250/mo

$100,000/yr $400 per eye at 250 per year

2 Variaable cost (LenSx, Wavetec ORA, Mastel Keroscope)

$400/eye

3 Fee with ASC for cataract

surgery/IOL $2,000/yr

4 Fee with ASC for FLRCS (50%

Volume versus annual cost:

FLRCS

How do you pay for FLRCS?

1.  Raise the price for all Refractive Cataract

Surgery Cases( Charge the same fee whether manual or laser) $500/eye

2.  Increase Cataract Volume: $2000/eye

3.  Increase Conversion rate

One Practice (6 months: August

-January)

nd/Month Premium Channel IOL(% growth YOY) 2009-10 399 0 24 2010-11(Pre Femto, etc) 412 (3.3%) 0 30 (15.3%) 2011-12 465 (12.9%) 15 43 (43.3%)

FLRCS Direct and Indirect

Income; (250 cases a year)

1 Price Increase all Premium IOL Refractive Cataract Surgery Cases ($500/eye)

$125,000

2 Increased cataract surgery

Volume 5% (250/year x $2000) $500,000 3 Increased conversion to Premium Channel 10%( 50/ year $2500) $125,000 TOTAL: $750,000

4. Cost of new devices(LenSx,

WaveTec, Mastel) $200,000

Net Revenue: (Most from volume growth, not price increase)

Summary

1.  Refractive outcomes are the critical

component in successful Refractive Cataract Surgery.

2.  New surgical tools including a Surgical

Keratoscope, Intraoperative

Aberrometer, and Femtosecond Laser may enhance refractive outcomes and