Refractive Outcomes and Initial Clinical Experiences

Richard L. Lindstrom, MD Founder and Attending Surgeon: Minnesota Eye Consultants Adjunct Professor Emeritus: University of Minnesota, Department of Ophthalmology Associate Director: Minnesota Lions Eye Bank Refractive Outcomes and Initial Clinical Experiences With Femtosecond Laser Refractive Cataract Surgery

Disclosures Acufocus, Inc. C,I,R, Abbott Medical Optics, Inc. C,I, Adoptics C, Advanced Refractive Technologies C Alcon 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,I Confluence 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 Refractive errors result in significant vision loss with all lenses(kezirian, 100 2011) 40 B ett 80 60 20 W ors e e r HD Five-O ReSTOR SN60D3 ReSTOR Aspheric 0-2 -1 0 1 2 3

Single Procedure Postop Results @Month 1 Presby-IOL s only (n=45,678;kezirian:2011) 100% 80% 60% 57.4% 65.7% 40% 42.4% 20% 0% ± 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) 1.50 Mean Error (D) 1.00 0.50 0.00 0.50 0.16 0.20 0.10 0.04 0.15 1.00 1.50 ReSTOR SA60D3 ReSTOR SN60D3 ReZOOM Crystalens Five O Crystalens HD

Cylinder Enhancement Results (MEC:18%) (Abs. Postop Cyl)(Kezirian:2011) Stratified by Correction Amount Mean / SD Predic2on Error (D) 3.00 2.50 2.00 1.50 1.00 0.50 0.00 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. 0.24 0.22 0.22 Mean: 0.29 ± 0.41 D 0.11 0.30 0.13 0.34 0.50 0.00 0.25 0.50 0.75 1.00 1.25 1.50 Pre Enhancement As2gma2sm (D)

Refractive Cataract Surgery Tools Utilized 1. Alcon/LenSx Femtosecond Laser 2. Wavetec Intraoperative Aberrometer (Orange/ORA) 3. Mastel or Zeiss Surgical Keratoscope

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

ISK Mastel Illuminating Surgical Keratoscope Alignment Diagnostic Centration Verification Patent Pending

Innovative Alignment Systems By Mastel Illuminating Surgical Keratoscope Corneal Mires: Enhanced rendered image representing corneal mires created by the illuminated surgical keratoscope.

Innovative Alignment Systems By Mastel Illuminating Surgical Keratoscope TORIC IOL Mires: Enhanced rendered image representing toricity of the IOL with larger and dimmer mires opposing 90 degrees from those of the cornea.

Innovative Alignment Systems By Mastel Illuminating Surgical Keratoscope Corneal and IOL Mires: Multi-Focal 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.

Mastel Video

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 existing surgical microscopes

Power Calculation

ORange animation

LenSx Laser Alcon LenSx, Inc. Aliso Viejo, CA 2008: 1 st femtosecond laser used clinically in EU for Laser Refractive Cataract Surgery (Nagy, Budapest) 1 st femtosecond laser to receive FDA clearance for cataract surgery (2009) Currently three 510(k) clearances: - Anterior Capsulotomy - Corneal Incisions - Laser Phacofragmentation 1 st Laser Refractive Cataract Surgery procedure performed in US on Feb 29, 2010 (Slade, Houston) First case MEC: Aug. 22,2011

LenSx Video

Phaco Video

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) b. MICS Aspheric Monofocal(n=13)

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, (0.45D),45 (0.90D), 60 (1.35D)

Defocus Outcomes(n=25): Preoperative: -8.50 to +2.75 D 6. Defocus Outcome a. Range:0.00 to 0.75D (25) b. Mean: 0.30D (25) c. % 0.5D or less: 96% (24 of 25)

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 operative.

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 0.50 or less: 38% 100%

On Axis Incision Results: (n=13) 8. Mean effect of an on-axis incision Range 1.8-2.2mm(n=6) 0.25-0.50 D 2.8-3.2mm(n=7) 0.25-1.00 D Mean 0.39 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 0.50 or less: 0 92% (11 of 12)

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

Current Femtosecond Laser Astigmatism Correction Planning Nomogram for 2012 On axis incision: 1-8-2.2mm On axis incision: 2.8 mm-3.2 mm On axis incision Plus: 1 X 30 CRI On axis incision Plus: 1 X 45 CRI On axis incision Plus: 1 X 60 CRI On Axis Incision Plus: 2 X 45 CRI On Axis Incision Plus: 2 X 60 CRI 0.25 D 0.50 D 0.75 D 1.00-1.50 D 1.50-2.00 D 2.00-2.50 D 2.50-3.00 D

Visual Acuity with Technis Multifocal IOL US FDA Clinical Trial: Diffractive Multifocal Femtosecond Laser, Intraoperative Aberrometry Keratoscope (Multifocal) UCDVA 20/28 20/25 20/25 UCNVA 20/30 20/25 20/70 Femtosecond Laser, Intraoperative Aberrometry, Keratoscope (Monofocal)

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 15 Corneal Abrasion 2 8

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 hemorharge

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 2 Variaable cost (LenSx, Wavetec ORA, Mastel Keroscope) 3 Fee with ASC for cataract surgery/iol 4 Fee with ASC for FLRCS (50% toric, 50% MF, ACC ) $8,250/mo $100,000/yr $400 per eye at 250 per year $400/eye $2,000/yr $2000-$3000($2500 average)

Volume versus annual cost: FLRCS 100 $140,000 200 $180,000 300 $220,000 400 $260,000 500 $300,000 1000 $500,000

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 to premium IOL: $2500/eye

One Practice (6 months: August -January) Cat/Month (% growth YOY) Femtoseco nd/month 2009-10 399 0 24 2010-11(Pre Femto, etc) Premium Channel IOL(% growth YOY) 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, $200,000 WaveTec, Mastel) Net Revenue: (Most from volume growth, not price $550,000

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 reduce enhancement rates.