Refractive Outcomes and Initial Clinical Experiences

Transcription

1 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

2 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.

3 THE PROBLEM: RESIDUAL REFRACTIVE ERROR REDUCES VISUAL PERFORMANCE Refractive errors result in significant vision loss with all lenses(kezirian, ) 40 B ett W ors e e r HD Five-O ReSTOR SN60D3 ReSTOR Aspheric

4 Single Procedure Postop 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 )

5 Sphere Enhancement Results (MEC=18%) Spherical Equivalent. (Kezirian,2011) 1.50 Mean Error (D) ReSTOR SA60D3 ReSTOR SN60D3 ReZOOM Crystalens Five O Crystalens HD

6 Cylinder Enhancement Results (MEC:18%) (Abs. Postop Cyl)(Kezirian:2011) Stratified by Correction Amount Mean / SD Predic2on Error (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 Apr;30(4): Mean: 0.29 ± 0.41 D Pre Enhancement As2gma2sm (D)

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

8 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

9 ISK Mastel Illuminating Surgical Keratoscope Alignment Diagnostic Centration Verification Patent Pending

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

11 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.

12 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.

13 Mastel Video

14 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

15 Power Calculation

16 ORange animation

17 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

18 LenSx Video

19 Phaco Video

20 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)

21 Materials and Methods 4. On axis incision if astigmatism less than 1.0 diopters a mm for Diffractive Multifocal (12) b mm for MICS Aspheric Monofocal (13) 5. Corneal relaxing incision and on axis incision if astigmatism 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)

22 Defocus Outcomes(n=25): Preoperative: to 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)

23 Astigmatism Outcomes (n=25): Preoperative: D. A. Range: D (25) B. Mean: 0.39D C or less : 96%(24 of 25) * 92% of cases with 0.50D or less defocus and 0.50D or less of astigmatism post operative.

24 On Axis Incision Reults: (n=13) Preoperative: D 7. Astigmatism with on axis incision only Pre operative Post operative Change Range: D D -0.48D Mean:.77 D 0.29 D 0.50 or less: 38% 100%

25 On Axis Incision Results: (n=13) 8. Mean effect of an on-axis incision Range mm(n=6) D mm(n=7) D Mean 0.39 D 0.58 D

26 On Axis Incision Plus Femtosecons Laser Corneal Relaxing Incision: (n=12) 9. Astigmatism with on axis incision plus corneal relaxing incision Preoperative Postoperative Range: D D Mean: 1.71 D 0.50 D 0.50 or less: 0 92% (11 of 12)

27 Results of On Axis Incision and Corneal Relaxing Incision By Degree of Arc: 30,45, Mean effect of corneal relaxing incision plus on axis incision (8mm optical zone, 80% depth): (n=12) Range Mean 30 (n=4) D 45 (n=3) D 60 (n=5) D

28 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) (n=3) (n=5) Lindstrom ARC-T Diamond Knife 8 mm OZ (600 microns Depth) Nomogram

29 Current Femtosecond Laser Astigmatism Correction Planning Nomogram for 2012 On axis incision: mm 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 D D D D

30 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)

31 Complications # % 1 Anterior Capsule Tear Posterior Capsule Tear Vitreous Loss Wound Leak Lens Subluxation CME R.D PRK/Lasik Enhancement Secondary Glaucoma Uveitis (small retained nuclear clip aspirated at one month) femtosecond related? Suction Loss Unable to achieve suction Subconjunctival heme Patient complaint re: pressure Corneal Abrasion 2 8

32 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

33 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.

34 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)

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

36 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

37 One Practice (6 months: August -January) Cat/Month (% growth YOY) Femtoseco nd/month (Pre Femto, etc) Premium Channel IOL(% growth YOY) 412 (3.3%) 0 30 (15.3%) (12.9%) (43.3%)

38 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, Cost of new devices(lensx, $200,000 WaveTec, Mastel) Net Revenue: (Most from volume growth, not price $550,000

39 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.