Optometric Clinical Update 2018

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Tabitha Potter
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1 Optometric Clinical Update 2018 What s CHU Y. Ralph Chu, MD Chu Vision Institute 1

$S. LVC market in 16 years (Femto-LASIK in 2000) New LVC option for refractive surgeons to offer patients fearful of LASIK and those$ waiting for the next thing. Unlike PRK and LASI

waiting for the next thing. Unlike PRK and LASI

2 SMILE 2017 Chu Vision Institute U.S. LVC Market Impact of ReLEx SMILE ZEISS ReLEx SMILE will grow LVC market First major innovation in U.S. LVC market in 16 years (Femto-LASIK in 2000) New LVC option for refractive surgeons to offer patients fearful of LASIK and those waiting for the next thing. Unlike PRK and LASIK, SMILE was developed in Europe and arrives in the U.S. as an established technology; 1,000,000+ procedures performed internationally to bolster physician and patient confidence. ZEISS ReLEx SMILE receives FDA approval

$have refractive surgery again).² No flap-related complications (e.g. flap detachment) All-femtosecond laser procedure in one step without need to move the patient LASIK ReLEx SMILE incision approx.$ $6 mm 1. Comparison of visual ad refractive outcomes following femtosecond laser assisted LASIK with SMILE in patients with myopia or myopic astigmatism.$

3 ReLEx SMILE Characteristics and Benefits LASIK-like outcomes with a one-step, minimally-invasive procedure¹ Effectiveness and safety of procedure well received by patients (99% satisfied, 96% would have refractive surgery again).² No flap-related complications (e.g. flap detachment) All-femtosecond laser procedure in one step without need to move the patient LASIK ReLEx SMILE incision approx. 6 mm 1. Comparison of visual ad refractive outcomes following femtosecond laser assisted LASIK with SMILE in patients with myopia or myopic astigmatism. Journal of Refractive Surgery 2014 Sep, Sri Ganesh, Rishika Gupta. 2. Survey conducted as part of FDA clinical study. ReLEx SMILE Characteristics and Benefits Removing tissue from deeper corneal layers result in less impact on the corneal surface and nerves and lower risk of dry eye Dry eye disease after refractive surgery: comparative outcomes of small incision lenticuleextraction versus LASIK. Ophthalmology 2015 Apr, DenoyerA, LandmanE, Trinh L, Faure JF, AuclinF, BaudouinC. 3

5 April 2018 ReLEx SMILE with the VisuMax Introduction How does a

Ultrashort (1 fs = 10-15sec), infrared laser pulses trigger an optical

The plasma produces a shock wave that produces cavitation bubbles that

Placing thousands of these bubbles next to one other allows the

4 5 April 2018 ReLEx SMILE with the VisuMax Introduction How does a femtosecond laser work? Ultrashort (1 fs = 10-15sec), infrared laser pulses trigger an optical breakdown known as photodisruption and generate a plasma. The plasma produces a shock wave that produces cavitation bubbles that sever tissue in a focused area without injuring surrounding tissue. Placing thousands of these bubbles next to one other allows the creation of cuts of virtually any shape within the cornea. ReLEx SMILE with the VisuMax System Overview Laser Patient Supporting System (PSS) Platform 4

ReLEx SMILE with the VisuMax Introduction Video ReLEx SMILE with the VisuMax FDA Indications for Use Indications for Use: Reduction or elimination of myopia - 1.00 D to -8.00D (-8.01 D to -10.

5 ReLEx SMILE with the VisuMax Introduction Video ReLEx SMILE with the VisuMax FDA Indications for Use Indications for Use: Reduction or elimination of myopia D to -8.00D (-8.01 D to D will trigger a flagged warning), with D cylinder and MRSE -8.25D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year. 5

6 Similar to LASIK Postop SMILE ReLEx SMILE with the VisuMax Routine Post-Operative Management Routine follow up visits after SMILE 1 Day 1 Month 3 Months 1 Year Further optional visits 1 Week 6 Months Annually Additional visits as required according to the situation. 6

evening Day to day NV good/dv bad DV good/nv bad Always use both eyes Don t test each eye Prescribe temporary glasses if necessary Remain aware of adaptation process Often happens overnight

7 ReLEx SMILE with the VisuMax Expectations: Three Stages 1. Immediate & day one (swelling, healing response) 2. First few weeks 3. Three/four months (swelling, healing, adaptation) (adaptation presbyopic) Slight discomfort Dry eye sensation Night vision halos Slight blurring Visual fluctuations Visual fluctuations Morning to evening Day to day NV good/dv bad DV good/nv bad Always use both eyes Don t test each eye Prescribe temporary glasses if necessary Remain aware of adaptation process Often happens overnight Retreatment if required FDA Study Study Design & Objectives Design & Objectives Prospective, multi-center, open label, single-arm study Proposed sample size: 360 subjects Unilateral treatment with 12-month follow-up period Fellow eye treatment with approved laser procedure (clinical data not part of pivotal study) Objective: to evaluate the safety and effectiveness of the VisuMaxFemtosecond Laser lenticule removal procedure for the reduction or elimination of myopia from D to D with D cylinder and MRSE D (subjects with D cylinder were enrolled, but the cylinder was not treated as part of the clinical trial) 7

$FDA Study Effectiveness: Post-Operative UCVA Refractive Predictability MRSE Attempted vs.$

8 FDA Study Effectiveness: Post-Operative UCVA Refractive Predictability MRSE Attempted vs. Achieved Month 6 N=328 Month 12 N=310 n % n % ± 0.50D % % ± 1.00D % % 8

High MRSE Predictability at 6 Months 11 10 9 8 7 6 Achieved 5 MRSE (D) 4 3 2 1 0 Achieved = -0.057 + 0.

50D 0 1 2 3 4 5 6 7 8 9 10 11 Attempted Sphere Correction (D) High MRSE Predictability at 12 Months 11

9 High MRSE Predictability at 6 Months Achieved 5 MRSE (D) Achieved = * Attempted N = 328 ±1.00D Unity ±0.50D Attempted Sphere Correction (D) High MRSE Predictability at 12 Months Achieved 5 MRSE (D) Achieved = * Attempted N = 310 ±1.00D Unity ±0.50D Attempted Sphere Correction (D) 9

$FDA Study Refractive$ MRSE Stability: Predicted

10 FDA Study Refractive Stability: Mean Change in MRSE FDA Study Refractive Stability: Predicted MRSE at 12 months 10

FDA Study Patients with Post-op UCVA Pre-op

11 FDA Study Patients with Post-op UCVA Pre-op BSCVA MesopicContrast Sensitivity Remains Unchanged at All Study Visits Pre-operative Month 12 Contrast Sensitivity (Log Unit) Spatial Frequency (cpd) Median and interquartile range (IQR) 11

Change in Visual Symptoms at 12 Months Worse 1 Grade or No Change Better Halos Glare 1.3% 2.3% 96.1% 92.2% 2.6% 5.5% Starbursts 0.0% 99.0% 1.0% Hazy Vision 0.3% 98.1% 1.6% Blurred Vision 2.6% 95.8% 1.

12 Change in Visual Symptoms at 12 Months Worse 1 Grade or No Change Better Halos Glare 1.3% 2.3% 96.1% 92.2% 2.6% 5.5% Starbursts 0.0% 99.0% 1.0% Hazy Vision 0.3% 98.1% 1.6% Blurred Vision 2.6% 95.8% 1.6% Distortion 0.0% 99.7% 0.3% Double Images 0.0% 98.5% 1.5% Fluctuation 0.6% 98.8% 0.6% Focusing 3.6% 95.4% 1.0% Depth Perception 2.9% 95.8% 1.3% 0% 20% 40% 60% 80% 100% OSDI: Ocular Symptoms and Discomfort at 12 Months Ocular Symptoms (N=308) Experienced symptoms during last week Worse 2 Grades No Change or ± 1 Grade Better 2 Grades n % n % n % 8 3% % 14 5% Environmental Triggers (N=288) Feltuncomfortable in environmental 9 3% % 17 6% situations during last week 1 12

ReLEx SMILE Quickly Gaining Popularity O.U.S. 250,000 60.0% 200,000 50.0% Eyes p.a. 150,000 100,000 50,000 40.

$ZEISS ReLEx SMILE grew refractive procedures by more than 200% on average per ZEISS VisuMax laser over a$

13 ReLEx SMILE Quickly Gaining Popularity O.U.S. 250, % 200, % Eyes p.a. 150, ,000 50, % 30.0% 20.0% 10.0% % SMILE Procedures Percentage of SMILE procedures in SMILE clinics ReLEx SMILE China a predictor of U.S. market with VisuMax and SMILE? ZEISS ReLEx SMILE grew refractive procedures by more than 200% on average per ZEISS VisuMax laser over a 5-year period in China. 13

14 Conclusion First and only site in Minnesota Look forward watching this new procedure grow. Astigmatism Management Y. Ralph Chu, MD Chu Vision Institute Minneapolis, MN 14

Cataract Suite Markerless Eliminates manual eye marking and allows for seamless data transfer Pre-op eye Biometry and Pre-op eye Biometry and marking for 0- keratometry marking for 0- keratometry 180

$Hoffmann PC, Hütz WW. JCRS. 2010 Sep;36(9):1479-85. ² Visser N, Berendschot TT, Bauer NJ, et al. Accuracy of toric intraocular lens implantation in cataract and refractive surgery.$ $J Cataract Refract Surg. 2011;37(8):1394-1402. ³ Behndig A, Montan P, Stenevi U, Kugelberg M, Zetterström C, Lundström M.$ $Long-term clinical outcomes of toric intraocular lens implantation in cataract cases with preexisting astigmatism. J Cataract Refract Surg. 2014;40:1654-1660.$

15 Cataract Suite Markerless Eliminates manual eye marking and allows for seamless data transfer Pre-op eye Biometry and Pre-op eye Biometry and marking for 0- keratometry marking for 0- keratometry 180 axis 180 axis Manual data transfer Manual from data transfer from office office to to OR OR Intraoperative Intraoperative Incisions and Phaco and Toriclens marking of of toric IOL Incisions capsulorhexis and Phaco and lens extraction implantation toric IOL target axis capsulorhexis extraction and alignment axis Toric IOL implantation and alignment v Toric IOLs Benefits and Challenges ¹ Hoffmann PC, Hütz WW. JCRS Sep;36(9): ² Visser N, Berendschot TT, Bauer NJ, et al. Accuracy of toric intraocular lens implantation in cataract and refractive surgery. J Cataract Refract Surg. 2011;37(8): ³ Behndig A, Montan P, Stenevi U, Kugelberg M, Zetterström C, Lundström M. Aiming for emmetropia after cataract surgery: Swedish National Cataract Registry. J Cataract Refract Surg. 2012; 38(7): ⁴ Miyake T, Kamiya K, Amano R, et al. Long-term clinical outcomes of toric intraocular lens implantation in cataract cases with preexisting astigmatism. J Cataract Refract Surg. 2014;40: Benefits One-third of eyes demonstrate moderate to high astigmatism (>1.0D) that may benefit from toric IOLs.¹ Challenges 10º of toric IOL misalignment causes a 1/3 decrease in the desired effect.² Reference axis and toric axis marking contribute to a mean total error in toric IOL alignment of 4.9 ±2.1º⁴ Without intraoperative assistance, only 60% of patients exhibit post-op results within 0.5D of the intended refraction.³ 15

IOLMaster 700 The Next Generation Optical Biometer with SWEPT Source

zones Unsurpassed consistency / reliability Telecentric optics for

thickness (LT) Corneal thickness (CT) Total Corneal Power (Future

length measurements Fixation check to optimize measurements Identify

16 IOLMaster 700 The Next Generation Optical Biometer with SWEPT Source Biometer 3-Zone Telecentric Keratometry 18 measurement points in 3 zones Unsurpassed consistency / reliability Telecentric optics for distance independency Additional measurement capabilities Lens thickness (LT) Corneal thickness (CT) Total Corneal Power (Future development) Swept-sourced OCT for optimizing keratometry and axial length measurements Fixation check to optimize measurements Identify unusual eye morphology & ELP IOLMaster 700 Repeatability (Axial Length) 9 16

Cataract Suite Markerless CALLISTO eye The data injection function - OPMI LUMERA family 2 displays the markerlesstoriciol alignment data

Imports patient data from FORUM or USB stick at the touch of a button Crisp and clear visualization Multicolor data injection configurable

function Cataract Suite Markerlessvs. markers Clinical Data One site, n=62 With ZEISS Cataract Suite Within 2.88⁰±2.

17 Cataract Suite Markerless CALLISTO eye The data injection function - OPMI LUMERA family 2 displays the markerlesstoriciol alignment data inhigh resolution and color No distraction from the surgical field. Imports patient data from FORUM or USB stick at the touch of a button Crisp and clear visualization Multicolor data injection configurable by surgeon Integrated controls for relevant CALLISTO eye functions with the OPMI LUMERA 700 HD video recording Including assisting overlay function Cataract Suite Markerlessvs. markers Clinical Data One site, n=62 With ZEISS Cataract Suite Within 2.88⁰±2.76 from ideal target axis¹ Without Intraoperative Assistance Within 5.94⁰±10.67 from ideal target axis¹ ¹ Lackerbauer, C. Modern Solutions for Refractive Cataract Surgery: CALLISTO eye. Cataract & Refractive Surgery Today. February 2013;

18 Cataract Suite Markerless Clinical Data One site, n=668 Significantly higher percentage of patients having 0.50 D post-op residual cylinder in the CALLISTO eye group (p=0.028) vs. traditional ink-marking. ¹ Black D. Evaluation of Markerless Alignment System for ToricIOLs. Paper presented at: ASCRS/ASOA Cataract Suite Markerlessvs. ORA Clinical Data One site, n=52 patients, 104 eyes Over 2x percentage of patients within 0.25D and over 3x percentage of patients at 0.0D of intended refraction with ZCS markerless(p=0.004). At within 0.5D, 0.75D and 1.0D, statistically insignificant difference between ZCS markerlessand ORA. Data Courtesy of Jonathan Solomon, M.D., Bowie Vision Institute, Bowie, MD 18

CAUTION: Investigational Device Limited by Federal Law

19 Lenstec Bifocal IOL Designed to Eliminate the Compromise CORD SC9 Not Accommodating Not Multifocal CAUTION: Investigational Device Limited by Federal Law to Investigational Use Only - Not available for sale in the US 19

20 J. STUART CUMMING, M.D. CORD SC9 Characteristics CAUTION: Investigational Device Limited by Federal Law to Investigational Use Only - Not available for sale in the US 20

21 Early results SC9 Uncorrected Acuities 1 DAY N=33 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 42% 6% 3% 67% 18% 18% 85% 39% 39% 94% 76% 73% 20/20 or better 20/25 or better 20/32 or better 20/40 or better UCDVA UCIVA UCNVA CAUTION: Investigational Device Limited by Federal Law to Investigational Use Only - Not available for sale in the US 21

better 20/40 or better UCDVA UCIVA UCNVA CAUTION: Investigational Device Limited by

22 SC9 Uncorrected Acuities 1 WeeK N=33 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 100% 100% 100% 93% 93% 88% 83% 81% 52% 38% 13% 6% 20/20 or better 20/25 or better 20/32 or better 20/40 or better UCDVA UCIVA UCNVA CAUTION: Investigational Device Limited by Federal Law to Investigational Use Only - Not available for sale in the US Acufocus IC-8 Carl Zeiss 22

23 Traditional Solutions Rearrange Blur Clear near focus Blur Clear far focus Small Aperture Removes the Blur Clear extended range of focus 23

Single Focus* vs Extended Depth of Focus** LogMAR Visual Acuity -0.20-0.10 0.00 0.10 0.20 0.30 0.40 0.50 0.60 0.70 0.80 0.90 1.00 1.10 1.20 Presbyopic Eye Binocular IC-8 and Monofocal IOL 1.00 0.50 0.00-0.

24 Single Focus* vs Extended Depth of Focus** LogMAR Visual Acuity Presbyopic Eye Binocular IC-8 and Monofocal IOL Far Infinity 2.75 D Functional Range of Vision Intermediate 80 cm Near 40 cm *Presbyopic patient defocus curve KAMRA Inlay PMA (N=114) ** Binocular Target-corrected defocus curve at 6 months (N=12) Quantity and Quality IC-8 IOL Target-corrected to -0.75D Diffractive Multifocal IOL Trifocal IOL 24

25 IOL Image Quality Through Focus Image Quality Bench Test Data, 50 lp/mm, ISO Model Eye, White Light (Halogen nm), in Aqueous AT LISA Tri IC-8, SA TECNIS Mono ReSTOR 3.00 TECNIS 2.75 Symfony MTF Image Quality, 50 lp/mm Relative Defocus (Diopter) 0.00 Mean Binocular Uncorrected Visual Acuities Very good binocular uncorrected VA at 6 months achieved at for far, 0.04 for intermediate and 0.16 for near (all in logmar). Binocular UCVA (Mean, 95%CI) logmar Far Intermediate Near Mon 1 (n=108) Mon 3 (n=107) Mon 6 (n=105) 20/20 20/25 20/32 Mean IC-8 IOL MRSE: D at 6 months Mean Monofocal IOL MRSE: 0.01 D at 6 Months Dick et al, JCRS July

$00 D deviation from intended refractive target without an appreciable change in acuity any measured distance Visual Acuity by MRSE Group IC-8 IOL Eye Visual Acuity by MRSE Group Monofocal IOL$ Eye LogMAR Visual Acuity -0.1 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 within 0.5D from target (n=63) >0.5D but within 1D from target (n=35) >1D but within 1.

Eye LogMAR Visual Acuity -0.1 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 within 0.5D from target (n=63) >0.5D but within 1D from target (n=35) >1D but within 1.

5D but within 1D from target (n=35) >1D but within 1.

26 Tolerance to Deviations from Intended Target IC-8 IOL eyes can tolerate up to 1.00 D deviation from intended refractive target without an appreciable change in acuity any measured distance Visual Acuity by MRSE Group IC-8 IOL Eye Visual Acuity by MRSE Group Monofocal IOL Eye LogMAR Visual Acuity within 0.5D from target (n=63) >0.5D but within 1D from target (n=35) >1D but within 1.5D from target (n=5) 20/20 20/25 20/32 LogMAR Visual Acuity within 0.5D from target (n=63) >0.5D but within 1D from target (n=35) >1D but within 1.5D from target (n=5) 20/20 20/25 20/32 UCDVA UCIVA UCNVA UCDVA UCIVA UCNVA Data from European Post-Market Study on IC-8 IOL Addressing Corneal Astigmatism IC-8 IOL tolerates up to 1.50 D of corneal astigmatism Cylinder Tolerance LogMAR * UCDVA UCIVA UCNVA Visual Acuity Less than 0.75 D (N=114) 0.76 D to 1.5 D (N=25) More than 1.50 D (N=6) * 20/20 20/25 20/32 * Indicates Statistically Significant Data from European Post-Market Study on IC-8 IOL 26

What if Lens Alignment & Rotation Didn t Matter?

axis Intended axis Intended axis Effectiveness: 96.7% * Effectiveness: 83.

100% Effectiveness: 100% Effectiveness: 100% Effectiveness: 100% *Novis C. CurrOpinOphthalmol. 2000 Feb;11(1):47-50. Review.

27 What if Lens Alignment & Rotation Didn t Matter? 1 o Lens Rotation * 5 o Lens Rotation * 10 o Lens Rotation * 30 o Lens Rotation * 180 o mark 180 o mark 180 o mark 180 o mark Toric IOL Intended axis Intended axis Intended axis Intended axis Effectiveness: 96.7% * Effectiveness: 83.5% * Effectiveness: 67% * Effectiveness: 1% * True axis of as gma sm True axis of as gma sm True axis of as gma sm True axis of as gma sm IC-8 IOL Effectiveness: 100% Effectiveness: 100% Effectiveness: 100% Effectiveness: 100% *Novis C. CurrOpinOphthalmol Feb;11(1): Review. Patient Symptoms & Satisfaction Mean Symptom Rating at 3 Months Would you have the procedure again? 5 100% 95% Symptom Rating Blurry vision Fluctuating vision Dryness Glare Halo Double vision Ghosting 80% 60% 40% 20% 0% 5% No Yes Symptom rating : 0=Absent, 1=Very Mild, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe Data from European Post-Market Study on IC-8 IOL, N=105 27

Contrast Sensitivity Binocular contrast sensitivity is equivalent

Neuroadaptation and retinal response to illumination will further

Glare Mesopic with Glare 2.5 2.5 2.0 2.0 logcs 1.5 1.0 logcs 1.5 1.0 0.

0 0 3 6 9 12 Spatial frequency (cpd) Spatial frequency (cpd) IC-8

normal mono low normal mono high normal mono low normal European

6500 The low and high normal curves are defined as 1.

28 Contrast Sensitivity Binocular contrast sensitivity is equivalent to the contrast sensitivity in the monofocal IOL eye Neuroadaptation and retinal response to illumination will further boost the contrast performance in the IC-8 eye Mesopic with No Glare Mesopic with Glare logcs logcs Spatial frequency (cpd) Spatial frequency (cpd) IC-8 (029) Mono (029) OU (029) IC-8 (029) Mono (029) OU (029) mono high normal mono low normal mono high normal mono low normal European Post-Market Study on IC-8 IOL - Sub-Study at 6 months, n=36, Optec 6500 The low and high normal curves are defined as 1.96 SD from monofocal eye s CS curve IC-8 Small Aperture Lens Post--RK David Kent, MD The IC-8 IOL is not approved for use in the United States 28

$and high patient satisfaction Tolerant of refractive misses Alignment free astigmatism correction Bonus therapeutic application for aberrated or irregular cornea patients$

29 IC-8 IOL Summary Delivers on the promise of a premium IOL with the ease of use of a monofocal Excellent distance and intermediate as well as good near vision Low symptoms and high patient satisfaction Tolerant of refractive misses Alignment free astigmatism correction Bonus therapeutic application for aberrated or irregular cornea patients 29

Why I Have Decided to Implant Trifocal IOLs Technology in My Own Eyes

Why I Have Decided to Implant Trifocal IOLs Technology in My Own Eyes Dr Piovella Has the Following Possible Financial Interests or Relationships to disclose. As Consultant: Acufocus Carl Zeiss Meditec