Ride the Wave of Technological Innovations in Eye Care

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1 Ride the Wave of Technological Innovations in Eye Care David I. Geffen, OD, FAAO David I Geffen, OD, FAAO Consultant/Advisor/Speaker» Accufocus»Alcon»AMO» Annidis»Bausch + Lomb» Bruder Healthcare»EyeBrain» Optovue» Revision Optics Shire Tear Lab Tear Science TLC Vision 1

2 2

3 Stem Cell Technologies 3

4 Limbal Stem Cell Deficiency Sequelae Persistent epithelial defects Corneal scarring and ulceration Conjunctivalization of the cornea Severe visual loss Chronic pain Keratoplasty failure Procedures Donor Autograft Limbal Stem Cell Transplantation Conjunctival limbal autograft fellow eye Allograft Living-related conjunctival limbal allograft relative Keratolimbal allograft cadaver 4

5 Keratolimbal Allograft Donor Recipient Keratolimbal Allograft S/P Tube Shunt S/P KLAL S/P PK VA 20/30 5

6 Stem Cell Coated Contact Lenses Aniridia patients Contact lens overwear? Various ocular surface disease issues: Steven s Johnson syndrome Ocular pemphigoid Graft Vs Host Chemical burns 11 Sensimed Triggerfish lens: Diurnal IOP measurements 12 6

7 Glucose Monitoring Contact Lens 13 PROKERA Class II medical device comprising of CRYOTEK amniotic membrane into a thermoplastic ring set Combines the functionality of a symblepharon ring with the biologic actions of CRYOTEK amniotic membrane to create a unique treatment option for corneal and limbal wound healing 7

8 The Amniotic Membrane The amniotic membrane is the innermost lining of the placenta (amnion) Amniotic membrane shares the same cell origin as the fetus Stem cell behavior Structural similarity to all human tissue Avascular like the cornea 8

9 RPE Tissue regenerated from Stem Cells RPE Tissue Regenerated from Pluripotent Skin Stem Cells 9

10 Point Spread Function Refracting in PRACTICE David I. Geffen, OD, FAAO Refraction Over 100 years the same method Confusing for the patient Inaccurate Low Tech 10

11 20/20 is not Vision Optimized! PSF Refraction Is More Sensitive Changes in 0.05D are now noticeable 11

12

13 25 Patient Responses Easier to tell the difference High tech Less strain Feels more accurate 13

14 Generates More Accurate Rx Subjective refraction not auto-refraction Rx is at equal or higher level of reliability than a phoropter (unlike objective wavefront devices) Point Spread Function technology attains a higher level of sensitivity and accuracy Patients can discern differences more clearly with PSF than with Snellen letters PSF refines the Rx end point to 0.05D, 5X better than phoropters Provides highest level of visual acuity and contrast Maximum Plus Maximum Visual Acuity Prevention of over-minussing due to the true perception of the PSF and the target detail versus using Snellen optotypes which requires one self to determine their own visual stress point of smaller and darker. With the Vmax system if the patient is over-minused, the target simply looks blurry again. This allows for a decrease in the level of patient frustration by having an unambiguous which yields a higher lvel of clinical confidence. Confidence in the refraction was found to 95% amongst patients achieving identical or better refraction with the device compared to a manual phoropter 28 [1] Vmax Data of file. 14

15 Preferred by Patients PSF Refractor has been clinically proven Study with over 900 patients at 7 U.S Study Locations Results published at ARVO 2012 Significantly positive results when patients were asked to choose the PSF Rx versus the phoropter Rx 3% 7% 29 Better Equal Worse 90% Point Spread Function Refractor with Wavefront Abberometer 30 15

16 Hand Held Wavefront Abberometer 31 16

17 HD Analyzer 17

18 eyebrain Medical» The Problem Small amounts of binocular misalignment, which result in compensatory eye movements, causing excess visual demand. The Vision Council reported that 65% of Americans suffer from symptoms of Computer Vision Syndrome» Common Symptoms Digital eye strain Computer Vision Syndrome Headache Visual discomfort Dry eye sensation Fatigue Stiff neck or shoulders Slide #35 SightSync (Measurement Instrument)» Objective, accurate, quick» Technician-performed during pre-screening» seconds Detects & measures binocular misalignment at distance and near. SightSync Output Distance: 2.0 Base In Near: 2.8 Base In 18

19 The Solution (neurolens)» Synchronizes binocular vision at all distances, eliminating need for compensating eye movements.» Progressive prism technology, using measurements from SightSync» Built into spectacle lenses with patient s Rx Progressive Prism within Single vision or progressive designs 19

20 What current optometric investigators are saying about eyebrain's SightSync & neurolens technology:» "The most important breakthrough of my career as an optometrist."» "One of three WOW factors of my 30 year optometry career -- right up there with LASIK and premium cataract surgeries."» "It s literally rejuvenated my desire to practice optometry and it s driven me to be an even better doctor by having the technology in my practice."» "I just can t believe how many people come in with these symptoms. I went from thinking I might be able to help 3-5 patients a week with these lenses, but now I m thinking it s more like 3-5 patients every day! Slide #39 EyeGraine: Subgroup of Chronic Daily Headache Symptoms Primary Symptoms Frequent Headaches 3+ days per week Neck Pain/Stiffness Secondary Symptoms Dry eyes Fatigue with near work Photophobia, especially at night headlights 20

21 Study Data 67% 41 Point-of-Care Diagnostics 21

22 RAPID PATHOGEN SCREENER Ability to screen for viral infections Can Detect presence of Adnovirus in conjuctiva Overlapping Signs & Symptoms 22

23 The user interface Touch Screen is attachable to the left, right or back of the instrument to accommodate a variety of office space settings. Cognoptix Fluorescent Ligand Scanning (FLS) Beta amyloid-specific small molecules is dropped into a patient s eye, which is scanned by the Cognoptix SAPPHIRE instrument The small molecules are absorbed into the lens and bind to the amyloid aggregates The FLS system excites the fluorescent ligands that bind to amyloid

24 Technology Overview Tear Lab Revolutionary tear collection Non invasive Gives access to untrained users (CLIA waiver) Integrates into technician workflow Novel lab on a chip Less than 50 nl required Platform for rapid electrochemical biomarker assays Sample to Answer in less than 30 seconds 24

25 Tears as an in vitro Diagnostic Platform Tears are an ideal matrix for non invasive testing Derived from blood Largely acellular Tears known to have thousands of proteins & genes Potential for many ophthalmic & non ophthalmic markers Biomarker normalization using osmolarity Fundamentally corrects for tear film instabilities More accurate reporting of proteins, genes, metabolites Combines multiple markers & payments on a single chip 50 25

26 Osmolarity in Diagnosis & Grading of Dry Eye Osmolarity Disposable Chip 26

27 Future of Tear Biomarker Analysis: TearLab Next Generation Platform» Quantitative» Ability to measure Osmolarity Inflammation biomarkers Allergy biomarkers Etc.» Rapid testing (< 2 minutes)» Multiplexed biomarkers» EHR Integration Clinical Application: Normalization using osmolarity Customized chips with designed sensitivity & specificity Slide #53» When? TearLab Next Generation Platform CE Mark by end of k submission in early 2017 First test will have osmolarity + 1 or 2 additional markers Likely to be focused on inflammation New iterations possible every 6 months Slide #54 27

28 Prevalence of Abnormal Tear Film Quality in Contact Lens Wearers» 273 consecutive CL subjects across 7 OD sites» Subject discomfort symptoms and tear osmolarity measured» Abnormal osmolarity in 59% (161/273) Symptomatic: 70%» Symptomatic: 68.9% (188/273) Abnormal osmolarity: 60.1% (3/5 symptomatic CL wearers have abnormal osmolarity)» 85 patients were asymptomatic and 54.6% (48/85) had abnormal osmolarity Parameter Normal Osm (n= 112) Abnormal Osm (n=161) Age (yrs) 37.4 ± ± 14 Gender M 38 F 74 Osmolarity (mosm/l) Inter eye diff (mosm/l) Symptomatic (> 3) Median # of symptoms ± ± (67.0%) M 53 F ± ± (70.2%) 4 6 Bowling E, Bloomenstein M, Gaddle I, Clay G, Harrell M, Ward J, Brimer C. Prevalence of Abnormal Tear Film Quality and Stability Measured by Abnormal Tear Osmolarity Among Contact Lens Wearers, presented at American Academy of Optometry; Anaheim, Calif.; Nov. 8-13, Slide #55 Prevalence of Abnormal Tear Film Quality in 25 Contact Lens Wearers20» Symptoms # of symptoms and frequency of distribution is similar between normal vs abnormal osmolarity Tear osmolarity testing is critical to identify ocular surface stress and management essential to success % of subjects # of symptoms» Tear osmolarity can be a critical quantifiable objective measure Prognosis of CL discomfort check true alleviation of ocular surface stress vs placebo effect with change in CL/solution/symptoms. % of subjects Bowling E, Bloomenstein M, Gaddle I, Clay G, Harrell M, Ward J, Brimer C. Prevalence of Abnormal Tear Film Quality and Stability Measured by Abnormal Tear Osmolarity Among Contact Lens Wearers, presented at American Academy of Optometry; Anaheim, Calif.; Nov. 8-13, Slide #56 28

29 Presbyopia Correction Accommodating IOLs Corneal Inlay Technology Therapeutic treatment mm Total diameter 1.6mm Aperture 5 μ Thick 29

30 Where the KAMRA inlay falls within the Patient Spectrum Too Old for LASIK Too Young for IOL KAMRA Inlay Ages Ages Ages 60+ Near vision loss begins Surgical Procedure Description: A femtosecond laser created pocket in the stroma at a depth of μm with femtosecond laser spot/line settings of < 6x6 or equivalent is recommended. Pocket Emmetropic KAMRA (PEK) Epithelium Pocket Endothelium μ m 30

31 KAMRA Inlay Design Inlay improves near vision by extending depth-of-focus Central aperture is a hole in the inlay and has no power Inlay provides an unobstructed pathway for focused light to reach the retina Inlay Design 3.8mm Diameter 1.6mm Aperture 8,400 holes (5-11 μm) 6 μm thick Made from Polyvinylidene Difluoride (PVDF) 61 Inlay in vivo Image courtesy of Dr. Minoru Tomita Shinagawa LASIK Center Depth of Focus Pre-Op & Post-Op Pre-op 0.25D of depth of focus Several Months Post-op 2.50D of depth of focus AcuTarget HD Instrurment 62 31

32 The inlay may be visible in light eyes from an oblique angle or when a patient has a pupil smaller than 3.8mm in the non-implanted eye. Actual patient images courtesy of David Allamby, MD, Focus Clinics London Phase III clinical trials Hydrogel Inlay Increases prolate nature of cornea Under a femtosecond flap RainDrop 64 32

33 Refocus Restarted Clinical trial with redesign of method for creating the tunnels Now called the visibility implant system 65 Topical CURE for Presbyopia Eye Therapies Contains miotics but also proprietary components that allow full hours of near and far vision Encore Vision Contains drops that selectively target and disrupt the disulfide bonds in the lens Total of 3-4 weeks of treatment 66 and permanent results thus far 33

34 Financial Disclosure D. Schanzlin is one of the inventors and an investor in Perfect Lens Solutions to Multifocal IOL problems David Schanzlin, MD San Diego CTILII Telling it like it is Content Refractive Index Shaping (RIS) The System Premium IOL Features Creation of Custom multifocality Cancellation of Multifocality Refractive Multifocality Asphericity Summary 34

35 RIS (Refractive Index Shaping) Summary RIS lens inside IOL, no surface treatment Low energy levels per pulse Hydrophilicity based negative refractive index change In-Office procedure 23s procedure The Perfector System 35

36 Complications of current Premium IOLs Multifocal Neuroadaptation might not work Refractive Multifocal IOLs need perfect centration No custom adds and splits available No option to remove multifocality or change multifocality Aspheric No custom aspheric values, different companies offer different options RIS in Situ multifocal IOL options Refractive multifocal RIS shaping Customized split Custom near add Adjustment to settled and fixated IOL 36

37 RIS Option to Correct Patient Complications Refractive changes Multifocal cancellation Multifocal to Monofocal Before After 37

38 Monofocal to Multifocal to Monofocal Refractive Multifocal IOL RIS provides perfect centration Benefits of Refractive Multifocal Reduced halos, ghosting, and glare Theoretical improved contrast sensitivity vs diffractive IOL RIS additionally eliminates residual refractive error Increased depth of focus (additional toric adjustment if patient has >0.75 astigmatism) 38

39 RIS Aspheric IOL options Custom range between to 0.28 Can be used to provide added depth of focus RIS aspheric IOL results IOL Before RIS IOL After RIS Spherical Aberration changed from to Aspheric Concave Lens Diameter: 4.0mm Diopter: 2.02D 5.23D blank asphericity change Lens ID: L

40 Conclusion Safe and fast office procedure RIS change inside the IOL RIS technology to change the premium IOL market RIS technology to change patient satisfaction after complicated cataract surgery Calhoun Light Adjustable IOL 6 mm silicone optic and PMMA haptic IOL Using a UV laser so as to change the refractive error Post operative enhancement, correction, adjustment Optometry s role in 8-10 years based on demographics 30 Million patients with cataracts within 3 years and increases each year for the next 14 40

41 Femtosecond Lasers Cataract Cataract & Corneal (LASIK Flap) Procedures Corneal (LASIK Flap) 81 Femtophaco makes Mediocre surgeons good, Good surgeons better, Excellent surgeons exceptional. 41

42 ORA System : Designed to Optimize Every Cataract Procedure ORA s all new Optiwave technology takes intraoperative wavefront aberrometry to a new level of precision providing surgeons a higher level of confidence ORA (Optiwave Refractive Analysis) Copyright 2011 WaveTec VisionTM 83 What is Multi-spectral Imaging? New and unique way to view layers of the retina non-invasively The device uses a series of discrete monochromatic lights to create 12 en face spectral slices throughout the entire thickness of the retina Provides clinicians an enhanced view of the entire retina including the deep retinal architecture of the RPE and choroid Allows for very early detection of retinal pathology Allows you to document, follow, monitor, and treat or refer retinal pathologies with confidence Provides an interface for patient education and loyalty 42

43 Multi-spectral Imaging Deep Retinal & Choroidal Views Neural layers Photo receptors RPE Choroid RHA Multi-Spectral Imaging Fundus Camera Range OCT/SLO The doctor sees all of these images 43

44 PID 79 - Optos Composite 44

45 PID 79 - Optos Green PID 79 - Optos Red 45

46 PID 79 RHA, 662nm 91 PID 79 OCT, Macular Hole 92 46

47 PID Optos Composite 93 PID Optos Green 94 47

48 PID Optos Red 95 PID 158 RHA, 702nm 96 48

49 PID 158 OCT, RPE Disruption 97 PID 403 Optos OD Composite98 49

50 PID 403 Optos OD Green 99 PID 403 Optos OD Red

51 PID 403 RHA, 662nm AMD 101 Conclusions Many exciting advances in technology Important to be aware of the technologies and apply them to help us practice at a higher level and assist patients Patients are more educated than in the past and expect to see doctors who know the answers to their eye care questions and can communicate that knowledge 51

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