Visionary Optics. SynergEyes. North Suburban Vision Consultants, Ltd. Keratoconus Specialists of Illinois. S. Barry Eiden, OD, FAAO

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1 New Technologies in the diagnosis and management of dry Eye S. Barry Eiden, OD, FAAO North Suburban Vision Consultants, Ltd. Keratoconus Specialists of Illinois International Keratoconus Academy EyeVis Eye and Vision Technologies and Research Institute Assistant Clinical Professor University of Illinois Medical Center, Department of Ophthalmology, Cornea and Contact Lens Service Adjunct Faculty at the Indiana, Illinois, Salus, and UMSL Colleges of Optometry If you desire any information included in this presentation: Please sbeiden@nsvc.com Consulting, Research & Financial Interest* Disclosures: Alcon Alden Bausch & Lomb Cooper Vision Oculus Oasis OptoVue Special Eyes SynergEyes Visionary Optics EyeVis Technologies and Research Institute * International Keratoconus Academy * Demographics of Dry Eye 100+ million cases world wide / 40+ million USA >30% of patients report some dry eye symptoms >50% of CL wearers report dry eye symptoms (ocular dryness is the #1 most common complaint of CL wear) Common complaint S/P LASIK/Refractive S. Impacts optical outcomes of Cataract & Refractive Surgery

2 2007 International Dry Eye Workshop Study (DEWS) Dry Eye Definition: A multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbances, and tear film instability with potential damage to the ocular surface Accompanied by tear film hyper-osmolarity and inflammation of the ocular surface. (Ocular Surface, 2007,5:75-92) Two most important diagnostic tools in evaluation of OSD/DED: Historical / Subjective Info. Biomicroscopic Examination DED a simple description: Dry eye disease is caused by conditions that either increase evaporation of the tear film or decrease tear production. The resulting increase in tear film osmolarity (hyperosmolarity) leads to ocular surface inflammation, damage, and symptoms Geerling G, Schaumberg DA, Optometry Times March, History / Subjective Responses in DED can we quantify this information? Quantified Questionnaires: OSDI (ocular surface disease index) Speed (Standard patient evaluation of dryness)

3 Ocular Surface Disease Index (OSDI) What is OSDI? (by outcomes research group, Allergan, Inc. ) Rapid assessment of Sx s of ocular irritation consistent w/ded & its impact on vision related functions 12 items relating to Sx s exp. past 1 wk. Scale 0 to 100 (higher greater severity) Good correlation to DED physical findings* Good test/retest reliability* Ability to discriminate mild, mod, severe DED* (most freq. used survey in this regard) *Shiffman, Arch Ophthal 5/2000 OSDI Score Calculations: OSDI = (sum of scores) x 25 = (# Questions answered) Severity: 0 to 12 Normal 13 to 22 Mild 23 to 32 Moderate 33 to 100 Severe Standard Patient Evaluation of Eye Dryness (SPEED)* 8 Total Questions Evaluates Frequency & Severity of sxs Grade each question Freq:0 to 3 / Sev: 0 to 4 Total up responses: range from 0 to 28 >8 is concern for management Evaluation of sxs over time (present to 3mo) Independently validated by the Center for Contact Lens Research in Waterloo, Canada *Developed by Donald Korb, OD and Caroline Blackie, OD

4 SPEED Questionnaire Posterior Blepharitis / MGD Posterior Telangiactasia Obstruction and capping of meibomian gland orifices Meibum alterations (color / composition) Gland drop out Short TBUT Photos courtesy of Richard Yee, MD, Don Korb, MD and Justin Kwan, MD. Biomicroscopy & Dry Eye Meibomian Gland Dysfunction: A Prevalent Condition With Consequences Meibomian gland dysfunction (MGD) may well be the leading cause of dry eye disease throughout the world. 1 The International Workshop on Meibomian Gland Dysfunction: Executive Summary 1. Nichols KK, et al. The international workshop on meibomian gland dysfunction: executive summary. Invest Ophthalmol Vis Sci. 2011;52(4): Lemp MA, Nichols KK. Blepharitis in the United States 2009: a survey-based perspective on prevalence and treatment. Ocul Surf. 2009;7(2 suppl):s1-s14. 16

5 Untreated MGD Leads to the Dry Eye Cascade Decrease in lipid secretions and LLT Evaporation increases (4x to 16x) Decrease in aqueous layer thickness Unstable tear film SYMPTOMS START LLT indicates lipid layer thickness. Advanced Technologies in Dry Eye and OSD Diagnosis Morphological Changes Secondary to Obstruction Obstruction Obstruction Obstruction Central Duct Dilation Shrinking Acini Drop out Normal Gland Function & Structure Early Obstruction Function with Dilation of central duct Prolonged Obstruction: Further duct dilation, acini start to atrophy and shrink Advanced Obstruction: Observable gland drop out Images augmented from the MGD Workshop Report, 2011 Courtesy of Tear Science Tear Film Osmolarity Osmolarity is a measure of the concentration of active particles in a solution Integral in the contemporary definition of dry eye High positive predictive value with dry eye

6 Osmolarity and Predictive Value of Dry Eye Disease (DED) Positive Predictive Value: % of people with a positive test who actually have the disease Characteristics of Osmolarity Normal Healthy eyes are normal and stable Hyperosmolarity Causes inflammation and apoptosis Leads to a breakdown of homeostatic control causing tear film instability 308 mosm/l is most sensitive cut-off point that delineates a normal from a mild/moderate dry eye population Inter-eye difference = hallmark of DED ( > 8 mosms/l between eyes)*** Unstable tear film causes inter-eye differences Versura P. et al., Rev. Mol. Diagn. 13(2), (2013) Lemp MA et al., Am J Ophthalmol May;151(5): Why Measure Tear Osmolarity? Measuring osmolarity allows us to evaluate an actual physiologic marker rather than a sign of the disease such as staining or tear break up time, etc. Clinical Osmometer

7 Osmolarity in Diagnosis & Grading of Dry Eye Analytic Variability Analytic variability: This is the amount of expected variation present when evaluated with a known control test. Coefficient of Variability (CV) is the range of precision for any given test. TearLab s CV ~1.0% which is the equivalent of ±4 mosml/l Example: a 308 measurement is (within +/- 4) equal to Clinicians must not be concerned with such a small range (4 mosml/l) seen with tear osmolarity. Two Numbers Crucial to Understand Osmolarity MAXIMUM: Osmolarity above 308 in the higher of 2 eyes (300 or more is suspicious) DIFFERENCE: > 8 between eyes

8 Non-DED Patients T.O. is Low and Stable - DED Patients are Elevated and Unstable Keech A, et al. Curr Eye Res 2013 Apr;38(4) Dry Eye/OSD Can Decrease Visual Acuity and/or Quality of Vision DED / OSD Can Affect Surgical Outcomes & Expectations

9 What if + Sxs and Normal Osmolarity? Courtesy P. Karpecki Ocular Surface Disease Diagnostic and Treatment Algorithm, Tear Lab Tear Osmolarity Can Be Used As an objective measure To Follow The Response To Treatment Technologies to Evaluate Meibomian Glands & MGD Meibography Meibomian Gland Evaluator Tear Film Stablity Objective TBUT Lipid Layer Evaluation

10 Meibography Specialized imaging study developed exclusively for the purpose of directly visualizing the morphology of meibomian glands in vivo Directly evaluating meibomian gland structure Ryan J. Wise, Rachel K. Sobel, and Richard C. Allen. Meibography: A review of techniques and technologies. Saudi J Ophthalmol Oct; 26(4): Published online 2012 Sep 7. Meibo-Scan Development of the Oculus Meibo-Scan in cooperation with the Jenvis Research Institute (Germany), University of Applied Sciences Jena (Germany) and University of Waterloo (Canada) Meibography of the upper lid Authors: Dr Sruthi Srinivasan, Kara Menzies, Luigina Sorbara, and Professor Lyndon Jones are based at the Centre for Contact Lens Research, School of Optometry, University of Waterloo, Canada. Professor Wolfgang Sickenberger is based at the University of Applied Sciences, Jena, Germany Puplished: 09/2011 Meibo-Scan (Oculus Keratograph 5M): Meibography of the upper and lower eyelid Trans-illumination of the lids to clearly view the entire length of the MGs The MGs are assessed by IR-Diodes: The use of IR light to trans-illuminate the lid upper and lower eyelid Meibo-Scan Photo of normal MGs of the upper and lower eyelid

11 38 yo M w/history of mixed Blepharitis (A/P) and dry eye. MG Drop Out LipiView II High Resolution Meibography (Tear Science) Gland truncation Normal Meibomian gland structure Central dilation Gland drop out Meibo-Scan: 3D-Visualization of the Meibomian glands What are the next steps? In the near future the Meibo-Scan will be able to scan and quantify the dropout of the MGs automatically drop out

12 Meibomian Gland Evaluator Tear Science, Inc. Standardized method for assessing Meibomian gland functionality Instrument applies consistent, gentle pressure to the outer skin of the lower eyelid while visualizing the secretions from the Meibomian gland orifices though a biomicroscope Pressure applied to the eyelid is between 0.8 g/mm 2 and 1.2 g/mm 2 G R A D E Secretion Characteristics 3 Clear liquid oil 2 Colored/cloudy liquid 1 Inspissated (toothpaste consistency) 0 No secretion (includes capped orifices) Don t forget to pull back from the slitlamp and take a look! Meibomian Gland Evaluator NUMBER OF MGYLS BY SYMPTOM CATEGORIES (n = 133) 1, * Severe Sx (n = 28) Moderate Sx (n = 43) Minimal Sx (n = 64) Control Group (n = 24) Symptom Score, SPEED questionnaire (0-28) 10/28 ( ) 6 9/28 ( ) 5/28 ( ) 0/28 Number of MGYLS DRY NOT DRY *The mean number of MGYLS in the lower eyelid is correlated with dry eye symptoms, P = *MGYLS indicates Meibomian glands yielding liquid secretion. 1. Korb DR, Blackie CA. Meibomian gland diagnostic expressibility: correlation with dry eye symptoms and gland location. Cornea. 2008;27(10): Tear Film Stability Evaluation via: Tear Break Up Time Invasive (w/nafl) vs. Non-Invasive TBUT Inter-blink Interval Considerations * Non-Invasive TBUT Methods: - Observation of K mires - Time to subjective discomfort - Objective videokeratography

13 NIBUT (Oculus Keratograph): (Non Invasive Keratograph Break-Up Time) Automatic detection of the effected areas Regular mires Distortion of the mires 51 NIBUT- Normal Basics Score Grade 0 Grade 1 Grade 2 NIBUT: >24s Grade 0 Tear film Non Invasive Break Up Time (NIBUT) with Keratograph First BUT & Average BUT, Area, Slope: and Classification (0, 1, or 2) NIBUT Abnormal Basics Score Grade 0 Grade 1 Grade 2 NIBUT: First: 0.5s Average: 4.2s Grade 2 Area = > 50% Steep Slope

14 Effect of a Tx on NIBUT Use of tear film stabilizer before use 10 minutes after use Lipid Layer Assessment: Tear Film Interferometry LipiView Interferometry TearScience, Inc. Differentiation of Aqueous Deficient vs. Lipid Deficient Dry Eye K 5 NITBUT Relationship Between Lipid Layer and Tear Film Instability lipid layer thickness was significantly thicker in the control group than in the obstructive MGD group (P =.028) Lipid layer thickness was significantly negatively correlated with upper and lower meibomian gland losses Youngsub Eom; Jong-Suk Lee; Su-Yeon Kang; Hyo Myung Kim; and Jong-Suk Song. Correlation Between Quantitative Measurements of Tear Film Lipid Layer Thickness and Meibomian Gland Loss in Patients With Obstructive Meibomian Gland Dysfunction and Normal Controls. American Journal of Ophthalmology (155(6): e2)

15 TF-Lipid Layer Analysis: TF-Scan Keratograph The TF-lipid layer is measured by White Ring Illumination: Focus on the surface of the tear film & observe the bifringence pattern Coloration = thicker lipid layer White = thinner lipid layer Thin Lipid Layer Thick Lipid Layer Tear Volume Measures Schirmer Testing Phenol Red Thread Test Tear Meniscus Height

16 Objective Tear Meniscus Ht. (Oculus Keratograph) Keratograph takes a photo non invasive objective measurement repeatable Documentation NL >/= 2.0mm Inflammatory vs. Non-Inflammatory Dry EYE InflammaDry detector (RPS Sarasota, Fla) Detects MMP-9 in tear sample Matrix Mettaloproteinase (MMP-9): inflammatory marker that is known to be elevated in patients with dry eye disease. MMP-9 is a cytokine produced by epithelial cells experiencing inflammation. Anterior Segment OCT tear meniscus height InflammaDry Limit of Detection Normal levels of MMP-9 in human tears ranges from 3-41 ng/ml POSITIVE TEST RESULT MMP-9 40 ng/ml NEGATIVE TEST RESULT MMP-9 < 40 ng/ml

17 MMP-9 Levels in Two Types of Dry Eye MMP-9 Activity in Tear Samples NL Normal MGD Meibomian Gland Disease EVAPORATIVE DRY EYE SS Sjögren s Syndrome AQUEOUS DEFICIENCY P < compared with normal subjects [1] Solomon A, Dursun D, Liu Z, Xie Y, Macri A, Pflugfelder SC. Pro- and anti-inflammatory forms of interleukin-1 in the tear fluid and conjunctiva of patients with dry-eye disease. Invest Ophthalmol Vis Sci Sep;42(10): OK, we diagnosed dry eye, Now what do we do about it??? Treatment of Dry Eye Disease Elevated MMP-9 may predict which patients will respond to anti-inflammatory therapy. Patients who test positive can be treated with one of the following: 1-3 Cyclosporine Steroid Azithromycin Doxycycline [1] De Paiva CS, Corrales RM, Villarreal AL, et al. Exp Eye Res 2006; 83(3): [2] Gurdal C, Genc I, Sarac O, et al. Current Eye Research 2010; 35(9): [3] Li DQ, Zhou N, Zhang L, et al. Invest Ophthalmol Vis Sci 2010; 51(11): Dry Eye Therapy it should be based on the cause Is it due to exogenous causes? Is it due to anatomical issues? Is it assoc. w/ blepharitis / MGD? Is there an inflammatory component? Is there an aqueous deficiency (ADDE)? Is there a lipid deficiency evaporative component (EDE)? Key: treat the etiology(s)

18 Advanced Technologies in Dry Eye and OSD Treatment LipiFlow (Tear Science) Thermal Pulsation System LipiFlow safely and effectively treats Meibomian Gland Obstruction in both upper and lower eyelids simultaneously, in an in-office procedure, taking only 12 minutes per eye LipiFlow Thermal Pulsation MiBo Thermaflow (by TearScience, Inc.) (Mibo Medical Group) Thermo-electric heat applied via dual eye pad through ultrasound gel 108 degree F Typically 3 treatments over 6 weeks

19 BlephEx Treatment (Rysurg) micro-blepharo-exfoliation (MBE) Intense Pulsed Light Treatment (IPL) BlephEx MICROBLEPHAROEXFOLIATION (MBE) Spins a micro-sponge 2,500 RPM along margin Removes biofilm and bacterial load on lid margins Complementary tx along with MG therapies (Lipiflow or Miboflow) Repeated every 4-6 months Intense Pulsed Light Treatment (IPL) *dev. by R. Toyos, MD Memphis, Tn. Originally developed for Dermatology (Rosacea Tx) Short bursts of wavelength specific light ( nm) Treat ear to ear (better effect vs. only lid tx) + Effect via: Increase in temperature ( worlds best hot compress! ) should express glands after tx Direct closure of superficial vessels reduces release of inflammatory mediators assoc. w/ MGD Anti infective : kills pathogenic flora (bacteria and demodex) Year 1: 3-4 Tx s monthly then maintenance Tx Q 6-12mo.

20 ProKera Amniotic Membrane Used to promote healing Severe Dry Eye w/ PED s Dry Eye Disease So common and so complex! Thank You! S. Barry Eiden, OD, FAAO DED Billing, coding and financials Diagnostic evaluation and testing: Visit codes Procedure coding for testing Out of pocket charges for non-covered Dx Therapeutic intervention: Visit codes Procedure coding for treatments Out of pocket charges for non-covered Tx s