10/12/2016. Why Measure Cone Function? Photoreceptor Function. Conditions Affecting Cone Function. How Does Your Patient Benefit?

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1 Disclosure of Relevant Financial Relationships Cone Function Testing: Functional Compliment to the OCT Early Disease Detection & Ophthalmic Health Management SUNY Distinguished Professor Name: Sherman uses equipment- on loan from Topcon, Innova, Optovue for patient care and research Sherman is or has been a paid consultant to all 3. Photoreceptor Function Why Measure Cone Function? Cones, located mostly in the central fovea, allow you to see in sharp detail as well as in color. Rods, located in the periphery allow you to see in the dark and are more sensitive to motion. Rods have more redundancy, outnumbering cones 100:1 Damage to cones has greater impact on vision due to the lack of redundancy Even a small amount of retinal and/or neural damage may be detected by measuring cone function Subtle changes in cone function can identify an underlying problem even before the patient is aware Conditions Affecting Cone Function Retinal Conditions Macular Degeneration Diabetic Retinopathy Retinitis Pigmentosa Stargardt s Disease Drug-Induced Toxicity Glaucoma Chronic Open-Angle Glaucoma Narrow/ Acute Angle Closure Glaucoma Neurological Diseases Optic Neuritis Multiple Sclerosis TBI/ Concussion How Does Your Patient Benefit? Early identification of disease and eye health issues Earlier intervention & treatment Detection of disease advancement Evaluation of treatment efficacy Increased compliance in motivation 1

2 How Does Your Practice Benefit? Cone Function Testing is billable in medical exams 92283, Color Vision Extended, Anomaloscope or Equivalent National Medicare average $56 Earlier detection can increase revenue in wellness exams Earlier Structural Test Billings Earlier Medical Exams Increased Nutraceutical Sales Practice Building Easy, quantifiable management of Plaquenil patients What is Cone Function Testing? Sensitive Functional Test Detects Minor Cone Function Changes from Disease or Injury Combination of color and contrast sensitivity measured simultaneously Provides Valuable Assessment of Patients Quality of Vision Reimbursable using with published equivalence to Anomaloscope How Does a Cone Function Test Work? Why Isolate Cone Function? Colored letters isolate cone function by cone type for accurate, repeatable results De-saturated letters detect cone function threshold Quantitative Results indicate type and severity of color deficiency Progression Analysis identifies both degeneration & improvement Red Cone Green Cone Blue Cone 1 V Z N F U 2 F V N H P 1 H V R N F 1 D R E Z U 2 D R E Z U 2 F V N H P 3 R P F D U 4 Z E D H P 5 H R P E D 5 H R P E D 5 H R P E D 7 N Z V E H 8 U V R N F 9 E R P D N 10 D V H F E 3 N Z V E P 4 Z E D N F 7 R P F D U 8 V Z N F H 9 H P F D N 10 V H U R E 3 R P F D U 4 N Z V E H 6 D R E Z U 6 F V N H P 6 V Z N F U 7 Z E D H P 8 U V R N F 9 H P F D N 10 V N P U D 2-3 cone types are used to perceive most colors Cone Function Testing presents precise wavelengths Isolating cone function by type for greater specificity Eliminating compensation from other cone types for greater sensitivity Providing earlier detection Reporting Progression Analysis Cone Function vs. Color Vision Testing Isolating Cone Function eliminates Compensation from Multiple Cone Types unlike Other Color Vision Tests Cone Function Testing is Superior for Early Disease Detection & Progression Published Peer Reviewed Research demonstrates higher Sensitivity and Specificity due to the following: Cone Function Isolation Periodic Calibration Validation Against Anomaloscope Analysis Reports show clear definition between normal color vision and deficiency Graphical results are easy to review results with patient Reports are easily attached to Electronic Medical Records 2

3 Progression Analysis Cone score progression is displayed for each cone type Time frame selectable to post-diagnosis or treatment Alerts show statistically significant change of 15 points or greater Research shows marked cone function degradation with those with known eye disease Therefore: Isolation of individual cone types Provides better separation of Normals from Abnormals Separates Acquired Color Deficiency from Hereditary Identifies patients needing more care and analysis Critical for Progression Analysis Acquired Color Deficiency Red Green Blue Cone Function Test Significant Publications 1996 US Army, Cone Specific Measures 2011 Rapid Quantification of Color Vision The Cone Function Test 2012 US Army, Retinal Disorders and Optic Neuritis 2012 University of California San Francisco, Glaucoma 2012 University of California San Francisco, Multiple Sclerosis 2013 Duke University, Dry AMD, Phase I 2013 Shiga University, Glaucoma 2013 Omni Eye Institute, Retinal Health & Nutrition 2014 Nova SE University, Retinitis Pigmentosa 2014 Capt. James A. Lovell VA Hospital, Diabetic Retinopathy; Retinal Health & Nutrition 2014 Duke University, Dry AMD, Phase II 2015 Shiga University, Glaucoma, Phase II 2015 University of California San Francisco, Multiple Sclerosis Duke University Clinical Trial- Dry AMD OBJECTIVE Because anatomical findings in dry AMD can be uncorrelated to progression or severity, the discovery of therapies for dry AMD is dependent on functional endpoints as standardized biomarkers able to assess the severity, risk of progression, and response to treatment before significant visual changes occur. Elenor Lad, MD Duke University Clinical Trial- Dry AMD Early AMD Detection Can We Make an Impact? CONCLUSION: This pilot study supports the feasibility and reliability of using LLVA, microperimetry, and CCT (Rabin Cone Test) in early dry AMD. Nutraceuticals UV Protection Blue Light Protection Education- Impact of Smoking Genetic Profile Testing Progression Monitoring Clinical Trial conducted by: Duke University Medical Center Article published in: Retina 0:1-11,

4 Shiga University Clinical Trial- Glaucoma Shiga University Clinical Trial- Glaucoma OBJECTIVE pseudoisochromatic plates or panel D-15 frequently characterize it (Color Vision Deficiency) as combined or nonspecific color vision deficiency. We hypothesized that the RCCT (Rabin Cone Test) may also be useful to evaluate acquired color vision deficiency in glaucoma... FIGURE 2. Correlation between CCT scores and MD in the glaucoma group is shown. (A) Correlation between L CCTs and MD. (B) Correlation between M CCTs and MD. (C) Correlation between S CCTs and MD. Correlations were determined by the Spearman rank correlation test. Our results may suggest a correlation between anatomic abnormalities detected by OCT and chromatic discrimination thresholds measured by RCCT. (Rabin Cone Test). FIGURE 3. Correlation between the CCT scores and GCIPL thickness in the glaucoma group. (A) Correlation between L CCTs and GCIPL. (B) Correlation between M CCTs and GCIPL. (C) Correlation between S CCTs and GCIPL. Correlations were determined by the Spearman rank correlation test. Shiga University Clinical Trial- Glaucoma UCSF Clinical Trial- Multiple Sclerosis FIGURE 1. RCCT results for each cone are compared between those of the glaucoma group () and the control group (*). The mean M and S CCTs in the glaucoma group are significantly lower (P < 0.05 for both comparisons) than those in the control group (M CCTs¼ , vs , respectively; S CCTs ¼ vs , respectively). CONCLUSION The RCCT (Rabin Cone Test) may be useful for evaluating acquired color vision deficiency in glaucoma and may help advance current understanding of the pathophysiology of glaucomatous damage. Clinical Trial conducted by: Shiga University Medical Science, Dept of Ophthalmology Article published in: IOVS 2014 Red, Green, and Blue CCT scores positively correlated with independent prnfl, mrnfl, and GCIPL layer thickness (** p<0.001), and negatively correlated with INL (` p=0.05 Red, * p<0.05 Green, Blue). CONCLUSION Color cone contrast (Rabin Cone) testing is correlated with inner retinal layer thicknesses in MS (RNFL and GCIPL), and provides added predictive value of visual pathway injury. Clinical Trial conducted by: University California, San Francisco Medical Center Cone Function Testing vs OCT Stargardt s Disease Cone Function Testing vs OCT Stargardt s Youngest Sib Age 12 20/400 ou Age 9 20/400 ou Age 7 20/20 ou 4

5 10/12/2016 Cone Functional Testing vs OCT Stargardt s Middle Sib Cone Function Testing vs OCT Stargardt s Oldest Sib Cone FunctionTesting vs VEP Lupus/Plaquenil 59 yo F Cone Function Testing vs VEP Lupus/Plaquenil 57 yo F 20/20 OU 20/20 OU Normal VF Normal VF Normal OCT Normal OCT Normal Multispectral Imaging Normal Multispectral Imaging Normal perg Cone Function Testing may be earlier indicator of macular changes pvep abnormal Edward Harmer, OD Edward Harmer, OD Cone Functional Testing in Central Serous Cone Functional Testing vs OCT Polypoidal Choroidal Right Eye Only (Evolved from Central Serous 20 Years Earlier) Cone Function Testing in an Army pilot shows normal RE and moderate Red Green Blue color deficiency LE OCT Affected RE VA: 20/40 SD-OCT imaging shows shallow Pigment Epithelial Detachment Repeat of Cone Functional Test one month later- pilot tested normal in each eye. OCT confirmed complete resolution of PED James Robinson, OD OCT Unaffected LE VA 20/25 5

6 Cone Function Testing vs OCT TBI + Hemorrhage (Head-On Automobile Accident) Cone Function Testing Demylinating Optic Neuropathy Right eye Left eye Service member with h/o automobile accident mtbi and hemorrhage behind OS VA: 20/20 ou Cone Contrast Test shows normal color vision RE and below normal on green & blue LE Advanced imaging of optic nerve fiber layer and macula using SD-OCT Recent history of demylinating optic neuritis LE 20/20 OU Moderate green deficiency LE, mild green deficiency RE Repeated Cone functional testing each month Severity of green color deficiency slowly but completely resolves to normal for each eye in 3 months James Robinson, OD James Robinson, OD Cone Function Testing vs OCT Multiple Concussions Rabin Cone Test detected first abnormality Normal VA Some temporal visual field loss Never had head MRI Normal OCT Summary, Conclusions, and Financial Impact of Cone Function Testing and OCT Jerry Sherman, OD Thank You! 6