32nd

Annual

Cornea, Contact Lens

& Contemporary Vision Care Symposium The Westin Memorial l 945 Gessner Road l Houston, TX 77024

Printable Course Notes December 5-6, 2015

The 32nd Annual Cornea, Contact Lens, and Contemporary Vision Care Symposium

CourseMaster: Jan Bergmanson, OD, PhD Program Location: Westin Memorial City, 945 North Gessner Road, Houston, TX 77024

SATURDAY DECEMBER 5, 2015

Total Hours = 6 D/T & 2 General

7:00 am – 8:00 am REGISTRATION/CONTINENTAL BREAKFAST/VISIT EXHIBITS

Saturday AM Sessions - COPE Course ID: 47274-CL

New Contact Lens Developments and Applications Session - Moderated by Jan Bergmanson, OD, PhD 1 GENERAL & 2 D/T HOURS

8:00 am – 8:30 am Multifocal Silicon Hyrdogels – an Expanding Range

Maria Walker, OD, MS GEN

8:30 am – 9:00 am Successful Multifocal Contact Lenses Jerry Legerton, OD, MS, MBA GEN

9:00 am – 9:30 am Tear Exchange in Hybrid Lenses – how good is it? Roxana Hemmati, OD DT

9:30 am – 10:00 am BREAK/VISIT EXHIBITS

10:00 am – 10:35 am Controlling Myopia: Where do we stand? David Berntsen, OD, PhD DT

10:35 am – 11:00 am Panel Discussion DT

UHCO Award for Distinguished Research on the Cornea and Contact Lenses Orthokeratology Session - Moderated by Jan Bergmanson, OD, PhD

1 GENERAL HOUR

11:00 am – 12:00 pm Orthokeratology: Then and Now Norman Leach, OD, MS GEN

12:00 pm – 1:00 pm LUNCH/VISIT EXHIBITS

Saturday PM Sessions - COPE Course ID: 47356-AS

Dry Eye Allergy Session - Moderated by Maria Walker, OD, MS 2 D/T HOURS

1:00 pm – 1:30 pm Contact Lens Comfort on the Range William Miller, OD, MS, PhD DT

1:30 pm – 2:00 pm Treating Allergy in Dry Eye Patients William Townsend, OD DT

2:00 pm – 2:30 pm Managing the Dry Eye of the Smoker Daniel Powell, OD, MS, PhD DT

2:30 pm – 2:45 pm Panel Discussion DT

2:45 pm – 3:15 pm BREAK/VISIT EXHIBITS

Surgery Session - Moderated by Maria Walker, OD, MS 2 D/T HOURS

3:15 pm – 3:45 pm Odyssey of Corneal Cross Linking John Goosey, MD DT

3:45 pm – 4:15 pm Corneal Inlay Update: Future of Presbyopia Treatment

Jim Owen, OD, MBA, FAAO DT

4:15 pm – 4:45 pm CryoPreserved Amniotic Tissue: A New Hope Seema Nanda, MT, OD DT

4:45 pm – 5:00 pm Panel Discussion DT

SUNDAY DECEMBER 6, 2015

Total Hours = 5 D/T & 3 General 7:00 am – 8:00 am REGISTRATION/CONTINENTAL BREAKFAST/VISIT EXHIBITS

Sunday AM Session - COPE Course ID: 47306-CL

GP Session - Moderated by William Townsend, OD 2 D/T HOURS

8:00 am – 8:30 am Scleral Lens Tear Exchange William Miller, OD, MS, PhD DT

8:30 am – 9:00 am Midday Foggy Vision – What Blurs Vision? Maria Walker, OD, MS DT

9:00 am – 9:30 am Does the Scleral Lens Induce Expansion – Corneal Swelling?

Jan Bergmanson, OD, PhD DT

9:30 am – 9:45 am Panel Discussion DT

9:45-10:15 am BREAK/VISIT EXHIBITS

Dry Eye Session - Moderated by William Townsend, OD 2 D/T HOURS

10:15 am – 10:45 am Severe Dry Eye Diagnosis Amber Gaume, OD DT

10:45 am – 11:15 am New Dry Eye Instrumentation on the Ranch Daniel Powell, OD, MS, PhD DT

11:15 am – 11:45 am Expanding Your Diagnostic Range Through Tear Sampling William Townsend, OD DT

11:45 am – 12:00 pm Panel Discussion DT

12:00 pm – 1:00 pm LUNCH/VISIT EXHIBITS

Sunday PM Session - COPE Course ID: 47275-CL

New Technology and Environment Session - Moderated by Norman Leach, OD, MS 1 GENERAL & 1 D/T HOUR

1:00 pm – 1:30 pm Smart Contact Lenses: The Future is Now Jerry Legerton, OD, MS, MBA GEN

1:30 pm – 2:00 pm Ditzel or Doom?? Evaluation and Management of Periocular Skin Lesions

Mirwat Sami, MD DT

2:00 pm – 2:20 pm Melanoma is on the Rise – Diagnosis and Prevention Jan Bergmanson, OD, PhD DT

2:20 pm – 2:35 pm Panel Discussion Featuring Thomas Baugh, OD GEN

2:35 pm – 3:05 pm BREAK/VISIT EXHIBITS

Shape Session - Moderated by Norman Leach, OD, MS 1 GENERAL HOUR

3:05 pm – 3:25 pm Ocular Contour Driven Contact Lens Design Jerry Legerton, OD, MS, MBA GEN

3:25 pm – 3:45 pm Corneal Reshaping is Not Permanent? Norman Leach, OD, MS GEN

3:45 pm – 4:00 pm Panel Discussion GEN

2015 Professional Responsibility - Course COPE Course ID: 43792-EJ

1 GENERAL HOUR

4:00 pm – 5:00 pm 2015 Professional Responsibility Course Previously Recorded by Joe DeLoach, OD

GEN

Multifocal Silicone Hydrogels – an Expanding Role

Maria K. Walker, OD.MS. 4901 Calhoun Road Houston, TX 77098 Tel: (713) 743-6421

mkwalker@central.uh.edu Course Description:

This course is intended to provide practitioners with information on selection and management of multifocal lenses in the presbyopic patient. Course Objectives:

o To provide a clinically applicable basis for multifocal lens selection according to patient characteristics.

o To provide an overview of the fitting process of multifocal contact lenses. o To review the availability of new silicone hydrogel technologies.

Outline:

I. Applicable patient characteristics when fitting a multifocal contact lens

a. Vocations and Occupations – think about suitability for daily, monthly, extended wear.

b. Pupil size and centration

i. Larger pupils tend to be less successful with multifocal designs than smaller pupils

ii. Pupils centration does not always line up with optic zone of lens

II. Soft multifocal designs available in silicone hydrogel (from big 4 companies)

a. Daily wear: Clariti 1 day multifocal

i. UV protection

b. Monthly/biweekly wear:

i. Air Optix Aqua Multifocal: Center-near design (Precision Profile Design)

ii. Purevision 2 for presbyopia: Three-zone progressive design

iii. Biofinity multifocal: Center near and center distance designs

iv. AV oasys for presbyopia: Zonal Aspheric Optical Design

III. Other market availabilities

a. Custom designs through most labs

i. Can specify extended range diameters, base curves, and powers.

ii. Also able to offset optic zone if needed.

b. Don't forget about our hydrogel multifocal options – they still work.

i. Most hydrogels are daily wear

1

Successful Multifocal Contact Lenses

What will it take to beat monovision?

Jerome A. Legerton, OD, MS, MBA, FAAOMy Journey

• 26 years in Private Practice

• 21 years in product development

• 48 Issued US Patents; 61 pending applications

• 3 Alcon (PBH< WJ< Ciba); Multifocal contact lenses• 3 AMO (VISX); Presbyopia laser surgery• 14 Paragon Vision Sciences; Paragon CRT® , Refractive Error

Regulation, NormalEyes® mini-scleral lenses• 11 Synergeyes®; Family of lenses and processes• 2 Preventive Ophthalmics, Inc; DxAMD™ Early detection AMD• 5 Innovega, Inc; iOptik® wearable computer• 7 VICOH, LLC; Family of contact lens designs• 1 Eye Care for Humanity; humanitarian spectacle eyewear• 1 Myolite, Inc. Refractive error regulation• 1 Pacific Dynamic, Inc. Modular LED lighting

Disclosure

• Founder, Shareholder; VICOH, LLC

• Consultant; Paragon Vision Sciences

Why Have Simultaneous Vision Contact Lenses Provided Limited Patient Satisfaction?

• They are pretty good in GP lenses, However;• GP are time consuming• GP have discomfort and foreign body limitations

• Simultaneous Vision has limited success in hydrogels• Why?

Cause of Visual Compromise in Simultaneous Vision Hydrogels

• Uncorrected cylinder• Failure to center over the visual axis

• Lens to lens variance due to wide manufacturing tolerances

• On eye lens distortion • Need for pupil size dependent design

Ingredients for Success with Simultaneous Vision

• Correct all low order aberrations (Sphere and cylinder)

• Center the optics over the visual axis

• Size the near segment based on pupil size and pupil reactivity

• Manufacture optics equivalent to GP lenses• Maintain good surface wetting

2

We Will Damage PSF with a Simultaneous Vision Lens

So we must maintain optical integrity so much the more in every other way• Correct all sphere and cylinder • Center over the visual axis • Produce excellent optics

Key Ingredients in a Successful Soft Multifocal

• Non-deforming lens design• Segment Size

• Pupil size and reactivity determines segment size

• Segment Location• Measured individual lens displacement• Pupil shift with focal demand and illumination change

• Add Power• Determined like spectacle lenses from

• Regular near point testing• Vocational and avocational demands• Precision optics deliver full add power

Lens Deformation

• All soft lenses today deform on the eye• Base curve 2 to 6 diopters flatter than the cornea conforms to the cornea

• Base curve 4 mm steeper than the sclera conforms to the sclera.

• Can only happen by deformation that varies from one patient to the next.

Industry needs a non-deforming design to use as a platform for multifocal contact lenses

Pupil Size and Reactivity

These data report the means but not the individual variance in reactivity

Chateau, 1996N = 112 (224 eyes)

Where do Hydrogel Lenses Center Relative to the Visual Axis?

• Most ride down and out

• The visual axis is nasal

• Most all multifocals are visual axis sensitive

Measuring Lens Decentration

Topography over best fit multifocal will demonstrate displacement of near segment optics from center of pupil

Courtesy: Dianne Anderson OD, FAAO

3

Lens Geometric Center Relative to Illumination and Focal Demand

Displaced center add optics induce COMA. Clinically significant at 0.4 mm from visual axis

Chateau1996

N = 224 eyes

Pupil Shift with Focal Demand

Pupil shifts superior nasal with near demand and decreased illumination

Mean Pupil Size Decreases with Age

What does this say for one size fits all?

Taking contact lens correction to the next level will require registration of the lens optics with the visual axis

• The best multifocal designs are visual axis sensitive

• Myopia Control designs may be best if registered

The Era of Visual Axis Registration

OD

Photopic 2.6Mesopic 4.3Scotopic 5.3

Measuring Pupil Size, Reactivity and Location

Photopic (x,y)0.542, -0.213Scotopic (x,y)0.316, 0.035

The Future

Be willing to apply the same science to fitting contact lenses for presbyopia that you apply to your success with progressive addition spectacle lenses

4

• Legerton’s Three Rules• Every lens design will work on whom it works • The practitioner that puts the most lenses on patients will fit the most patients

• You can’t fit from an empty wagon

• Create a Presbyopic Contact Lens Evaluation Procedure

• Have three to five designs to evaluate on every patient

But What Do I Do Now? Clinical Suggestions• Measure pupil size and reactivity• Fit a variety of lenses• Attempt to optimize lens centration• Conduct “over-topography”

• Conduct “over-aberrometry” if you have instrumentation

• Attempt to learn lens parameters of various designs• Segment size

• Hard or soft progression of center add

Revisiting the Clinical Goals for Multifocal Success

• Correct all low order aberrations (Sphere and cylinder)

• Center the optics over the visual axis

• Size the near segment based on pupil size and pupil reactivity

• Manufacture optics equivalent to GP lenses• Maintain good surface wetting

THANK YOU

Controlling Myopia: Where do we stand?

David A. Berntsen, OD PhD FAAO University of Houston College of Optometry

4901 Calhoun Rd Houston, TX 77204-2020

713-743-5836 dberntsen@uh.edu

Course Description: This course reviews current research involving methods to control myopia progression. Eye care providers will gain an evidence-based understanding of what is currently known about available treatments for myopia.

Course Learning Objectives: To summarize current prevalence of myopia To summarize the effects of currently available optical designs on peripheral defocus To discuss current optical treatment strategies for myopia To discuss pharmacological treatment strategies for myopia To discuss environmental treatment strategies being studies for myopia To summarize current controversies in the clinical literature regarding currently available

treatments To discuss what eye care providers can currently tell their patients based on the most

recent evidence Outline:

I. Overview of treatments studied and the reported reductions in myopia by published clinical studies a. spectacles (bifocal and progressive addition lenses [PALs]) b. GP lenses c. undercorrection d. orthokeratology e. soft bifocal contact lenses f. pharmaceuticals

i. atropine ii. pirenzepine

II. Peripheral defocus theory of myopia (animal model summary)

i. Local retinal mechanism (Smith et al. 2013) ii. Peripheral hyperopia increases eye growth (Smith et al. 2009)

III. Effect of standard optical corrections on peripheral defocus

a. Single vision spectacles increase peripheral hyperopic defocus with increasing minus power (Lin et al. 2011; Berntsen et al. 2013)

b. Many spherical soft contact lens designs reduce peripheral hyperopic defocus (Moore 2014)

i. Spherical soft contact lenses cause peripheral myopic shift as increase minus power (Moore 2015)

IV. Effect of contact lens corrections for myopia control on peripheral defocus a. Multifocal soft contact lenses

i. Center-distance design (Berntsen and Kramer 2013) ii. Center-near design (Moore 2015)

b. Orthokeratology (Kang 2011)

V. How much myopic defocus is needed (threshold versus dose-response)? i. Orthokeratology studies (Cho 2005; Kakita 2011) ii. Soft multifocal designs (Sankaridurg 2011) iii. Start with orthokeratology or soft bifocal? iv. Is pupil size/retinal exposure important for myopia control?

1. bigger pupils may be better (Chen 2012; Santodomingo-Rubido 2013)

VI. Outdoor Effect on Myopia Onset and Progression

a. Time Outdoors Protective against Myopia Onset i. Jones-Jordan 2007; Rose 2008; Dirani 2009

b. Is time outdoors protective against myopia progression? i. Jones-Jordan 2012; Wu 2013; He 2015

VII. Atropine a. Effective at multiple concentrations (Chia 2015) b. Rebound effect depending on concentration used after cessation (1% down to

0.01%) c. 0.01% atropine: changes seen in refractive error but not axial growth? (Chia

2015; Chua 2006)

VIII. Myopia Management Questions a. When to start treatment before myopia onset?

i. Zadnik 2015: Predicting children who will be myopic by grade 8 (13 years old):

1. less hyperopic than +0.75 D for grade 1 (age 6 years) 2. +0.50 D or less hyperopic for grades 2 and 3 (ages 7 and 8 years) 3. +0.25 D or less hyperopic for grades 4 and 5 (ages 9 and 10

years) 4. emmetropic or more myopic for grade 6 (age 11 years)

ii. Methods before onset: Outdoors (He 2015); Atropine (Fang 2010); multifocal SCLs

b. Combination therapies?

i. Sequential treatment strategy ii. Concurrent treatment strategy

IX. Myopia Control Studies in Progress

a. Clinical Trials needed to further guide clinical practice b. Bifocal Lenses in Nearsighted Kids (BLINK) NIH/NEI Clinical Trial now enrolling

BLINK Study: www.blinkstudy.org

Orthokeratology: Then and Now Norman E. Leach, OD, MS

I. Historical Development A. Corneal Reformation B. Early mechanical devices 1. Patent Eye Cups (1850) 2. Corneal Restorer (1865) C. Early contact lenses 1. Tuohy Lens (1948) 3. Micro-Lens (1951) 2. Contour Lens (1955) D. Beginnings of orthokeratology 1. Robert Morrison (1956-1958) a. Reported on myopia progression in teenage lens wearers. 2. George Jessen (1962) a. First to deliberately try to reshape the cornea. II. Early Orthokeratology: Four University Studies A. Traditional Flat Fit 1. Kerns (1976) 2. Binder, May, & Grant (1980) 3. Brand, Polse, & Schwalbe (1983) B. Tabb Steep Method 1. Coon (1982) III. Reverse Geometry and Accelerated Orthokeratology A. Three zone lenses 1. Wlodyga & Bryla (1989) B. Four zone lenses IV. FDA Approval for Overnight Orthokeratology A. Paragon Vision Sciences CRT (2002) 1. Corneal reshaping B. Bausch + Lomb VST (2004) 1. Orthokeratology V. Concepts of Modern Orthokeratology A. Terminology 1. Base Curve/Treatment Zone

2. Reverse Curve/Zone 3. Alignment Curve/Zone 4. Peripheral Curve B. Fitting Characteristics 1. Centration 2. Central Bearing 3. Paracentral Pooling 4. Peripheral touch and edge clearance VI. Fitting Methods A. Empirical (K-readings and Rx) B. Inventory dispensing/fitting set C. Topography based lens designs D. Diagnostic lens fitting VII. The Certification Process

Contact Lens Comfort on the Range

William L. Miller, OD, MS, PhD

The Tear Film and Ocular Surface Society (TFOS) in 2013 published results of the

International Workshop on Dry Eye Discomfort in Investigative Ophthalmology and Visual

Science (54:11). This course will look at the definition of contact lens discomfort (CLD),

epidemiology as well as possible causes.

The course will specifically focus on the evidence-based rationale for treatment and

management of this condition. Treatment and management of contact lens-induced

discomfort is often addressed through a variety of approaches by the individual practitioner.

However, much of what is attempted is anecdotal with little support from evidenced-based

medicine. This course will highlight what we know and don’t know about treating and managing

this important issue influencing wearing time and ultimately successful contact lens wear in our

patients.

Learning Objectives:

1. To review concepts of definition and classification of CLD; 2. To review the ideas regarding factors that influence CLD, including material, design and care

solution factors; 3. To review the ocular surface tissues and glands thought to be associated with CLD, in

addition to tear film factors that may or may not contribute to CLD.

Specific topics to be addressed will include:

I. Definition

a. Review of terminology and current classification scheme

b. Epidemiology

i. relation to dry eye

ii. Factors involved in CLD

II. Precise contributors to CLD

a. Contact lens material

b. Contact lens design

c. Contact lens care systems/regimens

d. Contact lens wear schedule and habits

III. Impact on the ocular surface

a. Lacrimal, mucin secreting and meibomian glands

b. Tear film characteristics

c. Neurobiology

IV. Management and Therapy

a. Adjusting the Replacement Frequency

b. Changing lens material

c. The value of wetting agents

i. external

ii. internal

d. Lens factors

i. Edge shape

ii. Base curve

iii. Diameter

iv. Back surface shape

v. Center thickness

e. Lens Care systems

f. Nutrition

g. Punctal occlusion

h. Topical medication

i. Environment

j. Blinking behaviour

k. Neuromodulation.

Treating Allergy in the Dry Eye Patient William D. Townsend, OD, FAAO 1. Is this really an issue?

a. Vehof J. et al Prevalence and risk factors of dry eye disease in a British female cohort. Br J Ophthalmol 2014;98:1712–1717

i. 3824 women from the Twins UK cohort aged 20–87 years evaluated for DED; 10% had Dx of dry eye, 21% had DE symptoms

ii. Risk factors significantly associated w/ DED were age, asthma, eczema, the presence of any allergy, cataract surgery, rheumatoid arthritis, osteoarthritis, migraine and stroke.

b. Vellani E. et al. In-vivo confocal microscopy of the ocular surface: ocular allergy and dry eye. Curr Opin Allergy Clin Immunol 2013, 13:569–576 a. Evaluated conjunctival inflammatory (allergy-related) cell density w/ confocal

microscopy of anterior seg: inflammatory cell density: i. Negatively correlated with tear stability and corneal sensitivity

ii. Positively correlated with the vital staining score c. Gaikwad SL. et al, Contact allergy masquerading as seronegative Sjögren’s S. Oral Surg

Oral Med Oral Pathol Oral Radiol 2013;116:e375-e378 i. 58-year-old woman 1o diagnosed with seronegative Sjögren’s S.

ii. Clinical features included dry eye, dry mouth, increased T-lymphocytes in parotid gland tissue

iii. Antinuclear antibody test was weakly positive. iv. Test results for extractable nuclear antigen, anti-dsDNA, rheumatoid factor,

antiecyclic citrullinated peptide antibodies, and C3/C4 were normal or negative. v. After treatment for contact allergy all “Sjögren’s S signs and symptoms resolved

2. Allergy and Dry Eye: Medications- friend or foe a. Most commonly prescribed medications for allergy; systemic antihistamines and systemic

decongestants i. Antihistamines Wong J. et al. Non-hormonal systemic medications and dry eye.

Ocular Surface 2011;9(4):212-226. 1. Exhibit antimuscarinic effects on peripheral muscarinic receptors

a. Decreasing tear production by reducing i. Aqueous output from the lacrimal glands

ii. Mucin output from the goblet cells 2. Potency of the therapeutic effect on allergies not proportional to the

propensity for the adverse effects of antihistamines. 3. Because of differences in binding affinity for muscarinic receptors 2nd

generation H1 antihistamines have fewer anticholinergic effects than 1st generation

4. First generation H1 antihistamines a. Poor selectivity for the H1- receptor, cross blood-brain barrier b. Examples: chlorphenamine, azelastine, diphenhydramine.

Promethazine 5. Second generation H1 antihistamines

a. Better selectivity b. Examples: cetirizine, fexofenadine > loratidine

6. Topical vs. systemic antihistamines for ocular allergy a. Patients on epinastine experienced

i. no change in tear volume, tear flow, tear turnover, TFBUT, or conjunctival staining.

b. Patients treated for 4 days w/ loratidine 10 mg/day experienced i. 34%, decrease in tear volume

ii. 35% decrease in tear flow of 35% iii. 22% increase in corneal & conjunctival fluorescein staining

ii. Decongestants 1. Gobbels MJ. Et al. Affect of topically applied oxymetazoline on tear volume

and tear flow in humans. a. Thirty minutes after instillation of 0.026% oxymetazoline reduction

in i. Tear volume 37%, P < 0.001

ii. Tear flow -43%, P<0.001 b. Maximum effect 90 min after instillation

i. Tear volume -63%, P< 0.001 ii. Tear flow -71%, P<0.001).

3. Mechanisms of action a. Type I hypersensitivity (Figure 1) b. Type 2 hypersensitivity (Figure 2) c. Auto immune effects on tear-producing glands (Figure 3)

4. Recommendations a. Reduce inflammation without affecting

i. Mucarinic receptors

ii. α-adrenergic receptors b. Manage coexistent dry eye and allergy with

i. Anti-inflammatory agents (avoid steroids) ii. Cyclosporine A (Restasis)- consider increasing to QID

iii. Androgen-based products (topical, compounded) iv. Non-preserved AT v. Punctal occlusion (reduce inflammation 1st)

vi. Pipeline - 2% rebamipide ophthalmic solution (Acucela) in FDA

Page 1 of 1

Course Outline: Managing the Dry Eye of a Smoker 32nd Annual Cornea, Contact Lens, and Contemporary Vision Care Symposium, Houston, TX

December 5, 2015

Daniel Powell, OD, PhD

Clinical Assistant Professor, The Ocular Surface Institute

College of Optometry, University of Houston, Houston, TX

Outline (30 min. course):

I. Overview of Tobacco Smokers

A. Global and National Statistics

B. Types of smoke-producing tobacco products

C. Exposure

1. Classification of tobacco smoke

2. Smoke components

D. Health concerns

1. Systemic

2. Ocular

E. Epidemiological Studies: Tobacco Smoking and Dry Eye

1. Blue Mountains Study

2. Beaver Dam Study

3. Indonesian Dry Eye Study

II. Tear film

A. Review of layers

B. Structure of the tear film lipid layer

C. Tear film characteristics of a cigarette smoker

1. General dry eye test results

2. Inflammatory biomarkers

3. Byproducts of lipid peroxidation

4. Tear thinning and evaporation

III. Potential targeted remedies and treatments

A. Abstinence

B. Environmental changes

C. Ocular lubrication

D. Other treatments

IV. Conclusions

A. Future directions

B. Contact information: drpowell@Central.uh.edu

Odyssey of Corneal Cross Linking

Introduction

Corneal collagen cross linking is a technique which uses photodynamic action to strengthen chemical bonds in the cornea thereby halting the progressive, irregular changes in corneal curvature frequently seen in keratoconus and other forms of corneal ectasia.

Currently employed techniques were developed by researchers at the University of Dresden, Germany in the late 1990’s. UV light was used to induce collagen

cross linking in porcine and rabbit corneas. Their investigations proved that the treated corneas contained high molecular weight polymers of collagen due to the fibril cross linking. The resulting corneas were found to be stiffer as a result of this cross linking process.

Human studies of UV induced corneal cross linking began in 2003 at the University of Dresden.

Surgical Technique

Primary goal is to allow riboflavin to diffuse into the cornea. This involves the removal of the corneal epithelium (epi off) or weakening of the epithelial barrier of the cornea through various agents such as BAK (epi on). In all instances the patient is given analgesic drops and a lid speculum is used. After epithelial disruption riboflavin drops (0.1%) are given at intervals of 1-5 minutes for a period of 15-30 minutes or until the riboflavin can be seen in the anterior chamber of the eye using slit lamp examination. The patient is then positioned with a UV light (365-370um) at a small distance (1-5cm) from the corneal apex for 30 minutes. Following irradiation antibiotic drops and a bandage contact lens is typically placed and the patient is sent home with antibiotic drops to be used 3-4 times daily.

Outcomes

C. G. Carus University Hospital, Dresden, Germany Study The strength of this study is the large sample size at the length of one year. The study enrolled 480 eyes of 272 patients

i. 241 eyes with greater than six month data post cross linking ii. 33 eyes with greater than 3 year data post cross linking iii. Significant decrease in mean keratometry in the 1st year (-2.68D) iv. 87% were stable or improved in 3 years

Siena Eye Cross Study The strength of this study is the large sample size at 1 year. There is also a

small sample size at 4 years. The study enrolled 363 eyes with progressive keratoconus.

i. 44 eyes with > 48 months of data post cross linking ii. Significant reduction of mean keratometry in the 1st year (-1.96D) and at 4

years (-2.26D) Australian Study

This ongoing study has the best published design and definition of progression to date. The researchers are looking at patients with clearly defined keratoconus and will follow them for 5 years. The 3 year data was published in 2014. Primary outcome results: significant of Kmax at all time points treated.

i. Treated average Kmax flattening was -1.03 +/- 0.19D. 6/46 eyes (13%) flattened by > 2.0D. 1 eye steepened by > 2.0D.

ii. Control average Kmax steepening was +1.75 +/- .38D. No eyes flattened by > 2.0D. 19/49 eyes (39%) steepened by > 2.0D.

US FDA Trials There are 11 US sites with 204 eyes enrolled for keratoconus and 178 enrolled for ectasia. Data is currently unavailable for this ongoing study.

Personal Experience

Conclusions

Initial results appear to offer a promising less invasive treatment for keratoconus. Ideal methodology for this treatment continues to evolve.

Future of Presbyopia Treatment Jim Owen, OD, MBA, FAAO

.

� AMO � Alcon � Allergan � Science Based Health � Tear Lab � Tear Film Innovations

KAMRA Flexivue

Raindrop

Flexivue (3 mm)

KAMRA (3.8 mm) ICOLENS (3 mm)

Raindrop (2 mm) • Flexivue

• By Presbia (Amsterdam, Netherlands) • 3.0 mm Diameter / 1.8 mm Central Zone • 0.15 mm Central Hole • 15 – 20 microns thick • Center Ø Power • Peripheral ring of + ADD (+1.50 to +3.00) • Hydrogel

50 to +3.50 to +3.50 to +3.050 to +3.50 to +3.t

KAMRA (3.8 mm) InVue (3 mm) Flexivue (3 mm)

Raindrop (2mm) • Raindrop (Formerly Presbylens and Vue+)

• By Revision Optics (Lake Forest, CA) • 2.0 mm Diameter • SAME Refractive Index as Cornea • Changes curvature of cornea (+ lens shape) • Creates Multifocal Cornea (Dist, Inter, Near) • Proprietary material

KAMRA (3.8 mm) ICOLENS (3 mm)

Flexivue (3 mm)

Raindrop (2 mm) • KAMRA Inlay

• By AcuFocus (Irvine, CA) • 3.8 mm Diameter / 1.6 mm Aperture • Made of Polyvinylidene Fluoride (PVDF) • Small Aperture – Increased Depth of Focus

• Best achieved with specially designed pocket software

• Allows accurate placement of pocket location

• Dimensions can be customized for specific patient anatomy

iFS 150 Khz

patient anatomy

Wavelight Recent release-first cases Sept 2015

Design Features

Method of action Bifocal

Refractive lens Yes

Lens power +1.50 to +3.50

Material used Hydrophylic polymer

Biocompatible Yes

Inlay diameter 3.2mm

Inlay thickness 15-20 microns*

Implantation depth 300 microns

Nutrient flow process Through central 0.15mm hole

CE Mark Yes

* Thickness increases with increasing refractive power

Thickness*: 15 µm Diameter: 3.2 mm

Peripheral zone with refractive

power: +1.5 D to +3.5 D

Central zone without refractive

power

*Thickness varies based on power

8

� A transparent hydrogel implant, placed 280 to 300 microns deep pocket in the cornea of the patient’s non dominant eye

� Flexivue Microlens received CE Mark in 2009 � Currently undergoing Phase 2 of clinical trial under the FDA � LIKELY APPROVED 2019 � Available in over 40 countries across Europe, Latin America,

the Middle East, Africa and South Korea

� Presbyopic, aged between 40 and 65 years (ideal patient early 50’s so power swap not needed)

� UCDVA in Dominant Eye, or BCDVA if planning concurrent Laser correction >20/25

� UVCNA < 20/50 � Endothelial Cell count >2000 in the non dominant eye � Minimum 480um � Monovision tolerance, patients must undergo a contact lens trial � Photopic Pupil >3mm � Good LASIK candidate ◦ Stable refraction ◦ Clear lens

Distance vision: the rays pass through the central zone of the implant (blue line) and through the free peripheral corneal tissue (interrupted blue line).

Flexivue Microlens Inlay – Distance Vision

For near vision the rays passing through the refractive peripheral zone (red lines) will be focused on the retina

Flexivue Microlens Inlay - Near Vision

• Hydrogel Inlay •2 mm Diameter •≈ 30 μm Thick •80% Water Content •Same Refractive Index as the Cornea

• Allows for Nutrient and Oxygen Flow through the Cornea

• Mechanism of Action: Profocal Shape Changing Technology

Design Features

Method of action Corneal Reshaping

Refractive lens No

Lens power N/A

Material used Medical grade hydrogel

Biocompatible Yes

Inlay diameter 2mm

Inlay thickness 30 microns

Implantation depth 150-180 microns

Nutrient flow process Proprietary micro-porous material

CE Mark Yes

Stromal Cushion 100 µm

16

Likely FDA approved early 2017

* Current Recommendation 1/3 of the Central Corneal Thickness

� Inlay Naturally Reshapes the Cornea, Creating a Profocal Cornea with a Smooth Transition from

Near to Intermediate to Distance

Ideal pre-op refraction +0.50 - +0.75

Features Benefits Clear • No Cosmetic Issues

• Near 100% Light Transmission

Hydrogel Material • Safe for the Cornea • 80% Water • Same Refractive Index as the Cornea • Allows for Nutrient & Oxygen Flow

Through the Cornea

2 mm in Diameter • Placed on the Constricted Pupil, it Improves Near and Intermediate Vision while Not Limiting Distance Vision Binocularly

≈30 μm Thick • Gently Reshapes the Cornea Changing Refractive Power Giving Patients Back their Near and Intermediate Vision

3.8 mm

1.6 mm

Thickness = 5 μm

Weight = 100 mcg

Material = Polyvinylidene Fluoride PVDF (IOL haptics)

Inlay matches corneal curvature

8,400 micro-perforations

(5-11µ)

Pseudo-random pattern

Maximize

nutrient flow

Minimize visual symptoms

• The inlay works like an aperture in a camera (opening)

• This small opening allows only focused images in the eye

• Only focused light rays allowed to reach the retina

• Same principle used in camera lenses to increase depth-of-focus

Pinhole Principle: “Increased Depth of

Focus”

�

•

•Produced prototype out of Dacron fabric

• Implanted 1st inlay in 2002

•Proved concept

2001-02 • Developed next-

generation inlay

• Clinical evaluation on new material

2003-04 • Filed and initiated 1st IDE

• CE Mark granted

2005-06 6

2007-08

• Solved key inlay design challenges

2009-10

• Initiated 2nd IDE study; completed enrollment

• Began targeted OUS KAMRA™ inlay commercialization

• Launched AcuTarget™

2013-14

• Moved to pocket- based procedures • Launched AcuTarget HD™ • Completed FDA panel

meeting

2011-12

• Submitted all PMA modules to FDA

• Expanded regulatory approvals & commercialization activities

2015

• US Approved

2

on newon newon newon new matermater mater materialialialial

2013-14

200000000000

MAJOR LEARNINGS: • Polyvinylidene Flouride (PVDF) & carbon is the right material • Thin profile reduces changes to anterior corneal surface • Microperforations must vary in size and be distributed in a pseudo-random

pattern to maximize nutritional flow and minimize diffraction • Must be implanted into a femtosecond-laser created pocket • Inlay must be implanted at least 200 microns deep • Laser settings need to be adjusted to < 6x6 micron spot/line (or

equivalent) • Steroid and dry eye therapy are critical for modulating the healing

response

CLK: Combined LASIK KAMRA – Stopped performing PEK: Pocket Emmetropic KAMRA PLK: Post-LASIK KAMRA 100 % Pocket Procedures

PLK2: Planned 2 Stage KAMRA

• For all ametropic patients we perform LASIK, with a target of -0.75D to achieve optimal results.

200μm

LASIK Flap

Epithelium

Endothelium

Dry Eye, Fluctuating Vision, Slow Visual Recovery,

� STAGING OF THE LASIK and Pocket KAMRA Procedure was assessed: ◦ Pocket creation first, immediately followed by

LASIK, with KAMRA inlay insertion the SAME day ◦ Pocket creation first, immediately followed by

LASIK, with KAMRA inlay insertion DELAYED by 1 day, 3 days, 1 week, 2 weeks and 4 weeks ◦ LASIK procedure first, followed by Pocket

Creation and KAMRA insertion at 1 week to 1 month

MRSE UCDVA UCNVA

Over +1 20/20 J-5

0.75 to 0.99 20/20 J-3

0.5 to 0.74 20/20 J-5

0.25 to 0.49 20/16 J-3

0 to 0.24 20/16 J-2

-0.25 to -0.01 20/16 J-1

-0.50 to -0.26 20/16 J-1

-0.75 to -0.51 20/16 J-1

-1 to -0.76 20/20 J-1

Less than -1 20/25 J-1

-0.25 to -0.01 20/16 J-1

-0.50 to -0.26 20/16 J-1

-0.75 to -0.51 20/16 J-1

2 Optimal residual refractive error between -0.01D to -0.75D

31.5% of patients enrolled in the clinical trial had a pre-op MRSE in the optimal range

0.25 to 0.49 20/16 J-3

0 to 0.24 20/16 J-268.5% of patients enrolled in the clinical trial hand a pre-op MRSE

between 0.00D to 0.50D

KEY LEARNING: Dominant eye: plano

+0.50 20/20 wont be happy Non Dominant eye: -0.75 < 0.50D cyl

� Have found the Acutarget very helpful in determining candidacy for RLE vs KAMRA

� Every patient in 50+ has lens changes-significant?

� Increased depth of focus, no clear refractive endpoint

� Measure Refraction with lights on � Use mid-point of refractive range � Best for some is Red-Green technique

� Pred Forte qh x 48 hours then qid remainder of week

� Then FML or Lotemax

�QID x 3 W

�TID x 1 MO

�BID x 1 MO

o Make decision at this point

whether to d/c steroids

� Ocular Surface Management ◦ Preservative free artificial

tears � Hourly for the first week, then � 6 x/day for a month, � then PRN

◦ Temporary or permanent punctal plugs in EVERYONE ◦ Omega-3 fatty acids ◦ Topical cyclosporine

P KAMRA Inlay Raindrop Flexivue Microlens

Method of action Small Aperture Corneal Reshaping Bifocal

Refractive lens No No Yes

Lens power N/A N/A Periphery: +1.50 to +3.50 Central: plano

Material used Polyvinylidene Fluoride (PVDF) Medical grade hydrogel Hydrophylic polymer

Biocompatible Yes Yes Yes

Inlay diameter 3.8mm 2mm 3.2mm

Inlay thickness 5 microns 30 microns 15-20 microns*

Implantation depth 200 microns 150-180 microns 300 microns

Nutrient flow process 8,400 microperforations, 1.6 mm central opening Proprietary micro-porous material Through central

0.15mm hole

Surgical Procedure PEK, PLK, PLK2, CLK Flap only

Studying combination with LASIK, working on Pockets

Pocket only Studying dual-interface approach

* Thickness increases with increasing refractive power 36

KAMRA Inlay Raindrop** Flexivue Microlens

Patient Candidates Emmetropes, Ametropes, Post-LASIK, Pseudophakes

Emmetropes, early data on Ametropes and Pseudophakes Emmetropes

UCNVA Mean J2 (20/25) 1 100% > J2 (20/25) 4 Mean J2 (20/25) 6

Change in UCNVA Mean 3.2 lines gained1 Mean 5 lines4 Mean gain 6 lines6*

UCIVA Mean 20/251 100% > 20/324 Not Reported

UCDVA Mean 20/201 100% > 20/204 Mean 20/506

Change in UCDVA May lose two letters1 Not reported Mean loss 3 lines6*

BCDVA Mean 20/201 Not Reported Mean 20/255

Change in BCDVA Mean 20/201 Not Reported 37% lost 1 line6*

Satisfaction 95% satisfied2 87% “do again” 3 95% satisfied 90% satisfaction in European

Economic Area

Glare/Halo Mean scores for glare/halo are ~2 = mild (0-7 scale) 1

11% mod/severe glare4 5% mod/severe halo4 12% “always/sometimes” glare/halo7

Longest Follow-Up 3- year (current design) 5-year (prior design)

7 years ~500 patients5 data has yet to be shared 500+ at 3+ year f/u8

*Statistically significant change **Binocular data only

37

STRENGTH WEAKNESS

K AMR A

• Product commercially available (50 countries) • FDA approved • Continuous, natural range of vision • Protect against presbyopic progression • Uninterrupted optical pathway • Significant improvements in near and mid

vision while maintaining good distance

• Wound healing • Restricts light • Chair time

RVO

• Product commercially available Europe • Good outcomes across full range • Clear, Does not restrict light

• Will lose effect (presbyopia progression & epithelial remodeling)

• Haze formation over visual axis • Shallow implantation risks thinning/melt • Limited ability to address post-LASIK presby as only

flap procedure • May be difficult to find in future if removal

required

P R E S B

• Multiple powers to allow for customization • Significant improvements in near • Clear, Does not restrict light

• Will lose effect (presbyopia progression) • Will need to be changed over time • Significant loss of UCDVA/CDVA in inlay eye • Centration • Glare/halo

11/16/2015

1

Cryo-Preserved Amniotic Tissue: A New Hope

Seema Nanda, ODUHCO / Texas Eye InstituteCCLS Meeting, Houston TX

5th December 2015

Disclosures

Speaker Bureau

University of Houston College of Optometry

Allergan Pharmaceuticals

B&L Pharmaceuticals Biotissue, Inc. Ocusoft, Inc.

How a Scar is born…

11/16/2015

2

Pain (dolor), redness (rubor), swelling (tumor), heat (calor):

leukotrienes, prostaglandins are released

Decreased visionSurface irregularities:  SPK, filaments, EBMD, Salzmann’s nodules, tear film abnormality

Corneal edema (endothelial cell inflammation)

Inflammatory infiltrates, WBC recruitment

Poor regeneration, healingLimbal stem cell shock

Inflammation’s Effect on Healing

Neurotrophic cornea: ‐ nerve damage

Susceptibility to infection ‐ poor healing, alteration of host 

defenses

Corneal stromal haze ‐ sub‐epi fibrosis, scarring

Neovascularization (VEGF)

Permanent visual impairment

Inflammation’s Effect on Healing

Controlling Inflammation is Key to Preventing Tissue Damage!Controlling Inflammation is Key to Preventing Tissue Damage!

An Uncertain

FutureLimited

Quality of Life

Fear, Isolation,

& Frustration

Loss of Independence

Scarring: More than vision loss…

…profound emotional

impact.

11/16/2015

3

Controlled Inflammation

Promote Healing

Exact Replacement

Active Pathway

More Tissue DamageDeficient Healing

Uncontrolled Inflammation

Passive Pathway

Regeneration

UlcerationScar FormationVision Loss

Tissue Injury

Different Outcomes of Tissue Injury

Corneal Conundrum: A New Hope

• Anterior Basement Membrane Dystrophy

• Neurotrophic Ulcer

• Dry Eyes

Anterior/ Epithelial Basement Membrane Dystrophy: ABMD / EBMD

11/16/2015

4

• Most common corneal dystrophy, affecting ~2% of the population. More common in the elderly.

• ~10% experience RCE as aconsequence of faulty attachment complexes. • Hemi‐desmosomes of the

basal epithelial cells, the underlying basement membrane, and the sub‐adjacent anchoring fibrils of Bowman's layer attach poorly.

Anterior Basement Membrane Dystrophy: ABMD

• After an erosion, persistence of devitalized epithelium and fragments of basement membrane may inhibit normal re‐epithelialization and formation of secure attachment complexes. 

• Superficial debridement for removal of abnormal epithelium and basement membrane thereby leaving a smooth substrate of Bowman's layer. 

ABMD

• The adjacent normal epithelium can resurface this area, allowing formation of competent attachment complexes and resulting in prompt cessation of erosive symptoms with much reduced frequency of recurrences.

• Some pts. can have reduced vision &/or RCE from the extreme deposition of an abnormal BM & collagenous material btwn. the epithelium and Bowman's layer.• May lead to irregular 

astigmatism and abnormal tear breakup. 

• Patients typically complain of monocular visual distortion, diplopia, or “ghost images.” 

ABMD: Superficial Keratectomy

11/16/2015

5

ABMD + Dry Eye Syndrome

•

65-year-old Russian female • History of ABMD & with

secondary Dry Eye Syndrome

• Oc Meds: Restasis bid OU, Preservative Free Artificial Tears qid OU

• Eyes hurt all the time, tired of pain/dryness especially when reading

• Wants to try alternative tx for symptoms

• Start treatment with Aminoticmembrane: Prokera

• Followed for 3 wks OS, then 2 wks OD following Superficial Keratectomy

• Can be performed on other epithelial defects, post-debridement

• VA: OD: 20/40OS: 20/40

ABMD / EBMD

Typical Map‐Dot‐Fingerprint Dystrophy:loose epithelium was debrided then placed with A.M. lens to aid in its wound healing.

• Central epithelium is removed with a dry cellulose sponge. Central cornea with epithelium removed. 

• Cellulose sponge is used to identify a plane in the fibrous membrane. Fibrous membrane is then peeled as continuous cellophane‐like sheets with jeweler's forceps. 

• Irregular epithelium, aberrant basement membrane zone, and dense sub‐epithelial fibrous tissue that has replaced Bowman's layer.

• Once removed, a smooth substrate of intact Bowman's layer remains after re‐epithelialization with the elimination of irregular astigmatism

ABMD: Superficial Keratectomy

.

11/16/2015

6

Active amniotic membrane is a biologic therapy that can:

• Promote regenerative healing

• Reduce inflammation

• Minimize scar formation

• Minimize pain

Emerging Therapeutic Options: Amniotic Membrane

• Amniotic membrane is the inner most lining of the placenta (amnion) and shares the same cell origin as the fetus

• Contains cytokines and growth factors

• Anti‐Inflammatory (protease inhibitors)

• Anti‐Angiogenic

• Anti‐Scarring

• Aids in rapid wound healingand re‐epithelialization

Amniotic Membrane

• Creates a Fetal Environment to Achieve Corneal Healing

• Amniotic membrane shares the same cell origin as the fetus

Biologically Active Tissue

Regenerates the cornea, rather than repairs

11/16/2015

7

CryoTek™ cryopreservation method ensures retention of key active components of the Extracellular Matrix (ECM)

Only method that retains both: Integrity of the tissue structure Key active ECM and healing

components Safe and effective Extensive Number of Peer Review

Articles / Publications Bio-Tissue™ Cryopreserved

Amniotic Membrane is the ONLYAmniotic Membrane granted wound healing indication by the FDA.

Why Cryopreservation Matters…

Han Solo

Neel Desai1,2

M. T. Cooke3, C. J. Mandrycky3,

J. O’Connell4 & Todd C. McDevitt3,4, 5, 6

Study: Characterization of Commercial Cryopreserved

vs. Dried Amniotic Membrane

(ARVO 2012)

1 Director, Cornea Surgery, The Eye Institute of West Florida; 2  Medical Director, International Sight Restoration Eye Bank; 3  Georgia Institute of Technology, Atlanta, GA;  4  Amniox Medical, Marietta, GA; 5  Associate Professor, Wallace H. Coulter Department of Biomedical Engineering;  6   Petit Faculty Fellow, Parker H. Petit Institute for Bioengineering and Bioscience, Georgia Institute of Technology, Atlanta, GA, USA.

Findings:• NO High Molecular

Weight Hyaluronic Acid found in Dry Membrane

• Cryo-Tek noted an abundance of HMW Hyaluronic Acid

• Important for regenerative properties.

Desai et al, ARVO, 2012Desai et al, ARVO, 2012

M Healon®    CryoTek™     Dry

High MW HA

Low MW HA

Comparison of Dry vs. Cryopreserved

11/16/2015

8

Study Results: Absence of PTX3 in Dry Membrane

PTX3 is the activator for Heavy Chain (HC)-Hyaluronic Acid (HA) complex.4

PTX3 is abundantly present in cryopreserved AMPTX3 was poorly detected in dried AM. This result suggests that dehydration processing damages the integrity of HC-HA complex.

CryoTek™   Dry

Desai et al, ARVO, 2012Desai et al, ARVO, 2012

HC•HA

TSG‐6

II

HC

bikunin

He et al, J Biol Chem, 284:20136‐46, 2009Zhang et al, J Biol Chem, 287:12433‐44, 2012He et al, J Biol Chem, 284:20136‐46, 2009Zhang et al, J Biol Chem, 287:12433‐44, 2012

Formation of HC-HA Complex in Amniotic Membrane

Formation of HC•HAFormation of HC•HA Complex with PTX3

Adult: PTX3 Complex  activates complement pathway by phagocytes, DCs, fibroblasts , etc.

PTX3 Complex: strongly inhibits inflammation and angiogenesis and 

promotes regeneration. 

Dehydrated Membrane Disk

11/16/2015

9

11/16/2015

10

• Cryopreserved Amniotic Membrane via the Cryo‐Tek™ method preserves histologic features and ECM (collagens and sulfated proteoglycans) better than Dry Amniotic Membrane by Purion™ method. 

• Dry Amniotic Membrane by Purion™ method showed:

• degradation of HMW HA to LMW HA and HC‐HA complex, 

• absence of PTX3, and 

• lack of inhibition of giant cell formation 

• These findings further indicate that Dry Amniotic Membrane has deprived active components and lost the efficacy of promoting active wound healing of the amniotic tissue.

Study Conclusion

Neurotrophic Ulcer

Seema Nanda, ODClinical Professor

University of Houston College of Optometry

Texas Eye Institute

Prokera Slim 

What is a Neurotrophic Ulcer?• Rare degenerative corneal

disease: • caused by an impairment of

trigeminal corneal innervation,

• leading to a decrease or absence of corneal sensation.

• Ocular & systemic diseases can determine a lesion at different levels of the 5th CN: • nucleus in the pons,

Gasserian ganglion, trigeminal ophthalmic branch, nasociliary nerve, or long ciliary nerve

11/16/2015

11

What is a Neurotrophic Ulcer?

• The corneal epithelium is the first target showing dystrophic changes and defects with poor tendency to spontaneous healing. • The progression of the disease

may lead to corneal ulcers, melting, and perforation.

• Clinical diagnosis is determined from the Hx. & clinical findings, the management of this condition is one of the most difficult and challenging among all corneal diseases.

Possible Etiologies:Ocular:• Post-herpes infections (HSV, HZO)• Chemical and physical burns• Drug toxicity: abuse of topical

anesthetics, timolol, betaxolol, diclofenac sodium, sulfacetamide30%

• Post-surgical or laser treatment (trauma of ciliary nerves)

• Corneal incisions• Chronic ocular surface injury or

inflammation• Contact lens wear• Corneal dystrophies: Lattice,

Granular, Macular

Neurotrophic Ulcer Pt. 1

• 81-year-old Asian Indian male

• History of HZO / POAG• Seen by general

ophthalmologist for severe epithelial defect and keratitis with corneal edema.

• NI after treatment for 4 wks. with BCL, lubricants, and anti-virals

• Referred to corneal specialist after several weeks of non-responsive treatment

• Initial VA OD: CF at 2ft. OS: LP (CRVO in 1998)

• H/O dry eyes, cataracts• H/O lid tarsorraphy OU

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12

HZO Keratitis: Cause of Neurotrophic Ulcer

1

3

2

4

**Total treatment time: 10 weeks, with 5 PKS lenses VA 20/80

Neurotrophic Ulcer Pt. 2

• 64-year-old British female Computer Analyst

• History of RCE, (Recurrent Corneal Erosion)

• Seen by general ophthalmologist many times for RCE

• NI after treatment with BCL, anitbiotics, and lubricants

• Referred to corneal specialist after 2 weeks of non-responsive treatment

• Possible Neurotrophic Ulcer

• BVA OD: 20/40 OS: 20/200

• H/O CL wear, dry eyes from staring at computer monitor

11/16/2015

13

• May occur secondary to corneal injury or spontaneously.

• In the latter case, some predisposing factor, such as diabetes or a corneal dystrophy, may be the underlying cause.

Recurrent Corneal Erosion

• Management of RCE syndrome is usually aimed at regenerating or repairing the epithelial basement membrane to restore the adhesion between the epithelium and the anterior stroma.

• Painful RCE syndrome, results from abnormalities in the epithelial basement membrane.

RCE: Neurotrophic Ulcer Pt. 2

• Day 1 – fit with PKP (Prokera Plus Lens)

• Followed up every 2-3 days for 2 weeks, before membrane dissolved.

• Switched to PKS –Prokera Slim afterwards

• Total treatment time: 21 days.

• VA post-treatment: 20/40

Neurotrophic Ulcer Pt. 2

1

3

2

4

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14

Neurotrophic Ulcer Pt. 2

Last follow‐up visit:  Day 20  scVA: 20/40

Dry Eyes: Superficial

Punctate Keratitis

Seema Nanda, ODClinical Professor

University of Houston College of Optometry

Texas Eye Institute

Prokera Slim 

Dry Eyes: Superficial Punctate Keratitis

55‐year‐old Caucasian Female

History of Dry Eye Syndrome, GP BF Lens wearer

Oc Meds: Restasis bid OU, Preservative Free Artificial Tears qid OU

Eyes hurt all the time, tired of pain/dryness especially with computer

Wants to try alternative treatment for condition

Starts Prokera Slim

11/16/2015

15

Dry Eyes: SPK

Day 1 Day 14

The epithelial defect has improved/resolvedDecreased stromal inflammationIf improved, but not enough, a new PROKERA® can be placed after 10-day global period.

Reimbursement by Medicare & Non-Medicare providers PROKERA® is not limited to a specific list of ICD-10 codesPROKERA® CPT code 65778

Placement of amniotic membrane on the ocular surface for wound healing; self-retaining

Add -58 Modifier for 1-day post-PKP

Results & Reimbursement

ICD-10Prokera is used to facilitate healing in which the ocular surface cells have been damaged, or the underlying stroma is inflamed or scarred.

Some conditions may include: • Band keratopathy• Bullous keratopathy• Chemical burns of the ocular surface • Corneal epithelial defects • Corneal ulcer • High risk corneal transplants • Superficial keratectomy • Keratitis (bacterial or viral) • S/P Pterygium surgery • Stevens-Johnson Syndrome

11/16/2015

16

New treatment available to conditions that were once untreatable.

Pt. now able to get functional vision Active Amniotic membrane modulates healing towards

regeneration, away from inflammation and reduces scarring.

When used early reduces inflammation and minimizes scarring to prevent sight threatening complications

FDA-cleared therapeutic devices that simultaneously reduce inflammation and promoting “regenerative healing”

Self-retaining biologic corneal bandage

Summary: A New Hope

Scleral Lenses Tear Exchange

William L Miller, OD, MS, PhD

Scleral contact lenses have been used as a form of refractive correction for over a century. Over the past decade, modern designs coupled with better materials have led to a renaissance in fitting these lenses in patients with irregular corneal surfaces as a result of keratoconus, Pellucid marginal degeneration and corneal surgery.

Recently, some have promoted their use in normal corneas. As with any new contact lens technology and/or indication a few challenges have arisen that should be managed including mid-day Fogging, conjunctival impingement and conjunctival prolapse.

The issue of potential corneal edema as well as the issue of sufficient tear exchange

and long-term implications in especially diseased corneas while wearing scleral lenses is

important to determine in this ever increasing mode of contact lens wear. Smith et al.

(2004) reported corneal edema of 3.5% with 3 hours of scleral contact lens wear. Others

(Michaud 2012) have advocated scleral lens vaults be kept less than 250 microns to

present corneal hypoxia. While Compan et al. 2014 recommended that the vault be less

than 150 and the Dk reach at least 125. Additionally, little has been reported on the level of

tear exchange of the post-lens tear film while wearing scleral contact lenses. Tear exchange

may influence oxygen levels under the lens and as well as the status of the tear film. Lack of

tear exchange can allow cellular debris to accumulate potentially creating an environment

for inflammation.

Learning Objectives:

1. To summarize the rationale for scleral lens prescribing

2. To illustrate current issues (suspected and real) in patients wearing scleral contact

lenses.

3. The practitioner will develop an understanding of the role of tear exchange in scleral gas permeable contact lens wear. 4. To describe recent work investigating the corneal thickness and tear exchange in a group

of scleral contact lens wearers.

I. Brief History of Scleral Contact Lenses

a. August Muller/Adolph Fick

b. Glass to plastic

II. Rationale and indications for use

a. Irregular corneas

1. Keratoconus

2. PMD

3. PKP/LKP

4. Post-refractive Surgery

III. Challenges

a. Mid-day Fogging

b. Conjunctival impingement

c. Conjunctival prolapse

IV. The Hypoxia Issue- is it real or imagined?

a. What is needed to avoid hypoxia?

b. Should we worry?

V. Tear Exchange with Scleral Contact Lenses

a. The importance of tear exchange under non-gas permeable scleral contact lenses

has been stressed as far back as 1970 by Ko, Maurice and Ruben.

b. Tear exchange is an essential criterion for removing cellular debris.

c. The fluorophotometer is useful in measuring the amount of fluorescein that

decays over time from behind the lens.

c. Current study results indicate a very low level of tear exchange in a variety of

scleral contact lens designs.

VI. What should we do to ensure adequate corneal physiology?

a. Importance since most of these corneas have been altered or have disease.

Midday Foggy Vision – What Blurs Vision?

Maria K. Walker, OD.MS. 4901 Calhoun Road Houston, TX 77098 Tel: (713) 743-6421

mkwalker@central.uh.edu

Course Description:

This course is intended to provide practitioners with information on the causes and effects of midday foggy vision with scleral contact lenses. Course Objectives:

o To briefly review the role of scleral lenses in managing ocular surface disorders. o To provide a clinically applicable description of midday foggy vision and discuss the etiology of the

condition. o To provide information on managing midday foggy vision with scleral lenses.

Outline:

I. Overview of scleral lenses and the patients we fit them in.

a. Ocular surface disease

i. Known irregularities in protein and lipid components of tear film.

b. Irregular astigmatism

i. Keratoconus and the associated tear film irregularities

ii. Post-transplant patients and the associated tear film irregularities

II. Etiology of Midday fogging (MDF) in scleral contact lens wear

a. Protein concentration increased in MDF

b. Overall lipid concentration increased in MDF

i. One study shows increase in cholesterol esters in small group of patients.

c. More prevalent in dry eye disease, with tight fitting lenses with little tear exchange.

d. Role of patient-specific risk factors

III. Management of (MDF)

a. Fit management

i. Reducing apical and limbal clearance reduces MDF

ii. Loosening the edge profile can alleviate the severity of MDF

b. Pharmacologic management

i. Artificial tears with increased viscosity can reduce MDF

ii. Treatment of underlying dry eye disease can be helpful in management.

Does the Scleral Lens Induce Expansion – Corneal Swelling?

Jan P. G. Bergmanson, OD, PhD, PhD hc, DSc, FCOptom, FAAO

Texas Eye Research and Technology Center

University of Houston College of Optometry

The scleral contact lens (ScCL) is the original contact lens introduced late 1800 but, although it could

provide significant visual improvements, it did not work well physiologically. It was not untill early this

centuary that the ScCL re-emerged. Thanks to advances in modern manufacturing technology and the

development of highly gaspermeable materials, the ScCL became a viable option especially for patients

with irregular astigmatism. However, the question whether the modern ScCL has completely eliminated

corneal hypoxia has yet to be resolved.

Objective

The intent of this lecture is to review the scientific literature that have addressed this issue and to

describe research conducted at the Texas Eye Research and Technology Center. Knowledge about

corneal oxygen requirement and clinical effects of corneal swelling together with ScCL material

specification and fitting characteristics will be helpful in diagnosing hypoxia or avoiding it in the first

place.

Outline

1. There are 4 theory based peer reviewed publications – 3 saying the cornea in the ScCL wearing

eye will swell and one saying there will be no such effect.

2. How do I diagnose edema ?

- Symptomology

- Pachymetry – what is the normal thickness range?

- Clinical signs – verical striae, folds, haze, bullae.

3. How did we design a study to answer the clinical question whether ScCL induces edema or not?

- 33 patients (Keratoconus, PKP, Post-RK), 69 eyes – signed University approved consent form.

- Pachymetry with Pentacam – both central and peripheral cornea.

- Patients had pachymetry before having their scleral lenses delivered and 1 to 14 months

after dispense.

- Lenses dispensed were 17-18.2 mm in diameter and had a Dk of 100.

4. Results

- No statistically significant difference was found before and after wearing ScCL.

- When edama was present, it was within physiological limits.

5. Conclusions

- Current ScCL (17-18.2 mm; Dk 100) when fitted adequately will induce little or no edema.

- When edema is present it is within the range you expect to have after a night’s sleep.

- Some adaptation in swelling may occur.

- Especially post-surgical patients may need endothelial cell count monitoring.

- Keratoconic corneas may have different swelling charaterisitcs compared to the normal

cornea.

Skin cancers are the most common carcinomas in the US regardless whether you live in the sunbelt or

north of this region. More than 1 million new cases are diagnosed each year. Malignant melanoma is

the most lethal of the skin cancers killing over 9,000 Americans each year. The total annual cost for

treating the melanoma victims in the US is a staggering $3.3 billion.

This lecture informs on the findings from the recently released Centers for Disease Control and

Prevention (CDC) report on melanoma. CDC collected the data from death certificates and from US

Cancer Statistics over a period stretching from 1982 to 2011.

While the other 2 main skin cancers start in the epithelium, the melanomas originate from melanocytes

in the connective tissue just internal to the epidermis. The melanocytes mutate to become cancerous

and the known cause to this mutation is ultraviolet radiation (UVR), which on the surfaceof Earth is UVA

and UVB, since the more toxic UVC is blocked by the ozone.

From 1982 to 2011 the melanoma incidence rate doubled to a total of 65,647 cases. In the year of 2030

CDC is projecting 112,000 new cases to be diagnosed at an annual cost of $1.6 billion. However, if

proposed prevention programs are activated and maintained, 20% of the melanoma cases from 2020 to

2030 can be avoided and allow a saving of $250 per year, which over this decade could save up to $2.7

billions.

Recommended preventive measures include UVR blocking sunglasses, wide brimmed hats and

sunscreen with SPF of 15 or higher. The advice is to look for or provide shaded areas when outdors and

to avoid sunbathing and indoor tanning. Communities are encouraged to increase shaded areas at

playgrounds, public pools and other public places.

Health care practitioners should always apply the ABCD rule when examining their patients. This

acronym stands for A-assymetry; B-border; C-color; D-diameter and will be further elaborated in the

presentation.

The intent of this presentation is to inform about the increased incidence and cost of the deadly

malignant melanomas and to enhance our awareness of this lethal malignancy. Familiarity with the

proposed preventive measures will most useful practical knowledge. Presented diagnostic insights will

be helpful to the doctor permitting an early diagnosis, which carries with it a better prognosis.

11/17/2015

1

Amber Gaume Giannoni, OD, FAAO, Diplomate (ABO)Director, Dry Eye Center, UHCO

Email: agaume@central.uh.edu

•Advisory Board Member for Alcon

•Advisory Board Member for Allergan

•Alcon Speaker’s Bureau

•Receive authorship honoraria from:

•Optometric Management

•Contact Lens Spectrum

I do not have any financial or proprietary interests relative to this presentation

International Dry Eye Workshop 2007:

“A multi-factorial disease of the tears and ocular surface that results in symptomsof discomfort, visual disturbance and tear film instability with potential damageto the ocular surface. It is accompaniedby increased osmolarity of the tearfilm and inflammation of the ocular surface.”*

Hallmark: Severity of patient symptoms rarely correlate with observed clinical signs.

Aqueous-Deficient:

o Aqueous production is insufficient to keep the eyes moist.

Evaporative:

o Tears thin at a faster than normal.

o Due to a tear lipid deficiency and/or poor quality meibumsecretions from dysfunctional meibomian glands (i.e. MGD).

• Sjogren’s syndrome• Rheumatoid Arthritis• Juvenile Arthritis• Diabetes Type I and II• Juvenile Diabetes• Metabolic Syndrome • Lupus• CREST syndrome• Thyroid Dysfunction• Graft vs Host Disease

• Sarcoidosis• Androgen Deficiencies • Inflammatory Bowel Disease • Rosacea• Psoriasis• Fibromyalgia• Chronic Fatigue Syndrome• Alcoholism• Parkinson’s Disease

• Steven’s Johnson’s syndrome

ASSOCIATIONS WITH DRY EYE DISEASE (NOT ALL-INCLUSIVE) Chronic Systemic Inflammation!

Can lead to:

• Increased inflammatory cytokines in tear film

• Increased osmolarity of tear film

• Inflammation of lacrimal glands and meibomian glands

• Hypo-secretion of aqueous and meibum

• Tear instability ; increased evaporation; fluctuating vision

• Surface damage

11/17/2015

2

Sjogren’s SyndromeMulti-system autoimmune disease characterized by

progressive hypofunction of salivary and lacrimal glands

• *Primary SS – occurs alone

• *Secondary SS – occurs with autoimmune disease

• Newer research indicates that all tear layers may be affected (Tincani A, et al. 2012)

www.Sjogren‘ssyndrome support.org

• Combination of genetic, environmental & hormonal factors• Viral or bacterial infection is thought to activate the

immune system in pre-disposed individuals

• Tincani A, et al. 2012• Ice JA, et al. 2012

COMMON (MIS)PERCEPTIONS:

• “SS is an uncommon/rare disease”

• “Optometrists will rarely see a patient with SS”

• “SS is so serious that an OD will be unlikely to be the

first to diagnose it”

• “If there isn’t significant corneal damage, dry mouth

and joint pain, it can’t be SS”

• “If a patient has SS, not much can be done”

Sjogren Syndrome: Epidemiology:▪ Occurs in ~1% of the population (4 million Americans)

▪ Only 1 in 4 have been diagnosed

▪ 1 of top 3 most common autoimmune disease

▪ 90-95% are females over 40

www.huffingtonpost.com •Venus Williams: Dx’d at 31

• My youngest SS patient is 9 (male)

Average time to reach a

diagnosis is 5 years!

11/17/2015

3

ww http://www.sjogrens.org/

Systemic effects occur in 30-70% of patients

• Pts don’t tell dentist

about dry eye….

• Pts don’t tell OD about

dental decay….

• Pts don’t tell GI doctor

about memory loss….

(Tincani A, et al. 2012)

• Sjogren’s patients have an increased risk of anxiety and depression.**

• Similar to those undergoing dialysis, experiencing moderate angina or enduring disabling hip fractures.*

• Has the potential to result in severe economic loss through decreased worker productivity.***

***Medical Outcome Survey***Thomas et. al, 1998

*** Report of the Global Dry Eye Market, Market Scope 2004

Traditional Blood for Sjogren’s Syndrome:

• ANA (+)…………….70%

• RF(+)…………… 60-70%

• ESR…………….. 80% show elevation

• Anti-Ro/SS-A (+)…….…..60-70%

• Anti-La/SS-B (+)………...40%*

*In SS, the combined sensitivity/specificity of classic blood markers is only 40-60% (Tincani A, et al. 2012)

Clinical suspicion:*• Symptoms of dry mouth > 3 mo• Symptoms of dry eye > 3 mo• Signs of dry eye:

• Schirmer: <5mm in 5 min in 1 eye• Significant ocular surface staining in 1 eye

• Other autoimmune disease: • Most commonly RA and/or Hypothyroidism

* Dry eye and dry mouth can be caused by many factors

New Diagnosis Standards (endorsed by American College of Rheum):

2 of 3 criteria must be present:

• Significant ocular surface staining in 1 eye• (+) Minor salivary gland biopsy (i.e. lip)• (+) Blood work:

• (+) Anti-SSA/Ro or (+) Anti-SSB/La antibodies OR

• (+) Rheumatoid Factor AND (+) ANA titer (>1:320)

• Sjogren’s International Collaborative Clinical Alliance (SICCA)

New Blood Markers for Sjogren syndrome?

Includes traditional biomarkers

3 new proprietary markers

Claim to increase early detection and cumulative specificity to 92.1%

11/17/2015

4

SSA/Ro and/or SSB/La antibodies:

• Found in 40-60% of patients with Sjögren syndrome

• Increases as the disease gets more advanced

• 20-30% of SS patients test negative

• Are non-organ specific and occur in other AI diseases

New Organ-Specific Biomarkers:

SP-1 – Salivary Protein 1: • High expression in lacrimal and submandibular glands

CA6 – Carbonic Anhydrase 6: • High expression in acinar cells of the submandibular and

parotid glands

PSP – Parotid Secretory Protein: • Expressed in the acinar cells of the salivary glands

Current Screening New SS Panel

• Combined serology sensitivity & specificity is 40-60%

• Combined sensitivity is 87% and specificity is 82.5%

• Cumulative specificity for CA6, SP-1, and PSP is 92.2%

• None of the “classic” serology

tests diagnose early• Identifies ~50% of early cases

(Ro and La Negative)

• Miss approximately 25-35% • Should pick up additional cases

1. Tincani A, et al. Novel aspects of Sjögren’s Syndrome in 2012. BMC Med Apr 4 2013;11:93. doi: 10.1186/1741-7015-11-93. 2. Shen L, et al.Novel autoantibodies in Sjogren’s Syndrome. Clin Immunol 2012;145:251-255. 3. Huang Y, et al. The immune factors involved in the pathogenesis, diagnosis, and treatment of Sjogren’s Syndrome. Clin Dev Immunol 2013; Article ID 160491. doi:10.1155/2013/160491.4. Ramos-Casals M, Brito-Zeron P, Siso-Almirall A, Bosch X. Primary Sjogren’s Syndrome. BMJ 2012;344:e3821

Remember, current diagnosis takes approximately 5 years

Earlier detection and diagnosis could help prevent serious ocular and systemic complications

11/17/2015

5

Unacceptable Samples

Excellent Samples

11/17/2015

6

• Send to IMMCO Lab Only (if collecting in-office)

• Can’t order biomarkers separate from Sjo test

• Can also send to LabCorp for collection

• CPT: 36416• “Collection of blood by capillary blood specimen

(e.g. finger, heel, ear stick)”

• Lab will charge patient’s insurance directly (include info

with sample).

No CLIA certificate necessary (only the “collection”

performed in-office, not the actual lab test)

Must follow OSHA guidelines and Good Clinical Practices regarding blood-borne pathogens

– TRAIN YOUR STAFF APPROPRIATELY –

Patient Cost:

• Medicare: no out-of-pocket expenses for lab tests

• Most are billed a co-pay between $0 -$100

• If billed full fee: $580 • ~1% of the time

1. Copious lubricants (drops, gels, ointments, inserts)

• Tears with hyaluronic acid may be more effective (Baudouin Rev Med Intern. 2004)

• Recommend non-preserved formulations due to frequent dosing

11/17/2015

7

2. Filament removal/bandage lens• Topical acetycysteine?

3. Punctal occlusion:

• Collagen vs. silicone vs. cautery

4. Autologous Serum

5. Environmental Education

• NO SMOKING• NO ALCOHOL• DRINK WATER• Humidifier• No ceiling fan• Avoid forced heat/cooling vents

6. Moisture chamber goggles (day/night) 7. Aggressively treat MGD and inflammation• Oral tetracyclines

• Add/Increase Omega 3• 1,000-4,000 EPA/DHA per day

• Topical ophthalmic cyclosporine

• Topical corticosteroids • Careful with long-term cumulative effects

• Topical and/or oral macrolides

• Topical Androgen/Testosterone/DHEA

8. Coverage:

• Scleral contact lenses• Amniotic membrane

9. Oral cholinergic parasympathomimetic agonists• Increases tear* and saliva production

• pilocarpine tablets 5mg bid-qid (i.e. Salagen®)• Non-selective muscarinic agonist• More side effects• Less expensive

• cevimeline 30 mg tid-tid (i.e. Evoxac®)• Selective muscarinic agonist• Less side effects• More expensive

*Tsifetaki et al 2003; Ono et. al 2004

11/17/2015

8

May also act on cardiac muscle and smooth muscle!

• Possible side effects (non-inclusive): • Headache• Sweating, nausea, diarrhea,• Irregular heart beat

• Avoid in asthma, GI ulcers, acute iritis, narrow angles

10. Medical Management:Refer for other associated problems:

• Rheumatology (RA, thyroid, SLE)• PCP (monitor blood work for lymphoma etc.)• Dentistry (dry mouth, cavities, sores)• Gynecology (dryness)• Gastroenterologist (digestion, reflux)• Dermatology (dryness)• Neurology (depression, neuropathy)• Psychology (depression)

Which of these conditions are Sjogren’s

patients at more risk to develop?

A. LeukemiaB. LymphomaC. Diabetes D. Hypertension

• 16 fold greater risk than normal population

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1798190/

Cumulative risk of developing lymphoma: 3.4% in first 5 years 9.8% at 15 years

Risk increases with time:

1 in 5 patients with SS will die from lymphoma Early detection is the key! Ask about chronic swelling and nodules

Solans-Laque R, et. all. 2011; Loinnidis et al, 2002

Final Thoughts…..

Sjogren syndrome is not all that rare

Early detection is important

YOU can diagnose this disease

YOU can make a substantial difference

Page 1 of 2

Course Outline: New Dry Eye Instrumentation on the Ranch 32nd Annual Cornea, Contact Lens, and Contemporary Vision Care Symposium, Houston, TX

December 6, 2015

Daniel Powell, OD, PhD

Clinical Assistant Professor, The Ocular Surface Institute

College of Optometry, University of Houston, Houston, TX

Outline (30 min. course):

I. Dry Eye Overview

A. Definition & Classification

B. Pathophysiology

C. Prevalence

D. Risk factors

II. Dry Eye Diagnosis

A. Symptoms (questionnaires)

B. Clinical tests for dry eye: A quick review

1. Ocular surface staining

2. Tear quality and stability assessment

3. Tear production

4. Tear osmolarity

C. Recent and new and diagnostic technologies

1. Tear osmolarity

2. Non-invasive Tear Break-Up Time (Oculus Keratograph 5M)

a. Clinical application

b. Obtaining and evaluating an image

3. Tear film lipid layer interferometry

a. Clinical application

i. Thickness (normal vs. abnormal values)

ii. Spreading characteristics

iii. Stability

b. Instruments

i. Oculus Keratograph 5M (Oculus, Inc.)

ii. LipiView (Tear Science, Inc.)

c. Obtaining and evaluating an image

4. Meibography

a. Clinical application

i. Gland dropout

Page 2 of 2

ii. Acini appearance

b. Instruments

i. Oculus Keratograph 5M

ii. LipiView II Dynamic Imaging System (Tear Science, Inc.)

5. Lab-Based Dry Eye Tests

a. InflammaDry

b. Sjö test

D. Emerging technologies

1. Optical Coherence Tomography (OCT)

2. Infrared thermography

3. Interferometry beyond the LipiView

III. Closing remarks

A. Conclusion(s)

B. Contact information: drpowell@Central.uh.edu

Expanding Your Diagnostic Range Through Tear Sampling William D. Townsend, OD, FAAO 1. Why tears, anyway?

a. Functions; nourishing, lubricating and protecting ocular surface b. Maintains homeostasis of the ocular surface

2. What’s in tears, anyway a. Electrolytes (sodium, potassium, calcium, magnesium, zinc, chloride, and bicarbonate b. Proteins (491 species) c. Lipids (more than 600 species) d. Mucins e. Vitamins f. Immunoglobulins g. Peptide growth factors h. Hormones i. Bacteria- Propionibacterium, Staphylococcus, Streptophyta, Corynebacterium, and

Enhydrobacter j. Immuno-active cells

3. Sampling tears- not as easy as it might seem a. Location; lacrimal lake vs. general tear film b. Volume: less is more- the harvesting of lacrimal fluid can alter tears

i. Nano-volumes better than milli-volumes c. Analysis; on location vs. transport- on-site preferred d. Offices submitting claims for reimbursement tests using tear sampling require a Clinical

Laboratory Improvement Amendments (CLIA) Waiver Certificate. 4. Tear film osmolarity

a. Historical background b. Freezing point technology c. Impedance measuring technology d. Implications of nanometric technology

i. Smaller sample 50 nl ii. Does not disturb ocular surface

iii. Repeatable iv. Reimbursable

e. TearLab (tearlab.com) i. Impedance-based technology

ii. Highly repeatable, consistent iii. Techniques easily mastered by techs iv. Must-know fact about DES and Tosm

1. Osmolarity normally maintained within narrow range 2. In DED, Tosm range widens-

a. More severe DES range may vary widely w/in minutes v. Show me the money

vi. Outright purchase- $9500 vii. Flex Agreement- no fee for instrument

1. 1 box (20 patients per month) $15 per test card 2. 5-6 boxes per month = $10 per test card

viii. Reimbursement info- rsc@tearlab.com

1. 8386-1 Microfluidic analysis utilizing an integrated collection and analysis device, tear osmolarity

2. Texas- $22.48 per eye + office visit (typically 92012) ix. In the pipe line- P2 device incorporates evaluation for inflammatory marker

1. IL- replaces MMP-9 as marker for DES (more specific) 5. Immunoassay for inflammatory markers (InflammaDry)

a. “The InflammaDry gives us complimentary, but not duplicative, information when mated with Tear Osmolarity.” Darrell E. White, MD SkyVision Centers

b. DES leads to elevated inflammatory markers in tear film interleukins, matrix metalloproteinases

c. Sambursky R et al. Sensitivity and specificity of a point-of-care matrix metalloproteinase 9 immunoassay for diagnosing inflammation related to dry eye. JAMA Ophthalmol. 2013 Jan;131(1):24-8

i. Evaluated InflammaDry in dry eye patients: 1. Sensitivity = 85% (in 121 of 143 patients 2. Specificity of 94% (59 of 63)

d. Acera A. et al. Inflammatory Markers in the Tears of Patients with Ocular Surface Disease. Ophthalmic Res 2008;40:315–321

i. Evaluated concentration of interleukins IL-1 and IL-6) & metalloproteinase 9 (MMP-9)

ii. Results 1. Tear levels IL-1 and IL-6 significantly higher in conjunctivochalasis 2. Tear levels MMP-9 elevated in all of the studied pathologies especially

MMP-9 levels were significantly elevated in blepharitis, allergic eye disease*, dry eye and conjunctivochalasis*

iii. Reimbursement info- www.rpsdetectors.com 1. 83516, “immunoassay for analyte other than infectious agent antibody or

infectious agent antigen; qualitative or semi-quantitative, multiple step method

2. Texas: Medicare $15.70 per eye, Medicaid $15.74 per eye 6. Conclusion: This technology allows practitioners to better diagnose, treat, and evaluate the

patient’s response to therapy. It expands our ranges and prepares us for utilizing new technologies currently in “the pipeline.”

11/18/2015

Smart Contact Lenses:

The Future is Now

Jerome A Legerton, OD, MS, MBA, FAA0

My Journey• 26 years in private practice; San Diego, California

• 20 years in product development

• 48 Issued US Patents; 61 pending applications

– 3 Alcon (PBH< WJ< Ciba); Multifocal contact lenses– 3 AMO (VISX); Presbyopia laser surgery– 14 Paragon Vision Sciences; Paragon CRT® , Refractive Error Regulation,

NormalEyes® mini-scleral lenses– 11 Synergeyes®; Family of lenses and processes– 2 Preventive Ophthalmics, Inc; DxAMD™ Early detection AMD– 5 Innovega, Inc; iOptik® wearable display systems– 7 VICOH, LLC; VICOH® Family of contact lens designs– 1 Eye Care for Humanity; humanitarian spectacle eyewear– 1 Myolite, Inc. Refractive error regulation– 1 Pacific Dynamic, Inc. Modular LED lighting

Disclosure

• Founder, Shareholder: Innovega Inc.

• Consultant: Paragon Vision Sciences

March of Technology

Connectivity to Rich Media

๏ The internet of things

๏Machine to Machine to bypass human effort

๏ Information to People to enrich our lives

๏ How fast can we process?

๏ Improving the quality (and quantity) of life

๏Making the invisible visible

๏ Seeing and mentally processing faster than vision

Spectacle Wearable Devices

right neighborhood

11/18/2015

Sergey Brin

The Beginning or the End?

Google Glass

Right eye views screen13º horizontal x 7º vertical640 X 360 pixels

The Evolution of Visual Experience

Nature to Cave Art

Cartoons, Mixed Reality, 3D and iMax

Why did Facebook pay $2 Billion for Oculus Rift?

11/18/2015

the visual experience

The Experience Opportunity

Oculus Rift

Mark Zuckerberg

Characteristics Google Glass Oculus Rift

Reality augmented virtual

Size small large

Weight light heavy

Field of View tiny huge

Mobile yes no

Field of ViewGoogle Glass

13º H X 7º V FOV640 X 360

iOptik®53º H X 34º V FOV1280 X 720

Defining the value proposition in an experience economy

Connectivity:

Your Virtual or Augmented Reality Dashboard

Personalized Ultimate Reality

11/18/2015

The Wagons Are Circling

Epson

VUZIX - Intel

Lumus

Zeiss

VUZIX

Recon

SONY

Google

SONY

Microsoft

SONY

Facebook

Olympus

And the Investment Continues

What about contact lenses:

๏Sensing

๏Drug delivery

๏Myopia control – Refractive Error Regulation

๏Photonics and Molecular Biology

๏Presbyopia

๏Low Vision

๏Wearable displays

• Micro Electronic components– LED– Sensors– Controller/processors– Power sources– Antenna

• Micro-Electro-Mechanical-Systems (MEMS)• Precision passive optics

– Birefringence– Fiber optics– Reflective optics– Deflective optics– Nano-features; imprinted, inscribed, molded– Spectral filters

Antecedents

Sensing

๏ IOP – Sensimed - Triggerfish

๏ UC Davis – Silver Wire

Sensing

Google – Alcon

๏ Blood Sugar

๏ Blood Alcohol

๏ Inflammatory mediators

๏ Systemic disease molecular

Correlates

๏ Pulse

๏ Blood Oxygen level

11/18/2015

Camera Contact Lens

๏Google

๏ Iris recognition

๏General image capture

๏ Low vision

Drug Delivery

๏ Collagen Mesh – Ocugenics

๏ Imprinted and Surface Nanoparticle

๏Micro-fluidics

Refractive Error Regulation

Electromagnetic Radiation Refractive Therapy

๏Myolite

๏ Chromaticity

๏ Brightness

๏ Direction

๏ DurationUS Patent: 8,876,284

Princeton University: Michael McAlpine

3 D Printed Quantum Dot LED Contact Lens

Photonics and Molecular Biology

Seasonal Affective Disorder

๏ Vistakon

Multiple Patents Pending

Presbyopia

Accommodating Contact Lenses

๏ Vistakon

๏Energized Fluid Meniscus

Multiple Patents Pending

11/18/2015

Presbyopia

Electro-Optical

๏ eVision Smart Optics

๏ University of Manchester

Multiple Patents Pending

Telescopic Low Vision

Folded Reflective Optics with Shutter Polarizer

๏ UCSD

๏ EPFL

๏ Innovega

๏ Paragon Vision Sciences

Night Vision

๏Military and Low Vision

๏ University of Michigan

๏Photo-excited Graphene

Wearable Displays

Contact lens alone:

๏ University of Washington

Wearable Displays

Contact Lens Alone

๏ Semprius

๏ Thin film micro-solar cells

Wearable Displays

Contact Lens Enabled

๏ Innovega – iOptik®

$6.5 M FundingNSF SBIR; Phase I and II

DARPA SBIR; Phase I and II

DARPA Program; SCENICC

11/18/2015

Multiplexing OpticsCenter lenslet with outer polarizer filter to separate display and non-display paths

• Optical Modeling: Jim Schwiegerling, PhD; University of Arizona

49

120 Degree Transparent Augmented Realty

Stylish Comfortable EyewearEye-borne Optics Facilitate

๏ Field of view

๏ Style and Comfort

๏ Multiple eyewear configurationsiOptik® Soft Lens

๏ Gas permeable polarizer

๏ Central Micro-lens for display

๏ Non-Display polarized optical path

Stylish Comfortable Eyewear

Contact lens enabled “Immersible”

Virtual Reality Eyewear

Regular Geometric Optics

Where do we go from here?

Alice: “Would you tell me, please, which way I ought to go from here?"

“Cheshire Cat: That depends a good deal on where you want to get to.”

Alice in WonderlandLewis Carroll

Connectivity will happen

Contact Lens Practitioners: Get ready – It’s a MEGATREND

New reasons to wear contact lenses

New sources of ocular challenge and discomfort

11/18/2015

Roles for Eye Care Practitioners๏Managing psychophysiological optics considerations and adaptation

issues related to a new set of near eye display related problems.

๏ Prescribing and fitting of smart contact lenses and display eyewear; implementing the technology for low vision, vision therapy and sports performance enhancement.

๏ Diagnostic and therapeutic applications:

๏ Lab on lens

๏ Drug delivery and photonic therapies

THANK YOU

Ditzel or Doom?? Evaluation and Management of Periocular Skin Lesions Mirwat S. Sami, M.D.

Houston Oculofacial Plastic Surgery and Houston Eye Associates 4747 Bellaire Blvd, Suite 347

Bellaire TX 77401 Office: (713) 668-1264 Cell: (832) 643-1587 m.ssami@yahoo.com

Course Description: The talk is aimed at helping primary care eye doctors meet the challenge of examining and diagnosing commonly encountered eyelid and periocular lesions, including skin cancers. Several external photographs gathered by the lecturer will be used to present periocular lesions, their key features and differential diagnoses. Risk factors pertaining to periocular malignancies will be outlined. Appropriate and most cutting-edge therapeutic options will be discussed. Course Objectives:

To gain understanding about the different risk factors associated with periocular skin malignancies and preventative measures

To recognize the importance of thorough external eye exams To recognize the signs and symptoms of benign versus malignant lesions To gain understanding of the different types of eyelid lesions that can manifest in

different age groups To recognize the importance of timely referral and intervention for tumor removal

and eyelid reconstruction Learn the protocols for appropriate surveillance moving forward for patients with

eyelid lesions, based on current practice patterns To gain understanding of newest techniques and therapies available to patients in

treatment of benign and malignant lesions

Melanoma is on the Rise – Diagnosis and Prevention

Jan P. G. Bergmanson, OD, PhD, PhD hc, DSc, FCOptom, FAAO

Texas Eye Research and Technology Center

University of Houston College of Optometry

Skin cancers are the most common carcinomas in the US regardless whether you live in the sunbelt or

north of this region. More than 1 million new cases are diagnosed each year. Malignant melanoma is

the most lethal of the skin cancers killing over 9,000 Americans each year. The total annual cost for

treating the melanoma victims in the US is a staggering $3.3 billion.

This lecture informs on the findings from the recently released Centers for Disease Control and

Prevention (CDC) report on melanoma. CDC collected the data from death certificates and from US

Cancer Statistics over a period stretching from 1982 to 2011.

While the other 2 main skin cancers start in the epithelium, the melanomas originate from melanocytes

in the connective tissue just internal to the epidermis. The melanocytes mutate to become cancerous

and the known cause to this mutation is ultraviolet radiation (UVR), which on the surfaceof Earth is UVA

and UVB, since the more toxic UVC is blocked by the ozone.

From 1982 to 2011 the melanoma incidence rate doubled to a total of 65,647 cases. In the year of 2030

CDC is projecting 112,000 new cases to be diagnosed at an annual cost of $1.6 billion. However, if

proposed prevention programs are activated and maintained, 20% of the melanoma cases from 2020 to

2030 can be avoided and allow a saving of $250 per year, which over this decade could save up to $2.7

billions.

Recommended preventive measures include UVR blocking sunglasses, wide brimmed hats and

sunscreen with SPF of 15 or higher. The advice is to look for or provide shaded areas when outdors and

to avoid sunbathing and indoor tanning. Communities are encouraged to increase shaded areas at

playgrounds, public pools and other public places.

Health care practitioners should always apply the ABCD rule when examining their patients. This

acronym stands for A-assymetry; B-border; C-color; D-diameter and will be further elaborated in the

presentation.

The intent of this presentation is to inform about the increased incidence and cost of the deadly

malignant melanomas and to enhance our awareness of this lethal malignancy. Familiarity with the

proposed preventive measures will most useful practical knowledge. Presented diagnostic insights will

be helpful to the doctor permitting an early diagnosis, which carries with it a better prognosis.

1

OCULAR CONTOUR DRIVEN CONTACT LENS DESIGN

Jerome A. Legerton, OD, MS, MBA, FAAO

Disclosure• Founder, Shareholder: VICOH, LLC• Consultant: Paragon Vision Sciences

Moving from Art to Science• Contact lens fitting has historically been an art. Market

forces press for the need to convert it to a technology driven science:• Corneal GP fitting involved too many independent parameters of a

lens design that were in turn ordered in increments that were smaller than what was known to be clinically significant

• Most all corneal GP lenses were custom designed and ordered

• Clinical metrology was not available to individually measure corneal contour

• Soft lenses have been nearly uni-parameter and without the options for individual fitting of eyes• Base curve is used to control fit regardless of the large standard

deviation in limbal and scleral geometry

Problem: Flaw of Use of Base Curve Radius to control lens fit• Lens required to “drape” central cornea while requiring either circumferential stretching over sclera or causing scleral indentation

= Lens Deformation• Lens deformation causes loss of optical integrity

• Limits the ability to correct higher order aberrations• Limits simultaneous multifocal performance

• Scleral indentation causes variable lens comfort• One size fits all results in variable indentation or

compression from eye to eye• Has impact on end of the day comfort

Refining Soft Lens Comfort and Vision Ushers in a Need for ScienceClinical Requirements:

• Freedom from lens deformation and induced higher order aberrations

• Freedom from late in the day dimensional changes

• Freedom from changes in corneo-scleral morphology due to excessive edge strain

Need:• Knowledge of limbal and scleral contour

• Control of design respective to contour

How do we learn about scleral contour?

• Keratometry and topography limited• Keratometry measures a radius over a chord of about

2.8 mm• Topography measures surface elevation over a chord of

about 9.5mm

• Need: Instrumentation to measure ocular contour out to about 16 mm• Eaglet Eye: Eye Surface Profiler• Oculus: Pentacam• Visante OCT

• Modification of Cirrus™ OCT holds potential due to precision and market penetration

2

Roadmap to Understanding Contour and Design Requirements• Measurement is the first step to modulation• Discover eye shape• Simplify design variables• Create novel design features and utilize advanced manufacturing to :• Avoid lens deformation in soft lenses• Create the optimum lens-eye relationship for comfort and vision

• Create designs that are orientationally stable

Strategy for Lens Design

• Apply modern technology to measure ocular contour

• Method:• Fringe topography• Adequate sample of eyes• Analyze shape

circumferentially out to 15.5 mm

Eaglet-Eye: Eye Surface Profiler• 250,000 Data Points

Measurement and Analysis of Data

What did we learn about ocular contour?

0 0.06 0.12 0.18 0.24 0.3 0.36 0.42 0.48 0.54 0.6 0.66 0.72 0.78 0.84 0.9 0.96

0 0.002302 0.006083 0.010255 0.014707 0.021918 0.02698 0.032601 0.036583 0.043705 0.051786 0.060478 0.06819 0.075681 0.084563 0.092945 0.103816

0 0.001329 0.002908 0.004338 0.005507 0.007736 0.010835 0.014525 0.018684 0.023823 0.029262 0.034311 0.039131 0.04467 0.051099 0.058258 0.066287

0 0.001232 0.002564 0.004226 0.006098 0.00895 0.011612 0.014734 0.020186 0.026258 0.03126 0.037081 0.042443 0.046195 0.051727 0.060049 0.068641

0 0.001105 0.003301 0.004596 0.005292 0.007657 0.010202 0.011308 0.012343 0.013469 0.015734 0.019949 0.025655 0.03095 0.035495 0.039451 0.045246

0 0.002963 0.007667 0.01047 0.012323 0.012156 0.01398 0.014403 0.016006 0.01879 0.022703 0.026226 0.024539 0.030923 0.032526 0.039639 0.046813

0 0.000496 0.002262 0.004108 0.007234 0.01083 0.013237 0.015643 0.019469 0.023235 0.027091 0.031167 0.036673 0.044169 0.050975 0.056251 0.061528

0 -0.001451 0.000278 0.004427 0.007396 0.008625 0.009194 0.010723 0.014922 0.020522 0.025091 0.03163 0.040489 0.046878 0.050857 0.055586 0.063715

Precision measurement of ocular sag every 60 microns of chord over 15.5 mm

Contour Data for Mean Eye

Average Sag OS(mm)

-0.5

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

-8.5 -8 -7.5 -7 -6.5 -6 -5.5 -5 -4.5 -4 -3.5 -3 -2.5 -2 -1.5 -1 -0.5 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 5.5 6 6.5 7 7.5 8 8.5

Average Sag OD (mm)

-0.5

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

-8.5 -8 -7.5 -7 -6.5 -6 -5.5 -5 -4.5 -4 -3.5 -3 -2.5 -2 -1.5 -1 -0.5 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 5.5 6 6.5 7 7.5 8 8.5

3

Contour Data to Six Standard Deviations

The geometric diversity from the limbus out far exceeds the potential of one size fits all being best for every eye

The Enigma of Scleral Contour

A traditional peripheral concave curve toward the eye has the greatest likelihood of impingement.

A convex to the eye curve conforms the best.

Red = Mean eye profile

Green = Lens with concave scleral zone

Black = Lens with uncurved scleral zone

Blue = Lens with convex toward sclera

Convex Landing Zone Geometry

Red = Mean ScleraGreen = Standard concave to eye Black = Un-curved targeted to touch at 13.0 mmBlue = Convex to eye targeted to touch at 13.0 mm

Contour Based Soft Lens Design

Ideal geometry with prescribed corneal alignment, scleral alignment and extension beyond limbus

Independent Peripheral Sag Control

A single shape can be prescribed with selected “depths”

to produce the desired scleral alignment

Red = Mean eye profileOrange = Corneal radius continued through scleral zone

Three Moving Parts• Base Curve Radius:

• Suggested increments of 0.3 mm from 7.10 to 8.90• Overall Diameter

• Suggested increments of 0.4 mm• Peripheral Sag Control

• Single geometry modulated in 50 micron steps

4

APPLYING OCULAR CONTOUR TO SOFT LENS DESIGN

Soft Lens History and Outcome

• First lens manufacturing circa 1965 – 1970• Spin casting• Diamond turning on single axis lathes

Both resulted in lenses that were either monocurveor bi-curve as extensions of rigid corneal lens design• Discovery that base curve radius had to be much flatter than the keratometry values

Outcome: Use of base curve radius to control sagittal depth

Flaw of Use of Base Curve Radius

• Lens required to “drape” central cornea while requiring either circumferential stretching over sclera or causing scleral indentation

= Lens Deformation• Lens deformation causes loss of optical integrity

• Limits the ability to correct higher order aberrations• Limits simultaneous multifocal performance

• Scleral indentation causes variable lens comfort• One size fits all results in variable edge strain and

indentation or compression from eye to eye• Has impact on end of the day comfort

Optical Performance of Soft Lenses [September, 2013]

Soft Lens Deformation• Results. Longitudinal spherical aberration measurements on-

and off-eye, however, deviated significantly from that expected of a thin lens with spherical surfaces due to surface asphericities. The difference between on- and off-eye optics can be modeled as a tear lens or as relative lens thickness changes caused by lens flexure.

• Conclusions. The results of the current study reveal that the major difference between the on-eye lens optics and the manufacturers’ specifications is not due to lens errors but due

to eye-lens interactions, which could be either lens flexure or a tear lens forming behind the soft contact lens.

Optometry and Vision Science, Vol. 90, No. 9, September 2013

Corneoscleral Morphology after Soft Lens Wear [November. 2012]

5

Scleral Indentation from Soft Lenses

Results. The soft contact lenses had a statistically significant effect on the morphology of the anterior segment layers (p G 0.001). Conclusions. In this preliminary study, we have shown that soft contact lenses can produce small but significant changes in the morphology of the limbal/scleral region and that OCT technology is useful in assessing these changes.

Optometry and Vision Science, Vol. 89, No. 11, November 2012

Understanding Edge Strain [July, 2014]

Results for a typical SCL Design: (BC, 8.60; diameter, 14.2 mm;

Mean Eye = 2.7%. strainSmallest, flattest and most aspheric = -2.6% strain (loosest) Largest, steepest and least aspheric = 8.5% strain (tightest)

Change in BC of 0.4 mm = change in strain <2.5%, Change in diameter of 0.5 mm = change in strain < 2%

Variation of Edge Strain on Mean Eye with Change in Lens Diameter and Base Curve

Effect of Corneal Radius and Diameter on Edge Strain of a Single Lens

Product Opportunity

Apply same logic and design concepts to soft lenses as used in scleral lens

• Select base curve close to the central keratometry value to avoid draping and random deformation

• Select the overall diameter from the corneal diameter (HVID) to have equivalent extension from limbus on all eyes

• Control the sagittal depth at a key peripheral chord

Need 1: Avoid optic zone deformation

• Requires matching the base curve radius to the flat keratometry more closely

• Prevents the random spherical aberration and low order effective power differences of lenses of different power

6

Need 2: Create equal extension of lenses onto sclera• Requires measuring Horizontal Visible Iris Diameter and selecting overall diameter to provide near equal extension

• Lenses of three diameters are generally required:

If HVID: 11.2 or smaller = 14.0 mm

11.3 to 12.2 = 14.4 mm12.3 or larger = 14.8 mm

CONTROL OF EXTENSION BEYOND THE CORNEASelecting overall diameter as a function of corneal radius

Evaluating Overall diameter

Observe the extension of the lens beyond limbus with biomicroscope:• Lens diameter is the variable

related to corneal diameter• Goal is to have proportionate

extension regardless of corneal diameter

1.2 to 1.5 mm

Need 3: Shift Control of Sag to the Periphery of the Lens

Requires independent fitting zone in the periphery of the lens:Optimum: Single geometry controlled by an angleAngle determined by technology driven methods:

Visante OCT (Zeiss)

Fringe Topography: Eye Surface Profiler (Eaglet-Eye)Shiempflug (Pentacam)

Modification to CIRRUS™

OR Diagnostic Lens Observation

Zeiss Cirrus OCT

• Anterior Segment

New Anterior Segment Premier Module

Available for Models 5000 and 500

Anterior Segment Premier ModuleGlaucoma, Cornea, and Refractive Applications

• Comprehensive anterior segment imaging with new magnetic external lenses

• Quick switching to anterior segment scanning

• First-in-class full anterior chamber imaging from a retinal OCT

ChamberView™

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The first full anterior chamber view from a retinal OCT

Case courtesy of Dr. Shamika Gune

ChamberView™ (15.5 mm x 5.8 mm)

Moving from Manual to Automated

Calipering:

1. Key chord length

2. Depth at key chord

Eye Surface Profiler• Automated metrology:

1. Select Key Chord = 14.0 mm2. Sag value

Average Nsag & Tsag = 3.330

14.0 mm

14.0 mm

PERIPHERAL SAG CONTROL™

Holding the base curve radius and overall diameter constant while changing the SAG in the landing zone

Contour Data to Six Standard Deviations

Use “Peripheral Sag Control” to achieve optimum edge strain

for every eye

8.3 14.4 Peripheral Sag 3.750

SAG = 3.736 mm

8

8.3 14.4 Peripheral Sag 4.051

SAG = 4.051 mm

8.3 14.4 Peripheral Sag 4.421

SAG = 4.421 mm

Minimizing Soft Lens Deformation

• Fit the Base Curve Radius Close to the Flat Keratometry

• Select Diameter in relation to Corneal Diameter (HVID)

• Select Peripheral Sag Value at the Diameter• Empirically with Zeiss Visante OCT, Eaglet-Eye Eye Surface Profiler or CIRRUS OCT

• Or by observation with Diagnostic Lenses

Three Independent Zones • Base Curve Radius:

• 0.3 mm increments = 68 micron (average) per 0.3 mm change in BCR• Purpose of change is to more closely match the keratometry value and

NOT to control the total sag

• Overall Diameter• Tailored to corneal diameter• Sag increases to match eyes increase in sag over diameter• Purpose of the change is to have equal extension beyond the cornea

and NOT to control the total sag

• Peripheral Sag at Selected Lens Diameter• 50 to 150 micron increments• Usual change is 150 microns

Landing Zone Sag Control has greater influence on total sag than Base Curve Radius for a given Overall Diameter

Non Deforming Lens Outcomes

• Minimal deformation in the optic zone which allows control of Higher Order Aberrations

• Minimal corneo-scleral morphology changes due to closer match to scleral contour

• Precise control of edge strain allows uniform fitting of all eyes

• Tangent or Convex to the eye landing zone does not tighten with environmentally induced dimensional instabilityIt’s about Vision, Comfort and Health – Doing the

best job we can to care for our patients

Diameter too small

9

OCT allows for evaluation of peripheral lens to eye relationship

Evaluating Peripheral Sag Evaluating Peripheral Sag

Observe the lens to eye relationship with biomicroscope:• Lens movement on blink in

upward gaze• Displacement?• Excessive movement?

• Lens movement on push up• Conjunctival “tugging”?

• Excessive edge lift?

Conjunctival “Blanching” Indicates PSC is Too Great

• Base curve radius approximating mean corneal curvature

• 1.2 to 1.5 mm of lens extension beyond the limbus

• Good centration

• Lens movement on push up

• Freedom from conjunctival “tugging” on push up

• No visible edge lift or “fluting” in straight ahead gaze

• Good lens comfort

Final Parameter Success Criteria

Where do we go from here?Alice: “Would you tell me, please, which way I ought to go

from here?" “Cheshire Cat: That depends a good deal on where you

want to get to.”

Alice in WonderlandLewis Carroll

Elevation is the destination: Customization will happen

The geometric diversity of the human ocular contour is sufficiently broad to render “one size fits all” strategies limited to satisfy the full continuum of eyes and patients.• Customized lens design has the potential to:

• Increase comfortable wearing time each day• Improve visual acuity in all light levels and with all pupil sizes• Reduce mechanical induced inflammatory processes for poor lens–eye

relationships.

• Design and manufacture lenses based on population distribution data of ocular contour and customize lenses for all eyes within the distribution based on available clinical measurements

Treat each patient as a unique individual and each eye with regard to its unique contour and optical needs

Ocular Contour Based Lens Design

10

APPLYING OCULAR CONTOUR TO HYBRID LENS DESIGN

Ocular Contour Based• Base curve driven by flat keratometry value (Flat K)• Fit controlled by Peripheral Sag Control™

• Determined by instruments which measure individual eye scleral contour• OCT• Eaglet Eye ESP

• OR; Determined by diagnostic lens observations

A NOVEL COMPOSITE: Spherical Design

Refining Hybrid Lens Comfort and Vision Ushers in a Need for ScienceClinical Requirements:

• Freedom from junction elevation disparity

• Freedom from changes in corneo-scleral morphology

Need:• Elimination of junction and GP contact with cornea

• Uniform post lens tear film thickness

• Control of design respective of ocular contour

• Novel lens to eye relationship• Annulus of soft material under the central rigid portion• Rigid material never touches the eye• Rigid soft junction sealed by soft annulus

• Base curve is not used for fitting • Rigid material never touches the eye• Intended only to provide nice tear reservoir

• Peripheral sagittal depth used to control the fit• Series of sagittal depth values for each base curve• Provides uniform and predicable soft landing• Avoids corneo-scleral indentation – uniform edge strain

VICOH Novel and Patented Technology

Soft Corneal Contact

Comfort Cushion™ lens to

eye relationship• Annulus of soft

material under the central rigid portion

• Rigid material never touches the eye

• Rigid soft junction sealed by soft annulus

Contour Based Hybrid Lens Design

Ideal geometry with prescribed corneal clearance, scleral alignment and extension beyond limbus

11

• Greatest geometric diversity in the human eye is from the limbus out

• Control the fit in the periphery of the lens

• Base curve control is reduced in importance to control lens-eye relationship

• Provide an annulus of soft material behind the peripheral aspect of the rigid center

Peripheral Sag Control is optimum for controlling the fit of a soft, hybrid or scleral lens

Fundamental Conclusions7.8 14.8 4300

7.8 14.8 4600 7.8 14.8 4900

1. Select base curve radius from flat keratometry meridian value (K)

2. Select landing Peripheral Sagittal depth from diagnostic lens evaluation OR order mean value as starting lens and refine order for annual supply

Novel while simple

•The Peripheral Sag Control (PSC) is the sole feature which controls the fit

•PSC generates the sagittal depth of the lens needed because of the large variation in scleral contour outside the limbus

Understanding Peripheral Sag Control™ (PSC)

The lens periphery controls the fit for each eye

12

• Optical Coherence Tomography, Scheimpflug or Eaglet Eye ESP Imaging• Caliper sagittal depth at 9.5 mm chord• Caliper depth at 14.8 mm chord• Select Sag to nearest 100 microns

• Diagnostic Lens Method• Place lens with median PSC and observe movement

• Too much movement go to deeper peripheral sag

• Too little movement go to shallower peripheral sag

2. Peripheral Sag Determination Peripheral Sag Selection• The PSC is the parameter that can produce proper sag while having a base curve radius close to the

corneal radius

–Edge lift control with the PSC

• Less PSC is more lift and more PSC is less lift

• A greater PSC reduces edge lift

• A lesser PSC increases edge lift

1. Eliminate rigid-soft junction to cornea mechanical touch

2. Avoid lens flexure and induced HOA3. Maintain near alignment to central cornea4. Eliminate corneo-scleral morphology changes

from lenses• Avoid random incidence of deviation of the local slope of

the periphery of the lens with the local slope of the eye• May cause discomfort from conjunctival “tugging”

• May cause discomfort form excessive movement and edge lift• May induce inflammation from excessive strain forces on ocular

tissue

Control the lens-to-eye relationship in an individual way to optimize vision, comfort and health

Advantages of Annulus Composite Technology

FINAL FIT SUCCESS

• Base curve radius approximating mean corneal curvature

• 1.2 to 1.5 mm of lens extension beyond the limbus

• Good centration

• Lens movement on push up

• Freedom from conjunctival “tugging” on push up

• No visible edge lift or “fluting” in straight ahead gaze

• Good lens comfort

Final Parameter Success Criteria 7.6 4600

7,20 54 300

13

The geometric diversity of the human ocular contour is sufficiently broad to render “one size fits all” strategies limited to satisfy the full continuum of eyes and patients.• Customized lens design has the potential to:

• Increase comfortable wearing time each day• Improve visual acuity in all light levels and with all pupil sizes• Reduce mechanical induced inflammatory processes for poor lens–eye

relationships.

• Design and manufacture lenses based on population distribution data of ocular contour and customize lenses for all eyes within the distribution based on available clinical measurements

Treat each patient as a unique individual and each eye with regard to its unique contour and optical needs

Ocular Contour Based Lens Design

T H A N K Y O U

Corneal Reshaping is Not Permanent?

Norman E. Leach, OD, MS

I. What is the Mechanism of Corneal Reshaping? A. Corneal bending? B. Anterior Limiting Lamina (Bowman’s zone) changes? C. Stromal changes? D. Corneal epithelium changes? E. All of the above? II. Normal Human Cornea III. Corneal Thickness Studies A. Carkeet, et. al., (1995) B. Iskeleli, Oral, & Celikkol (1996) C. Swarbrick, et. al. (1998) D.. Lu Fan, et.al. (1999) E. Nichols, et.al. (2000) F. Mitsui, et. al. (2002) G. Edward Chow (2002) H. Leach, et. al. (2007) I. Berke, et. al. (2007) J. Fukuda, et. al. (2007) K. Jurkus, et. al. (2009) IV. How does it work? A. Epithelial compression/proliferation? B. Epithelial migration? C. Stromal changes?

1

2015 Texas Professional Responsibility Course“Eight Shades of Gray”

UNIVERSITY OF HOUSTON  COLLEGE OF OPTOMETRY

JOE  W.  DELOACH,  OD,  FAA0

COURSEMASTER

Welcome to the Professional Responsibilities Coursesponsored by the University of Houston College ofOptometry. As you know, this course is a requirement forTexas license holders. What you may not know is that allfees associated with this course are devoted to permanentprojects that are important for the future of the profession.

Thank you for choosing UHCO for your continuingeducation.

The development and production of the 2015 Professional Responsibility Course is underwritten by the 

Harris Lee Nussenblatt Lecture  Series Endowment.This endowment was established in 1992 by the 

Nussenblatt Family in memory of former Associate Professor Harris Nussenblatt, OD.

The Lecture Series focuses on issues related to professional ethics, public health and practice 

administration

2

The content of the Professional Responsibility Course is at the discretion of the Texas Optometry Board.  This year, the Board requested only a few issues be addressed.  The rest of the agenda will address the core concept of this course, professional ethics. 

UHCO and the Coursemaster thank the following leaders of our profession for their contribution and advice in developing this years program:  Ron Hopping, Jeff Jones, Clarke Newman, Stacie Virden, Peter Cass, Laurie Sorrenson, Kevin Katz, and Bj Avery.  Special thanks to Clarke Newman for his research and invaluable opinions and to Jeff Jones for supplying the title of the course.

Preface

AGENDA I – TEXAS OPTOMETRY BOARD

Drug prescribing information ◦New classification of Schedule II Drugs◦Reference for pain management drugs◦Rules 280.5 and 280.10 listing types of drugs that may be prescribed  

Professional designation 

Importance of reading newsletter

Issues with EHRs

New Rule 277.10 – Remedial Plans

AGENDA II – SITUATION ETHICS

What are the challenges in ethical behavior

Examples of challenges in ethical behavior

3

New Drug Prescribing InformationReclassification of Hydrocodone to Schedule II

Implementation DatesOctober 6, 2014 – the actual adoption dateApril 8, 2015 – the actual implementation date for the majority of the regulation changes

What this really means for Texas ODs

Optometrists in Texas cannot prescribe Schedule II narcotics and most all pharmacies are already using the adoption date as the implementation date.  You must find alternate sources of pain management for your patients.

New Drug Prescribing InformationMisc. Issues

• To find or look up the classification of any controlled substance – reference www.dea.gov/druginfo/ds.shtml or                www.deadiversion.usdoj.gov/schedules

• You can find a good deal of information on controlled substances, drug abuse and patient diversion tactics at http://www.pharmacy.texas.gov/sb144.asp

• To review the medications that you are allowed to prescribe under current Texas law, reference www.tob.state.tx.us, specifically Rules 280.5 and 280.10

Practice of License HolderProfessional Identification

The Statute:  Section 351.362

Rules:  Rule 279.10

Name(s) of the optometrists practicing at a location must be visible before entry into the reception area

Does not apply to doctors acting in a temporary capacity as defined in the rule as “no more than two consecutive months”

4

Practice of License HolderProfessional Identification

Legal identification per state law includes:

‐ Optometrist

‐ Doctor, Optometrist

‐ Doctor of Optometry

‐ O.D.

It is illegal to use any designation or advertising that could mislead the public into thinking you are any other health care practitioner other than an optometrist.  This is not the Optometry Board’s law – this is a State law the Optometry Board must uphold. www.statutes.legis.state.tx.us/Docs/OC/htm/OC.104.htm

Texas Optometry Board Newsletter

The Optometry Board releases a newsletter once a year to all licensees.  The newsletter identifies issues the Board feels are important to all practicing optometrists as well as explanations of all new Rules passed since the last newsletter.

You are legally obligated to stay abreast of and follow the law.  “Ignorance” is not an excuse.

The newsletter is the easiest way to keep up with any new laws or rules and you are encouraged to read it “cover to cover”.  If you are not receiving the newsletter, contact the Optometry Board.

Texas Optometry Board  512‐305‐8500

Electronic Medical Records

This is really easy folks.  You cannot put statements into a record that do not accurately reflect the services you provided on that date of service.

Since wellness or routine care examinations can often reveal very little to no change from visit to visit, it is imperative your documentation, that will often look very similar year to year, be representative of the care delivered during that date of service.

Additional documentation such as review of history statements and/or attestation statements are a good means of making it clear your patient’s records are completely accurate and truthful (remember, most all EHRs have an internal audit feature that tracks the time and date of every entry!)

5

Examination and Medical Records 

All optometrists are encouraged to review the examination requirements found under Rule 277.7 that apply to the initial evaluation of a patient where an ophthalmic prescription is generated.

(1) An accurate identification of the patient;

(2) The date of the examination;

(3) The name of the optometrist or therapeutic optometrist conducting the examination;

(4) Past and present medical history, including complaint presented at visit;

(5) A numerical value of the monocular uncorrected or monocular corrected visual acuity in a standard acceptable format;

(6) The results of a biomicroscopic examination of the lids, cornea, and sclera;

Examination and Medical Records

(7) The results of the internal examination of the media and fundus, including the optic nerve and macula, all recorded individually;

(8) The results of a retinoscopy. A tape from an automatic refractor is acceptable;

(9) The subjective findings of the examination. A tape from a computer assisted refractor/photometer is acceptable if the instrument is being used to obtain subjective findings;

(10) The results of an assessment of binocular function, including the test used and the numerical endpoint value;

(11) The amplitude or range of accommodation expressed in numerical endpoint value including the test used in the examination;

(12) A tonometry reading including the type of instrument used in the examination; and

(13) Angle of vision: the extent of the patient's field to the left and right. he initial evaluation of a patient where an ophthalmic prescription is generated

Documentation Notes

Be aware that the Board Rules require that the examining optometrist PERSONALLY make and record the examination elements listed in orange (biomicroscopy, internal evaluation, subjective refraction)

Optometrists should also be aware that, although not a requirement of the Texas Optometry Board, the rule that the attending physician personally “make” the patient’s HPI is commonly cited, while the rest of the history may be delegated to an assistant/technician as long as the it is clear the physician has reviewed the information

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NEW Rule 277.10 – Remedial Plans

This Rule gives the Board the authority to resolve typically more minor violations by mutual agreement to a remedial plan

If the licensee completes the requirements of the remedial plan, the violation is removed from the licensee’s record two years after completion of the remedial plan and is not reported to the national physician data bank

Remedial plans may be issued a maximum of once every two years

Remedial plans may be initiated by the Executive Director of Investigative Committee but must be approved by vote of the Board

Remedial plans may include a $1,000 administrative fee

And now…

Situation Ethics

Are Ethics a Real Issue?

We all face “ethical” decisions every day – it’s not limited to what most would consider as lying, immorality, religious beliefs or generally being a “good or bad person”

Ethical decisions can range from something terrible like deciding to rob a bank to something seemingly benign like not handing out bonuses to your staff because you really want to buy a new car

Our decisions are influenced by a host of internal and external influences

Not all decisions have a “right” answer – many are “shades of gray” (thanks Jeff!)

Much of the information in the next few slides can be found in the excellent reference www.ethicsunwrapped@uttexas.edu

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“Ethics Unwrapped” identifies 22 moral standards that define how 

we make decisions.  The next slides review eight standards considered 

most applicable to doctors.

Moral Standards

Role Morality

Actions or decisions are justified because of the unique role we play (as doctors) in or because we separate our personal beliefs from our work beliefs. 

EX: Selling patient ocular supplements when you wouldn’t take them yourself

Conflict of Interest

Actions or decisions are influenced by professional or economic interests

EX:  “Stretching” medical necessity (is that specular microscopy REALLY necessary even though it will add to the month’s bottom line)

Moral Standards

Ethical Fading

“What was I thinking?”  Decisions are based more on an emotional response than a rational response (“moral disengagement”)

EX: Insider trading with a pharmaceutical company

Incentive Gaming

Decisions or actions influenced by potential incentives, usually monetary.

EX: Incentive bonus systems – employed doctors and/or staff

(NOTE: Unwrapped authors define the new American Dream as “minimal effort for maximum gain”)

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Moral Standards

Incrementalism

No one wakes up one day and decides to lose their morality.  It is almost always a progressive lowering of the ethical bar, often based on prior success with lower standards.

EX: Stretching medical necessity progresses to billing fraud

Moral Equilibrium

Also called “moral licensing” – keeping score on our good behavior allows us to justify a certain degree of behavior we otherwise would not consider acceptable

EX: Indigent care efforts make it reasonable to overbill patients with insurance

Moral Standards

Moral Imagination

Success defined by many as winning.  In the movie “Margin Call”, Jeremy Irons says “there are only three ways to win – be first, be smarter or cheat.”  When winning rules our lives, our emotional barometer can lead our imagination to find ways to cheat and consider it part of doing business.

EX: Embezzlement

Moral Myopia

Possibly the most common and deadly – it is the “everyone is doing it” scenario.  Blurring the right behavior is often fueled by potential for financial gain.

EX:  The classic scenario of “run this test – you’ll get paid” forgetting the rule of medical necessity

Again, we must emphasize that not all seemingly straight forward “ethical” decisions are always so clear cut.  While some actions are obviously unethical (billing for services not rendered) others can be “shades of gray” (individual decisions regarding medical necessity of care).

With that in mind, let’s look at some “situations” and how they can often be difficult to address

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Situation Ethics – Case One

A fifteen year old patient, cheerleader at her school, presents with an obvious chlamydial conjunctivitis (Effects, at a 

minimum, 4% of all females 14‐19 y/o.  Gottlieb – Pediatrics 12/2009).  Are you obligated to inform the minor’s parents of this diagnosis and are you required to report this STD to the 

health department?

The Legal Ins and Outs

In Texas, a minor may consent to treatment of STDs by a physician without parental consent.  The attending physician has the authority to decide if the parents have rights to the medical records. (Texas Family Code Title2; Subtitle A; Chapter 32; Subchapter A; Sec. 32.003).  The question is does this apply to an optometrist?

In Texas, the attending health care provider is required to report the diagnosis of all STDs to the  Texas Department of State Health Services (www.dshs.state.tx.us). This DOES apply to an optometrist.                         

NOTE:  It is widely believed that STDs are significantly under reported!

The Ethical Dilemma

FACT:  Treatment and education are essential

Can you just call it an infection and let it go at that?

Can you say you’re not sure of a positive diagnosis and just treat as an infection of “unknown or non‐confirmed etiology”?

How do you discuss the situation with the minor in private?

Can you just refer the condition out to someone else?

Is it better to not report and break the law or report and potentially cause real problems for your patient?

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So Who Can Get Me?

The Texas Optometry Board

The Texas Department of State Health Services

The minor (the consent issue could be problematic and make it necessary to refer a minor wanting to consent to treatment to a physician as defined by Texas law)

Yourself – remember your Oath?

“I WILL advise my patients fully and honestly of all which may serve to restore, maintain or enhance their vision and 

general health.”

Situation Ethics – Case Two

One of your highly valued employees is pregnant.  She is conducting herself in a manner you feel is detrimental to her health and the baby’s health – smoking, gaining too much weight, drinking heavily on the weekends.  What would you do?

The Legal Ins and Outs

There is no legal requirement or authority on your part.  The controlling Texas case on this subject is Collins vs TX, (TX Court of Appeals, 1994).  Legally, there must be clear and convincing evidence of mental illness or intent to harm before a woman may be committed to care against her will (FYI – Collins was using cocaine during her pregnancy)

Firing the employee is very complicated.  Texas is an employment at will state but this means little when it come to protected classes like pregnant employees.  If the employee pushed for wrongful termination, the suit would be long, painful, expensive and with potential for significant penalty to the employer from an unpredictable jury.

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The Ethical Dilemma

Do you have rights as an employer to protect your practice and your employee by counseling the employee on her actions in general and how they may effect her work performance (smoking, drinking, obesity)?

More importantly, do you have a duty as an individual, friend, counselor or humanitarian to discuss the situation with the woman?

So Who Can Get Me?

Your employee ‐ Equal Employment Opportunity Commission and hungry legal counsel will be happy to assist with wrongful termination, gender discrimination, pregnancy discrimination (Pregnancy Discrimination Act of 2014)

Yourself – your duty of care obligations as a health care provider and humanitarian 

Situation Ethics – Case Three

A parent brings a child in for an examination.  The parent is obviously intoxicated and in no condition to drive.  What should you do?

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The Legal Ins and Outs

In Texas, this is a no‐brainer.  See Texas Child Endangerment – Drunk Driving Protection Act.  The Act provides a separate mechanism for charging and punishing a person who drives while impaired with a passenger under the age of 15. The statute’s penalties are more severe than Texas’ traditional DWI penalties. 

The Ethical Dilemma

Should you consider the significantly damaging effects conviction of the parent would bring?

Would providing transportation or a taxi home remove your obligations to report?

Should you consider the mental trauma the child will go through seeing their parent taken away in cuffs?

How can you be sure the parent meets the definition of legally intoxicated?

So Who Can Get Me?

The courts.  Failure to report  carries potential jail time of 30 days to 5 years and fines ranging from $300 to $10,000, or both.

The parent – if your assumptions are wrong!

Yourself – could you live with injury to a child that could have been avoided if you would have reported the potentially dangerous situation?

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Situation Ethics – Case Four

One of your employees is strongly suspected of stealing from one or more of your other employees.  You feel the only way to get to the bottom of this is make the suspect take a polygraph test.  What can/should you do?

The Legal Ins and Outs

The Employee Polygraph Protection Act of 1988 prohibits employers from “requiring, requesting, suggesting or causing” an employee to take a polygraph test – with exceptions.  One of the exceptions is investigation of a crime in your business.  There are requirements and regulations involved in these exceptions, a lot of them.

You cannot take any action against an employee for refusal to take a polygraph test

The Ethical Dilemma

How sure are you?  If you are that sure, would it be better to find other ways to terminate the employee?

Can you threaten to polygraph everyone in hope the perpetrator will confess or run? (remember – illegal to “suggest” the polygraph!)

Provide extra security for your employee’s personal items – like individual lockers   

http://www.lockers.com/products/extra‐wide‐standard‐metal‐locker‐double‐tier‐3‐wide‐6‐feet‐high‐15‐inches‐deep

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So Who Can Get Me?

The “suspect” – if you try to push illegal polygraph testing

The “suspect” – if you take actions related to their employment that you cannot prove

Your other employees – unlikely legal action but you have an obligation to protect them

Situation Ethics – Case Five

Your associate is making false claims to Medicare by up‐coding office visits and performing medically unnecessary tests.  What should/can you do?

The Legal Ins and Outs

The False Claims Act (FCA) allows for treble damages (damages being the fraudulent claim amount) PLUS $11,000.00 fine PER CLAIM 

Fraud is no longer just criminal activity – FCA states that providers “should know” what is medically necessary and should know all billing, coding and reimbursement laws and regulations.  Not knowing can now be considered synonymous with fraud.

The False Claims Act specifically states providers are obligated to self report erroneous billing practices, especially fraudulent activity – even if discovered during a self‐audit (new annual Federal requirement for MC/MD providers)

15

The Ethical Dilemma

“Self reporting” means you will, at a minimum, pay back the fraud or abuse claims.  If the violation is excessive, the addition per claim fine is possible if not likely.  This can also easily open the door for a full audit as well as reporting you to all other Federal agencies for potential investigation (all other payers, IRS, DEA, EEOC…you name it, it is “tattle time” in Washington)

These actions can obviously have significant financial impact on you, your practice and the livelihood of your employees.

So Who Can Get Me

EVERYONE – CMS to start with then the potential reverse funnel to all other payers, IRS, DEA, EEOC.  These actions by the Feds are unlikely if you fess up.  BUT THE POTENTIAL RAMIFICATIONS OF NON‐DISCLOSURE ARE SEVERE IF NOT FINANICALLY FATAL

Situation Ethics – Case Six

A patient comes in at 5:00 on Friday with symptoms of flashing lights for the last day.  You have plans for the evening, the symptoms do not sound very severe so you conduct a decent but not dilated retinal evaluation using your OptoMap but find nothing.  You tell the patient to return in a month.  Two weeks later you see them at the mall and they tell you they just had retinal detachment surgery.  What would you do?

16

The Legal Ins and Outs

Dilated retinal evaluations, especially with symptoms of potential retinal disease present, is a standard of care issue no matter what time of day (See AAO Preferred Practice Pattern “Posterior Vitreous Detachment, Retinal Breaks and Lattice Degeneration” and AOA Optometric Clinical Practice Guideline “Retinal Detachment and Related Peripheral Vitreoretinal Disease”)

OptoMaps are wonderful but are not a legal substitute for a dilated retinal evaluation (Texas Optometry Board Rule 279.3 (a)(1)(B)

The Ethical Dilemma

Whether the patient actually had a retinal break at the time you evaluated them or not, your care was sub‐standard.  The only issue remaining is patient management.  Suggestions include:

Do not deny or admit to anything

Show great concern and compassion

Isolate but do not alter the medical record in any way

So Who Can Get Me

The patient – this would be a clear case of negligent care.  No one could prove there was a retinal break when you examined the patient but they can easily prove you did not follow standard of care

Yourself – remember the Oath?

With full deliberation I freely and solemnly pledge that: I will practice the art and science of optometry faithfully and conscientiously, and to the fullest scope of my competence…

I WILL strive continuously to broaden my knowledge and skills so that my patients may benefit from all new and efficacious means to enhance the care of human vision

17

Situation Ethics – Case Seven

You diagnose a new patient as a significant glaucoma suspect and suggest additional testing.  Your patient refuses to proceed with anything their vision insurance doesn’t cover and will not give you any medical insurance information.  What would you do?

The Legal Ins and Outs

“Informed Consent” is the responsibility of the doctor.  “Informed refusal” is the right of the patient.  Doctors are very unlikely to be held responsible for the medical consequences of informed refusal if the standards for informed consent are met

Sec. 351.360. PROFESSIONAL STANDARD OF THERAPEUTIC OPTOMETRIST.A therapeutic optometrist, including an optometric glaucoma specialist, is subject to the same standard of professional care and judgment as a person practicing as an ophthalmologist under Subtitle B.

The Ethical Dilemma

There really isn’t one.  You have three choices:

Provide comprehensive, documented informed consent – this must include documentation of the risks and potential complications of non‐compliance.  Continue to follow up with the patient with your best medical recommendations. ATTEMPT TO PIN DOWN WHY YOU HAVE A CARE REFUSAL ISSUE AND SOLVE THAT PROBLEM

Give the patient the option of seeing another eye care provider

“Divorce” the patient – let’s talk about that concept

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So Who Can Get Me

With proper informed consent, no one.  Anyone can attempt to sue you for anything but proper documentation usually prevails.  This applies to this patient, the abusive contact lens patient, the patient who won’t take their medication and the like.

Situation Ethics – Case Eight

You are fairly certain you have the flu and are running a fever.  You also have a full schedule and are behind on your lab bills.  What would you do?

The Legal Ins and Outs

Texas Optometry Act 351.454(a) ‐ “An optometrist or therapeutic optometrist may not practice optometry or therapeutic optometry while knowingly suffering from a contagious or infectious disease, as defined by the Texas Department of Health, if the disease is one that could reasonably be transmitted in the normal performance of optometry or therapeutic optometry.”

OSHA/CDC regulations prohibit health care workers  with known contagious disease from treating patients if there is likelihood of disease transmission

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The Ethical Dilemma

The responsibility of the world on your shoulders – practice bills to pay, staff members rely on you for income, new house needs new furniture

Do you really have a contagious disease? 

Are you just convincing yourself it’s just s sinus infection? 

So Who Can Get Me

Honestly, more people than you think.  A patient or employee COULD file a complaint against you with CDC or OSHJA – both really bad things

And remember show and tell?

This is not to be fooled with.  If you have a contagious disease that could be communicated to another person through the normal 

activity of your business, stay home till you are well

Thank you for your attention and have a great 2015

jwdeloach@uh.eduwww.tob.state.tx.us