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
8:30 am – 9:00 am
9:00 am – 9:30 am
9:30 am – 10:00 am
10:00 am – 10:35 am
10:35 am – 11:00 am
Multifocal Silicon Hyrdogels – an Expanding
Range
Successful Multifocal Contact Lenses
Tear Exchange in Hybrid Lenses – how good is it?
BREAK/VISIT EXHIBITS
Controlling Myopia: Where do we stand?
Panel Discussion
Maria Walker, OD, MS
Jerry Legerton, OD, MS, MBA
Roxana Hemmati, OD
David Berntsen, OD, PhD
GEN
GEN
DT
DT
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
12:00 pm – 1:00 pm
Orthokeratology: Then and Now
LUNCH/VISIT EXHIBITS
Norman Leach, OD, MS
GEN
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
1:30 pm – 2:00 pm
2:00 pm – 2:30 pm
2:30 pm – 2:45 pm
2:45 pm – 3:15 pm
Contact Lens Comfort on the Range
Treating Allergy in Dry Eye Patients
Managing the Dry Eye of the Smoker
Panel Discussion
BREAK/VISIT EXHIBITS
William Miller, OD, MS, PhD
William Townsend, OD
Daniel Powell, OD, MS, PhD
DT
DT
DT
DT
Surgery Session - Moderated by Maria Walker, OD, MS
2 D/T HOURS
3:15 pm – 3:45 pm
3:45 pm – 4:15 pm
4:15 pm – 4:45 pm
4:45 pm – 5:00 pm
Odyssey of Corneal Cross Linking
Corneal Inlay Update: Future of Presbyopia
Treatment
CryoPreserved Amniotic Tissue: A New Hope
Panel Discussion
John Goosey, MD
DT
Jim Owen, OD, MBA, FAAO
DT
Seema Nanda, MT, OD
DT
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
8:30 am – 9:00 am
9:00 am – 9:30 am
9:30 am – 9:45 am
9:45-10:15 am
Scleral Lens Tear Exchange
Midday Foggy Vision – What Blurs Vision?
Does the Scleral Lens Induce Expansion – Corneal
Swelling?
Panel Discussion
BREAK/VISIT EXHIBITS
William Miller, OD, MS, PhD
Maria Walker, OD, MS
DT
DT
Jan Bergmanson, OD, PhD
DT
DT
Dry Eye Session - Moderated by William Townsend, OD
2 D/T HOURS
10:15 am – 10:45 am
10:45 am – 11:15 am
11:15 am – 11:45 am
11:45 am – 12:00 pm
12:00 pm – 1:00 pm
Severe Dry Eye Diagnosis
New Dry Eye Instrumentation on the Ranch
Expanding Your Diagnostic Range Through Tear Sampling
Panel Discussion
LUNCH/VISIT EXHIBITS
Amber Gaume, OD
Daniel Powell, OD, MS, PhD
William Townsend, OD
DT
DT
DT
DT
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
1:30 pm – 2:00 pm
2:00 pm – 2:20 pm
2:20 pm – 2:35 pm
2:35 pm – 3:05 pm
Smart Contact Lenses: The Future is Now
Ditzel or Doom?? Evaluation and Management of
Periocular Skin Lesions
Melanoma is on the Rise – Diagnosis and Prevention
Panel Discussion Featuring Thomas Baugh, OD
BREAK/VISIT EXHIBITS
Jerry Legerton, OD, MS, MBA
Mirwat Sami, MD
Jan Bergmanson, OD, PhD
GEN
DT
DT
GEN
Shape Session - Moderated by Norman Leach, OD, MS
1 GENERAL HOUR
3:05 pm – 3:25 pm
3:25 pm – 3:45 pm
3:45 pm – 4:00 pm
Ocular Contour Driven Contact Lens Design
Corneal Reshaping is Not Permanent?
Panel Discussion
Jerry Legerton, OD, MS, MBA
Norman Leach, OD, MS
GEN
GEN
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
Successful Multifocal Contact Lenses
Jerome A. Legerton, OD, MS, MBA, FAAO
My 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
•
What will it take to beat monovision?
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
Ingredients for Success with Simultaneous Vision
• Correct all low order aberrations
• Uncorrected cylinder
(Sphere and cylinder)
• Failure to center over the visual axis
• Center the optics over the visual axis
• Lens to lens variance due to wide
• Size the near segment based on pupil size and
manufacturing tolerances
• On eye lens distortion
• Need for pupil size dependent design
• Manufacture optics equivalent to GP lenses
pupil reactivity
• Maintain good surface wetting
1
We Will Damage PSF with a Simultaneous Vision Lens
Key Ingredients in a Successful Soft Multifocal
• Non-deforming lens design
• Segment Size
• Pupil size and reactivity determines segment size
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
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.
• 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
Pupil Size and Reactivity
Chateau, 1996
N = 112 (224 eyes)
• 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
Where do Hydrogel Lenses Center Relative to
the Visual Axis?
These data report the means but not the individual
variance in reactivity
Measuring Lens Decentration
• Most ride down and out
• The visual axis is nasal
• Most all multifocals are
visual axis sensitive
Courtesy: Dianne Anderson OD, FAAO
Topography over best fit multifocal will demonstrate
displacement of near segment optics from center of pupil
2
Lens Geometric Center Relative to Illumination and
Focal Demand
Pupil Shift with Focal Demand
Chateau
1996
N = 224 eyes
Displaced center add optics induce COMA. Clinically
significant at 0.4 mm from visual axis
Mean Pupil Size Decreases with Age
Pupil shifts superior nasal with near demand and
decreased illumination
The Era of Visual Axis Registration
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
What does this say for one size fits all?
Measuring Pupil Size, Reactivity and Location
OD
Photopic 2.6
Mesopic 4.3
Scotopic 5.3
Photopic (x,y)
0.542, -0.213
Scotopic (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
3
But What Do I Do Now?
• 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
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
• Have three to five designs to evaluate on
every patient
Revisiting the Clinical Goals for Multifocal Success
• Correct all low order aberrations
(Sphere and cylinder)
• Center the optics over the visual axis
THANK YOU
• Size the near segment based on pupil size and pupil
reactivity
• Manufacture optics equivalent to GP lenses
• Maintain good surface wetting
4
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.
B.
C.
D.
Empirical (K-readings and Rx)
Inventory dispensing/fitting set
Topography based lens designs
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
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
Page 1 of 1
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 34 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.
`
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Future of Presbyopia Treatment
Jim Owen, OD, MBA, FAAO
`
AMO
Alcon
Allergan
Science Based Health
Tear Lab
Tear Film Innovations
.
KAMRA
Flexivue
Raindrop
KAMRA (3.8 mm) • Flexivue
ICOLENS (3
Flexivue (3
Raindrop (2 mm)
• By Presbia (Amsterdam,
mm)
mm) Netherlands)
• 3.0 mm Diameter / 1.8 mm Central Zone
• 0.15 mm Central Hole
• 15 – 20 microns thick
• Center Ø Power
50 to
t +3.00)
+3.0
+3.
• Peripheral ring of + ADD (+1.50
• Hydrogel
KAMRA (3.8 mm) • Raindrop (Formerly Presbylens and Vue+)
InVue (3 mm)
Flexivue (3
Raindrop (2mm)
• By Revision Optics mm)
(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) • KAMRA Inlay
ICOLENS (3
Flexivue (3
Raindrop (2 mm)
mm)
•mm)
By AcuFocus (Irvine,
CA)
• 3.8 mm Diameter / 1.6 mm Aperture
• Made of Polyvinylidene Fluoride (PVDF)
• Small Aperture – Increased Depth of Focus
Thickness*: 15 µm
• Best achieved with specially
designed pocket software
• Allows accurate placement of
pocket location
• Dimensions can be customized
for specific patient anatomy
Diameter: 3.2 mm
Design Features
Method of action
Peripheral zone
with refractive
power: +1.5 D to
+3.5 D
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
Central zone
without refractive
power
*Thickness varies based on power
* Thickness increases with increasing refractive power
Wavelight
iFS 150 Khz
Recent release-first
cases Sept 2015
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
Flexivue Microlens Inlay – Distance
Vision
Distance vision: the rays pass through the central
zone of the implant (blue line) and through the free
peripheral corneal tissue (interrupted blue line).
`
`
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
Flexivue Microlens Inlay - Near Vision
For near vision the rays passing through the
refractive peripheral zone (red lines) will be focused
on the retina
• 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
Likely FDA approved early 2017
16
* 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
Inlay matches corneal
curvature
3.8 mm
8,400
micro-perforations
Weight = 100
mcg
(5-11µ)
1.6 mm
Pseudo-random
pattern
Maximize
nutrient flow
Thickness = 5 μm
Minimize visual
symptoms
Material = Polyvinylidene
Fluoride PVDF (IOL haptics)
• 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”
`
+OCIGUQHKORNCPVGFEQTPGCQDVCKPGFXKC
EQPHQECNOKETQUEQR[
'PFQVJGNKCN%GNNU
-GTCVQE[VGU
1%6
%QTPGCN0GTXGU
•%QTPGCKUSWKGVRQUVQR
2013-14
MAJOR LEARNINGS:
2011-12
2015
• US Approved
Moved to pocket• Polyvinylidene Flouride (PVDF)
& carbon is the right •material
2009-10
based procedures
• Launched
• Thin profile reduces changes to anterior• Submitted
corneal
surface
all PMA
AcuTarget HD™
modules to FDA
• Microperforations
must
vary
in
size
and
be
distributed
in a pseudo-random
•
Completed
FDA panel
2007-08
• Expanded regulatory
meeting
• Initiated 2 IDE study; approvals &
pattern to maximize nutritional
flow and minimize diffraction
completed enrollment commercialization
activities
• Began targeted OUS
• Must2005-06
be implanted
a femtosecond-laser
created pocket
6 • Solvedinto
KAMRA™ inlay
key inlay
commercialization
• Inlay must be implanted
at least
200 microns deep
design challenges
• Launched
AcuTarget™ to < 6x6 micron spot/line (or
• Laser settings
need to be adjusted
• Filed and initiated
2003-04
equivalent)1 IDE
• CE Mark granted
• Steroid
and dry eye therapy are critical for modulating the healing
• Developed nextgeneration inlay
2001-02
2
20
00
0
0 response
nd
st
• Clinical evaluation
on new mater
material
ial
• Produced prototype out
of Dacron fabric
• Implanted 1st inlay in
2002
• Proved concept
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.
`
Epithelium
200μm
LASIK Flap
Endothelium
Dry Eye, Fluctuating
Vision, Slow Visual
Recovery,
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
2
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
KEY LEARNING:
Dominant eye: plano
+0.50 20/20 wont be happy
Non Dominant eye: -0.75
< 0.50D cyl
68.5% of patients enrolled in the
clinical trial hand a pre-op MRSE
between 0.00D to 0.50D
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
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
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`
Have found the Acutarget very helpful in determining
candidacy for RLE vs KAMRA
Every patient in 50+ has lens changes-significant?
`
`
`
`
Pred Forte qh x 48 hours
`P
then qid remainder of
week
` Then FML or Lotemax
QID x 3 W
TID x 1 MO
¾
BID x 1 MO
¾
¾
o Make decision at this point
whether to d/c steroids
`
Ocular Surface
Management
◦ Preservative free artificial
tears
x Hourly for the first week, then
x 6 x/day for a month,
x then PRN
◦ Temporary or permanent
punctal plugs in
EVERYONE
◦ Omega-3 fatty acids
◦ Topical cyclosporine
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
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
15-20 microns*
Inlay thickness
5 microns
30 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
*Statistically significant change
**Binocular data only
KAMRA Inlay
Patient Candidates
Raindrop**
Emmetropes, Ametropes, Post-LASIK, Emmetropes, early data on Ametropes and
Pseudophakes
Pseudophakes
Flexivue Microlens
STRENGTH
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*
K
A
M
R
A
R
V
O
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
WEAKNESS
•
•
•
•
•
•
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
•
•
•
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
•
•
•
•
37
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
Cryo-Preserved Amniotic
Tissue: A New Hope
Seema Nanda, OD
UHCO / Texas Eye Institute
CCLS 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…
1
11/16/2015
Inflammation’s Effect on Healing
Pain (dolor), redness (rubor), swelling (tumor), heat (calor):
leukotrienes, prostaglandins are released
Decreased vision
Surface irregularities: SPK, filaments, EBMD, Salzmann’s nodules, tear film abnormality
Corneal edema (endothelial cell inflammation)
Inflammatory infiltrates, WBC recruitment
Poor regeneration, healing
Limbal 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
Controlling Inflammation is Key to Preventing Tissue Damage!
Scarring:
More than vision loss…
An
Uncertain
Future
Limited
Quality of
Life
Fear,
Isolation,
&
Frustration
…profound
emotional
impact.
Loss of
Independence
2
11/16/2015
Different Outcomes of Tissue Injury
Passive Pathway
Uncontrolled Inflammation
More Tissue Damage
Deficient Healing
Tissue Injury
Active Pathway
Controlled Inflammation
Promote Healing
Exact Replacement
Ulceration
Scar Formation
Vision Loss
Regeneration
Corneal Conundrum: A New Hope
• Anterior
Basement
Membrane
Dystrophy
• Neurotrophic
Ulcer
• Dry Eyes
Anterior/ Epithelial Basement
Membrane Dystrophy: ABMD / EBMD
3
11/16/2015
Anterior Basement Membrane
Dystrophy: ABMD
• Most common corneal dystrophy, affecting ~2% of the population. More common in the elderly.
• ~10% experience RCE as a
consequence 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.
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: Superficial Keratectomy
• 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.” 4
11/16/2015
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 Aminotic
membrane: Prokera
• Followed for 3 wks OS,
then 2 wks OD following
Superficial Keratectomy
• Can be performed on
other epithelial defects,
post-debridement
• VA:
OD: 20/40
OS: 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.
ABMD: Superficial Keratectomy
• 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
5
11/16/2015
Emerging Therapeutic Options: Amniotic Membrane
Active amniotic membrane is a biologic
therapy that can:
• Promote regenerative
healing
• Reduce inflammation
• Minimize scar formation
• Minimize pain
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 healing
and re‐epithelialization
Biologically Active Tissue
•
•
Creates a Fetal Environment to Achieve Corneal Healing
Amniotic membrane shares the same cell origin as the fetus
Regenerates the cornea, rather than repairs
6
11/16/2015
Why Cryopreservation Matters…
 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 ONLY
Amniotic Membrane granted wound
healing indication by the FDA.
Han Solo
Study: Characterization of
Commercial Cryopreserved
vs.
Dried Amniotic Membrane
(ARVO 2012)
Neel Desai1,2
M. T. Cooke3,
C. J. Mandrycky3,
J. O’Connell4 & Todd C. McDevitt3,4, 5, 6
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.
Comparison of Dry vs. Cryopreserved
M
Healon® CryoTek™ Dry
Findings:
• NO High Molecular
Weight Hyaluronic
Acid found in Dry
Membrane
High MW HA
• Cryo-Tek noted an
abundance of HMW
Hyaluronic Acid
• Important for
regenerative
properties.
Low MW HA
Desai et al, ARVO, 2012
7
11/16/2015
Study Results: Absence of PTX3
in Dry Membrane
CryoTek™ Dry
PTX3 is the activator for
Heavy Chain (HC)Hyaluronic Acid (HA)
complex.4
PTX3 is abundantly present
in cryopreserved AM
PTX3 was poorly detected
in dried AM.
This result suggests that
dehydration processing
damages the integrity of
HC-HA complex.
Desai et al, ARVO, 2012
Formation of HC-HA Complex in
Amniotic Membrane
Formation of HC•HA
Formation of HC•HA Complex with PTX3
HC
II
bikunin
TSG‐6
HC•HA
He et al, J Biol Chem, 284:20136‐46, 2009
Zhang et al, J Biol Chem, 287:12433‐44, 2012
Adult: PTX3 Complex activates complement pathway by phagocytes, DCs, fibroblasts , etc.
PTX3 Complex: strongly inhibits inflammation and angiogenesis and promotes regeneration. Dehydrated Membrane Disk
8
11/16/2015
9
11/16/2015
Study Conclusion
• 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.
Neurotrophic
Ulcer
Prokera Slim Seema Nanda, OD
Clinical Professor
University of Houston
College of Optometry
Texas Eye Institute
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
10
11/16/2015
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, sulfacetamide
30%
• 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
11
11/16/2015
HZO Keratitis: Cause of
Neurotrophic Ulcer
2
1
4
3
**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
12
11/16/2015
Recurrent Corneal Erosion
• 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.
• 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
2
4
3
13
11/16/2015
Neurotrophic Ulcer Pt. 2
Last follow‐up visit: Day 20 scVA: 20/40
Dry Eyes:
Superficial
Punctate Keratitis
Prokera Slim Seema Nanda, OD
Clinical Professor
University of Houston
College of Optometry
Texas Eye Institute
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
14
11/16/2015
Dry Eyes: SPK
Day 1
Day 14
Results & Reimbursement
The epithelial defect has improved/resolved
Decreased stromal inflammation
If 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 codes
PROKERA® CPT code 65778
Placement of amniotic membrane
on the ocular surface for
wound healing; self-retaining
Add -58 Modifier for 1-day post-PKP
Prokera is used to facilitate healing in
which the ocular surface cells have been
damaged, or the underlying stroma is
inflamed or scarred.
ICD-10
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
15
11/16/2015
Summary: A New Hope
 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
16
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
•Advisory
Board Member for Alcon
•Advisory
Board Member for Allergan
•Alcon
Speaker’s Bureau
•Receive
authorship honoraria from:
•Optometric Management
•Contact Lens Spectrum
Amber Gaume Giannoni, OD, FAAO, Diplomate (ABO)
Director, Dry Eye Center, UHCO
I do not have any financial or proprietary interests
relative to this presentation
Email: agaume@central.uh.edu
International Dry Eye Workshop 2007:
Aqueous-Deficient:
o
“A multi-factorial disease of the tears and
ocular surface that results in symptoms
of discomfort, visual disturbance and
tear film instability with potential damage
to the ocular surface. It is accompanied
by increased osmolarity of the tear
film and inflammation of the ocular surface.”*
Evaporative:
o
o
Hallmark: Severity of patient symptoms rarely correlate with
observed clinical signs.
ASSOCIATIONS WITH DRY EYE DISEASE (NOT ALL-INCLUSIVE)
• 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
Aqueous production is
insufficient to keep the eyes
moist.
Tears thin at a faster than
normal.
Due to a tear lipid deficiency
and/or poor quality meibum
secretions from dysfunctional
meibomian glands (i.e. MGD).
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
1
11/17/2015
Sjogren’s Syndrome
Multi-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
Average time
to reach a
diagnosis is
5 years!
• My youngest SS
patient is 9 (male)
2
11/17/2015
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
of anxiety and depression.**
risk
• 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
ww http://www.sjogrens.org/
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)
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)
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 Blood Markers for Sjogren syndrome?
 Includes traditional biomarkers
 3 new proprietary markers
 Claim to increase early
detection and cumulative
specificity to 92.1%
• Sjogren’s International Collaborative Clinical Alliance (SICCA)
3
11/17/2015
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:
Current Screening
New SS Panel
• Combined sensitivity is 87%
and specificity is 82.5%
 SP-1 – Salivary Protein 1:
• High expression in lacrimal and submandibular glands
• Combined serology sensitivity
& specificity is 40-60%
 CA6 – Carbonic Anhydrase 6:
• High expression in acinar cells of the submandibular and
parotid glands
• 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
 PSP – Parotid Secretory Protein:
• Expressed in the acinar cells of the salivary glands
• Cumulative specificity for CA6,
SP-1, and PSP is 92.2%
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
4
11/17/2015
Excellent Samples
Unacceptable Samples
5
11/17/2015
•
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

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 –
with sample).
Patient Cost:
• Medicare: no out-of-pocket expenses for lab tests
• Most are billed a co-pay between $0 -$100
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
• If billed full fee: $580
• ~1% of the time
6
11/17/2015
5. Environmental Education
2. Filament removal/bandage lens
• Topical acetycysteine?
3. Punctal occlusion:
• Collagen vs. silicone vs. cautery
4. Autologous Serum
6. Moisture chamber goggles (day/night)
• NO SMOKING
• NO ALCOHOL
• DRINK WATER
• Humidifier
• No ceiling fan
• Avoid forced heat/cooling vents
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
7
11/17/2015
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
Which of these conditions are Sjogren’s
patients at more risk to develop?
A. Leukemia
B. Lymphoma
C. Diabetes
D. Hypertension
•
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)
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
16 fold greater risk than normal population
Solans-Laque R, et. all. 2011; Loinnidis et al, 2002
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1798190/
Final Thoughts…..
 Sjogren
 Early
syndrome is not all that rare
detection is important
YOU can diagnose this disease
YOU can make a substantial difference
8
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 1 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
Page 2 of 2
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 widensa. 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 (MMP9)
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
The Beginning or the End?
Right eye views screen
13º horizontal x 7º vertical
640 X 360 pixels
Sergey Brin
Google Glass
Nature to Cave Art
The Evolution of Visual Experience
Cartoons, Mixed Reality, 3D
and iMax
Why did Facebook pay $2 Billion
for Oculus Rift?
11/18/2015
The Experience Opportunity
the visual experience
Oculus Rift
Mark Zuckerberg
Field of View
Google Glass
13º H X 7º V FOV
640 X 360
Characteristics
Reality
Google Glass
Oculus Rift
augmented
virtual
Size
small
large
Weight
light
heavy
Field of View
tiny
huge
Mobile
yes
no
iOptik®
53º H X 34º V FOV
1280 X 720
Connectivity:
Defining the value proposition in an
experience economy
Your Virtual or Augmented
Reality Dashboard
Personalized Ultimate Reality
11/18/2015
The Wagons Are Circling
And the Investment Continues
VUZIX
VUZIX - Intel
Google
Lumus
Facebook
Recon
Zeiss
Microsoft
SONY
Epson
Olympus
SONY
SONY
What about contact lenses:
๏ Sensing
๏ Drug delivery
๏ Myopia control – Refractive Error Regulation
๏ Photonics and Molecular Biology
๏ Presbyopia
๏ Low Vision
๏ Wearable displays
Antecedents
• 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
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
Drug Delivery
๏ Collagen Mesh – Ocugenics
๏ Imprinted and Surface Nanoparticle
๏ Micro-fluidics
๏ Google
๏ Iris recognition
๏ General image capture
๏ Low vision
Refractive Error Regulation
Princeton University: Michael McAlpine
Electromagnetic Radiation Refractive Therapy
๏ Myolite
๏ Chromaticity
๏ Brightness
๏ Direction
๏ Duration
US Patent: 8,876,284
3 D Printed Quantum Dot LED Contact Lens
Photonics and Molecular Biology
Seasonal Affective Disorder
๏ Vistakon
Presbyopia
Accommodating Contact Lenses
๏ Vistakon
๏Energized Fluid Meniscus
Multiple Patents Pending
Multiple Patents Pending
11/18/2015
Presbyopia
Telescopic Low Vision
Folded Reflective Optics with
Shutter Polarizer
Electro-Optical
๏ eVision Smart Optics
๏ University of Manchester
๏ UCSD
๏ EPFL
๏ Innovega
๏ Paragon Vision Sciences
Multiple Patents Pending
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
Wearable Displays
Contact Lens Enabled
๏ Innovega – iOptik®
$6.5 M Funding
NSF SBIR; Phase I and II
DARPA SBIR; Phase I and II
DARPA Program; SCENICC
๏ Thin film micro-solar cells
11/18/2015
Multiplexing Optics
120 Degree Transparent Augmented Realty
Center lenslet with outer polarizer filter to separate display and
non-display paths
• Optical Modeling: Jim Schwiegerling, PhD; University of Arizona
49
Stylish Comfortable Eyewear
Contact lens enabled “Immersible”
Virtual Reality Eyewear
Eye-borne Optics Facilitate
๏ Field of view
๏ Style and Comfort
๏ Multiple eyewear configurations
Stylish Comfortable Eyewear
iOptik® Soft Lens
๏ Gas permeable polarizer
๏ Central Micro-lens for display
๏ Non-Display polarized optical path
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 Wonderland
Lewis 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.
Disclosure
OCULAR CONTOUR DRIVEN
CONTACT LENS DESIGN
• Founder, Shareholder: VICOH, LLC
• Consultant: Paragon Vision Sciences
Jerome A. Legerton, OD, MS, MBA, FAAO
Moving from Art to Science
Problem: Flaw of Use of Base Curve
Radius to control lens fit
• Contact lens fitting has historically been an art. Market
• Lens required to “drape” central cornea while
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
Refining Soft Lens Comfort and Vision
Ushers in a Need for Science
Clinical 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
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
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
Need:
• Knowledge of limbal and scleral contour
• Control of design respective to contour
• Eaglet Eye: Eye Surface Profiler
• Oculus: Pentacam
• Visante OCT
• Modification of Cirrus™ OCT holds potential due to precision and
market penetration
1
Roadmap to Understanding Contour and
Design Requirements
Strategy for Lens Design
• Measurement is the first step to modulation
• Apply modern
• Discover eye shape
technology to measure
ocular contour
• Method:
• 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
• Fringe topography
• Adequate sample of eyes
• Analyze shape
circumferentially out to
15.5 mm
Eaglet-Eye: Eye Surface Profiler
Measurement and Analysis of Data
• 250,000 Data Points
What did we learn about ocular contour?
Contour Data for Mean Eye
Average Sag OD (mm)
4.5
4
3.5
3
2.5
2
1.5
1
0.5
-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
-0.5
0
-0.5
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 OS(mm)
4.5
Precision measurement of ocular sag every 60 microns of chord over 15.5 mm
4
3.5
0
0
0
0
0
0
0
0
0.06
0.002302
0.001329
0.001232
0.001105
0.002963
0.000496
-0.001451
0.12
0.006083
0.002908
0.002564
0.003301
0.007667
0.002262
0.000278
0.18
0.010255
0.004338
0.004226
0.004596
0.01047
0.004108
0.004427
0.24
0.014707
0.005507
0.006098
0.005292
0.012323
0.007234
0.007396
0.3
0.021918
0.007736
0.00895
0.007657
0.012156
0.01083
0.008625
0.36
0.02698
0.010835
0.011612
0.010202
0.01398
0.013237
0.009194
0.42
0.032601
0.014525
0.014734
0.011308
0.014403
0.015643
0.010723
0.48
0.036583
0.018684
0.020186
0.012343
0.016006
0.019469
0.014922
0.54
0.043705
0.023823
0.026258
0.013469
0.01879
0.023235
0.020522
0.6
0.051786
0.029262
0.03126
0.015734
0.022703
0.027091
0.025091
0.66
0.060478
0.034311
0.037081
0.019949
0.026226
0.031167
0.03163
0.72
0.06819
0.039131
0.042443
0.025655
0.024539
0.036673
0.040489
0.78
0.075681
0.04467
0.046195
0.03095
0.030923
0.044169
0.046878
0.84
0.084563
0.051099
0.051727
0.035495
0.032526
0.050975
0.050857
0.9
0.092945
0.058258
0.060049
0.039451
0.039639
0.056251
0.055586
0.96
0.103816
0.066287
0.068641
0.045246
0.046813
0.061528
0.063715
3
2.5
2
1.5
1
0.5
-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
-0.5 0
-0.5
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
2
Contour Data to Six Standard Deviations
The Enigma of Scleral Contour
Red = Mean eye profile
Green = Lens with concave
scleral zone
Black = Lens with uncurved
scleral zone
Blue = Lens with convex
toward sclera
The geometric diversity from the limbus out far exceeds the
potential of one size fits all being best for every eye
A traditional peripheral concave curve toward the eye has the greatest
likelihood of impingement.
A convex to the eye curve conforms the best.
Convex Landing Zone Geometry
Red
Green
Black
Blue
= Mean Sclera
= Standard concave to eye
= Un-curved targeted to touch at 13.0 mm
= Convex to eye targeted to touch at 13.0 mm
Independent Peripheral Sag Control
Contour Based Soft Lens Design
Ideal geometry with prescribed corneal alignment,
scleral alignment and extension beyond limbus
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
Red
= Mean eye profile
Orange = Corneal radius
continued through scleral zone
A single shape can be prescribed with selected “depths”
to produce the desired scleral alignment
3
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 monocurve
or 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
Optical Performance of Soft Lenses
[September, 2013]
• 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
Soft Lens Deformation
Corneoscleral Morphology after Soft Lens
Wear [November. 2012]
• 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
4
Scleral Indentation from Soft Lenses
Understanding Edge Strain [July, 2014]
Results for a typical SCL Design: (BC, 8.60; diameter, 14.2 mm;
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
Mean Eye = 2.7%. strain
Smallest, 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
Need 1: Avoid optic zone deformation
Apply same logic and design concepts to
soft lenses as used in scleral lens
• Requires matching the base curve radius to
• Select base curve close to the central keratometry
value to avoid draping and random deformation
• Select the overall diameter from the corneal
the flat keratometry more closely
• Prevents the random spherical aberration
and low order effective power differences of
lenses of different power
diameter (HVID) to have equivalent extension
from limbus on all eyes
• Control the sagittal depth at a key peripheral
chord
5
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 mm
12.3 or larger = 14.8 mm
CONTROL OF
EXTENSION BEYOND
THE CORNEA
Selecting overall diameter as a function of
corneal radius
Need 3: Shift Control of Sag to the
Periphery of the Lens
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
Requires independent fitting zone in the periphery of the lens:
Optimum: Single geometry controlled by an angle
Angle determined by technology driven
methods:
Visante OCT (Zeiss)
Fringe Topography: Eye Surface Profiler (Eaglet-Eye)
Shiempflug (Pentacam)
Modification to CIRRUS™
OR
1.2 to 1.5 mm
Zeiss Cirrus OCT
Diagnostic Lens Observation
Anterior Segment Premier Module
Glaucoma, Cornea, and Refractive Applications
• Comprehensive anterior segment imaging
with new magnetic external lenses
• Anterior Segment
New Anterior Segment Premier Module
Available for Models 5000 and 500
• Quick switching to anterior segment scanning
• First-in-class full anterior chamber imaging
from a retinal OCT
ChamberView™
6
The first full anterior chamber view from a retinal OCT
Moving from Manual to Automated
Calipering:
1. Key chord length
2. Depth at key chord
ChamberView™ (15.5 mm x 5.8 mm)
Case courtesy of Dr. Shamika Gune
Eye Surface Profiler
• Automated metrology:
1. Select Key Chord = 14.0 mm
2. Sag value
Average Nsag & Tsag = 3.330
14.0 mm
PERIPHERAL SAG
CONTROL™
Holding the base curve radius and overall
diameter constant while changing the SAG in
the landing zone
14.0 mm
Contour Data to Six Standard Deviations
8.3 14.4 Peripheral Sag 3.750
Use “Peripheral Sag Control” to achieve optimum edge strain
for every eye
SAG = 3.736 mm
7
8.3 14.4 Peripheral Sag 4.051
SAG = 4.051 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
8.3 14.4 Peripheral Sag 4.421
SAG = 4.421 mm
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
Diameter too small
• 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 instability
It’s about Vision, Comfort and Health – Doing the
best job we can to care for our patients
8
Evaluating Peripheral Sag
OCT allows for evaluation of peripheral lens to eye relationship
Conjunctival “Blanching” Indicates PSC is
Too Great
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?
Final Parameter Success Criteria
• 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
Where do we go from here?
Ocular Contour Based Lens Design
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 Wonderland
Lewis Carroll
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
Elevation is the destination: Customization will happen
Treat each patient as a unique individual and each eye
with regard to its unique contour and optical needs
9
APPLYING OCULAR
CONTOUR TO HYBRID
LENS DESIGN
A NOVEL COMPOSITE:
Spherical 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
Refining Hybrid Lens Comfort and Vision
Ushers in a Need for Science
Clinical Requirements:
• Freedom from junction elevation disparity
• Freedom from changes in corneo-scleral morphology
Need:
VICOH Novel and Patented Technology
• 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
• Elimination of junction and GP contact with cornea
• Uniform post lens tear film thickness
• Control of design respective of ocular contour
Soft Corneal Contact
• 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
Contour Based Hybrid Lens Design
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
Ideal geometry with prescribed corneal clearance, scleral
alignment and extension beyond limbus
10
Fundamental Conclusions
7.8 14.8 4300
• 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
7.8 14.8 4600
7.8 14.8 4900
Novel while simple
Understanding
Peripheral Sag Control™ (PSC)
• The Peripheral Sag Control (PSC) is
the sole feature which controls the fit
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
• PSC generates the sagittal depth of
the lens needed because of the large
variation in scleral contour outside the
limbus
The lens periphery controls the fit for each eye
11
2. Peripheral Sag Determination
• 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
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
Advantages of Annulus Composite
Technology
1. Eliminate rigid-soft junction to cornea mechanical
touch
2. Avoid lens flexure and induced HOA
3. Maintain near alignment to central cornea
4. Eliminate corneo-scleral morphology changes
from lenses
FINAL FIT SUCCESS
• 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
Final Parameter Success Criteria
7.6 4600
• 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
7,20 54 300
• No visible edge lift or “fluting” in straight ahead gaze
• Good lens comfort
12
Ocular Contour Based Lens Design
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
THANK YOU
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
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Corneal Reshaping is Not Permanent?
Norman E. Leach, OD, MS
I.
What is the Mechanism of Corneal Reshaping?
A.
B.
C.
D.
E.
Corneal bending?
Anterior Limiting Lamina (Bowman’s zone) changes?
Stromal changes?
Corneal epithelium changes?
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?
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 Course
sponsored by the University of Houston College of
Optometry. As you know, this course is a requirement for
Texas license holders. What you may not know is that all
fees associated with this course are devoted to permanent
projects that are important for the future of the profession.
Thank you for choosing UHCO for your continuing
education.
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
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Preface
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.
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
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New Drug Prescribing Information
Reclassification of Hydrocodone to Schedule II
Implementation Dates
October 6, 2014 – the actual adoption date
April 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 Information
Misc. 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 Holder
Professional 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”
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Practice of License Holder
Professional 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!)
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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)
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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?
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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
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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.edu
www.tob.state.tx.us
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