Contact Lenses - Modern medicine

Transcription

Contact Lenses - Modern medicine
july 2015
VOL. 7, NO. 7
Practical Chairside Advice
OptometryTimes.com
Optic neuropathy
diagnosed via hypertension
Although low blood pressure correlates
with NA-ION, other risk factors exist
before
after
EXCELLENT OVERALL CHOLESTEROL
DEPOSIT RESISTANCE 1,2
SUPERIOR WETTABILITY 3†
Resists cholesterol deposits throughout
the lens better than other two-week or
monthly replacement SiHy lenses tested.**
BEFORE Cirrus OCT 3D visualization of ONH
near onsetSmooths
of NA-AION.
Cirrus
3D
andAfter
protects
theOCT
lens.
Providing
a hydrophilic
environment
visualization
of ONH
edema resolution
at fivethat helps
week follow-up
visit.maintain lens moisture.
Managing
myopia with
contact lenses
By Gretchyn Bailey, NCLC, FAAO
Editor in Chief, Content Channel Director
Liverpool, UK— The British Contact Lens Association (BCLA) opened the first day of its 2015
conference with a day-long focus on myopia management. Professor Brien Holden,
BAppSc, PhD, DSc, chief executive officer
of the Brien Holden Vision Institute, offers
points to remember when managing myopia
with contact lenses.
There is a massive increase in4,5the prevaTEAR FILM STABILITY
lence of myopia and high myopia, according to Dr. Holden. As the number of myopes
increase, the number of people with uncorrected refractive error will increase.
Traditionally, myopia is measured as -0.75
D in one or both meridians. Today, myopia
should be considered at –0.50 D, according
to Dr. Holden.
stableiftear
film, is -0.50
“EveryoneProvides
knowsa that
a child
which is important for consistent
D, at the end
of the year she won’t5 be -0.50
comfort and visual acuity.
D,” he says.
Dr. Holden proposes to control myopia by
See Myopia on page 5
Ask your sales representative about the AIR OPTIX®
family of contact lenses or visit MYALCON.COM
By Pierce Kenworthy, OD, and Bruce Onofrey, OD, RPh, FAAO
A
phosphodiesterase inhibitor (PDE5) use.6
nterior ischemic optic neuropathy
(AION) was first described in 1974.1
NA-AION generally remains stable long
It results from non-perfusion of the
term with visual fields unlikely to show any
posterior ciliary blood supply to the
improvement, but spontaneous improvement
optic nerve head.2 Classic symptoms of anof up to three lines of visual acuity has been
By Colleen E. McCarthy
shown in up to 40 percent of patients. The
terior ischemic optic neuropathy include
Content Specialist
optic nerve head edema resolves and makes
sudden, painless vision loss, mild to severe
TM
way
for
pallor
in
six
to
11
weeks
following
vision
loss,
inferior
altitudinal
field
defect,
PERFORMANCE DRIVEN BY SCIENCE
Cincinnati, OH— If you caught a recent episode of
the acute NA-AION episode. Also, within
and optic disc edema, which usually resolves
ABC’s Shark Tank, you may have gotten a
five years of initial eye involvement, the felspontaneously in about two months and is
at eyewear’s
latest
startup
company.
low
contralateral
eye
can
become
involved
replaced
by
sectoral
or
more
often
general*AIR OPTIX® AQUA (lotrafilcon B), AIR OPTIX® AQUA Multifocal (lotrafilcon B) and AIR OPTIX® COLORS (lotrafilcon B) contact lenses: Dk/t = 138 @ -3.00D. AIR OPTIX® NIGHT & look
DAY® AQUA
(lotrafilcon A) contact
lenses: Dk/t
= 175 @ -3.00D.
AIR OPTIX®
for Astigmatism (lotrafilcon B) contact
resistance compared to ACUVUE^ OASYS^, ACUVUE^ ADVANCE^, PureVision^, Biofinity^ and Avaira^
3 lenses: Dk/t = 108 @ -3.00D -1.25 x 180. Other factors may impact eye health. **Superior overall lipid deposit
5
Frameri
is
an
online
optical
retailer
that ofin
15
to
19
percent
of
patients.
ized
optic
atrophy.
contact lenses. †Compared to ACUVUE^ OASYS^, ACUVUE^ ADVANCE^, PureVision^, Biofinity^ and Avaira^ contact lenses. ^Trademarks are the property of their respective owners.
Important
information
for
AIR
OPTIX
AQUA
(lotrafi
lcon
B),
AIR
OPTIX
AQUA
Multifocal
(lotrafi
lcon
B),
and
AIR
OPTIX
for
Astigmatism
(lotrafi
lcon
B)
contact
lenses:
For
daily
wear
or
extended
wear
up
to
6
nights
for
near/farfers
moderately
priced
frames
and
lenses—but
Optic nerve size, particularly a small cup,
sightedness, presbyopia and/or astigmatism. Risk of serious eye problems (i.e. corneal ulcer) is greater for extended wear. In rare cases, loss of vision may result. Side effects like discomfort, mild burning or stinging may occur.
it different
isthat
that
lenses
are
has long
been for
thought
be a (lotrafi
risk lcon
factor
forlenses:Case
report
Important
information
AIR OPTIXto
COLORS
B) contact
For daily wear
only for near/far-sightedness. Contact lenses, even if worn for cosmeticwhat
reasons, makes
are prescription
medical devices
mustthe
only be
worn under
the prescription, direction and supervision of
4 an eye care professional. Serious eye health problems may occur as a result of sharing contact lenses. Although rare, serious eye problems can develop while wearing contact lenses. Side effects
interchangeable
between
frames.
The
wearer
development
of
NA-AION.
A 49-year-old
male first
noticed
an care instructions provided by their eye doctor.
like discomfort, mild burning or stinging mayThough
occur. To helpthis
avoid case
these problems,
patients must followHispanic
the wear and replacement
schedule
and the lens
Important
information hypertension
for AIR OPTIX NIGHT
AQUA risk
(lotrafilcon inferior
A) contact lenses:
Indicated
for vision
for eye
daily wear
(worn only while awake)
extended
while awake
asleep)
for upinto
to 30 a
can or
pop
out wear
the(worn
lenses
and and
snap
them
will represent
as& aDAY
major
nasal
shadow
incorrection
his left
while
nights. Relevant Warnings: A corneal ulcer may develop rapidly and cause eye pain, redness or blurry vision as it progresses. If left untreated, a scar, and in rare cases loss of vision, may result. The risk of serious problems is greater
for
extended
wear
vs daily
wear and smoking
this risk.
A one-year post-market
found 0.18%
(18 the
out offridge
10,000) ofat
wearers
developed
infection, with
0.04%in
(4 out
of 10,000) of
of wearers
experiencing
a
different
frame
a matter
seconds.
Or the
factor
for
the
disorder,
thereincreases
are also
many
lifting astudy
cooler
from
work
dur- a severe corneal
permanent reduction in vision by two or more rows of letters on an eye chart. Relevant Precautions: Not everyone can wear for 30 nights. Approximately 80% of wearers can wear the lenses for extended wear. About two-thirds of
wearer
can
pop
out
the
optical
lenses
and
opt
cases
of
low
blood
pressure
and
developing
the
day.
It
was
described
as
painless
wearers achieve the full 30 nights continuous wear. Side Effects: In clinical trials, approximately 3-5% of wearers experience at least one episode of infiltrative keratitis, a localized inflammation of the cornea which may be accompanied
by mild to severe pain and may5require the use of antibiotic eye drops for up to one week. Other less serious side effects were conjunctivitis, lid irritation or lens discomfort including dryness, mild burning or stinging. Contraindications:
instead
fordisease
tinted
turning
hislens
frames
mentlenses
of NA-AION.
and fairly
sudden.
He did
seek
One
Contact
should not be worn
if youretrospective
have: eye infection or study
inflammation (redness
and/or swelling);
eye disease,
injury not
or dryness
thatmedical
interferes with contact lens
wear; systemic
that lenses,
may be affected
by or impact
wear;
certain allergic conditions or using certain medications (ex. some eye medications). Additional Information: Lenses should be replaced every month. If removed before then, lenses should be cleaned and disinfected before wearing again.
into
sunglasses.
evaluation
for
the
visual
complaint
at
that
showed
that
there
is
a
two-fold
Always follow the eye care professional’s recommended lens wear, care and replacement schedule. Consult package insert for complete information, available without charge by calling (800) 241-5999 or go to myalcon.com.
References: 1. Nash W, Gabriel
M. Ex vivo
analysis
of cholesterol with
deposition for commercially available silicone hydrogel contact lenses using a fluorometric enzymatic assay. Eye Contact Lens. 2014; 40(5): 277-282. 2. Ex vivo measurement
increase
risk
of NA-AION
See Neuropathy on page 1
See Frameri on page 6
After Shark Tank, Frameri
online optical finds success
®
®
®
®
®
®
of lipid deposits (total cholesterol) on lenses worn daily wear through manufacturer-recommended replacement period; CLEAR CARE® Cleaning & Disinfecting Solution used for cleaning and disinfection; significance demonstrated at
the 0.05 level; Alcon data on file, 2008. 3. Ex vivo measurement of contact angles on lenses worn daily wear using Clear Care for cleaning and disinfection; significance demonstrated at the 0.05 level; Alcon
data on file, 2009. 4. Guillon M, Maissa C, Wong S, Patel K, Lemp J. Tear film dynamics over silicone hydrogel contact lenses with different lipid deposition profiles. Optom Vis Sci. 2014; 91: E-abstract 145196.
5. Alcon data on file, 2014.
Q&
A product
| agustin
gonzales
oninformation.
owl vision, generic vs. branded, and going to private practice See page 41
See
instructions for complete
wear, care and safety
© 2015 Novartis
2/15
AOA15014JAD
JULY 2015
VOL. 7, NO. 7
OptometryTimes.com
PRACTICAL CHAIRSIDE ADVICE
Optic neuropathy
diagnosed via hypertension
Although low blood pressure correlates
with NA-ION, other risk factors exist
BEFORE
AFTER
BEFORE Cirrus OCT 3D visualization of ONH
near onset of NA-AION. AFTER Cirrus OCT 3D
visualization of ONH edema resolution at fiveweek follow-up visit.
Managing
myopia with
contact lenses
By Gretchyn Bailey, NCLC, FAAO
Editor in Chief, Content Channel Director
Liverpool, UK— The British Contact Lens Association
(BCLA) opened the first day of its 2015 conference with a day-long focus on myopia management. Professor Brien Holden,
BAppSc, PhD, DSc, chief executive officer of the Brien Holden
Vision Institute, offers points to
remember when managing myopia with contact lenses.
There is a massive increase in
the prevalence of myopia and high
myopia, according to Dr. Holden.
As the number of myopes increase,
the number of people with uncorrected refractive error will
increase.
Traditionally, myopia is measured as -0.75 D in one or both meridians.
Today, myopia should be considered at –0.50
D, according to Dr. Holden.
“Everyone knows that if a child is -0.50
See Myopia on page 5
By Pierce Kenworthy, OD, and Bruce Onofrey, OD, RPh, FAAO
nterior ischemic optic neuropathy
(AION) was first described in 1974.1
It results from non-perfusion of the
posterior ciliary blood supply to the
optic nerve head.2 Classic symptoms of anterior ischemic optic neuropathy include
sudden, painless vision loss, mild to severe
vision loss, inferior altitudinal field defect,
and optic disc edema, which usually resolves
spontaneously in about two months and is
replaced by sectoral or more often generalized optic atrophy.3
Optic nerve size, particularly a small cup,
has long been thought to be a risk factor for
development of NA-AION.4 Though this case
will represent hypertension as a major risk
factor for the disorder, there are also many
cases of low blood pressure and development of NA-AION.5 One retrospective study
showed that there is a two-fold
increase risk of NA-AION with
A
phosphodiesterase inhibitor (PDE5) use.6
NA-AION generally remains stable long
term with visual fields unlikely to show any
improvement, but spontaneous improvement
of up to three lines of visual acuity has been
shown in up to 40 percent of patients. The
optic nerve head edema resolves and makes
way for pallor in six to 11 weeks following
the acute NA-AION episode. Also, within
five years of initial eye involvement, the fellow contralateral eye can become involved
in 15 to 19 percent of patients.5
After Shark Tank, Frameri
online optical finds success
By Colleen E. McCarthy
Content Specialist
A 49-year-old Hispanic male first noticed an
inferior nasal shadow in his left eye while
lifting a cooler from the fridge at work during the day. It was described as painless
and fairly sudden. He did not seek medical evaluation for the visual complaint at
Cincinnati, OH— If you caught a recent episode of
ABC’s Shark Tank, you may have gotten a
look at eyewear’s latest startup company.
Frameri is an online optical retailer that offers moderately priced frames and lenses—but
what makes it different is that the lenses are
interchangeable between frames. The wearer
can pop out the lenses and snap them into a
different frame in a matter of seconds. Or the
wearer can pop out the optical lenses and opt
instead for tinted lenses, turning his frames
into sunglasses.
See Neuropathy on page 20
See Frameri on page 6
Case report
Q&A | AGUSTIN GONZALES on owl vision, generic vs. branded, and going to private practice SEE PAGE 41
| PRACTICAL CHAIRSIDE ADVICE
FROM
THE
Chief Optometric Editor
3
Optometry’s future is in good hands
By Ernie Bowling, OD, FAAO
Chief Optometric Editor
He is in private practice in Gadsden, AL, and
is the Diplomate Exam Chair of the American
Academy of Optometry’s Primary Care Section
[email protected]
256-295-2632
n the last day of January, I had the distinct honor to lecture at the Georgia Optometric Association’s Super CE meeting
in Atlanta. Having practiced in northwest
Georgia for the majority of my career, I got to
see a lot of old friends and make many new
ones. The highlight of the weekend for me
personally was getting to spend some time
catching up with Ben Casella, OD, FAAO.
Ben is a third-generation optometrist from
Augusta, GA. He is a graduate of the UAB
School of Optometry, and I’m proud to say
one of my former students. After completing an ocular disease residency at SUNY,
he returned to the family practice started in
1948 by his grandfather. Ben is a member
O
Dr. Bowling shares why ODs like
Ben Casella make the future bright
OptometryTimes.com/BenCasella to view.
Dr. Bowling and Dr. Casella smile for the
camera at the GOA meeting in Atlanta.
of our Optometry Times Editorial Advisory
Board and authors the magazine’s glaucoma
column (see page 14). I do not know a more
clinically savvy young optometrist.
He is also very active politically on behalf
of our profession. Ben is currently the trea-
surer of the Georgia Optometric Association,
working his way through the officer chairs.
Ben was named the Young OD of the South
by SECO International in 2014. I’m certain
his father Thomas is very proud of his son’s
accomplishments. Talking with Ben, he obviously has a great pride in the family practice that is now in his charge, but you really see his eyes brighten when he talks of
his wife Laura and their two children Carter
and Elisabeth.
The future of our profession is in the hands
of these young optometrists. They are going
to stand on—and expand upon—the hardfought gains by the generations of ODs who
came before them. They know from where
our profession has come but more importantly know where our profession is now and
have a vision of where our profession needs
to be in the years to come so optometrists
everywhere can better care for their patients.
When I see Dr. Ben Casella and many of the
young ODs at these meetings—optometrists
who are passionate about our
profession and willing to put
Provide
their time and treasure
culturally
toward its betterment—I
competent
care See page
know optometry’s future
16 for more on
is in good hands.
this story.
Editorial Advisory Board
Ernie Bowling, OD, FAAO Chief Optometric Editor
Editorial Advisory Board members are optometric thought leaders. They contribute ideas,
offer suggestions, advise the editorial staff, and act as industry ambassadors for the journal.
Jeffrey Anshel, OD, FAAO
Michael P. Cooper, OD
Alan G. Kabat, OD, FAAO
Mohammad Rafieetary, OD, FAAO
Joseph Sowka, OD, FAAO
Ocular Nutrition Society
Encinitas, CA
Chous Eye Care Associates
Tacoma, WA
Southern College of Optometry
Memphis, TN
Charles Retina Institute
Memphis, TN
Sherry J. Bass, OD, FAAO
Douglas K. Devries, OD
David L. Kading, OD, FAAO
Michael Rothschild, OD
Nova Southeastern University College
of Optometry
Fort Lauderdale, FL
SUNY College of Optometry
New York, NY
Eye Care Associates of Nevada
Sparks, NV
Specialty Eyecare Group
Kirkland, WA
West Georgia Eye Care
Carrollton, GA
Justin Bazan, OD
Steven Ferucci, OD, FAAO
Danica J. Marrelli, OD, FAAO
John Rumpakis, OD, MBA
Park Slope Eye
Brooklyn, NY
Sepulveda VA Ambulatory Care
Center and Nursing Home
Sepulveda, CA
University of Houston College
of Optometry
Houston, TX
Practice Resource Management
Lake Oswego, OR
Lisa Frye, ABOC, FNAO
Katherine M. Mastrota, MS, OD, FAAO
Eye Care Associates
Birmingham, AL
Omni Eye Surgery
New York, NY
Eyecare Consultants Vision Source
Englewood, CO
Ben Gaddie, OD, FAAO
John J. McSoley, OD
Gaddie Eye Centers
Louisville, KY
University of Miami Medical Group
Miami, FL
University of Alabama at Birmingham
School of Optometry
Birmingham, AL
David I. Geffen, OD, FAAO
Ron Melton, OD, FAAO
Peter Shaw-McMinn, OD
Gordon Weiss Schanzlin
Vision Institute
San Diego, CA
Educators in Primary Eye Care LLC
Charlotte, NC
Southern California College of Optometry William D. Townsend, OD, FAAO
Sun City Vision Center
Advanced Eye Care
Sun City, CA
Canyon, TX
Jeffry D. Gerson, OD, FAAO
Highland, CA
Diana L. Shechtman, OD, FAAO
William J. Tullo, OD, FAAO
Patricia A. Modica, OD, FAAO
Nova Southeastern University
Fort Lauderdale, FL
TLC Laser Eye Centers/
Princeton Optometric Physicians
Princeton, NJ
Marc R. Bloomenstein, OD, FAAO
Schwartz Laser Eye Center
Scottsdale, AZ
Crystal Brimer, OD
Crystal Vision Services
Wilmington, NC
Mile Brujic, OD
Premier Vision Group
Bowling Green, OH
Benjamin P. Casella, OD
Casella Eye Center
Augusta, GA
Michael A. Chaglasian, OD
Illinois Eye Institute
Chicago, IL
WestGlen Eyecare
Shawnee, KS
Milton M. Hom, OD, FAAO
A. Paul Chous, OD, MA
Azusa, CA
Chous Eye Care Associates
Tacoma, WA
Renee Jacobs, OD, MA
Practice Management Depot
Vancouver, BC
Pamela J. Miller, OD, FAAO, JD
SUNY College of Optometry
New York, NY
Laurie L. Pierce, LDO, ABOM
Hillsborough Community College
Tampa, FL
John L. Schachet, OD
Leo P. Semes, OD
Joseph P. Shovlin, OD, FAAO, DPNAP
Northeastern Eye Institute
Scranton, PA
Kirk Smick, OD
Clayton Eye Centers
Morrow, GA
Loretta B. Szczotka-Flynn, OD, MS, FAAO
University Hospitals Case Medical Center
Cleveland, OH
Marc B. Taub, OD, MS, FAAO, FCOVD
Southern College of Optometry
Memphis, TN
Tammy Pifer Than, OD, MS, FAAO
University of Alabama at
Birmingham School of Optometry
Birmingham, AL
J. James Thimons, OD, FAAO
Ophthalmic Consultants of Fairfield
Fairfield, CT
Walter O. Whitley, OD, MBA, FAAO
Virginia Eye Consultants
Norfolk, VA
Kathy C. Yang-Williams, OD, FAAO
Roosevelt Vision Source PLLC
Seattle, WA
Digit@l
4
JULY 2015
t VOL. 7, NO. 7
Content
CONTENT CHANNEL DIRECTOR Gretchyn M. Bailey, NCLC, FAAO
[email protected] 215/412-0214
CONTENT SPECIALIST Colleen McCarthy
[email protected] 440/891-2602
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CHECK OUT THE LATEST OPTOMETRY TIMES BLOGS
In 2015, Optometry Times is offering weekly blogs from some of the leaders in the
optometric profession. Haven’t read them yet? Here’s what you’re missing.
Dr. Tracy Schroeder Swartz, the newest blogger for Optometry Times, shares
some lessons that she’s learned as the owner of a jet ski that apply to her life as
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Dr. Michael Brown lays out the laws of the optometric jungle for the recentlygraduated class of 2015. Whether you earned your OD this year or 20 years
ago, Dr. Brown has some good advice on remembering what it’s all about.
Dr. Scott Schachter says that vision begins at the tear film—so why aren’t we
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Dr. Steve Nelson, another new blogger on the Optometry Times block, responded
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VOL. 7, NO.
OptometryTimes.com
PRACTICAL
CHAIRSIDE
ADVICE
MD resident
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What we can leases atta
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defends opbuzz on both
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explains why hinder patients and create
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two weeks
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In his second
OD-performed
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be legal. He
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writing the
desays that after from both sides of the
’s attempts
ceived reactions
believes optometryare best debate and now
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at expanded
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See Blink on
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| PRACTICAL CHAIRSIDE ADVICE
Myopia
Continued from page 1
D, at the end of the year she won’t be -0.50 D,” he says.
Dr. Holden proposes to control myopia by not using standard spectacles and contact lenses which promote myopia,
delaying the onset of myopia, and using interventions that
will reduce the rate of myopia.
The eyecare community needs to identify and treat the
young, faster growing, at-risk myopes. Two questions need
to be answered:
Can we control the progress of a child destined for
high myopia?
Does myopia control reduce pathological consequences?
The World Health Organization (WHO) and the Brien
Holden Vision Institute (BHVI) recently held a global scientific meeting on myopia to review scientific evidence and
create recommendations to prevent blindness from myopia.
In addition, BHVI is launching The Myopia Institute,
which will provide evidence-based information about myopia, educate society about the adverse influence of myopia, and develop strategies for reducing vision impairment
caused by myopia.
In Focus
der aberrations are manipulated
via mathematical algorithms to
optimize retinal image quality
across a wide range of distances.
These lenses show a 40-48 percent reduction in axial length.
7
Dose matters Wearing myo-
pia control contact lenses on
a consistent basis and remaining
compliant increases success.
Such contact lenses worn 10 hours
a day showed a 47 percent reduction,
lenses worn 12 hours a day showed
a 58 percent reduction, and lenses
worn 14 hours a day showed a 66
percent reduction.
Key myopia management points
We need to change our attitudes Any myopia in a
1
2
young child is a major risk factor.
The only soft contact lens available today that
does not have a myopia-provoking spherical aberration in the periphery of the optic is lotrafilcon
A Power profiles of lenses vary; some have a negative
spherical aberration profile that exacerbates myopia.
3
Outdoors is good Increasing the time outdoors de-
4
Ortho-k works “Ortho-k lenses are the most success-
5
Peripheral plus lenses work Peripheral plus contact
lays the onset of myopia and reduces the rate of progression. Children today are spending more time indoors,
especially with digital devices.
Taiwan recently proposed a new law which would ban
children under the age of 2 from using electronic devices,
levy a fine on parents who allow children to use iPads and/
or smartphones, and allow digital device use for children
under age 18 for a “reasonable” length of time.
ful myopia control treatment that we have,” says Dr.
Holden.
Overall, ortho-k lenses provide a 30 percent reduction in
axial length increase.
lenses bring the peripheral image forward toward the
retina; correcting peripheral hyperopia helps to control
myopia. The lenses consistently reduce the rate of progress of myopia by 40 percent each year.
“If you want to do something tomorrow,” Dr. Holden says,
“fit every kid aged 7 to 27 with peripheral plus lenses.”
6
Stepped anti-myopia (SAM) and extended depth
of focus (EDOF) contact lenses work Higher-or-
2013 n=325; 2014 n=263
8
5
Fear, handling, and discomfort are concerns Confidence
in these contact lenses from both
public and eyecare professionals
is needed.
9
Myopia is both a challenge
and an opportunity Myopia
is a challenge to eye health.
Myopia is also an opportunity for:
Contact lenses
Eyecare practitioners to prevent
high myopia
Contact lens industry
Health and welfare of children
and adults
Prevention of global blindness
6
In Focus
Frameri
Continued from page 1
Frames run at $99 per pair. The frames
come in three different shapes with a wide
range of color options. Plano and single vision lenses are $50, while progressive lenses
run $250. The lenses are polycarbonate, ARcoated, EMI-coated, scratch resistant, and
$99
The cost of a pair of Frameri
frames. Single-vision lenses
are $50, and PALs are $250
smudge resistant. Frameri offers 10 different
tints for sunglasses lenses. Frameri runs its
own optical lab in-house.
Founder Konrad Billetz says that even after
wearing glasses since he was a kid, he didn’t
know much about eyewear. But the price, the
inconvenience, and the limited choices were
always a problem, so he set to find a way to
improve the experience for glasses wearers.
“We put together a team of industrial designers, computer nerds, and smart geeks,
and we figured it out,” he says. “We want
to make glasses for people who wear them.
JULY 2015
Frameri plans to
offer its frames in
traditional optical
shops.
How can we make them better? What are
the problems that people run into?”
After a year of research and design, the
company officially launched last July. From
the beginning, Billetz says, it was about coming up with the best design to meet the needs
of the wearer.
But what further differentiates Frameri
from its online optical competition is that
the company has plans to offer its frames
in traditional optical shops.
Bridging the gap between optical
and e-commerce
“We view ourselves as the bridge between
traditional optical shops or independent opticals and e-commerce,” Billetz says. “For
a long time, e-commerce has had that horrible reputation because it takes away from
the opticians. We don’t want to conflict with
|
the opticians—we want to work with them.”
Not only will opticals be able to carry
Frameri products, Billetz says that if a patient makes any future purchases on the Frameri site, the eyecare professional will be
compensated.
“The product is all about owning multiple
frames. Well, if they don’t get the frames at
your shop, and they get them from Frameri,
you should be compensated, as well,” he
says. “Instead of conflicting with the way
eyewear is done, we want to be that bridge.”
Several ODs told Optometry Times they actually loved the idea behind Frameri.
“I think it is a fantastic idea to have the
same set of lenses be used in multiple frames
of different styles,” says Optometry Times
Editorial Advisory Board member Justin
Bazan, OD. “Most people seem to have one
or maybe two primary pairs that they wear
on a regular basis. By utilizing the same set
of lenses, you are greatly reducing the cost
associated with multiple pairs, which helps
to facilitate the purchase of them.
“I think this innovative concept will be incorporated into other manufacturers’ frame
See Frameri on page 8
IN BRIEF
Oraya’s IRay wins silver for medical design excellence
NEWARK, CA—Oraya Therapeutics and Bridge Design announced that the the company’s
Oraya IRay Radiotherapy System has won
the silver award in the radiological and
electromechanical devices category of the
18th Annual Medical Design Excellence
Awards (MDEA).
The MDEA is the medtech industry’s
premier design competition committed to
searching worldwide for the highest caliber
finished medical devices, products, systems, or packaging available on the market. The awards program celebrates the
achievements of the medical device manufacturers, their suppliers, and the many
people behind the scenes—engineers, scientists, designers, and clinicians—who are
responsible for the cutting-edge products
that are savings lives, improving patient
healthcare, and transforming medtech.
The 2015 MDEA Juror Panel selected 45
exceptional finalists in 10 medical technology product categories. Products were
judged based on design and engineering
innovation; function and user-related in-
novation; patient benefits; business benefits; and overall benefit to the healthcare
system.
“We, alongside our partner Bridge Design, are honored to be recognized with
this prestigious award,” says Jim Taylor,
president and CEO of Oraya Therapeutics.
“Our goal in designing and developing the
IRay system was to offer eyecare practitioners and their patients an innovative,
comfortable and non-invasive treatment
option for wet AMD. We believe that physician ease-of-use and patient comfort have
played a significant role in the rapidadoption of Oraya Therapy in Europe and its
continued integration into standard clinical care.”
The IRay Radiotherapy System delivers
low-voltage X-rays for the treatment of wet
age-related macular degeneration (AMD).
Oraya says theIRay system’s relatively small
footprint is designed for installation in a
clinic or hospital, without the need for
added room shielding, and to be easy to
operate. The key proprietary elements of
the system consist of a low-energy X-ray
tube, a self-contained automated beam positioning system, Oraya Therapy software,
the I-Guide eye stabilization device and
an eye tracking system. Combining these
elements into a product that would be patient friendly as well as providing reliability and efficiency with patient workflow
was critical.
Bridge Design worked in close collaboration with Oraya to design and engineer
the IRay system from conception to commercialization. Extensive ergonomic studies were undertaken to gain a clear understanding of physicians’ and patients’
needs, and to inform the development of
the product for an international market.
Oraya Therapy is available at 11 sites in
three countries including the United Kingdom, Germany and Switzerland, and additional sites are in the active planning
stages. The IRay system is CE marked in
Europe. In the U.S., the IRay System is an
investigational device and is not available
for sale.
ACRYSOF IOL VISION SIMULATOR
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Search “AcrySof ” in the iPad apps section
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Patients can compare the simulated
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© 2015 Novartis 3/15 IOL15005JAD
8
In Focus
Frameri
Continued from page 6
designs,” he says. “Personally, I have really loved a frame style
and wanted to get it in other colors, but would hesitate because
the cost of the lenses. Being able to just swap out the lenses is a
great solution for that.”
Eric White, OD, says he’d be interested in Frameri as an alternative for online optical retailers.
“E-commerce is here, and we have to find a way to expand and
$1.2
billion, the value of five-year old Warby Parker, one
of the innovators of online optical retailing and has
expanded to brick-and-mortar stores
introduce our patients to it without loosing them,” he says. “I feel
this would be a good alternative, especially if they are willing to
work with the independent OD.”
While Ryan Powell, OD, says he has not had experience with
Frameri, he’s intrigued by the concept.
“I think that patients and customers purchasing glasses in my
opticals would be interested in an interchangeable lens option. That
would be something new to the market that is interesting,” he says.
Dr. Powell does have his concerns with online optical companies.
“When you say ‘inexpensive, online,’ my first thought is poor
quality,” he says. “A poor quality frame with low-end lenses would
not be something we would be interested in offering our patients.
JULY 2015
|
We want to be able to provide eyeglasses that we can stand behind. We
want to feel confident that the buyer of the eyeglasses at our practice
is getting a quality product and that the value of the product is found
in the longevity of the lenses and frame and the quality of his vision.”
Why eye care has become a hot spot for startups
Frameri is just one of many new startups to hit the eyecare space in
the last few years. Companies like Warby Parker, Blink, and Opternative have all attempted to change aspects of the eyecare experience in one way or anther. So, what makes this industry so attractive to startup companies?
The startup community is growing in all industries, Billetz says,
but eye care has been a very promising space because there hasn’t
been a lot of innovation in the industry in the past.
“This is a marketplace that is very ripe for disruption,” he says,
using Warby Parker’s massive success as an example. “I don’t want
to say that what’s currently done is broken, but I think that there’s
a lot of areas for improvement. The difficult part has been working
in such a traditional field while still trying to create new things.”
Billetz says that you would never look down upon innovations in
the tech world, but that’s how the eyecare industry tends to react to
these startups’ new ideas. There is a sense that change is bad, he says.
“I would hope that the industry begins to understand that this is
a collaborative movement to improve things. We’re looking at making these better, and let’s embrace that and accept that, really see
what works, and make things better for the customer,” he says. “It
should be everybody’s goal at the end of the day.”
Online optical becomes big business
ACRYSOF® IQ TORIC INTRAOCULAR LENSES IMPORTANT PRODUCT INFORMATION
CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.
INDICATIONS: The AcrySof® IQ Toric posterior chamber intraocular lenses are intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to
removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected
distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision.
WARNINGS/PRECAUTIONS: Careful preoperative evaluation and sound clinical judgment should be
XVHGE\WKHVXUJHRQWRGHFLGHWKHULVNEHQHWUDWLREHIRUHLPSODQWLQJDOHQVLQDSDWLHQWZLWKDQ\RIWKH
conditions described in the Directions for Use labeling. Toric IOLs should not be implanted if the posterior capsule is
ruptured, if the zonules are damaged, or if a primary posterior capsulotomy is planned. Rotation can
reduce astigmatic correction; if necessary lens repositioning should occur as early as possible prior to lens
encapsulation. All viscoelastics should be removed from both the anterior and posterior sides of the lens;
residual viscoelastics may allow the lens to rotate. Optical theory suggests that high astigmatic patients (i.e.,
> 2.5 D) may experience spatial distortions. Possible toric IOL related factors may include residual cylindrical
error or axis misalignments. Prior to surgery, physicians should provide prospective patients with a copy of the
3DWLHQWΖQIRUPDWLRQ%URFKXUHDYDLODEOHIURP$OFRQIRUWKLVSURGXFWLQIRUPLQJWKHPRISRVVLEOHULVNVDQGEHQHWV
associated with the AcrySof® IQ Toric Cylinder Power IOLs. Studies have shown that color vision discrimination is
QRWDGYHUVHO\DHFWHGLQLQGLYLGXDOVZLWKWKH$FU\6RI ®1DWXUDOΖ2/DQGQRUPDOFRORUYLVLRQ7KHHHFWRQYLVLRQ of the AcrySof® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects
secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve
diseases) has not been studied. Do not resterilize; do not store over 45° C; use only sterile irrigating solutions
such as BSS® or BSS PLUS® Sterile Intraocular Irrigating Solutions.
ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings and
precautions.
© 2015 Novartis
3/15 IOL15005JAD
Frameri joins the ranks of online optical retail companies like Warby
Parker, which just raised $100 million to expand its brick and mortar
stores from 12 to 20 by the end of the year. Just five years old, Warby
Parker is now valued at $1.2 billion.
And Frameri, while not even a year old yet, has been getting a lot
of attention. Last year, a month before the company even launched,
the company appeared on the ABC show Shark Tank to pitch to the
show’s lineup of investors.
Frameri didn’t walk away with a deal, but that was OK, says Billetz. In between the time the show approached the company about
appearing and the time he went to shoot the episode, Frameri had
already secured some significant investments.
Last summer, Frameri won a $100,000 investment from America
Online co-founder Steve Case. And Billetz, 28, made Forbes’ 2015 30
under 30 list in the manufacturing and industry category.
What you can learn from online optical companies
Dr. Bazan says ODs can learn from the growth of online optical companies.
“It is becoming more apparent from the popularity of companies
like Frameri that more and more consumers are looking for trendy
eyewear that is in the $100 to $200 range,” says Dr. Bazan. “The average Main Street OD should be studying these companies and finding ways to be competitive in their own offices.”
When his patients request their prescription with plans to use it at
an online optical retailer, Dr. Bazan says he uses it as an opportunity
to bring their attention to his moderately-priced frames.
“Often, they will find something they love, and we can get it done
for them on the spot,” he says. “Other times, they learn the differences between that eyewear and the premium eyewear we have in our
optical. They key was to have something competitive in our optical,
which gave us an opportunity to do business with them.”
| PRACTICAL CHAIRSIDE ADVICE
Opinion
9
Lutein and zeaxanthin:
Beyond retinal health
By Stuart Richer, OD, PhD
placebo-controlled study. Nutrition. 2013 JulAug;29(7-8):958-64.
O
5. Richer S, Park D-W, Epstein R, et al. Macular
Re-pigmentation Enhances Driving Vision in
Elderly Adult Males with Macular Degeneration. J
Clin Exp Ophthalmology. ISSN: 2155-9570, 2012,
3(3)1000217.
severe cataract.6
Separately, it been determined
that for every 300-mcg (about 1/3
ptometrists like to think about
of a milligram) increase in dietary
ocular nutritional supplements
lutein and zeaxanthin, there was a
in narrow terms, focusing on
statistically significant three perAREDS2 or the carotenoids’ visual
cent decrease in nuclear cataract
benefits. For example, it is now well
STUART RICHER,
risk.7 The dietary carotenoids also
established by the AREDS2 study
OD, PHD, FAAO,
that dietary lutein and zeaxanthin
promote cardiovascular health and
is director of ocular
reduce the risk of developing adhave anti-inflammatory effects.8
preventive medicine
vanced catastrophic vision loss in
Further properties of dietary caat James Lovell
Federal Health Care
patients with high-risk retinopathy.1
rotenoids leading to a potential reFacility
in
Chicago.
duction of cardiovascular risk inWe also know that the lack of the
He is also associate
clude lowering of blood pressure,
ocular carotenoids in the diet can
professor of family
reduction of pro-inflammatory cyinfluence visual function through
and preventative
tokines, markers of inflammation
optical as well as biological mechmedicine at Chicago
Medical School
(such as C-reactive protein), and
anisms.2,3 This includes mitigating
and assistant
improvement of insulin sensitivglare disability and improving glare
clinical professor
ity in muscle, liver, and adipose
recovery time, contrast sensitivity,
at University of
tissues.9 Most exciting of all, luchromatic contrast, visual range,
Illinois at Chicago
and neural processing speed and
tein and zeaxanthin promote betdepartment of
ophthalmology and
efficiency. Notably, macular re-pigter brain health. Within our own
visual science.
mentation with lutein in Chinese
laboratory, in the Zeaxanthin and
drivers or zeaxanthin in U.S. drivVision Function study, zeaxanthin
ers, as shown in our lab, improves night
has been found to promote better long term
driving vision.4,5
delayed memory.10
All of these extra–retinal health factors
should be taken into account when choosing
Other optical enhancements
an ocular supplement. While supplemental
How many of us appreciate that dietary lumesozeaxanthin (and endogenous lutein detein and zeaxanthin also support the health
rived mesozeaxanthin) can build macular
of the human lens beyond optical enhancepigment and enhance retinal pigmentation
ment through biological mechanisms? In
and vision, mesozeaxanthin has not been
AREDS2, dietary lutein and zeaxanthin
found in the ocular lens, brain, and extrawere found to have anti-cataract properocular tissues—thus far offering no added
ties.In subjects in the lowest quintile of diprotection to systemic and brain health.
Dietary carotenoids
promote cardiovascular heath
and provide antiinflammatory and
emerging neurocognitive benefits.
etary lutein and zeaxanthin intake, there
was a 32 percent reduction in progression
to cataract surgery, a 30 percent reduction
in development of any cataract, and a 36
percent reduction in development of any
REFERENCES
1. Age-Related Eye Disease Study 2 (AREDS2)
Research Group, Secondary analyses of the
effects of lutein/zeaxanthin on age-related macular
degeneration progression: AREDS2 report No. 3.
JAMA Ophthalmol. 2014 Feb;132(2):142-9.
2. Hammond BR, Fletcher LM, Roos F, et al. A doubleblind, placebo-controlled study on the effects of
lutein and zeaxanthin on photostress recovery, glare
disability, and chromatic contrast. Invest Ophthalmol
Vis Sci. 2014 Dec 2;55(12): 8583-9.
3. Bovier ER, Renzi LM, Hammond BR, et al. A
double-blind, placebo-controlled study on the effects
of lutein and zeaxanthin on neural processing speed
and efficiency. PLoS One. 2014 Sep 24; 9(9).
4. Yao Y, Qiu QH, Wu XW, Cai ZY, Xu S, Liang XQ.
Lutein supplementation improves visual performance
in Chinese drivers: 1-year randomized, double-blind,
6. Age-Related Eye Disease Study 2 (AREDS2)
Research Group, Lutein/zeaxanthin for the treatment
of age-related cataract: AREDS2 randomized trial
report no. 4. JAMA Ophthalmol. 2013 Jul;131(7):84350.
7. Ma L, Hao ZX, Liu RR, et al. A dose-response
meta-analysis of dietary lutein and zeaxanthin intake
in relation to risk of age-related cataract. Graefes Arch
Clin Exp Ophthalmol. 2014, 252(1):63-70.
8. Gammone MA, Riccioni G, D’Orazio N, Carotenoids:
potential allies of cardiovascular health? Food Nutr
Res. 2015 Feb 6;59:26762.
9. Vishwanathan R, Schalch W, Johnson EJ. Macular
pigment carotenoids in the retina and occipital cortex
are related in humans. Nutr Neurosci. 2015 Mar 9.
10. Hoffman K, Richer SP, Wrobel J, et al. A
prospective study of neuro-cognitive enhancement
with carotenoids in elderly adult males with early
age related macular degeneration. Science Domain
International Ophthalmology. 2015;4(1):1-8.
Dr. Richer is president of the Ocular Nutrition Society (ONS).
He is associate editor of Journal of the American College of
Nutrition and a Physician Information & Education Resource
(PIER) consultant to the American College of Physicians.
[email protected]
MY FAVORITE APP
Golf Pad
I like Golf Pad for keeping score,
yardage per shot, and courses played.
The GPS feature
reports to the center
of the green, which
is not the same as
distance to the pin, yet
it suits my needs in
a single device. The
one drawback is the
appearance of using
a phone during golf.
—Renee Jacobs, OD, MA
Vancouver
10
Focus On
CO-MANAGEMENT
JULY 2015
|
How technology changed optometry’s
role in cataract comanagement
The cataract surgery landscape is ever evolving, and so must our role
Times—they are a changing. Look mom, no hands! Look,
no wires! No ethernet connection necessary. No phone
cord needed. No wires. No need to remove the corneal flap.
No key to open my door. No reason to remove the whole
capsule. No reason to actually even use drops for cataract
surgery. Driverless cars. Pilotless planes. No sugar in my
soda. No meat in my burger. Wait, back up. No drops for
cataract surgery? What you talkin’ ‘bout, Willis?
salt solution in the surgery is important to
wash out the nucleus, yet it also washes
away the preoperative drops. Omidria has
the opportunity to maintain a stable pupil
size that will decrease complications associated with diameter-related complications. The concern some surgeons have
is the use of ketorolac and its long-term
effects on macula edema. Thus, management of these patients should include a
close analysis of the macula and early
signs of any cystoid changes.
Simplifying post-op
Changing landscape
but can you look at him before
he goes blind, or worse, his insurance runs out?” Newer technology adds simplicity but also
potentially adds new challenges
for management, like your battery dying on your PDA. Dropless cataract surgery falls into
that category—just no batteries.
Cataract surgery has entered that
technology zone enabling surgeons the opportunity to provide
sutureless and bladeless surgery,
in vivo axis orientation and aberrometry measurements, and
BY MARC R.
now, remove the drops from this
BLOOMENSTEIN,
procedure. The advent of techOD, FAAO Director
nology creates a changing landof optometric
scape for the comanaging OD.
services at Schwartz New therapy
I remember a time when I
Omidria (phenylephrine and keLaser Eye Center in
Scottsdale, AZ.
saw a perfectly round anterior
torolac injection, Omeros) is the
capsulotomy performed by the
first FDA-approved medication for
femtosecond. I was astounded
anterior segment surgery to be
and marveled at the precision of the cut.
delivered intracamerally. Omidria, which
However, the capsule was adhering to
contains the mydriatic phenylephrine 1%
The advent of technology creates a
changing landscape for the optometrist
who is following his patients after
surgery.
the endothelial cells of the patient’s eye.
This particular patient was seeing 20/15
and had absolutely no visual problems,
yet the optometrist who was following
this patient had some concerns. The capsule eventually folded on itself and left a
triangular flap of tissue on the superior
corneal endothelium.
The call I got sounded like this: “Dude,
I think the cornea is breaking up from in
the inside. The patient is only visiting,
and the nonsteroidal anti-inflammatory
drug (NSAID) ketorolac 0.3%, is added
to 500 ml of balanced salt solution to irrigate the anterior chamber during cataract surgery. It is indicated to maintain
the pupil’s size by inhibiting intraoperative miosis and to reduce postoperative
ocular pain.
This medication creates an opportunity
to provide a constant mydriasis during
the whole procedure. The use of balanced
In another opportunity to break the shackles of drops, a movement is growing to
place the antibiotic and steroid in the eye
during cataract surgery. Yes, truly making the post-operative management more
simplified and cost effective. Evidence
has grown to support this use in other
countries, where over 400,000 surgeries
had been performed with this alternative
drop method with a 0.029 percent endophthalmitis incidence.1
Impress Pharmaceuticals is the first
company to bring to market a commercially available combination of triamcinolone and moxifloxacin. The combo drug
is delivered transzonularly using a bent
cannula. The goal of the anterior vitreous placement is designed to delay the
drug clearance and aid in any postoperative cystoid macular edema. Thus a
dropless management of cataract surgery
will help the patients who have difficulties with drop placement, lowering the
patient cost and compliance. Yet, this
also means a new way for optometrists
to manage the cataract patient. The bolus of medication needs to be
placed in the region between the equator and the capsular bag. Although some
surgeons have reported that 95 percent of
their patients healed without any topical
therapy,2 there is a learning curve that is
needed so that the surgeon can ensure
the sufficient dose makes its way through
the zonules. The patient will present with
inflammation that will necessitate the use
of topical steroid instillation. The comSee Technology in cataract on page 12
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CORTICOSTEROID COVERAGE IS NOT THE SAME
LEARN MORE ABOUT DUREZOL® EMULSION FORMULARY ACCESS IN YOUR AREA AT MYALCON.COM/FORMULARY
INDICATIONS AND USAGE:
DUREZOL® Emulsion is a topical corticosteroid that is indicated for:
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12
Focus On
CO-MANAGEMENT
Technology in cataract
Continued from page 10
bination medication will create a visual
disturbance that may take days to clear.
Snow globe medication
That wow factor, as well as the drops,
is replaced with a dose of verbal Valium
needed to assure the normality of the
scenario. The medication breaks up in
the vitreous and resembles floaters, most
notably in the first few days following
the surgery. Although each patient is different, the typical asteroid field will last
for the few weeks following the surgery. I
should be taken when appropriate.
Topical Ophthalmic Use Only
DUREZOL® Emulsion is not indicated for
intraocular administration.
BRIEF SUMMARY OF PRESCRIBING
INFORMATION
INDICATIONS AND USAGE
Ocular Surgery
DUREZOL® (difluprednate ophthalmic
emulsion) 0.05%, a topical corticosteroid, is
indicated for the treatment of inflammation
and pain associated with ocular surgery.
Endogenous Anterior Uveitis
DUREZOL® Emulsion is also indicated for the
treatment of endogenous anterior uveitis.
DOSAGE AND ADMINISTRATION
Ocular Surgery
Instill one drop into the conjunctival sac of
the affected eye 4 times daily beginning
24 hours after surgery and continuing
throughout the first 2 weeks of the
postoperative period, followed by 2 times
daily for a week and then a taper based on
the response.
Endogenous Anterior Uveitis
Instill one drop into the conjunctival sac of
the affected eye 4 times daily for 14 days
followed by tapering as clinically indicated.
DOSAGE FORMS AND STRENGTHS
DUREZOL® Emulsion contains 0.05%
difluprednate as a sterile preserved emulsion
for topical ophthalmic administration.
CONTRAINDICATIONS
The use of DUREZOL® Emulsion, as with other
ophthalmic corticosteroids, is contraindicated
in most active viral diseases of the cornea
and conjunctiva including epithelial herpes
simplex keratitis (dendritic keratitis), vaccinia,
and varicella, and also in mycobacterial
infection of the eye and fungal disease of
ocular structures.
WARNINGS AND PRECAUTIONS
IOP Increase
Prolonged use of corticosteroids may result
in glaucoma with damage to the optic nerve,
defects in visual acuity and fields of vision.
Steroids should be used with caution in the
presence of glaucoma. If this product is used
for 10 days or longer, intraocular pressure
should be monitored.
Cataracts
Use of corticosteroids may result in posterior
subcapsular cataract formation.
Delayed Healing
The use of steroids after cataract surgery may
delay healing and increase the incidence of
bleb formation. In those diseases causing
thinning of the cornea or sclera, perforations
have been known to occur with the use of
topical steroids. The initial prescription and
renewal of the medication order beyond
28 days should be made by a physician
only after examination of the patient with
the aid of magnification such as slit lamp
biomicroscopy and, where appropriate,
fluorescein staining.
Bacterial Infections
Prolonged use of corticosteroids may
suppress the host response and thus increase
the hazard of secondary ocular infections.
In acute purulent conditions, steroids may
mask infection or enhance existing infection.
If signs and symptoms fail to improve after 2
days, the patient should be re-evaluated.
Viral Infections
Employment of a corticosteroid medication
in the treatment of patients with a history of
herpes simplex requires great caution. Use
of ocular steroids may prolong the course
and may exacerbate the severity of many
viral infections of the eye (including herpes
simplex).
Fungal Infections
Fungal infections of the cornea are
particularly prone to develop coincidentally
with long-term local steroid application.
Fungus invasion must be considered in any
persistent corneal ulceration where a steroid
has been used or is in use. Fungal culture
JULY 2015
Contact Lens Wear
DUREZOL® Emulsion should not be instilled
while wearing contact lenses. Remove
contact lenses prior to instillation of
DUREZOL® Emulsion. The preservative in
DUREZOL® Emulsion may be absorbed by soft
contact lenses. Lenses may be reinserted
after 10 minutes following administration of
DUREZOL® Emulsion.
ADVERSE REACTIONS
Adverse reactions associated with ophthalmic
steroids include elevated intraocular
pressure, which may be associated with optic
nerve damage, visual acuity and field defects;
posterior subcapsular cataract formation;
secondary ocular infection from pathogens
including herpes simplex, and perforation
of the globe where there is thinning of the
cornea or sclera.
Ocular Surgery
Ocular adverse reactions occurring in 5-15%
of subjects in clinical studies with DUREZOL®
Emulsion included corneal edema, ciliary
and conjunctival hyperemia, eye pain,
photophobia, posterior capsule opacification,
anterior chamber cells, anterior chamber
flare, conjunctival edema, and blepharitis.
Other ocular adverse reactions occurring in
1-5% of subjects included reduced visual
acuity, punctate keratitis, eye inflammation,
and iritis. Ocular adverse reactions occurring
in < 1% of subjects included application site
discomfort or irritation, corneal pigmentation
and striae, episcleritis, eye pruritis, eyelid
irritation and crusting, foreign body
sensation, increased lacrimation, macular
edema, sclera hyperemia, and uveitis. Most
of these reactions may have been the
consequence of the surgical procedure.
Endogenous Anterior Uveitis
A total of 200 subjects participated in the
clinical trials for endogenous anterior uveitis,
of which 106 were exposed to DUREZOL®
Emulsion. The most common adverse
reactions of those exposed to DUREZOL®
Emulsion occurring in 5-10% of subjects
included blurred vision, eye irritation, eye
pain, headache, increased IOP, iritis, limbal
and conjunctival hyperemia, punctate
keratitis, and uveitis. Adverse reactions
occurring in 2-5% of subjects included
anterior chamber flare, corneal edema, dry
eye, iridocyclitis, photophobia, and reduced
visual acuity.
USE IN SPECIFIC POPULATIONS
Pregnancy
Teratogenic Effects
Pregnancy Category C. Difluprednate has
been shown to be embryotoxic (decrease
in embryonic body weight and a delay in
embryonic ossification) and teratogenic
(cleft palate and skeletal) anomalies when
administered subcutaneously to rabbits
during organogenesis at a dose of 1–10
mcg/kg/day. The no-observed-effect-level
(NOEL) for these effects was 1 mcg/kg/day,
and 10 mcg/kg/day was considered to be
a teratogenic dose that was concurrently
found in the toxic dose range for fetuses
and pregnant females. Treatment of rats
with 10 mcg/kg/day subcutaneously
during organogenesis did not result in any
reproductive toxicity, nor was it maternally
toxic. At 100 mcg/kg/day after subcutaneous
administration in rats, there was a decrease
in fetal weights and delay in ossification,
and effects on weight gain in the pregnant
females. It is difficult to extrapolate these
doses of difluprednate to maximum daily
human doses of DUREZOL® Emulsion,
since DUREZOL® Emulsion is administered
topically with minimal systemic absorption,
and difluprednate blood levels were not
measured in the reproductive animal studies.
However, since use of difluprednate during
human pregnancy has not been evaluated
and cannot rule out the possibility of harm,
DUREZOL® Emulsion should be used during
pregnancy only if the potential benefit
justifies the potential risk to the embryo or
fetus.
Nursing Mothers
It is not known whether topical ophthalmic
administration of corticosteroids could
result in sufficient systemic absorption
to produce detectable quantities in
breast milk. Systemically administered
corticosteroids appear in human milk and
could suppress growth, interfere with
endogenous corticosteroid production, or
cause other untoward effects. Caution should
be exercised when DUREZOL® Emulsion is
administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients
have not been established.
Geriatric Use
No overall differences in safety or
effectiveness have been observed between
elderly and younger patients.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, and
Impairment of Fertility
Difluprednate was not genotoxic in vitro in
the Ames test, and in cultured mammalian
cells CHL/IU (a fibroblastic cell line derived
from the lungs of newborn female Chinese
hamsters). An in vivo micronucleus test of
difluprednate in mice was also negative.
Treatment of male and female rats with
subcutaneous difluprednate up to 10 mcg/
kg/day prior to and during mating did not
impair fertility in either gender. Long term
studies have not been conducted to evaluate
the carcinogenic potential of difluprednate.
Animal Toxicology and/or Pharmacology
In multiple studies performed in rodents
and non-rodents, subchronic and chronic
toxicity tests of difluprednate showed
systemic effects such as suppression of
body weight gain; a decrease in lymphocyte
count; atrophy of the lymphatic glands and
adrenal gland; and for local effects, thinning
of the skin; all of which were due to the
pharmacologic action of the molecule and
are well known glucocorticosteroid effects.
Most, if not all of these effects were reversible
after drug withdrawal. The NOEL for the
subchronic and chronic toxicity tests were
consistent between species and ranged from
1–1.25 mcg/kg/day.
PATIENT COUNSELING INFORMATION
Risk of Contamination
This product is sterile when packaged.
Patients should be advised not to allow the
dropper tip to touch any surface, as this may
contaminate the emulsion.
Use of the same bottle for both eyes is not
recommended with topical eye drops that are
used in association with surgery.
Risk of Secondary Infection
If pain develops, or if redness, itching, or
inflammation becomes aggravated, the
patient should be advised to consult a
physician.
Contact Lens Wear
DUREZOL® Emulsion should not be instilled
while wearing contact lenses. Patients should
be advised to remove contact lenses prior
to instillation of DUREZOL® Emulsion. The
preservative in DUREZOL® Emulsion may be
absorbed by soft contact lenses. Lenses may
be reinserted after 10 minutes following
administration of DUREZOL® Emulsion.
|
have a snow globe that I use to represent
the suspension of the steroid in a bottle,
although I have a Shake Weight to serve
the same purpose, “Shake it before you
take it!” The snow globe is a great way
to demonstrate the visual obstructions. It
is equally important to realize the commonality of these visual changes and differentiate them from a possible retinal
detachment, though rare, that may occur.
These tramicinolne particles may make
their way into the anterior chamber and
thus resemble anterior cells. The eyes
may be quiescent, yet it is still a challenge to know the exact makeup of the
particle. Thus, treat these as possible inflammatory cells, and start the patient
on a topical therapy. Another drop that
may have to be added is a topical hypotensive medication following the surgery.
Steroid responders make up a large percent of the population, and a steroid is
injected into the vitreous creates a risk
of prolonged intraocular pressure (IOP)
elevation. Managing doctors should follow the IOP of these patients closely and
most notably patients who have been diagnosed as steroid responsive.
Time will tell if droplets will go the
way of wireless tech or driverless cars.
Reduction of out-of-pocket expenses and
compliance sure do make a droplets cataract surgery seem appealing. Perhaps
when I am sitting in my car writing the
next article, while my car is taking me
to Laguna Beach, I will feel differently,
much like when you get over the hurdle
of a new drop regimen.
REFERENCES
1. Friling E, Lundstrom M, Stenevi U, Montan P.
Six-year incidence of endophthalmitis After cataract
surgery: Swedish national study. J Cataract Refract
Surg 2013. Jan;39(1):15-21.
2. Liegner JT. “Better surgery through chemicals:
topical and intracameral agents for the anterior
segment surgeon.” ASCRS/ASOA Symposium.
Washington, DC. 27 April 2014.
[email protected]
WANT MORE CONTENT ON
COMANAGEMENT?
Revised: June 2012
U.S. Patent 6,114,319
Manufactured For
Earning a spot on the medical team
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134 USA
1-800-757-9195
[email protected]
Manufactured By:
Catalent Pharma Solutions
Woodstock, IL 60098
© 2015 Novartis 1/15 DUR14090JAD-PI
OptometryTimes.com/earningaspot
Why wait to recommend cataract
surgery?
OptometryTimes.com/waitcatsurg
| PRACTICAL CHAIRSIDE ADVICE
CONTACT LENSES
Focus On
Prevent dropout by asking the right questions
Uncovering the problems with patients who say their contact lenses feel fine
The main reason for contact lens dropout is discomfort
and dryness, according to a survey done by Richdale.1 The
latest data on contact lens dropouts is approximately 16
percent annually. 2 Given these two statistics, one may assume that dryness and discomfort are the primary cause
of our patients dropping out of contact lens wear. Patients
do not decide suddenly to drop out of lens wear. It is a
progression that may occur over months or years.
The strugglers
they have not returned in 13-14
months do we call and find out
The progression of contact lens
where they are? Whose fault is it?
discomfort starts with those paMost of us say the patients’, but
tients we will call strugglers. These
I believe we, as doctors, need to
are the patients who come in to
take more responsibility for this.
the office and will tell you their
We need to be proactive in our
contact lenses feel “fine.” Unless
BY DAVID I.
practices to insure our patients
we ask more in-depth questions,
GEFFEN, OD, FAAO
are receiving the most up-to-date
we will not discover that these
Director of
technology, which may be better
patients may have some fluctuatoptometric and
ing vision. They may be noticing
refractive services in to address the changing lifestyles
of our patients. Keeping the pasome visual disturbances.
San Diego, CA.
tient in the same lenses year in
Next, we move on to the paand year out because it’s not broken is not
tient who may still say his contact lenses
in the patient’s or the practice’s best interfeel “fine,” but if we ask the right quesest. We know the patient will come in and
tions, we may uncover that the patient is
tell us his lenses feel “fine.” If we do not
experiencing reduced comfortable wearing
change anything after three or four years,
time. He will tell you he wears his lenses
patients may feel that they will just buy
all day, but unless we ask the right questheir lenses online the next year because
tions, you may not find out the last three
the doc isn’t changing anything, and they
hours of wearing time is dry and uncommight as well save some money.
fortable. The next step in the progression
is reduced wearing time.
The patient may still say her lenses feel
Stop progression to dropout
“fine,” but she takes her lenses out the minWhat we ask our patients about their lenses
ute she gets home from work. Next is the
is critical to stop the progression of the
temporary discontinuation of lens wear.
dropout. If we ask more probing questions,
Now, the patient may tell you her lenses
we will find out about the visual disturare not as comfortable, and she doesn’t
bances early on in the process, and we can
wear them to work and may wear them
make the necessary adjustments to bring
only on weekends or going out. Finally,
the patient back to the comfort she wants
we have the total discontinuation of lens
and deserves. A few examples:
wear and the dreaded contact lens dropout.
Do you feel like you want to remove
your lenses as soon as you get home
from work?
Taking responsibility
The process may take months or even years,
Are your contact lenses as comfortbut the result is often the loss of a patient
able at the end of the day as when
and tens of thousands of dollars of reveyou put them in?
nue to the practice. Most of us do not even
How would you rate your contact lens
realize the patient has stopped wearing
comfort on a scale from 1-10 at the
his lenses. How would we know? Do we
beginning of the day as compared to
look at our patient recall numbers, and if
the end of the day?
Do you think your contact lenses are
as comfortable as they could be?
These questions are much more likely
to tell us the patient is on the road to discomfort or dropout. Why do patients tell us
their lenses feel “fine?” Our patients often
think this is how lenses should feel—they
don’t know any better. Also, the patient
may be afraid if she complains, we will tell
her to stop wearing her lenses. By asking
the right questions, we will give patients
confidence that we are looking to help
them feel the best possible with lenses.
Another disconnect is the fact that 97
percent of patients are interested in trying
a new contact lens technology. However,
only 20 percent expect to learn about new
technology during their visit to their eye
doctor.3 This I find to be an amazing statistic in doctors’ failure to be more proactive
Patients do not
decide suddenly
to drop out of
lens wear. It is a
progression that
may occur over
months or years.
for our patients. So, go in to work tomorrow, and start asking the right questions!
REFERENCES
1. Richdale K, Sinnott LT, Skadahl E, et al.
Frequency of and factors associated with contact
lens dissatisfaction and discontinuation. Cornea.
2007 Feb;26(2):168-174.
2. Rumpakis J. New Data on Contact Lens
Dropouts: An International Perspective. Rev
Optometry. Available at: http://www.revoptom.
com/content/d/contact_lenses_and_
solutions/c/18929/. Accessed 4/21/15.
3. Rah, MJ, Reindel, W, Mosehauer, G. Interest
and acceptance of a new contact lens technology
in today’s practice. Poster session presented at:
118th Annual AOA Congress; 2015 Jun 34-28;
Seattle, WA.
Dr. Geffen sits on the advisory board and speaks for
Alcon, Bausch + Lomb, and Vmax and sits on the advisory
board for TearLab and Accufocus. He speaks for Allergan
and AMO. [email protected]
13
14
Focus On
GLAUCOMA
JULY 2015
|
Is glaucoma a neurological disease?
Examining the plausible correlation between glaucoma and cerebrospinal fluid
For years now, there has been considerable evidence indicating that glaucoma should be considered a neurological
disease and not an entity isolated to the eyes alone.1 Perhaps the most compelling evidence for such a characterization is the fact that the retinal ganglion cells affected
by glaucoma do not synapse until they arrive at the midbrain (specifically, the lateral geniculate nucleus).
Evidence of damage in the midbrains of simian models after induction of ocular hypertension2
furthers the evidence for glaucoma to be classified as a neurological disease. One other (rather
contemporary) notion regarding
glaucoma and its relationship
to the brain is a plausible correlation between glaucoma and
low cerebrospinal fluid (CSF).
Eye and brain pressure
low CSF pressure is a risk factor
for glaucoma. Further, high IOP
combined with low CSF pressure
would seemingly be a greater risk
factor for the development of glaucoma than the first two scenarios.
BY BENJAMIN
P. CASELLA, OD,
FAAO Practices
in Augusta, GA ,
with his father in
his grandfather’s
practice.
As the optic nerve exits the globe
and begins its journey through the retrobulbar space, it fenestrates through the lamina
cribrosa. It is at this point that there exists
a pressure gradient between intraocular
pressure (IOP) within the globe and CSF
pressure within the subarachnoid space
(or, as I tell my patients, “eye pressure and
brain pressure”). If this trans-laminar pressure gradient is high (specifically meaning a higher drop in pressure as the optic
The causal relationship
between CSF and IOP
This causal relationship between
CSF pressure and IOP at the location of the lamina cribrosa does
well to possibly (and at least in
part) explain a few aspects of glaucoma that remain somewhat elusive. First,
we have thin central corneal thickness as
a strong and independent risk factor for
the development of glaucoma.4 The cornea
and lamina cribrosa both derive from the
neuro-ectoderm in utero. So, perhaps a thin
central cornea (along with other hysterics) correlates with a lamina cribrosa that
isn’t as apt to handling a significant pressure gradient between IOP and CSF pres-
Whatever the reason, we understand
that high IOP doesn’t automatically
mean glaucoma, and low IOP doesn’t
automatically mean not glaucoma.
nerve goes from the globe to the retrobulbar
space), then there is a greater chance for
glaucomatous optic nerve damage to occur.3
There is more than one way for this scenario to occur. First, if IOP is high and CSF
pressure is normal, then there would be a
drop in pressure along this gradient. Second, if IOP is normal and CSF pressure is
low, the net effect would be the same drop
in pressure. So, overall net is a relatively
sure. Second, we have the separate clinical entity known as normal or low-tension
glaucoma (NTG) in which glaucomatous
damage occurs in the presence of statistically normal IOP. Perhaps the presence of
relatively low CSF pressure would at least
partially explain the pathogenesis in this
disease entity. Third, we have ocular hypertension with no signs or symptoms that
would lead us to suspect glaucoma (i.e. la-
beling a patient as having ocular hypertension rather than labeling that patient as a
glaucoma suspect). We all know that ocular
hypertension is the number-one risk factor for the development of glaucoma. Yet,
we all have patients with this condition
(and some with markedly high IOP) who
just never go on to develop any signs of
glaucoma. Perhaps some of these patients
also have protectively high CSF pressures,
thus lowering their trans-laminar pressure
gradients between IOP and CSF pressure
Whatever the reason, high IOP doesn’t automatically mean glaucoma, and low IOP
doesn’t automatically mean not glaucoma.
While more research is needed to explore
low CSF pressure and its potentially causal
relationship with glaucoma, the implications seem rational. The fact that patients
are typically diagnosed with NTG at older
ages points to vascular and hemodynamic
dysfunction as another contributing factor.
Yet, low CSF pressure as a potential risk
factor might explain why some patients develop glaucoma at lower IOPs than others.
The future of glaucoma holds considerable promise of new horizons on both the
diagnostic and therapeutic sides of this increasingly common disease. However, the
future will also entail an increasingly more
common discussion of non-IOP risk factors,
whether those factors can be modified or
not. The notion of CSF pressure and its relationship with glaucoma, at the very least,
continues a conversation about glaucoma
as a neurological disease and not something contained solely within the eyes.
REFERENCES
1. Yu L, Xie L, Dai C, Xie B, Liang M. Progressive
thinning of visual cortex in primary open-angle
glaucoma of varying severity. PLoS One. 2015 Mar
27;10(3):e0121007.
2. Dai Y1, Sun X, Yu X, et al. Astrocytic responses
in the lateral geniculate nucleus of monkeys with
experimental glaucoma. Vet Ophthalmol. 2012
Jan;15(1):23-30.
3. Jonas JB, Wang N. Cerebrospinal fluid pressure
and glaucoma. J Ophthal Vis Res. 2013 Jul;8(3):
257-263.
4. Brandt JD, Beiser JA, Kass MA, et al. Central
corneal thickness in the Ocular Hypertension
Treatment Study (OHTS). Ophthalmology. 2001
Oct;108(10):1779-88.
[email protected]
#&"1'*"'
% long
days
'#!$'%#!#%'#%
long-term
eye health.
For patients who wear their lenses intensely*
and put a priority on the long-term health of their eyes
/!!!&'!("#"#''#%""+ !"!," "&+"'%'#"'#!0%(+0
%"#"''"&&nearly invisible'#'+'& / " +&#*"'##!$% '#'"'(% +#"#!#%'"
#!&(%&##( % ''%+&# +*%2
/&' ) # #"†§) "#"'' "&
PVP=polyvinylpyrrolidone.
*Intense wear=Patients who wear lenses ≥14 hours a day, ≥5 days a week.
‡
Comparable to no lens wear on comfort and 5 out of 6 measures of ocular health (limbal hyperemia, corneal vascularization, corneal staining, bulbar conjunctival hyperemia, and papillary
conjunctivitis. The sixth measure was conjunctival staining.)
ACUVUE® Brand Contact Lenses are indicated for vision correction. As with any contact lens, eye problems, including corneal ulcers, can develop. Some wearers may experience mild
irritation, itching or discomfort. Lenses should not be prescribed if patients have any eye infection, or experience eye discomfort, excessive tearing, vision changes, redness or other eye
problems. Consult the package insert for complete information. Complete information is also available by visiting acuvueprofessional.com or by calling 1-800-843-2020.
†
Helps protect against transmission of harmful UV radiation to the cornea and into the eye.
§
WARNING: UV-absorbing contact lenses are NOT substitutes for protective UV-absorbing eyewear such as UV-absorbing goggles or sunglasses, because they do not completely cover the
eye and surrounding area. You should continue to use UV-absorbing eyewear as directed. NOTE: Long-term exposure to UV radiation is one of the risk factors associated with cataracts.
Exposure is based on a number of factors such as environmental conditions (altitude, geography, cloud cover) and personal factors (extent and nature of outdoor activities). UV-blocking
contact lenses help provide protection against harmful UV radiation. However, clinical studies have not been done to demonstrate that wearing UV-blocking contact lenses reduces the risk of
developing cataracts or other eye disorders. Consult your eye care practitioner for more information.
Reference: 1. Morgan PB, Chamberlain P, Moody K, Maldonado-Codina C. Ocular physiology and comfort in neophyte subjects fitted with daily disposable silicone hydrogel contact lenses.
Cont Lens Anterior Eye. 2013;36(3):118-125. Study conducted over 365 days.
ACUVUE®, 1-DAY ACUVUE® TruEye®, and HYDRACLEAR® are trademarks of Johnson & Johnson Vision Care, Inc.
Third-party trademarks used herein are trademarks of their respective owners.
© Johnson & Johnson Vision Care, Inc. 2015
ACU-10352273-D
June 2015
16
Primary Care
July 2015
|
Creating culturally competent care
Doctors and staff must understand the forces at work outside the exam room
By edwin c. Marshall, OD, Ms,
MPH, fAAO
Accepting the cultural
realities of your practice
Optometrists are educated in what
n the 4th century BC, Hippocrates
we consider to be the traditional
understood that illness has—in
constructs of health and illness.
addition to its biomedical conHowever, many of our patients
text—an environmental, social, and
today may subscribe to a differbehavioral context.1 Today, we unent “traditional” construct that deEDWIN C.
derstand that access to vision and
fines their needs, informs their perMARSHALL, OD,
eye care can be influenced by a
ceptions of health and illness, and
MS, MPH, FAAO,
variety of non-biomedical factors,
establishes
their attitudes toward
is professor emeritus
including health literacy, language,
seeking and receiving health care.
of optometry and
public health at
race and ethnicity, patient percepWhat is considered traditional or
Indiana University.
tions, trust, and cultural values and
usual in one culture may be conbeliefs.2 Both patients and optomsidered non-traditional or alternative in another culture. Our biomedical
etrists are more likely today to bring to the
construct may associate a certain morbidity
clinical encounter a complex cross-cultural
to a biomedical etiology—such as a metaarray of attitudes, customs, preferences,
bolic dysfunction or bacterial infection—
assumptions, expectations, practices, and
whereas a cultural construct may attribute
fears that help decode experiences, form
the same illness to spiritual imbalance, maperspectives, influence decisions, and drive
levolent spirits, susto (loss of soul), mal de
behavior.
ojo (evil eye), punishment, the wind, fatalism, or God’s will.
Why understand culture
Similarly, the reliance on traditional
Having an understanding of cultural norms
practices—such as healing rituals, prayer,
can help identify and mitigate many of the
meditation, herbs, massage, coining, and
cultural barriers that negatively impact qualcupping—may be more of a cultural norm
ity and perpetuate disparities in health and
than the willing acceptance of some biohealth care, especially among racial and
medical therapies, such as the long-term
ethnic populations who frequently are at
use of medications for chronic conditions
increased risk for certain ocular morbidilike open-angle glaucoma. Cultural beliefs,
ties like glaucoma and diabetic retinopalike the belief that talking about a specific
thy. With the racial and ethnic population
illness will cause the illness to occur, could
in the U.S. expected to increase from 37
present roadblocks to effective and efficient
percent to 57 percent by the year 2060, the
patient-doctor communication. Likewise,
need for cultural competency as a compounderestimating the role of the extended
nent of quality health care becomes more
compelling each day.3
Each of us represents a blend of cultures
that are conditioned by the collective and
diverse experiences of our age, race, ethnicity, gender, sexual orientation, education,
religion, socioeconomic status, geographic
– Showing respect when addressing the patient by
residence, and even our occupation or prousing the patient’s title and family name (e.g., Señor
fession. Cultural diversity can introduce an
Gonzalez) and not the first name (respecto)
unexpected dimension into the traditional
– Taking a personal and friendly approach (personalbiomedical paradigm of ophthalmic care.
ismo) to appreciating how cultural perspectives can
Conflicts can arise and interpersonal relainfluence patient perceptions about the diagnosis and
tionships can suffer when cultural-based
treatment of ocular conditions
dynamics clash. Such conflicts in health
– Considering patient perceptions and traditions
care can adversely affect communication,
(curanderismo) as helpful guides to clinical decisions
understanding, compliance, satisfaction,
– Maintaining a professional appearance in and of the
and ultimately the opportunity to achieve
office (esmero)
the most optimal health outcomes.
I
Keys to culturally
competent care
magenta
cyan
yellow
black
TAKE-HOME MESSAGE Cultural
perspectives about health and illness can
influence patient behavior and impact quality
of care. More today than ever before it is
important for optometrists to understand
and respect the cultural perspectives of their
patients in adapting care that is clinically, culturally, and linguistically appropriate. Cultural
competence is an attribute of patient-centered
care that helps build concordance between
the cultural traditions of the patient and the
biomedical traditions of the optometrist.
family in discussions, decision making, and
therapeutic care (familismo) could create
unforeseen challenges, such as reconciling
patient privacy with the decision-making
traditions of family-centered care. It is critically important that optometrists be nonjudgmental in accepting the cultural realities of their practices—that the diversity of
perceptions and beliefs about health and
illness are potential quality-of-care issues
that can impact both the delivery of services and their clinical outcomes.
Non–English-speaking patients
With 21 percent of the U.S. population aged
5 years and over currently speaking a language other than English at home, linguistic competence becomes an integral aspect
of the cultural competence paradigm.4 The
enhanced National Standards on Culturally and Linguistically Appropriate Services
(CLAS), published by the U.S. Office of Minority Health, target cultural and linguistic
barriers to healthcare delivery.
For example, the CLAS standards call for
competent language assistance and recommend against the use of untrained persons
and/or minors as ad hoc interpreters for
patients who have limited English proficiency and/or other communication needs.
The CLAS guidelines also call for the use
of multilingual print and multimedia materials and signage that would be easily
understood by patients who have limited
English ability.
Responding to a congressional directive,
the National Eye Institute launched the Nasee Cultural care on page 18
ES632980_OP0715_016.pgs 06.23.2015 23:58
ADV
Broad Managed
Care Coverage1
THE NUMBER OF DAILY DOSES DECLINES,
BUT THE EFFICACY DOESN’T
Once-daily post-op dosing when you're managing
patients after cataract surgery.
ILEVRO® Suspension dosed once daily post-op has been
shown to be noninferior to NEVANAC® (nepafenac ophthalmic
suspension) 0.1% dosed three times daily for the resolution
of inflammation and pain associated with cataract surgery.2,3
One drop of ILEVRO® Suspension should be applied once
daily beginning 1 day prior to cataract surgery through
14 days post-surgery, with an additional drop
administered 30 to 120 minutes prior to surgery.2
Use of ILEVRO® Suspension more than 1 day prior to
surgery or use beyond 14 days post-surgery may increase
patient risk and severity of corneal adverse events.2
Available in 1.7 mL and new 3 mL fill sizes
INDICATIONS AND USAGE
ILEVRO® Suspension is a nonsteroidal, anti-inflammatory prodrug
indicated for the treatment of pain and inflammation associated with
cataract surgery.
IMPORTANT SAFETY INFORMATION
Contraindications
ILEVRO® Suspension is contraindicated in patients with previously
demonstrated hypersensitivity to any of the ingredients in the formula
or to other NSAIDs.
Warnings and Precautions
6*.!/! (!! %*#%)!8%0$/+)!*+*/0!.+% (*0%%*9))0+.5
drugs including ILEVRO® Suspension there exists the potential
for increased bleeding time. Ocularly applied nonsteroidal antiinflammatory drugs may cause increased bleeding of ocular tissues
(including hyphema) in conjunction with ocular surgery.
6!(5! !(%*#8+,%(*+*/0!.+% (*0%%*9))0+.5 .1#/
(NSAIDs) including ILEVRO® Suspension may slow or delay healing.
Concomitant use of topical NSAIDs and topical steroids may increase
the potential for healing problems.
6+.*!(""!0/8/!+"0+,%(/)5.!/1(0%*'!.0%0%/
In some patients, continued use of topical NSAIDs may result in
!,%0$!(%(.!' +3*+.*!(0$%**%*#+.*!(!.+/%+*+.*!(
1(!.0%+*+.+.*!(,!."+.0%+*$!/!!2!*0/)5!/%#$0
threatening. Patients with evidence of corneal epithelial
.!' +3*/$+1( %))! %0!(5 %/+*0%*1!1/!
Patients with complicated ocular surgeries, corneal denervation,
corneal epithelial defects, diabetes mellitus, ocular surface
diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat
ocular surgeries within a short period of time may be at increased
.%/'"+.+.*!( 2!./!!2!*0/3$%$)5!+)!/%#$00$.!0!*%*#
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/!)+.!0$* 5,.%+.0+/1.#!.5+.1/!!5+* 5/
,+/0/1.#!.5)5%*.!/!,0%!*0.%/'* /!2!.%05+"+.*!(
adverse events.
6+*00!*/!.8® Suspension should not be
administered while using contact lenses.
Adverse Reactions
$!)+/0".!-1!*0(5.!,+.0! +1(. 2!./!.!0%+*/"+((+3%*#
0.0/1.#!.5+1..%*#%*,,.+4%)0!(50++",0%!*0/
were capsular opacity, decreased visual acuity, foreign body sensation,
%*.!/! %*0.+1(.,.!//1.!* /0%'5/!*/0%+*
For additional information about ILEVRO® Suspension, please refer
to the brief summary of prescribing information on adjacent page.
References: 1. Formulary data provided by Pinsonault Associates, LLC, PathfinderRx, June 2014.
2. ILEVRO® Suspension prescribing information. 3. NEVANAC® Suspension prescribing information.
For more resources for eye care professionals,
visit MYALCON.COM/ILEVRO
®
© 2014 Novartis
7/14
ILV14058JAD
18
Primary Care
Cultural care
Continued from page 16
tional Eye Health Education Program, which
provides culturally and linguistically appropriate, evidence-based materials for eyecare
professionals. (Available at: http://www.
nei.nih.gov/nehep)
JULY 2015
More resources
The concept of cultural and linguistic competency in health care is not new. In setting goals for the “preferred future” of the
optometric profession, the 2007 Optometry
2020 Summit called for optometrists and
their staff to have the knowledge, skills,
and attitude to serve patients of different
times human plasma exposure at the recommended human topical
ophthalmic dose for rats and 20 and 180 times human plasma
exposure for rabbits, respectively. In rats, maternally toxic doses ≥10
mg/kg were associated with dystocia, increased postimplantation
loss, reduced fetal weights and growth, and reduced fetal survival.
Nepafenac has been shown to cross the placental barrier in rats.
There are no adequate and well-controlled studies in pregnant
women. Because animal reproduction studies are not always
predictive of human response, ILEVRO® Suspension should be used
during pregnancy only if the potential benefit justifies the potential
risk to the fetus.
BRIEF SUMMARY OF PRESCRIBING INFORMATION
INDICATIONS AND USAGE
ILEVRO® Suspension is indicated for the treatment of pain and
inflammation associated with cataract surgery.
DOSAGE AND ADMINISTRATION
Recommended Dosing
One drop of ILEVRO® Suspension should be applied to the affected
eye one-time-daily beginning 1 day prior to cataract surgery,
continued on the day of surgery and through the first 2 weeks of the
postoperative period. An additional drop should be administered 30
to 120 minutes prior to surgery.
Use with Other Topical Ophthalmic Medications
ILEVRO® Suspension may be administered in conjunction with other
topical ophthalmic medications such as beta-blockers, carbonic
anhydrase inhibitors, alpha-agonists, cycloplegics, and mydriatics.
If more than one topical ophthalmic medication is being used, the
medicines must be administered at least 5 minutes apart.
CONTRAINDICATIONS
ILEVRO® Suspension is contraindicated in patients with previously
demonstrated hypersensitivity to any of the ingredients in the
formula or to other NSAIDs.
WARNINGS AND PRECAUTIONS
Increased Bleeding Time
With some nonsteroidal anti-inflammatory drugs including ILEVRO®
Suspension, there exists the potential for increased bleeding time
due to interference with thrombocyte aggregation. There have been
reports that ocularly applied nonsteroidal anti-inflammatory drugs
may cause increased bleeding of ocular tissues (including hyphemas)
in conjunction with ocular surgery. It is recommended that ILEVRO®
Suspension be used with caution in patients with known bleeding
tendencies or who are receiving other medications which may
prolong bleeding time.
Delayed Healing
Topical nonsteroidal anti-inflammatory drugs (NSAIDs) including
ILEVRO® Suspension, may slow or delay healing. Topical
corticosteroids are also known to slow or delay healing. Concomitant
use of topical NSAIDs and topical steroids may increase the potential
for healing problems.
Corneal Effects
Use of topical NSAIDs may result in keratitis. In some susceptible
patients, continued use of topical NSAIDs may result in epithelial
breakdown, corneal thinning, corneal erosion, corneal ulceration or
corneal perforation. These events may be sight threatening. Patients
with evidence of corneal epithelial breakdown should immediately
discontinue use of topical NSAIDs including ILEVRO® Suspension
and should be closely monitored for corneal health. Postmarketing
experience with topical NSAIDs suggests that patients with
complicated ocular surgeries, corneal denervation, corneal epithelial
defects, diabetes mellitus, ocular surface diseases (e.g., dry eye
syndrome), rheumatoid arthritis, or repeat ocular surgeries within
a short period of time may be at increased risk for corneal adverse
events which may become sight threatening. Topical NSAIDs should
be used with caution in these patients.
Postmarketing experience with topical NSAIDs also suggests that use
more than 1 day prior to surgery or use beyond 14 days post surgery
may increase patient risk and severity of corneal adverse events.
Non-teratogenic Effects.
Because of the known effects of prostaglandin biosynthesis inhibiting
drugs on the fetal cardiovascular system (closure of the ductus
arteriosus), the use of ILEVRO® Suspension during late pregnancy
should be avoided.
Nursing Mothers
ILEVRO® Suspension is excreted in the milk of lactating rats. It is not
known whether this drug is excreted in human milk. Because many
drugs are excreted in human milk, caution should be exercised when
ILEVRO® Suspension is administered to a nursing woman.
Pediatric Use
The safety and effectiveness of ILEVRO® Suspension in pediatric
patients below the age of 10 years have not been established.
Geriatric Use
No overall differences in safety and effectiveness have been observed
between elderly and younger patients.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
Nepafenac has not been evaluated in long-term carcinogenicity
studies. Increased chromosomal aberrations were observed
in Chinese hamster ovary cells exposed in vitro to nepafenac
suspension. Nepafenac was not mutagenic in the Ames assay or
in the mouse lymphoma forward mutation assay. Oral doses up
to 5,000 mg/kg did not result in an increase in the formation of
micronucleated polychromatic erythrocytes in vivo in the mouse
micronucleus assay in the bone marrow of mice. Nepafenac did not
impair fertility when administered orally to male and female rats at
3 mg/kg.
PATIENT COUNSELING INFORMATION
Slow or Delayed Healing
Patients should be informed of the possibility that slow or delayed
healing may occur while using nonsteroidal anti-inflammatory drugs
(NSAIDs).
Avoiding Contamination of the Product
Patients should be instructed to avoid allowing the tip of the
dispensing container to contact the eye or surrounding structures
because this could cause the tip to become contaminated by common
bacteria known to cause ocular infections. Serious damage to the eye
and subsequent loss of vision may result from using contaminated
solutions.
Use of the same bottle for both eyes is not recommended with topical
eye drops that are used in association with surgery.
Contact Lens Wear
ILEVRO® Suspension should not be administered while wearing
contact lenses.
Intercurrent Ocular Conditions
Patients should be advised that if they develop an intercurrent ocular
condition (e.g., trauma, or infection) or have ocular surgery, they
should immediately seek their physician’s advice concerning the
continued use of the multi-dose container.
Concomitant Topical Ocular Therapy
If more than one topical ophthalmic medication is being used, the
medicines must be administered at least 5 minutes apart.
Shake Well Before Use
Patients should be instructed to shake well before each use. U.S.
Patent Nos. 5,475,034; 6,403,609; and 7,169,767.
Contact Lens Wear
ILEVRO® Suspension should not be administered while using contact
lenses.
ADVERSE REACTIONS
Because clinical studies are conducted under widely varying
conditions, adverse reaction rates observed in the clinical studies of
a drug cannot be directly compared to the rates in the clinical studies
of another drug and may not reflect the rates observed in practice.
Ocular Adverse Reactions
The most frequently reported ocular adverse reactions following
cataract surgery were capsular opacity, decreased visual acuity,
foreign body sensation, increased intraocular pressure, and sticky
sensation. These events occurred in approximately 5 to 10% of
patients.
Other ocular adverse reactions occurring at an incidence of
approximately 1 to 5% included conjunctival edema, corneal edema,
dry eye, lid margin crusting, ocular discomfort, ocular hyperemia,
ocular pain, ocular pruritus, photophobia, tearing and vitreous
detachment.
Some of these events may be the consequence of the cataract
surgical procedure.
Non-Ocular Adverse Reactions
Non-ocular adverse reactions reported at an incidence of 1 to 4%
included headache, hypertension, nausea/vomiting, and sinusitis.
USE IN SPECIFIC POPULATIONS
Pregnancy
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exposure to nepafenac and amfenac was approximately 70 and 630
ALCON LABORATORIES, INC.
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© 2014 Novartis 7/14 ILV14058JAD
|
ethnicities, native languages, age, gender,
religions, and cultural backgrounds and to
be linguistically competent by providing
care in multiple languages and/or providing interpretation services.5
In 2008, the Association of Schools and
Colleges of Optometry (ASCO) approved
the ASCO Guidelines for Culturally Competent Eye and Vision Care to assist optometric institutions with preparing clinicians
to understand and respect diverse values,
beliefs, and expectations in addressing the
vision and eyecare needs of a multicultural
community.
In 2012, Transitions Optical introduced
the Transitions Cultural Connections initiative with a complimentary package of
multicultural resources for eyecare practitioners, which includes the recently released
consensus paper from its hosted roundtable discussion on the topic of improving
the eye health of culturally diverse populations. (Available at: http://www.mymulticulturaltoolkit.com)
The cultural competency
continuum
There is no cookbook or shortcut to cultural competence. It is a continuous and
progressive process. The cultural competence continuum involves a series of steps
from “cultural destructiveness” and “cultural incapacity” through “cultural blindness” and “cultural pre-competence” to
“cultural competence” and “cultural proficiency.”6 More simplistically, the continuum can be viewed as a progression from
“unconscious incompetence” in which there
is an absence of awareness of cultural differences to “unconscious competence” and
the ability to provide culturally appropriate care spontaneously.7
Culturally competent practitioners are
not expected to understand and respond to
every cultural aspect of every patient; they
are asked simply to challenge their own
cultural assumptions and preconceptions
while embracing a patient-centered culture
of care. The amalgam of knowledge, skills,
and attitudes that define cultural competence encompass both the clinician’s understanding of and respect for individual
patient values, beliefs, and needs and the
clinician’s awareness of her own values,
assumptions, and needs in adapting care
that is clinically, culturally, and linguistically appropriate.8
It is like looking at patients through their
cultural lens and integrating their perspectives into their personalized care.
| PRACTICAL CHAIRSIDE ADVICE
Benefits of cultural competency
According to a recent survey, 95 percent of
eyecare professionals believe that a good
understanding of a patient’s cultural background is constructive to a better patient
experience.9 Cultural competence:
Increases patient-doctor communication
and flow of diagnostic and therapeutic
information
Enhances interpersonal understanding
and trust
Facilitates greater patient access to and
timely use of appropriate healthcare
services
Creates opportunities for a more positive understanding of and compliance
with both traditional biomedical practices
as well as traditional cultural practices
Cultural competency improves the quality of the healthcare experience. Conversely,
culturally-blind care can lead to less than optimal and possibly negative outcomes among
diverse patient populations. The ultimate goal of optometric practice is
to provide quality healthcare practices and
achieve optimal eye and vision health for our
patients. While we provide the best clinical
care with the intention for quality in all cases,
the impact of our unconscious actions may
generate unintended consequences. Cultural
competence is a current day necessity for a
quality response to traditional healthcare
practices and to fostering patient-centered
climates of respect and trust for the values,
needs, and expectations of both the patient
and the doctor.
Primary Care
7. Campinha-Bacote, J. Many faces: addressing
diversity in health care. Online J Issues Nurs.
2003;8(1):3.
8. Mutha S, Allen C, Welch M. Toward Culturally
Competent Care: A Toolbox for Teaching
Communication Strategies. San Francisco, CA:
Center for the Health Professions, University of
California, San Francisco, 2002.
9. Online survey among a nationally representative
19
sample of 241 eye care professionals conducted by
Jobson Optical Research on behalf of Transitions
Optical, Inc. March 2014.
Dr. Marshall serves on the National Eye Health Education
Program Planning Committee of the National Eye Institute and
the Diversity Advisory Board of Transitions Optical, Inc.
[email protected]
As your dedicated partner in eye care
We Re-Envision Vision
REFERENCES
1. Lasker RD. Medicine & Public Health: The Power of
Collaboration. Committee on Medicine & Public Health.
New York, NY: The New York Academy of Medicine,
1997.
2. ORC/Macro. Identification of variables that influence
access to eye care: final report. National Eye Institute,
National Institutes of Health. July 28, 2005.
3. U.S. Census Bureau. U.S. Census Bureau projections
show a slower growing, older, more diverse nation a half
century from now. Available at: http://www.census.gov/
newsroom/releases/archives/population/cb12-243.
html. Accessed: 11/25/2014.
4. Ryan C. Language use in the United States: 2011.
U.S. Census Bureau, August 2013. Available at:
http://www.census.gov/prod/2013pubs/acs-22.pdf.
Accessed: 11/25/2014.
Meeting the need.
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increased number of patients diagnosed with retinal diseases. Regeneron is committed
to delivering targeted therapies that can impact your patients’ vision.
Learn more about our science to medicine approach at Regeneron.com.
5. American Optometric Association. Optometry 2020
Summit. 2007.
6. Cross TL, Bazron BJ, Dennis KW, et al. Towards a
Culturally Competent System of Care: A Monograph
on Effective Services for Minority Children Who Are
Severely Emotionally Disturbed. Washington, DC:
Georgetown University Child Development Center,
1989.
science to medicine is a registered trademark of Regeneron Pharmaceuticals, Inc.
©2015, Regeneron Pharmaceuticals, Inc.,
777 Old Saw Mill River Road, Tarrytown, NY 10591
All rights reserved
02/2015
RGN-0271
Case Report
20
JULY 2015
Neuropathy
Continued from page 1
that time, but one week later, he presented to the emergency room with
a headache and dizziness. He was
not currently taking any medications
but reported previous medical treat- PIERCE
ment one year prior for hypertension, KENWORTHY, OD
is a graduate of the
which was discontinued due to fi- Arizona College of
nancial constraints. The patient de- Optometry.
nied smoking and alcohol. His ocular
history was unremarkable, and his
family medical and ocular histories
were non-contributory. No allergies
were reported.
At the initial hospital visit, the patient’s blood pressure was significantly elevated at 212/115 mm Hg.
BRUCE ONOFREY,
CT, MRI, and blood work were or- OD, RPH, FAAO
dered and all returned normal for is clinical professor
his age. During his four-day hospital at the University of
stay, the patient was assessed by an Houston College of
ophthalmologist with pertinent find- Optometry.
ings including an afferent pupillary
defect (APD) of the left eye, normal
2
right optic nerve head (ONH), 3+ edema
ity of J10 in the left eye, compared
to J7 near acuity in the right. Distance acuity was not assessed due
to convenience testing in a hospital
setting. The plan at discharge was
to initiate antihypertensive treatment with amlodipine (Norvasc,
Pfizer), hydralazine (Apresoline,
Novartis), and lisinopril (Prinivil,
Merck). He was then instructed to
return in one week for a dilated
fundus exam and visual field.
The patient did not return to the
hospital but instead arrived at the
University Eye Institute 10 days after
discharge, complaining of a persistent inferior nasal shadow in the vision of his left eye. He reported good
compliance with clonidine (Kapvay,
Concordia) 0.1mg tid, hydralazine
(generic only) 100 mg tid, Lisinopril
(Prinivil, Merck) qam, and aspirin
81 mg bid. Blood pressure was measured at 140/105 mm Hg in-office
|
TAKE-HOME MESSAGE Non-arteritic anterior ischemic optic neuropathy (NA-AION) is
the most common type of ischemic optic neuropathy and results from non-perfusion of the
posterior ciliary blood supply to the optic nerve
head. Classic symptoms of anterior ischemic
optic neuropathy include sudden, painless, mild
to severe vision loss, inferior altitudinal field
defect and optic disc edema, which usually
resolves spontaneously in about two months
and is replaced by sectoral or more often
generalized optic atrophy. Few treatments are
available, but many systemic risk factors such
as hypertension can be treated to help prevent
the visual sequelae associated with NA-AION.
with an arm cuff.
Best-corrected visual acuity (BCVA) at
distance was 20/20 OD and 20/30 OS. Slit
lamp examination was unremarkable, reSee Neuropathy on page 22
AION results from
non-perfusion of
the posterior ciliary
blood supply to the
optic nerve head
of the left ONH, normal right eye confrontation visual fields (CVF), nasal field loss
both superior and inferior of the left eye
assessed with CVF, and reduced near acu-
1
Figure 1. Fundus photograph ONH edema
secondary to NA-AION.
Figure 2. 30-2 Humphrey Visual Field SITA Standard Inferior altitudinal defect explains inferior nasal shadow in
patient’s vision OS.
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22
Case Report
Neuropathy
Continued from page 20
vealing both conjunctiva were clear and
quiet, both corneas were clear, the anterior
chambers were free of cells and flare, and
the iris was flat and intact.
Fundoscopy revealed clear crystalline
lenses in both eyes as well as clear vitreous. The macula was flat with even pigment and showed a positive foveal reflex
OU. The optic nerve head of the right eye
appeared normal, but the left eye showed
optic nerve head edema, with the superior
portion of the nerve affected more than the
inferior portion (see Figure 1). Both eyes
demonstrated mild arteriovenous nicking
of the blood vessels.
Humphrey visual fields were overall normal in the right eye and showed an inferior
altitudinal defect in the left eye, which respected the horizontal midline (see Figure 2).
Optical coherence tomography (OCT) demonstrated significant retinal nerve fiber layer
(RNFL) thickening of the left eye, particularly
JULY 2015
was 20/20 OD and 20/25-2 OS. The patient
had been recording his blood pressure at 5
p.m. every day for the previous four weeks
and continued his antihypertensive treatment regimen. Blood pressure was measured
in office at 118/90 mm Hg. The edema of
40%
of patients show spontaneous improvement of up to
three lines of visual acuity
the left optic nerve head appeared almost
entirely resolved upon funduscopic examination (see Figure 6), but a 30-2 Humphrey
visual field indicated that the inferior altitudinal field loss remained (see Figure 7).
OCT showed a decrease in retinal nerve
fiber layer (RNFL) thickness superior tem-
poral (see Figure 8), which corresponded
with a GCC loss superior temporal as well
(see Figure 9). A 3-D visualization shows regression of swelling of the optic nerve head
compared to five weeks prior (see Figure 10).
The right eye was also assessed and determined to be stable and normal, with no
signs of NA-AION or other hypertensive
complications noted.
The patient was educated again regarding
the nature of his vision loss and the importance of continued blood pressure control
and management with his internist. He was
instructed to return for another dilated fundus exam in four months. That visit was still
pending at the time this report was prepared.
Discussion
The term “anterior ischemic optic neuropa-
3
Optic nerve size,
particularly a small
cup, has long been
thought to be a
risk factor for the
development of
NA-ION
superiorly (see Figure 3). The ganglion cell
complex (GCC) thickness was normal OD,
with possible thinning superior temporal
OS (see Figure 4). A 3-D visualization also
helped to view the extent of swelling of the
optic nerve head (see Figure 5).
The assessment at this visit was probable
non-arteritic anterior ischemic optic neuropathy with hypertension as a major risk factor. The patient was educated regarding the
likely permanent nature of his vision loss
and counseled regarding continued management of systemic risk factors. The patient
was instructed to continue blood pressure
management with his internist and return
for a follow-up dilated fundus exam in one
month for a repeat visual field.
Follow-up visit
He returned five weeks later reporting only
minimal improvement in his vision. BCVA
|
Figure 3. Cirrus OCT quantifying ONH edema OS near onset of NA-AION.
| PRACTICAL CHAIRSIDE ADVICE
4
Case Report
Figure 4. GCC
relatively normal at
onset of NA-AION.
23
thy” (AION) was coined by Sohan Singh Hayreh, MD, MS,
PhD, FRCS, FRCOphth, DSc, in 1974.1 It results from nonperfusion of the posterior ciliary blood supply to the optic
nerve head.2 Non-arteritic anterior ischemic optic neuropathy (NA-AION) is the most common type of ischemic optic
neuropathy and is the most common acute optic nerve disease of adults over age 50 years.7,8
See Neuropathy on page 24
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Figure 6. Fundus
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follow-up visit.
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24
Case Report
Neuropathy
JULY 2015
|
7
Continued from page 23
Though variations exist, classic symptoms of AION have been outlined by Dr.
Hayreh to include:
Sudden, painless visual deterioration
in one eye, usually discovered on waking in the morning
Visual acuity may vary from better than
20/20 to no light perception
Perimetry usually reveals relative or
absolute inferior altitudinal defect, inferior nasal sectoral defect or central
scotoma
Optic disc edema, which usually resolves
spontaneously in about two months and
is replaced by sectoral or more often
generalized optic atrophy.3
The research of Hoyt and his colleagues
from 1963-1974 provided insight into the
topographic localization of the optic nerve
fibers in monkeys by photocoagulating the
retinal nerve fibers. The ganglion cell defect
70%
of eyes treated with oral
corticosteroids showed improvement in visual acuity
may appear weeks after the initial ischemic
event, and it should correspond with a specific topographic region of the optic nerve
head where atrophy may be visualized.9-11
Though controversial, oral corticosteroids
have been proposed as one of the few treatment options available for NA-AION. In a
non-randomized cohort study of 613 eyes,
improvement in visual acuity was seen in
70 percent of treated eyes, whereas only 40
percent of untreated eyes showed improvement.5 Contrary to those findings, however,
other smaller studies have found no statis-
Figure 7. 30-2 Humphrey Visual Field SITA Standard, Inferior altitudinal defect persists at five-week follow-up visit.
development of NA-AION, but the resultant
after effect of an ischemic event on the size
of the optic nerve was not quantified until
recently. Hayreh and colleagues determined
that following an NA-AION, there was no
NA-AION generally remains stable, with
visual fields unlikely to show improvement,
but spontaneous improvement of up to
three lines of vision has been shown in up
to 40 percent of patients.
tically significant difference in visual acuity or visual fields between treated and untreated individuals.6
Optic nerve size, particularly a small cup,
has long been thought to be a risk factor for
statistically significant difference among the
cup-to-disc ratio, parapapillary atrophy, or
overall disc size between the affected eye
vs. the patient’s non-affected eye. This information provides the clinician with an
additional differentiation from other optic
nerve head disorders such as glaucoma.4
The previously presented case is interesting as it demonstrates NA-AION in a patient with uncontrolled high blood pressure.
There are also many cases of low blood pressure and development of NA-AION. Use of
phosphodiesterase five inhibitors (PDE5),
such as sildenafil (Viagra, Pfizer), has been
considered a possible risk factor because
the therapeutic dose has been shown to reduce blood pressure by at least 10 mm Hg,
thus producing systemic hypotension.5 One
retrospective study concluded that there is
a two-fold increase risk of NA-AION with
PDE5 use.6
A recent 2015 article summarized the natural course of NA-AION into the following
valuable points: NA-AION generally remains
stable, with visual fields unlikely to show
See Neuropathy on page 26
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Case Report
26
JULY 2015
|
8
9
Figure 8. Cirrus OCT five-week follow-up visit showing decrease in overall swelling with
more specific superior temporal RNFL loss OS.
Figure 9. GCC, decrease in ganglion cell thickness five weeks after
NA-AION.
Codes and Fees
FPS Exam
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Fundus Photo
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10
Figure 10. Cirrus OCT 3D visualization of ONH
edema resolution at five-week follow-up visit.
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Neuropathy
Continued from page 24
Conclusion
improvement, but spontaneous improvement
of up to three lines of vision has been shown
in up to 40 percent of patients. The optic
nerve head edema resolves and makes way
for pallor in six to 11 weeks following the
acute NA-AION episode. Lastly, within five
years of initial eye involvement, the fellow
contralateral eye was involved in 15 to 19
percent of patients.5
This case demonstrates an example of a patient who was living with untreated systemic
disease and whose first symptom of advancing hypertension was a visual field defect.
That symptom was followed by symptoms
of headache and dizziness, which finally
prompted a visit to the hospital. NA-AION
has an unknown etiology, but many risk
factors have been exhibited. Though a clini-
cian will often correlate NA-AION with low
blood pressure, nocturnal hypotension, and
medications used to treat erectile dysfunc-
15%
of patients experienced fellow contralateral eye involvement within 5 years
tion, the clinician must not forget that high
blood pressure is itself a major risk factor
| PRACTICAL CHAIRSIDE ADVICE
for the ischemic event.
Unfortunately, few options are available
for the treatment of NA-AION, but careful
co-management with primary-care doctors
and internists can have a profound impact
in treating the systemic diseases such as diabetes and hypertension that can contribute
to NA-AION development. In the case of this
49-year-old Hispanic male, the most valuable
treatment for his ocular condition was tight
blood pressure control.
REFERENCES
1. Hayreh SS. Anterior ischaemic optic neuropathy. I.
Terminology and pathogenesis. Br J Ophthalmol. 1974
Dec;58(12):955-63.
2. Hayreh SS. Ischemic optic neuropathy. Prog Retin Eye
Res. 2009 Jan;28(1):34-62
3. Hoyt WF. Anatomic considerations of arcuate scotomas
associated with lesions of the optic nerve and chiasm. A
nauta axon degeneration study in the monkey. Bull Johns
Hopkins Hosp. 1962 Aug;111:57–71.
Case Report
Dr. Kenworthy is currently a family practice resident at the
University of Houston College of Optometry and is joining
a private practice in the Houston Medical Center following
completion of residency. Dr. Onofrey is executive director of
continuing education programs at the University of Houston
College of Optometry.
[email protected]
[email protected]
27
INTERESTED IN MORE CASE
REPORTS?
Managing a partial thickness laceration
OptometryTimes.com/managinglaceration
Decreased vision on the left side leads to
hemianopia
OptometryTimes.com/visionhemianopia
HELP FOR YOUR PATIENTS WITH
Ocular Surface Disorders
4. Jonas JB, Hayreh SS, Tao Y, et al. Optic Nerve
Head Change in Non Arteritic Anterior Ischemic Optic
Neuropathy and Its Influence on Visual Outcome. PLoS
One. 2012;7(5):e37499.
5. Miller NR, Arnold AC. Current concepts in the
diagnosis, pathogenesis and management of nonarteritic
anterior ischaemic optic neuropathy. Eye (Lond). 2015
Jan;29(1):65–79.
6. Campbell UB, Walker AM, Gaffney M, et al. Acute
Nonarteritic Anterior Ischemic Optic Neuropathy and
Exposure to Phosphodiesterase Type 5 Inhibitors. J Sex
Med. 2015 Jan;12(1):139–51.
7. Hattenhauer MG, Leavitt JA, Hodge DO, et al. Incidence
of Nonarteritic Anterior Ischemic Optic Neuropathy. Am J
Ophthalmol. 1997Jan;123(1):103-7.
8. Hayreh SS. Anterior ischemic optic neuropathy:
differentiation of arteritic from non-arteritic type and its
management. Eye (Lond). 1990;4:25-41.
9. Hoyt WF, Luis O. Visual fiber anatomy in the
infrageniculate pathway of the primate. Arch Ophthalmol.
1962; 68:94–106.
10. Hoyt WF, Tudor RC. The course of parapapillary
temporal retinal axons through the anterior optic nerve. A
Nauta degeneration study in the primate. Arch Ophthalmol.
1963 Apr;69:503–7.
11. Hoyt WF, Kommerell G. Der Fundus oculi bei
homonymer Hemianopie. (Fundus oculi in homonymous
hemianopia). Klin Monbl Augenheilkd. 1973 Apr;162(4):
456–64.
ADDITIONAL RESOURCES
1. Hayreh SS, Joos KM, Podhajsky PA, et al. Systemic
diseases associated with nonarteritic anterior ischemic
optic neuropathy. Am J Ophthalmology. 1994 Dec
15;118(6);766-80.
2. Hayreh SS, Zimmerman MB. Non-arteritic anterior
ischemic optic neuropathy: role of systemic corticosteroid
therapy. Graefes Arch Clin Exp Ophthalmol. 2008
Jul;246(7):1029–46.
3. Rebolleda G, Perez-Lopez M, Casas-LLera P, et al. Visual
and anatomical outcomes of non-arteritic anterior ischemic
optic neuropathy with high-dose systemic corticosteroids.
Graefes Arch Clin Exp Ophthalmol. 2013 Jan;251(1):255–60.
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for one week to adapt to the lens
material and design. This adaptation phase was followed by four
weeks of daily lens wear of Air
Optix Colors and FreshLook, in
which each lens was worn in one
eye only, in a randomized contralateral eye design. Both lens types
had the same color pattern (color
Grey) and the Air Optix Colors contact lens was replaced after four
weeks and the FreshLook contact
lens after was replaced two weeks
(Figure 1). During each study visit,
visual acuity, subjective ratings,
and biomicroscopy data were collected. After 1, 13, and 27 days
of lens wear, study participants
completed a variety of subjective
ratings at home.
TAKE-HOME MESSAGE Air Optix Colors
cosmetic silicone hydrogel lenses were
compared to FreshLook ColorBlends lenses.
Overall, study participants preferred Air Optix
Colors for comfort and less dryness during
wear as well as visual acuity. This new lens
offers practitioners a silicone hydrogel lens
option for their patients interested in cosmetic
lens wear.
Study participants
Forty-seven participants were screened, of
which nine discontinued due to a variety
of non-study lens concerns, including discomfort with the FreshLook lens during the
screening visit, inconvenience, loss to followup, lens mix-up of OD/OS at the two-week
visit, or conjunctivitis. The mean age of the
remaining 38 participants included in the
2 day washout prior to screening
Screening and fitting
Dispense: Non-color lotrafilcon B (bilateral)
Air Optix Colors vs. FreshLook
Patient satisfaction and clinical performance
with the new cosmetic sihy lens were assessed in a clinical study comparing it to a
long-standing, successful conventional color
hydrogel lens, FreshLook ColorBlends, also
manufactured by Alcon. Ethics approval was
obtained through a Research Ethics Committee at the University of Waterloo prior
to the start of the study, and the study was
conducted following the tenets of the Declaration of Helsinki. RMANOVA and Tukey
Post-hoc comparisons were used for the analysis (p<0.05 was considered significant).
In this study, habitual soft lens wear-
1 week
adaptation
1 week assessment
1 month
color lens
wear
Dispense
Air Optix Colors, FreshLook
ColorBlends (contralateral)
2 week assessment
4 week assessment
Figure 1. Study flow chart
Subjective ratings:
Day 1, Day 13, Day 27
SPECIAL SECTI O N
| PRACTICAL CHAIRSIDE ADVICE
analysis was 29.7±10 years (ranging from
18 to 52 years) and included 34 female and
four male participants. At the final study
visit, six participants had a mix-up of OD/
OS lenses, and that data was not included
in the analysis. Figure 2 shows the appearance of the study lens on two participants
with different iris colors. Contact Lenses
2A
29
Figure 2. Example
image of a light green
eye (a) and a brown eye
(b) wearing Air Optix
Colors (color Grey for
both).
Visual acuity
High-contrast visual acuity (VA) at high illumination and low-contrast VA at high and
low illumination was measured at the dispensing visit and after two and four weeks
of cosmetic lens wear. After the assessment,
participants were asked to rate their satisfaction with vision using a 0-100 scale
(100=completely satisfied). Both lenses provided acceptable VA, and the subjective vi-
2B
Cosmetic lenses
are used more
commonly in Asia
than in the U.S. and
Europe
sion ratings reflected that (Figures 3 and 4).
For high-contrast VA, a difference between
lenses was found after four weeks of wear,
indicating that FreshLook performed marginally better compared to Air Optix Colors
(p=0.004), but this two-letter difference was
not considered clinically relevant (Figure 3).
Low-contrast VA ranged between +0.17 and
+0.19 logMAR with high illumination and
between +0.21 and +0.24 logMAR with low
illumination for both lenses with no differences found between lenses or over time (all
p>0.05). Overall satisfaction with vision at
high and low illumination was rated higher
with Air Optix Colors compared to FreshLook (p≤0.016); however, post-hoc comparisons indicated significant differences only
at the two-week visit (p≤0.02) (Figure 4).
Biomicroscopy findings
Biomicroscopy findings were clinically acceptable—no serious adverse events, either
related or unrelated to the study products occurred—and only one significant event was
noted (conjunctivitis). Corneal staining as
determined using the global staining score3
was overall slightly higher with FreshLook
compared to Air Optix Colors (p=0.037),
while the opposite was found for conjunctival staining (0-100 scale), which was mar-
ginally higher after wearing Air Optix Colors compared to FreshLook (p<0.001) (Figures 5 and 6). The eye wearing FreshLook
showed slightly more bulbar hyperaemia
compared to Air Optix Colors (p=0.002),
but this difference was negligible and not
of clinical significance. Palpebral conjunctival hyperemia and roughness were clinically normal between 22 and 31 units (0-100
scale), and no changes were seen throughout the study or between lenses (p>0.05).
Comfort and dryness ratings
Participants completed at-home ratings for
comfort and dryness on Days 1, 13, and 27
using a 0-100 scale (100=excellent comfort/
not dry at all). Ratings were completed following lens application, after four and eight
hours of lens wear, and prior to lens removal
(Figure 7). When combining all ratings, Air
Optix Colors was rated more comfortable
compared to FreshLook (p=0.002). As seen
in previous studies, lower comfort scores
were found at the end of the day (prior to
lens removal) compared to all other time
points (p<0.008).4,5 The comfort for Air Optix
Colors did not change over the four-week
study period; however, comfort ratings increased significantly for FreshLook, with
no difference between lens types on Day
27 (p>0.05).
Ocular dryness ratings followed a similar trend compared to the comfort results,
indicating that both lenses felt drier toward
the end of the day. It was not surprising to
find similar results for comfort and dryness ratings because this has been shown
previously.6 On Day 1 and Day 13, participants rated Air Optix Colors less dry than
FreshLook (p<0.01), but they noted no difference on Day 27 (p>0.05).
See Cosmetic lenses on page 30
SPECIAL SECTI O N
30
JULY 2015
Contact Lenses
Cosmetic lenses
Continued from page 29
3
High contrast visual acuity
— high illumination
Peripheral vision and halo
During the four-week period, participants
were also asked to indicate whether their
|
0.00
Air Optix Colors
FreshLook ColorBlends
13%
of participants noted color
print on FreshLook; 0%
noted for Air Optix Colors
-0.02
-0.04
-0.06
LogMAR
peripheral vision was affected by the color
in the lens. The majority of participants
enrolled in this study had no previous experience with cosmetic lens wear, and an
impact in peripheral vision with at least
one lens was reported by 12 (32 percent)
participants after lens application on the
first day. On Day 27 prior to lens removal,
only four (13 percent) participants noted the
-0.08
-0.10
-0.12
See Cosmetic lenses on page 32
-0.14
IN BRIEF
ENGLEWOOD, CO—Ampio Pharmaceuticals announced that a recent study found Optina
(low-dose danazol) to be safe and offers
significant improvements in visual acuity as well as reductions in central retinal
thickness (CRT) in patients with diabetic
macular edema (DME) when given the optimal dose.
A review of a representative set of images of the eye from the trial identified
positive changes in Optina-treated patients
compared to placebo, including the reversal of complications such as cystic lesions
andsubretinal fluid.
Analysis revealed that 69 percent of the
patients in the study received a medication
that manages kidney-induced high blood
pressure. When this group received the optimal Optina dose, patients showed a sixletter improvement compared to placebo,
regardless of whether or not they previously had anti-VEGF eye injections. There
was a significant 34-micron reduction in
CRT over placebo. Sixty percent of these
eyes showed a restoration of at least one
line of vision compared to only 27 percent
of placebo.
Dispense
4
2 weeks
4 weeks
Subjective vision ratings
— high illumination
100
Air Optix Colors
FreshLook ColorBlends
90
Score
Ampio shares Optina
DME study results
-0.16
80
70
60
Dispense
2 weeks
4 weeks
Figures 3 and 4. High contrast visual acuity (logMAR; Figure 3) and subjective vision ratings (0-100 scale;
0=completely dissatisfied, 100=completely satisfied; Figure 4) were collected during each visit. * indicates statistically
significant differences. Vertical bars denote 95 percent confidence interval.
Superior Coverage for
Complete Dry Eye Relief
Fourth Generation Tear Film Enhancement
Improves Tear Film Stability | Decreases Ocular Discomfort | Reduces Ocular Surface Staining
For more information and to order, call (800) 233-5469 or visit www.ocusoft.com
Clinical Study Results as Published in Clinical Ophthalmology *
*
Ousler III, George, et al. “An evaluation of Retaine ophthalmic emulsion in the management of tear film stability and ocular surface staining in
patients diagnosed with dry eye.” Clinical Ophthalmology 9 (2015): 235-43. Web. 5 Feb. 2015.
© 2015 OCuSOFT, Inc., Rosenberg, TX 77471 USA
SPECIAL SECTI O N
32
JULY 2015
Contact Lenses
Cosmetic lenses
5
Continued from page 30
Participants rated
Air Optix Colors as
more comfortable
than FreshLook
ColorBlends
Corneal staining
500
Air Optix Colors
FreshLook ColorBlends
450
400
Global staining score (0 - 10 000)
color print in the periphery with FreshLook,
but no participant indicated this with Air
Optix Colors. It can be expected that lens
wearers who habitually wear clear lenses
may go through an adaptation period and
are likely to become less aware of the color
print over time.
Halo scores were rated by the participants on a 0-4 scale (0=no halo). In an at-
|
350
300
250
200
150
100
50
74%
of participants preferred
Air Optix Colors; the remainder had no preference
Colors and FreshLook, respectively. Both
lens types showed an improved halo score
over time between the dispensing visit and
the four-week visit (p<0.05).
Overall lens preference
Study participants were asked whether they
had a lens preference over the course of
the study (Figure 8). After lens application
on the first lens wear day, 74 percent (28)
of participants preferred Air Optix Colors,
and the remainder of the participants had
no preference; no one preferred FreshLook.
At the end of the four-week study period,
only one participant preferred FreshLook,
while all other participants had either no
preference (41 percent; 13) or preferred Air
0
Dispense
2 weeks
4 weeks
6
Conjunctival staining
40
Air Optix Colors
FreshLook ColorBlends
Conjunctival staining score
tempt to test this in the clinic, a small LED
light of moderate intensity was placed in
the center of a large, square, black chart.
Participants viewed this light at three meters under dim illumination and rated how
far the halo around the light spread using
four reference points of equal distance away
from the light source. Overall, subjective
halo scores for Air Optix Colors were significantly lower, compared to FreshLook,
indicating less halo disturbance with Air
Optix Colors (p<0.001). Ratings at the dispensing visit were 0.50 vs. 0.84 and 0.31
vs. 0.61 at the four-week visit for Air Optix
30
20
*
10
*
0
Dispense
2 weeks
4 weeks
Figures 5 and 6. Corneal staining (global staining score; Figure 5) and conjunctival staining (0-100 rating score;
Figure. 6) were assessed during each visit. * indicates statistically significant differences. Vertical bars denote 95
percent confidence interval.
Optix Colors (47 percent; 15). This shift in
preference suggests that participants took
longer to adapt to FreshLook, while no such
adaptation period was needed for Air Optix
Colors.
Conclusion
Participants preferred Air Optix Colors over
FreshLook and rated it more comfortable
and less dry. At the four-week visit, logSee Cosmetic lenses on page 34
REGISTER TODAY!
INTERNATIONAL VISION EXPO 2015
EDUCATION: WEDNESDAY, SEPTEMBER 16–SATURDAY, SEPTEMBER 19
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VisionExpoWest.com | #VisionExpo
PROUD SUPPORTER OF:
SPECIAL SECTI O N
34
JULY 2015
Contact Lenses
Cosmetic lenses
Continued from page 32
MAR acuity was marginally lower with Air
Optix Colors compared to FreshLook; however, participants rated visual satisfaction
Participants found
color lens adapation
time shorter for Air
Optix Colors
7
|
Subjective comfort ratings
100
DAY 1
DAY 13
DAY 27
95
90
85
80
Research funded by Alcon; editorial and
financial support for this article provided
by Alcon.
The authors want to thank Drs. Ping Situ,
Amir Moezzi and Krithika Nandakumar for
helping with the data collection in this study.
75
Air Optix Colors
FreshLook ColorBlends
70
8
Removal
Lens preference
100
2. Snyder C. A primer on contact lens materials. Contact
Lens Spectrum. 2004;19(2):34-9.
Air Optix Colors
No preference
80
3. Sorbara L, Peterson R, Woods C, Fonn D.
Multipurpose disinfecting solutions and their interactions
with a silicone hydrogel lens. Eye Contact Lens. 2009
Mar;35(2):92-7.
FreshLook ColorBlends
Invalid/missing data
%
60
40
5. Fonn D, Situ P, Simpson T. Hydrogel lens dehydration
and subjective comfort and dryness ratings in
symptomatic and asymptomatic contact lens wearers.
Optom Vis Sci. 1999 Oct;76(10):700-4.
20
6. Fonn D, Dumbleton K. Dryness and discomfort with
silicone hydrogel contact lenses. Eye Contact Lens.
2003 Jan;29(1 Suppl):S101-4; discussion S15-8, S92-4.
val
mo
rs
Re
rs
8h
er
Aft
4h
er
ert
ins
27
Re
Da
y
Aft
ion
val
mo
rs
rs
4h
8h
er
Aft
er
ion
ert
ins
13
Da
y
Aft
val
mo
rs
Re
rs
8h
er
Aft
4h
er
Aft
y1
ins
ert
ion
0
Da
Dr. Luensmann is a clinical scientist Centre for Contact Lens
Research, School of Optometry and Vision Science, University
of Waterloo, Canada. Dr. Jones is director of the Centre
for Contact Lens Research, School of Optometry and Vision
Science, University of Waterloo, Canada.
[email protected]
[email protected]
8 hours
Figure 7. Subjective ratings for lens comfort were completed at home using a 0-100 scale 0 = completely
dissatisfied, 100 = completely satisfied. Participants rated their lenses 4x on the first lens wear day (Day 1) and on
the days prior to each assessment visit (Days 13 and 27). * indicates statistically significant differences. Vertical bars
denote 95 percent confidence interval.
REFERENCES
1. Morgan PB, Woods C, Tranoudis IG, Helland M, Efron
N, Teufl M, et al. International Contact Lens Prescribing in
2013. Contact Lens Spectrum. 2014;29(January):30-5.
4. Varikooty J, Keir N, Richter D, Jones LW, Woods C,
Fonn D. Comfort response of three silicone hydrogel
daily disposable contact lenses. Optom Vis Sci. 2013
Sep;90(9):945-53.
4 hours
Insertion
Removal
8 hours
4 hours
Insertion
Removal
4 hours
8 hours
65
Insertion
higher with Air Optix Colors. Both contact
lenses were clinically acceptable as determined by biomicroscopy. Because color contact lens wear was new to most study participants, they were more aware of the color
in their lenses and experienced minor halo
appearances at the beginning of the study;
however, the adaptation time for Air Optix
Colors was typically shorter compared to
FreshLook.
Figure 8. Subjective ratings of lens preference completed at home on Days 1, 13, and 27 of lens wear. Ratings were
completed immediately after lens application, after four and eight hours of lens wear, and prior to lens removal.
| PRACTICAL CHAIRSIDE ADVICE
InDispensable
35
Skechers Eyewear releases 2015 Kids collection
SOMERVILLE, NJ—Marcolin USA recently
debuted the Skechers Eyewear
2015 Kids collection, just in time
for families preparing for back to
school.
The new collection consists of 10
new optical styles with a blend of
fun and sporty accents.
Marcolin says this collection is
perfect for today’s kids who are
driven by brand awareness.
Highlights from the girls’ collection include stud and stone embellishments with denim-patterened
finishes on styles like SE1569 and
SE1570, seen at left, which are
both crafted in acetate.
The new optical styles for boys
are designed with today’s boys’
active lifestyle with sporty rubber
accents and tech materials.
The addition of aluminum 180-degree spring hinged temples on
SE1092, seen at left, and SE1093
provides flexibility.
An epoxy-filled SKECHERS
“SPX” logo treatment adds color to
the temples that are equipped with
rubberized tips for added comfort
and support.
SE1569
SE1570
SE1092
Coburn Technologies introduces SGX Pro Generator
SOUTH WINDSOR, CT—Coburn Technologies recently introduced and begun shipments of
its latest generation surface generator, SGX
PRO.
The SGX Pro is equipped with new
electronics and operating on a Windows 7
platform. According to Coburn, this generator’s touch screen interface and USB capabilities makes lens processing easier. Like
its predecessor, SGX Plus, the SGX Pro
generator delivers high performance,dry-cut
milling technology for processing Trivex,
CR39, polycarbonate, and high-index
lenses.
The SGX Pro is the fourth generation of
the SGX series of generators. According
to Coburn, SGX Pro has one of the widest
curve ranges on the market and has been
proven to provide the same dependability
and accuracy of earlier SGX models.
Coburn has discontinued production of
its SGX Plus generator at its world headquarters assembly plant.
The company will continue to provide
support and service to existing SGX Plus
generators and, in addition, offer an SGX
Pro upgrade kit for users looking to update
that equipment.
See InDispensable on page 36
36
InDispensable
JULY 2015
|
Kenneth Cole releases Spring/Summer 2015 collection
NEW YORK CITY—Kenneth Cole recently released its Spring/Summer 2015
collection.
The latest collection featues optical and sun styles for both men
and women in a range of sophisticated shapes and sizes inspired by
the urban lifestyle of the brand.
The tones of the collection range from milky color palettes to gradient colorations. In addition to the four styles featured below, the collection also features seven additional styles, including one women’s
sun style, three men’s sun styles, one women’s optical style, and two
men’s optical styles.
KC0226 is a women’s optical style
with a sleek metal profile with two-tone
colorations and crafted stainless steel.
It is complete with textured temples and
enhanced by a raised metal border. Color
combinations include satin black, brown, or
burgundy with gold or satin navy with silver.
KC0230 is a men’s optical style with
a modified rectangular profile and updated metal temple detail. This style is
offered in several colors, including soft
gradient fades, including grey to brown
and blue to brown, as well as solid matte
black.
KC7170 is a women’s sun style that features flat metal styling coupled with sleek
acetate temples adorned with clean metal
detailing. Shiny hematite-colored temples
are paired with shiny gold or shiny burgundy
metal fronts or offered in a contrasting shiny
black/shiny gold option, combined with gradient or smoke-colored lenses.
KC7173 is a men’s sun style that offers
an iconic screw and metal wrap-around detail accents the front of this handmade acetate frame. This style is offered in a neutral
palette ranging from black fade to tortoise,
translucent grey or translucent stone, and
shiny black.
See InDispensable on page 42
JULY 2015 / OptometryTimes.com
Go to:
37
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JULY 2015 / Optometry Times
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Alcon Laboratories Inc
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Ocusoft
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Regeneron Pharmaceuticals
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TTI Medical
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Q&A
| PRACTICAL CHAIRSIDE ADVICE
Agustin Gonzalez, OD, FAAO, ABCMO
41
Clinic director of Eye & Vision, Richardson, TX
Owl vision, generic vs. branded, going to private practice
How did you become interested in the vision of
Q
How did you
decide to go
into private
practice?
owls? When I was in optometry school, a Cornell professor came to visit. We studied
the refractory aspects of the
owl’s eyes. That fascinated
me because the eyes are simple yet complex organs—it’s
simple in the way it works
but very complex in the way
things have to happen for it
to work. I became very interested in that. Back then, it
was a big thing for me.
At one time I was managing a number of
Pearle Vision offices
in the Dallas area. As
with anything in retail,
you are the poster child
for how to do things
right and then you become the poster child
of part of the problem,
of not doing things the
way they wanted. So,
pressure mounted for
me to get rid of the operations, which I did.
That moment in time I
said I wanted to move
the largest into a private practice. There
was a moment there,
year number two,
where your amount of
commercial patients
starts dwindling down
because your prices
are going up, but your
amount of prior patients starts going up
because of the quality
of services you’re delivering. That happened
10 years ago, and I’ve
never looked back.
What sparked your interested in generic
Photo courtesy Agustin Gonzalez, OD, FAAO, ABCMO
meds? A long time ago, when
generic Tobradex hit the
market, I understood that it
wasn’t as effective as brandname Tobradex. So, I looked
more closely into what made
the products different. Then
with price increases in medications within the last five
years, it’s become a hot topic.
I realized that there is a big
gap between outcomes and
using the right medications.
That got me interested in the
biochemistry and molecular pharmacology of medications. I tell all my students
that just because a drug is
labeled by the FDA to be
in a category doesn’t mean
that they all work the same.
You have to find the unique
properties in the molecule
or formulation that are better suited for a particular patient, and that’s going to improve your clinical outcomes.
We all have great backgrounds in pharmacology—
we take more pharmacology hours than the MDs. But
if we do not discern how to
properly use a medication, it
becomes very difficult to attain the desired outcome.
sional. My first opera was
Rigoletto in Verona, and I’ve
seen it seven times.
Do you have any regrets?
I should have started
in private practice sooner.
I’ve been an optometrist
for 28 years, and I’ve been
in private practice for 10 of
those years. On the other
hand, if I didn’t go through a
cycle of commercial practice
or having worked in a hospital environment, there are a
lot of things I would not be
doing nowadays. You know,
I think no. I’ve had a good
path, I’ve had a good grip on
different modes of practice.
I think that I am in the moment of time where I should
be So, do I have any regrets?
No, not really.
What social media advice you have for ODs?
Get involved and learn the
nuts and bolts. Social media
is so personalized. Delegating social media to another
person is very inefficient.
In order for social media to
work, you need to understand your needs
and how to
voice them to
your patients.
Being able to
voice that
you’re the expert in this
particular
part of eye
What do you do for down
time? I’ve been a Dal-
las Opera season ticket holder
for about 12 years. My favorite opera is Iolanta. It’s about
a blind princess, so that’s one
that resonates for a profes-
To hear the full
interview with Dr.
Gonzalez, listen
online:
optometrytimes.com/
AgustinGonzalez
care is more effective than
delegating to somebody else.
What’s the craziest
thing you’ve ever done?
Have kids. [laughs] When
I was in college, we used
to cave dive in sink holes
in Florida to collect albino
crawfish. We would go out
about 120 feet, below sea
level, diving for these little boogers to collect for research. I grew up diving in
Puerto Rico, and at the time
we didn’t need certification.
More recently, I went zip lining in Puerto Rico on one of
the longest zip lines in the
world called Toro Verde or
“green bull.” For a guy who’s
not seeking adventure, I
enjoy tipping my hat every
once in a while.
—Vernon Trollinger
| PRACTICAL CHAIRSIDE ADVICE
InDispensable
42
ClearVision releases new kids styles
HAUPPAUGE, NY—ClearVision Optical introduces
its 2015 Kids Collection, featuring new
styles from Op Kids, Jessica McClintock for
Girls, and IZOD Boys.
The Jessica McClintock for Girls collec-
BRIEF SUMMARY
PAZEO (olopatadine hydrochloride ophthalmic solution)
0.7%.
For topical ophthalmic administration.
The following is a brief summary only; see full prescribing
information for complete product information.
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Contamination of Tip and Solution
As with any eye drop, care should be taken not to touch the
eyelids or surrounding areas with the dropper tip of the bottle
to prevent contaminating the tip and solution. Keep bottle
tightly closed when not in use.
Contact Lens Use
Patients should not wear a contact lens if their eye is red.
The preservative in PAZEO solution, benzalkonium chloride,
may be absorbed by soft contact lenses. Patients who wear
soft contact lenses and whose eyes are not red, should be
instructed to wait at least five minutes after instilling PAZEO
before they insert their contact lenses.
ADVERSE REACTIONS
Clinical Trials Experience
Because clinical trials are conducted under widely varying
conditions, adverse reaction rates observed in the clinical
trials of a drug cannot be directly compared to rates in
clinical trials of another drug and may not reflect the rates
observed in practice.
In a randomized, double-masked, vehicle-controlled trial,
patients at risk for developing allergic conjunctivitis received
one drop of either PAZEO (N=330) or vehicle (N=169) in
both eyes for 6 weeks. The mean age of the population
was 32 years (range 2 to 74 years). Thirty-five percent were
male. Fifty-three percent had brown iris color and 23%
had blue iris color. The most commonly reported adverse
reactions occurred in 2-5% of patients treated with either
PAZEO or vehicle. These events were blurred vision, dry
eye, superficial punctate keratitis, dysgeusia and abnormal
sensation in eye.
USE IN SPECIFIC POPULATIONS
Pregnancy
Risk Summary
There are no adequate or well-controlled studies with
PAZEO in pregnant women. Olopatadine caused maternal
toxicity and embryofetal toxicity in rats at levels 1,080 to
14,400 times the maximum recommended human ophthalmic
dose (MRHOD). There was no toxicity in rat offspring at
exposures estimated to be 45 to 150 times that at MRHOD.
Olopatadine should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus.
Animal Data
In a rabbit embryofetal study, rabbits treated orally at 400
mg/kg/day during organogenesis showed a decrease in live
fetuses. This dose is 14,400 times the MRHOD, on a mg/m2
basis.
An oral dose of 600 mg/kg/day olopatadine (10,800 times the
MRHOD) was shown to be maternally toxic in rats, producing
death and reduced maternal body weight gain. When
administered to rats throughout organogenesis, olopatadine
produced cleft palate at 60 mg/kg/day (1080 times the
MRHOD) and decreased embryofetal viability and reduced
fetal weight in rats at 600 mg/kg/day. When administered
to rats during late gestation and throughout the lactation
period, olopatadine produced decreased neonatal survival at
tion, featured below, has transformed to a
more grown-up collection and is offered in
colorful styles, edgy eye shapes, translucent
and fade materials, and clean, sculpted
temples.
60 mg/kg/day and reduced body weight gain in offspring at 4
mg/kg/day. A dose of 2 mg/kg/day olopatadine produced no
toxicity in rat offspring. An oral dose of 1 mg/kg olopatadine
in rats resulted in a range of systemic plasma area under
the curve (AUC) levels that were 45 to 150 times higher
than the observed human exposure [9.7 ng∙hr/mL] following
administration of the recommended human ophthalmic dose.
Nursing Mothers
Olopatadine has been identified in the milk of nursing
rats following oral administration. Oral administration of
olopatadine doses at or above 4 mg/kg/day throughout the
lactation period produced decreased body weight gain in rat
offspring; a dose of 2 mg/kg/day olopatadine produced no
toxicity. An oral dose of 1 mg/kg olopatadine in rats resulted
in a range of systemic plasma area under the curve (AUC)
levels that were 45 to 150 times higher than the observed
human exposure [9.7 ng∙hr/mL] following administration
of the recommended human ophthalmic dose. It is not
known whether topical ocular administration could result
in sufficient systemic absorption to produce detectable
quantities in the human breast milk. Nevertheless, caution
should be exercised when PAZEO is administered to a
nursing mother.
Pediatric Use
The safety and effectiveness of PAZEO have been established in pediatric patients two years of age and older. Use of
PAZEO in these pediatric patients is supported by evidence
from adequate and well-controlled studies of PAZEO in
adults and an adequate and well controlled study evaluating
the safety of PAZEO in pediatric and adult patients.
Geriatric Use
No overall differences in safety and effectiveness have been
observed between elderly and younger patients.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity
Olopatadine administered orally was not carcinogenic in
mice and rats in doses up to 500 mg/kg/day and 200 mg/kg/
day, respectively. Based on a 35 μL drop size and a 60 kg
person, these doses are approximately 4,500 and 3,600 times
the MRHOD, on a mg/m2 basis.
Mutagenesis
No mutagenic potential was observed when olopatadine
was tested in an in vitro bacterial reverse mutation (Ames)
test, an in vitro mammalian chromosome aberration assay or
an in vivo mouse micronucleus test.
Impairment of fertility
Olopatadine administered at an oral dose of 400 mg/kg/day
(approximately 7,200 times the MRHOD) produced toxicity
in male and female rats, and resulted in a decrease in the
fertility index and reduced implantation rate. No effects
on reproductive function were observed at 50 mg/kg/day
(approximately 900 times the MRHOD).
PATIENT COUNSELING INFORMATION
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JMC4800
The Op Kids is inspired by the brand’s
tween/teen apparel and offers cool shapes
with a tropical beach vibe. The collection
has three new styles and features patterned
designs, like camouflage and colorblocking, along with metallic and mixed materials
styles.
The IZOD Boys collection offers sportinfused designs with racing-inspired accents and textures and pops of color. The
latest release features four new styles, two
of which offer memory metal bridges for enhanced durability.
JCM4802
What she’s really searching for
is comfort.
What happens when she looks at digital screens all day long?
She blinks 5 times less, her tear film is destabilized, and she
experiences dryness.1 HYDRACLEAR® PLUS Technology helps
stabilize the tear film by mimicking the eye’s natural mucins,
allowing her to live more of the digital life she wants.
It’s no wonder patients like her report ACUVUE OASYS® Brand
Contact Lenses has superior comfort vs Air Optix® Aqua and
Biofinity® after 8 hours on digital screens.
Provide exceptional performance for her digital life
with ACUVUE OASYS® Brand.
Reference: 1. Patel S, Henderson R, Bradley L, Galloway B, Hunter L. Effect of visual display unit use on blink rate and tear stability. Optom Vis Sci. 1991;68(11):888-892.
ACUVUE® Brand Contact Lenses are indicated for vision correction. As with any contact lens, eye problems, including corneal ulcers, can develop. Some wearers may experience mild
irritation, itching or discomfort. Lenses should not be prescribed if patients have any eye infection, or experience eye discomfort, excessive tearing, vision changes, redness or other eye
problems. Consult the package insert for complete information. Complete information is also available from Johnson & Johnson Vision Care, Inc., by calling 1-800-843-2020 or by visiting
www.acuvueprofessional.com.
ACUVUE®, ACUVUE OASYS®, and HYDRACLEAR® are trademarks of Johnson & Johnson Vision Care, Inc.
Third-party trademarks used herein are trademarks of their respective owners.
© Johnson & Johnson Vision Care, Inc. 2015
ACU-10337497-A
June 2015
INTRODUCING New Once-Daily
PAZEOTM Solution
24 HOURS OF OCULAR ALLERGY
ITCH RELIEF
IN ONE DROP
New Once-Daily PAZEO™ Solution
for relief of ocular allergy itch:
The first and only FDA-approved once-daily drop with
demonstrated 24-hour ocular allergy itch relief1
Statistically significantly improved relief of ocular itching
compared to PATADAY® (olopatadine hydrochloride
ophthalmic solution) 0.2% at 24 hours post dose
(not statistically significantly different at 30-34 minutes)1
Statistically significantly improved relief of ocular itching
compared to vehicle through 24 hours post dose1
Study design: Two multicenter, randomized, double-masked, parallel-group, vehicle- and
active-controlled studies in patients at least 18 years of age with allergic conjunctivitis using the
conjunctival allergen challenge (CAC) model (N=547). Patients were randomized to receive study
drug or vehicle, 1 drop per eye on each of 2-3 assessment days. On separate days, antigen challenge
was performed at 27 (±1) minutes post dose to assess onset of action, at 16 hours post dose (Study
1 only), and at 24 hours post dose. Itching scores were evaluated using a half-unit scale from
0=none to 4=incapacitating itch, with data collected 3, 5, and 7 minutes after antigen instillation.
The primary objectives were to demonstrate the superiority of PAZEO™ Solution for the treatment
of ocular allergy itch. Study 1: PAZEO™ Solution vs vehicle at onset of action and 16 hours. Study 2:
PAZEO™ Solution vs vehicle at onset of action; PAZEO™ Solution vs PATADAY® Solution, PATANOL®
(olopatadine hydrochloride ophthalmic solution) 0.1%, and vehicle at 24 hours.1-3
PAZEO™ Solution: Safety Profile
Give your patients 24 HOURS
OF OCULAR ALLERGY ITCH
RELIEF with once-daily
PAZEO™ Solution1
Well tolerated1
The safety and effectiveness of PAZEO™ Solution have been established in patients two years of age and older1
The most commonly reported adverse reactions, occurring in 2% to 5% of patients, were blurred vision, dry eye,
superficial punctate keratitis, dysgeusia, and abnormal sensation in eye1
Once-daily dosing1
INDICATION AND DOSING
PAZEO™ Solution is indicated for the treatment of ocular itching associated with allergic conjunctivitis. The recommended dosage
is to instill one drop in each affected eye once a day.
IMPORTANT SAFETY INFORMATION
As with any eye drop, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle to
prevent contaminating the tip and solution. Keep bottle tightly closed when not in use.
Patients should not wear a contact lens if their eye is red. PAZEO™ Solution should not be used to treat contact lens-related
irritation. The preservative in PAZEO™ Solution, benzalkonium chloride, may be absorbed by soft contact lenses. Patients
who wear soft contact lenses and whose eyes are not red should be instructed to wait at least five minutes after
instilling PAZEO™ Solution before they insert their contact lenses.
The most commonly reported adverse reactions in a clinical study occurred in 2%-5% of patients
treated with either PAZEO™ Solution or vehicle. These events were blurred vision, dry eye,
superficial punctate keratitis, dysgeusia, and abnormal sensation in eye.
For additional information on PAZEO™ Solution, please refer to the brief summary of
the full Prescribing Information on the following page.
References: 1. PAZEO™ Solution Package Insert. 2. Data on file, 2011. 3. Data on file, 2013.
From Alcon, committed to providing treatment options for patients.
Olopatadine is licensed from Kyowa Hakko Kirin Co., Ltd. Japan
© 2015 Novartis 5/15 PAZ15011JAD