Glaucoma - Modern medicine

Transcription

JANUARY 2016
VOL. 8, NO. 01
PRACTICAL CHAIRSIDE ADVICE
SPECIAL SECTION
Glaucoma
Understanding
drainage in surgery
Procedures and practices for postoperative care
BUBBLES
The
1
p a t i e n t s l o v e j u s t g o t e v e n b e t t e r.
7
Figure 1. Insertion of the tube into the anterior
chamber to increase aqueous outflow. Image courtesy Ike Ahmed, MD
Figure 7. Baerveldt Glaucoma Implant.
Image courtesy of Abbott Medical Optics.
By Barbara J. Fluder, OD
OptometryTimes.com
Top financial
obstacles facing
ODs in 2016
By Colleen E. McCarthy
Content Specialist
Each year brings its own challenges, and
2016 will be no different.
Optometry Times Editorial Advisory Board
member John Rumpakis, OD, MBA, and Bryan
Rogoff, OD, MBA,
CPHM, director
Introducing
theof doctor
strategy for Pearle Vision, share the chalnext level of lens care.
lenges they expect optometrists will encoun• Exclusive
ter in the coming
year. HydraGlyde
technology for
Last year, we spoke with Dr. Rogoff about
long-lasting moisture
this same subject. Some of the challenges we
• Unsurpassed
disinfection
predicted for 2015
will continue
into 2016—
1
like increasing•deductibles—while
Preservative free to be others,
more
like the ICD-10 transition,
will stay a thing
like natural tears
of the past. Thankfully, the ICD-10 transition wasn’t as traumatic as many predicted at
this time last year. While practitioners likely
invested in training and preparing for the
switch, the actual transition hasn’t caused
any major problems, says Dr. Rogoff.
®
See 2016 challenges on page 5
ODs battle UPP,
CA hiring laws
G
laucoma drainage devices are increasingly flowing in many glaucoma pracContent Specialist
tices. You may be familiar with laser
procedures,
including
The laws governing ODs across the country
Introduce glaucoma
your patients
to new
CLEARargon
CARE® PLUS formulated with the unsurpassed
laser trabeculoplasty, selective laser trabec-®
are constantly evolving, so it can be hard to
cleaning
andand
disinfection
CLEAR
CARE – and
exclusive
now with
be familiar
withour
these
devices and the rauloplasty,
micropulseof laser
trabeculokeep track of who
® can do what from state
CLEAR CARE PLUS
®
®
the device chosen.
This artiplasty. Trabeculectomy
is a commonly
per-softtionale
to state. New laws in one state can lay the
Moisture Matrix
to provide
lensesbehind
with long-lasting
moisture.
HydraGlyde
formulated
with
cle describes what each device is, how they
formed filtering surgery as well.
groundwork for similar changes in another.
Ask your Alcon rep for more information or learn more at CLEARCARE.com.
work, complications, and postoperative care.
But, you may not know the differences
“Every state initiative can advance our
among Baerveldt Glaucoma Implant (Abbott
profession and is important to the American
Medical Optics), Ahmed Glaucoma Valve
Optometric Association (AOA),” says AOA
iStent ™
PERFORMANCE
DRIVEN BY SCIENCE
(New World Medical, Inc), iStent (Glaukos),
President Steve Loomis, OD.
The iStent trabecular micro-bypass is a
and ExPress Glaucoma FiltraSome of the new laws are smaller victomicro invasive glaucoma surgery (MIGS)
tion Device (Alcon). It is imries, while others will change the way optool.1 It is essentially a small snorkel com1
Gabriel M, Bartell J, Walters R, et al. Biocidal ef?cacy of a new hydrogen peroxide contact lens care system against bacteria, fungi, and Acanthamoeba species.
See Legislative changes on page 6
portant
for©optometrists
to CCS15069AD-B See Glaucoma drainage on page 22
Optom Vis Sci. 2014; 91: E-abstract
145192.
2015 Novartis 5/15
Q&A
| MARY K. MERCADO, OD NAIL POLISH, OPENING A PRACTICE, AND SKYDIVING
SEE PAGE 33
JANUARY 2016
VOL. 8, NO. 01
OptometryTimes.com
PRACTICAL CHAIRSIDE ADVICE
SPECIAL SECTION
Glaucoma
Understanding
drainage in surgery
Procedures and practices for postoperative care
1
Figure 1. Insertion of the tube into the anterior
chamber to increase aqueous outflow. Image courtesy Ike Ahmed, MD
Figure 7. Baerveldt Glaucoma Implant.
Content Specialist
Each year brings its own challenges, and
2016 will be no different.
Optometry Times Editorial Advisory Board
member John Rumpakis, OD, MBA, and Bryan
Rogoff, OD, MBA, CPHM, director of doctor
strategy for Pearle Vision, share the challenges they expect optometrists will encounter in the coming year.
Last year, we spoke with Dr. Rogoff about
this same subject. Some of the challenges we
predicted for 2015 will continue into 2016—
like increasing deductibles—while others,
like the ICD-10 transition, will stay a thing
of the past. Thankfully, the ICD-10 transition wasn’t as traumatic as many predicted at
this time last year. While practitioners likely
invested in training and preparing for the
switch, the actual transition hasn’t caused
any major problems, says Dr. Rogoff.
ODs battle UPP,
CA hiring laws
By Barbara J. Fluder, OD
G
Q&A
See 2016 challenges on page 5
7
laucoma drainage devices are increasingly flowing in many glaucoma practices. You may be familiar with laser
glaucoma procedures, including argon
laser trabeculoplasty, selective laser trabeculoplasty, and micropulse laser trabeculoplasty. Trabeculectomy is a commonly performed filtering surgery as well.
But, you may not know the differences
among Baerveldt Glaucoma Implant (Abbott
Medical Optics), Ahmed Glaucoma Valve
(New World Medical, Inc), iStent (Glaukos),
and ExPress Glaucoma Filtration Device (Alcon). It is important for optometrists to
Top financial
obstacles facing
ODs in 2016
Content Specialist
The iStent trabecular micro-bypass is a
micro invasive glaucoma surgery (MIGS)
tool.1 It is essentially a small snorkel com-
The laws governing ODs across the country
are constantly evolving, so it can be hard to
keep track of who can do what from state
to state. New laws in one state can lay the
groundwork for similar changes in another.
“Every state initiative can advance our
profession and is important to the American
Optometric Association (AOA),” says AOA
President Steve Loomis, OD.
Some of the new laws are smaller victories, while others will change the way op-
See Glaucoma drainage on page 22
See Legislative changes on page 6
be familiar with these devices and the rationale behind the device chosen. This article describes what each device is, how they
work, complications, and postoperative care.
iStent
| MARY K. MERCADO, OD NAIL POLISH, OPENING A PRACTICE, AND SKYDIVING
SEE PAGE 33
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| PRACTICAL CHAIRSIDE ADVICE
FROM
THE
Chief Optometric Editor
3
Help, I have been robbed!
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
ost of my travels take me through
Atlanta’s airport. The old saying here
in Th’ South seems to be true: If you
wanna go to hell, you have to fly through
Atlanta. Fortunately, my offspring live in
Georgia’s capital, so every time I’m passing
through Hartsfield-Jackson, I try to spend
some time with my children.
One Sunday evening after a trip to Chicago,
we had dinner at a Mexican restaurant we
had frequented at least a dozen times. After
a quick meal, returning to the parking lot
I found my truck to be the subject of what
the very polite Atlanta policeman later described as a classic “smash and grab.” The
passenger side windows were destroyed,
and my suitcase and computer bag gone.
My first thoughts weren’t of the nice suits
in my travel bag. Oh no, my first thought
M
was of my laptop. My life was on that laptop. Business data, photos, videos, you name
it—it was on there. I had a great collection
of anterior segment ocular photos of which
I was truly proud collected over a career.
But the greatest loss was my lectures: every
PowerPoint presentation I’ve ever given was
on that computer.
occasion I had placed them…in my suitcase.
So, what did I learn from this very painful experience? First, back up early and
often. There’s a shiny new one terabyte
hard drive sitting on the desk at my home
office. And Dropbox is my new best friend.
Heck, where before I had one backup copy of
my data, I now have three! Second, while I
had lost faith in people (I mean, how damn
low can someone go?), I have been doubly
blessed by the help of our Academy Primary
Care Section Diplomates who covered for a
missed lecture as I sorted through all the
details (again, something you really don’t
want to have to do), and the well wishes
of colleagues, many who have graciously
offered to help replenish my photos and
PowerPoints. Thanks, folks. I’ll gladly take
whatever you’re willing to share.
While my friends commiserated with my
loss, many said they also learned from my
Gee, Ernie, you dummy, didn’t you have
misfortune and immediately backed
backups? Of course I did. I’m obsesSee
up all their data. So let’s all learn
sive; I back everything up. Like I
our
a lesson. If you haven’t backed up
was taught, I kept those backups in
glaucoma
your data, I highly recommend you
a location separate from my comcoverage. Turn
do that. Now. More than once!
puter bag. Because I had work to
to page 14 for
do on this trip, on this particular
more.
My suitcase and
computer bag
were gone. My first
thought was of my
laptop. My life was
on that laptop.
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
JANUARY 2016
t VOL. 8, NO. 01
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2016 challenges
Continued from page 1
Increasing deductibles
Increasing deductibles means costs are shifting more and more onto the shoulders of
patients.
“Cost shifting is going to change how we
have to communicate with our patients,”
says Dr. Rumpakis. “I do think that it’s going
to significantly affect our patients’ willingness to comply with what they need to do.”
When you’re trying to justify the cost
of this diagnostic test or regular imaging
to keep that glaucoma in check, but those
services are not covered by the patient’s insurance—you’ll likely face some pushback.
There’s a good chance some patients aren’t
going to be very pleased to drop hundreds
of dollars on a service if they don’t see or
understand the direct benefit to them.
It’s all about communicating the value,
a skill that not enough doctors have mastered, says Dr. Rumpakis.
“I think optometrists are among the most
compassionate and caring healthcare providers out there—that is both our strength
and it is our weakness,” says Dr. Rumpakis. “The weakness is that oftentimes we
want to be our patients’ best friend instead
of being their doctor. We tend to capitulate
rather easily to what the patient wants to
do rather than really trying to be their doctor and make sure that they understand the
clinical needs.”
The demands of healthcare reform
Dr. Rumpakis says that healthcare reform
mandates that doctors perform at a higher
quality and volume with a lower price—
and it’s not going to be easy. And while all
healthcare providers will face this problem,
he says that optometrists are especially ill
equipped to manage these demands.
“I think that is going to be a challenge—
not to optometry particularly—but to all
healthcare practitioners,” says Dr. Rumpakis.
“But the problem in optometry is that we
don’t have the ancillary staff that is accessible to us like a general practitioner has.”
The costs of adding new members to your
staff can add up in terms of salary, but if
increasing head count allows you to see
more patients and maintain your quality
of care, it might be worth the investment.
Dr. Rumpakis says that building the right
team at your practice is a direct cost, but
you have to measure the return on investment over a three- to five-year period to
be able to get an appropriate cost analysis.
In Focus
5
It’s all about communicating the value,
a skill that not enough doctors have
mastered, says Dr. Rumpakis.
Consolidation, consolidation,
consolidation
It seems that practically every week of 2015
brought news of yet one company buying
up another, and the eyecare industry was
no different.
“This past year has been a tremendous
year for consolidation,” says Dr. Rogoff. “You
have some heavy hitters out there who have
been gobbling up a lot of stuff. That was the
biggest thing that has been on my radar on
for 2016: With everyone buying this, everyone buying that—what’s going to happen?”
One of the biggest was Essilor’s acquisition of Vision Source. Essilor also acquired
Professional Eyecare Resource Co-Operative
(PERC) and Infinity Vision Alliance (IVA).
“It’s nice to know that a company like Essilor is buying Vision Source and PERC as
opposed to a venture capitalist group whose
sole purpose is short-term profits,” says Dr.
Rogoff, “instead of long-term things that
would help out that buying group.”
And there are a number of other groups
out there buying up practices left and right,
so Dr. Rogoff says that independent doctors need to differentiate themselves. He
says doctors need to focus on marketing
and creating the best customer experience.
Increased competition
from corporate opticals
Another big trend we saw in 2015 was the
expansion of corporate opticals through
partnerships with other brands.
VSP partnered with CVS to bring vision
care centers to several of its stores in the
Washington, DC, and Baltimore areas, while
Luxottica is bringing its LensCrafters brand
to 500 Macy’s locations across the country.
These deals mean even more competition
for your patients.
“There has been such a movement—venture capitalists are seeing the value in optical, and obviously this was the year for
that,” says Dr. Rogoff.
Access to patients
We hate to say it, but insurance plans will
likely continue to be a major headache in
the coming year, just as they were in the
last year. Dr. Rumpakis says that access
to patients will not only continue to be a
problem, but that problem will likely grow
over the next year.
“I think that we’re going to start to see
greater narrowing of networks, meaning
more focus on who the patients can see for
their care,” says Dr. Rumpakis.
Bring on the New Year
Although the number of changes that have
happened and will continue to happen in
eye care can be daunting, Dr. Rumpakis
says change doesn’t need to be a bad thing.
“As part of my personal philosophy, I think
any time there’s disruption,” he says, “for
as many negatives as there are, there are
just as many opportunities. I think there are
plenty of opportunities for people to thrive
in this marketplace—but people have to be
willing to change their paradigm, not just
do things the way they’ve always done it.”
IN BRIEF
Alcon launches Air
Optix Colors iOS app
FORT WORTH, TX—Alcon has launched the Air
Optix Colors Color Studio app for iOS devices. The app allows users to upload a
photo and virtually “try on” any of the
nine colors of Air Optix Colors contact
lenses. The app is available for free in
the App Store.
“The cosmetic lens market is a fraction
of its potential size, and driving interest
means meeting patients where they are already receiving information—on their mobile devices,” says Carla Mack, OD, MBA,
FAAO, director of professional and clinical support for US Vision Care at Alcon.
Revamped for mobile and tablet, the
Color Studio app is equipped with new
functionality, including the ability to compare two lens colors and to virtually try
on makeup to create a custom look.
Says Dr. Mack: “A mobile app creates
opportunity for eyecare practitioners to
more easily integrate the Color Studio into
their practices, offering patients and staff a
tool to quickly evaluate how certain colors
might look, before trying on the lenses.”
6
In Focus
Legislative changes
tometrists in that state do business. And
other victories came in the form of blocking
laws that would be threats to optometry.
“Of course, state associations determine
their own specific priorities for each legislative session, and the AOA works stateby-state to help pass these bills, including
for expansion of scope, to fix abusive policies imposed by insurers and vision plans,
and to strengthen public health and quality
care safeguards,” says Dr. Loomis. “Also,
whenever and wherever there is a concern
about bill attacking optometry or potentially
JANUARY 2016
for business relationships among ODs andopticians, optical companies, and health
plans, including the outlawing of employment by opticians of optometrists.
As of January 1, a registered dispensing
optician, optical company, and health plan
will no longer be allowed to newly employ
an optometrist. For those that currently employ ODs, there will be a three-year transition period during which they must convert
to a landlord-tenant arrangement.
“AB 684 is all about safeguarding a doctor
of optometry’s independent clinical judgement for the benefit of the patient,” says
Barry Weissman, OD, PhD, FAAO, Califor-
A registered dispensing optician, optical
company, and health plan will no longer be
able to newly employ an OD in California.
undermining patient care, the AOA helps
state associations fight back and defeat it.”
The latest on the UPP battle
Earlier this year, 1-800 CONTACTS-backed
legislation that attempted to block unilateral
pricing polices (UPP) was introduced in 14
states around the country. According to Dr.
Loomis, over the last few months, anti-UPP
legislation was defeated thanks to advocacy
responses by state associations in six of the
targeted states: Arizona, Florida, Idaho, Louisiana, Mississippi, and Tennessee.
But the fight isn’t over. There are still
anti-UPP bills pending in California, Illinois, Minnesota, New York, Oregon, Rhode
Island, and Washington. And Dr. Loomis
says more states may see further action as
2016 grows closer.
Despite fending off anti-UPP legislation,
Arizona expects to see legislation to be introduced early next year that would eliminate
expiration dates and notation of brands on
contact lens prescriptions, prevent optometrists from selling products they prescribe,
and legitimizing prescriptions generated from
online refraction and vision kiosks without
the necessity of a health assessment from
an eyecare provider.
“The AOA stands ready to help affiliates
battle harmful legislation,” says Dr. Loomis.
Changes in California
Three new laws in California will affect
optometrists.
The first will go into effect on January 1,
2016, and establishes new, enforceable rules
nia Optometric Association president. “Importantly for doctors, the measure contains
enforceable protections to ensure the doctor will be able to maintain exclusive control over his or her practice. For doctors
currently employed in a retail setting, it is
anticipated they will be offered a lease or
employment from a doctor who has leased
space at the establishment over the next
three years.”
The state also enacted a law that will
allow for a therapeutic pharmaceutical
agents (TPA) certification for optometrists
who have not yet obtained it. Optometrists
who graduated before 1996 were left with
few pathways to obtain TPA certification because many TPA stand-alone courses were
discontinued. After 1996, students graduated optometry school with TPA certification. This new law will clarify the pathway
for those ODs who graduated prior to 1996.
And finally, California passed a law that
requires health plans and insurers to provide updated provider directories and sets
standards on how to make this possible.
This measure also requires online directories to be updated at least weekly. Further,
it requires health plans or insurers to reimburse enrollees for any amount over what
they would have paid for in-network services in circumstances where the enrollee
reasonably relied upon inaccurate, incomplete, misleading or confusing information
in a provider’s directory.
“This legislation builds upon the promise of the Affordable Care Act’s goal of increasing access to care,” says Dr. Weissman.
|
“Consistently accurate provider directories
are an integral component to assisting the
public in locating doctors accepting their
insurance and the resulting timely access
to vision and eye health care. It also will
help decrease the uncomfortable and costly
situations when a patient comes to the practice and learns the doctor is not a provider.”
The latest in Pennsylvania
In the spirit of keeping students safe, Pennsylvania enacted a law that requires school
bus drivers to carry a certificate of physical
and vision exam. An optometrist or ophthalmologist must conduct the vision exam.
What’s in the works
A number of bills are in various stages that
could affect optometrists in the coming
months should they become laws:
– A bill was introduced in Pennsylvania
in September that would allow ODs to administer and prescribe all FDA-approved
legend (requiring a prescription) and nonlegend drugs necessary for the treatment of
diseases and conditions of the eye and adnexa, including removal of foreign bodies,
drainage of superficial cysts, injection into
the adnexa and for anaphylaxis.
– A bill in Florida would prohibit a health
insurer, prepaid limited health service organization, or HMO from requiring an OD
to join a network solely for the purpose of
credentialing the provider for another organization’s vision care plan or restrict a
provider to a specific supplier of materials
or optical labs. Directories of network providers must be updated monthly to reflect
current vision care providers. Violators of
this law would constitute an unfair insurance trade practice.
– A bill in Kentucky would establish a
policy governing the procedures for changing the existing agreement with a provider
to include: requiring a face-to-face meeting
to discuss proposed changes if requested by
a medical provider; requiring certified letter detailing the proposed changes; requiring the provider either agree or not agree to
the proposed changes; and requiring that a
new agreement be established and agreed
upon after three or more material changes
are made to the existing agreement.
– A bill in Ohio would exempt the first $500
of prescription eyeglasses, contact lenses,
and other optical aids sold by licensed dispensers from sales and use tax.
– A bill in Illinois would encourage all
drivers in the state to get annual eye exams.
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8
Focus On
DIABETES
JANUARY 2016
|
What’s new in management, prevention
2015 was a year of advances, bringing new tools to the fight against diabetes
From new ways of predicting who will and won’t develop
diabetes, to new diabetes meds, to new evidence regarding which anti-vascular endothelial growth factor (VEGF)
might be better for your specific patient, the last year has
given us better tools for helping our patients with diabetes.
in the gut microbiome that fosA number of interesting develters insulin resistance, at least
opments have arisen in the last
some of which is attributable
year concerning risk assessment,
to both excess consumption of
treatment, and management of
refined carbohydrates and nonboth diabetes and diabetes-renutritive sweeteners like asparlated eye disease. The stage has
tame and sucralose.3,4 Elevated
been set by the increasing prevaA. PAUL CHOUS,
lence of diabetes, with 29.1 milliver enzymes ALT and AST also
MA, OD, FAAO,
lion Americans having diabetes,
have been shown to be highly
has a private
and another 86 million having
predictive of T2DM, particularly
practice specializing
pre-diabetes.1 More recently, analin women, and these are comin diabetes eye care
and education in
monly associated with non-alcoysis published recently in JAMA
Tacoma, WA.
holic fatty liver disease (NAFLD).5
shows that about 12 percent of
U.S. adults have diabetes, with
Both of these findings bolmore than half of the adult population
ster evidence that avoidance of added
having either diabetes or pre-diabetes, indietary sugars (the World Health Orgacluding an astounding 83 percent of U.S.
nization now recommends less than 40
adults over the age of 65 years.2 Worldgrams per day, with an ideal target less
than 25 grams per day)6 will lower diawide, diabetes rates continue to climb,
particularly in Asia. In fact, if we total
betes risk at a population level. Lifestyle
intervention continues to trump metformin for preventing T2DM over 15 years
in high-risk subjects from the Diabetes
Prevention Program (DPP), with 27 per-
Avoidance of
added dietary
sugars will lower
diabetes risk at a
population level
the number of people living with diabetes in China (100 million), India (50 million), and the U.S., this amalgam would
represent the third most populous country in the world.3
Clearly, we need to do a better job of
identifying those at highest risk for development of both diabetes and especially
sight-threatening eye disease. The other
thing we need is a whole lot of prevention.
Risk factors for type 2 diabetes
Some interesting and novel risk factors
for type 2 diabetes (T2DM) have arisen
within the last year, including alterations
cent and 18 percent reduced incidence
comparing 100 minutes/week walking to
metformin vs. no intervention.7 Interestingly, a composite index of microvascular
complications did not differ significantly
between the treatment groups, though
women assigned to the “lifestyle” group
were about 22 percent less likely to experience any microvascular complication,
including retinopathy.
The latest diabetes
medications
A number of new diabetes medications
have become available, including two new
glucagon-like peptide 1 (GLP-1) agonists:
Trulicity (dulaglutide, Lilly) and Tanzeum
(albiglutide, GSK), which improve postmeal insulin production, reduce glucagon
secretion, suppress appetite, and assist
with weight loss—significant benefits for
patients above ideal body weight (additionally, Novo received FDA approval for
double-strength Victoza (liraglutide, trade
name Saxenda for weight loss). A new
sodium glucose transporter -2 (SGLT2)
inhibitor was also released in the U.S.,
Jardiance (empagliflozin, Boehringer).
These oral drugs lower blood sugar by
reducing resorption of serum glucose in
the proximal renal tubule, leading to urinary excretion of glucose, reduced blood
pressure, and weight loss.
Figure 2. A 62-year-old male
recently diagnosed with type 2
diabetes presented to our office
with center-involved diabetic
macular edema (DME) OS >OD.
Best-corrected vision was 20/80
in both eyes. Based on DRCR.
net Protocol T, this gentleman
may be significantly more likely
to benefit from aflibercept (Eylea,
Regeneron).
A major finding of the EMPA-REG study
is that type 2 diabetes patients with high
cardiovascular risk placed on empagliflozin
were 38 percent less likely to die from
cardiovascular causes compared to patients on other diabetes meds.8 Two other
trials with SGLT2 inhibitors are ongoing
to see if this cardiovascular protection is
a class effect. If so, these drugs are anticipated to become major second-line
agents after metformin for treatment of
patients with T2DM.
The latest in diabetic eye
disease
In regard to diabetic eye disease, the evidence grows that anti-VEGF drugs are superior to laser therapy for diabetic macular edema (DME). Three-year data with
ranizibumab (Lucentis, Genentech) and
100-week data with aflibercept (Eylea,
Regeneron) show that visual gains are
maintained with these agents and are
superior to gird or focal macular laser
in isolation.9,10
The long-awaited Diabetic Retinopathy
Clinical Research Network (DRCR.net) Protocol T results were released last May and
showed that ranizibumab, aflibercept, and
bevacizumab (Avastin, Genentech) were
roughly comparable in efficacy for treatment of center-involved DME.12 Subgroup
analysis did show, however, that patients
with baseline visual acuities of 20/50 or
worse achieved better visual outcomes
with aflibercept compared with the other
two agents (about one additional line of
acuity. Adverse events were slightly elevated but infrequent and about the same
DIABETES
in all three groups—it must be remembered that patients with diabetic retinopathy (DR) and/or DME have higher
CV risk to begin with. Both Lucentis and
Eylea were also granted additional FDA
indications for treating non-proliferative
DR in patients with co-existing DME;
of course, both remain far more costly
than their off-label counterpart, Avastin.
I had the pleasure of attending a special
ARVO Diabetic Retinopathy Small Meeting at U.S. National Institutes of Health at
the end of August 2015. Attendees heard
from a number of esteemed investigators and clinicians about groundbreaking work into the pathophysiology, genetics, and treatment of DR and DME. I
look forward to sharing with you a few
items that particularly piqued my interest in my next department.
REFERENCES
1. CDC National Diabetes Statistics Report 2014.
Available at: http://www.cdc.gov/diabetes/data/
statistics/2014statisticsreport.html. accessed
12/08/2015.
2. Menke A, Casagrande S, Geiss L, et al.
Prevalence of and Trends in Diabetes Among
Adults in the United States, 1988-2012. JAMA.
2015 Sep 8;314(10):1021-9.
3. Guariguata L, Whiting DR, Hmableton I, et al.
Global estimates for diabetes prevalence in 2013
and projections for 2035. Diabetes Res Clin Pract.
2014 Feb;103(2):137-49.
4. Barlow GM, Yu A, Mathur R. Role of the Gut
Microbiome in Obesity and Diabetes Mellitus. Nutr
Clin Pract. 2015 Dec;30(6):787-97.
5. Suez J, Korem T, Zeevi D, et al. Artificial
sweeteners induce glucose intolerance by
altering the gut microbiota. Nature. 2014 Oct
9;514(7521):181-6.
Focus On
6. Ko SH, Baeg MK, Han KD, et al. Increased
liver markers are associated with higher risk of
type 2 diabetes. World J Gastroenterol. 2015 Jun
28;21(24):7478-87.
7. World Health Organization. WHO calls on
countries to reduce sugars intake among adults
and children. Available at: http://www.who.
int/mediacentre/news/releases/2015/sugarguideline/en/. Accessed: 9/10/2015.
8. Diabetes Prevention Program Research
Group. Long-term effects of lifestyle intervention
or metformin on diabetes development and
microvascular complications over 15-year followup: the Diabetes Prevention Program Outcomes
Study. Lancet Diabetes Endocrinol. 2015
Nov;3(11):866-75.
9. Zinman B, Wanner C, Lachin JM, et al.
Empagliflozin, Cardiovascular Outcomes, and
Mortality in Type 2 Diabetes. N Engl J Med. 2015
Nov 26;373(22):2117-28.
10. Boyer DS, Nguyen QD, Brown DM, et al.
Outcomes with As-Needed Ranibizumab after
Initial Monthly Therapy: Long-Term Outcomes of
the Phase III RIDE and RISE Trials. Ophthalmology.
2015 Dec;122(12):2504-2513.
11. Brown DM, Schmidt-Erfurth U, Do DV, et al.
Intravitreal Aflibercept for Diabetic Macular Edema:
100-Week Results From the VISTA and VIVID
Studies. Ophthalmology. 2015 Oct;122(10):204452.
12. Diabetic Retinopathy Clinical Research
Network, Wells JA, Glassman AR, et al. Aflibercept,
bevacizumab, or ranibizumab for diabetic macular
edema. N Engl J Med. 2015 Mar 26;372(13):1193203.
Dr. Paul Chous has a private practice specializing in
diabetes eye care and education in Tacoma, WA. He is the
author of Diabetic Eye Disease: Lessons From a Diabetic
Eye Doctor (Fairwood Press, Seattle, 2003), which was
included in the “Top 12 Diabetes Books” by Diabetes Update
magazine in 2004. He is a consultant to ZeaVision, Freedom
Meditech, Risk Medical Solutions, Regeneron and VSP.
IN BRIEF
Second annual virtual conference to be held January 16-17
BOCA RATON, FL—Online eyecare professional
community ODwire.org will hold its second annual live virtual optometric conference, CEwire2016, January 16-17.
CEwire2016 will be held live online
on January 16-17, 2016, from 11:00 a.m.
to 7:00 p.m. ET on both days. All lectures and exhibit hall will be available
on-demand to registrants for an additional 90 days.
CEwire2016 features more than 45
COPE-approved CE lecture hours on a
variety of topics, including comanagement, scleral lenses, and new technology.
The conference will also feature a large
virtual exhibit hall where attendees can
view materials, access show discounts
on products and services, and interact
live with participating vendors.
Last year, more than 1,500 eyecare professionals from the U.S., Canada, and
other countries attended CEwire2015.
“The cost and convenience factors of
a virtual conference offer advantages for
participants, as there are no travel costs
and the technology is universally available, enabling registrants to fulfill their
mandatory CE requirements at their own
convenience,” says ODwire.org cofounder
and conference co-organizer Paul Farkas, OD, FAAO.
Practitioners may register individually,
and group office registration provides a
discount and free staff attendance. Optometry students may register for free.
Profits from CEwire2016 will be distributed to The American Optometric Foundation and Volunteer Optometric Services
to Humanity (VOSH)/International. Last
year’s conference raised more than $20,000
for three optometric charities.
Visit www.cewire2016.com.
9
10
Focus On
PRACTICE MANAGEMENT
JANUARY 2016
|
Why you need a practice mission
You’ll need to know where you’re going to know if you’re getting there
“How are you?” Everyone knows that in casual conversation, the answer to this question is, “Fine,”(or “Good,” or
“Pretty good”). We ask it, and we answer every day without much thought or consideration. It is really more of a
polite greeting than an inquiry into one’s current status.
your practice vision or mission.
You must clearly articulate what
you are working to accomplish
with your practice. For instance,
if your mission is to provide all
the eyecare needs to as many
in your community as you can,
BY MICHAEL
your vision is different from that
ROTHSCHILD, OD
of a practice who limits its care
How’s the practice?
Director of What’s
to vision therapy. But what about when we ask it
Next-Leadership OD.
Here are two examples.
of each other professionally? It
Practice 1 is in a suburban/
may be something like, “How’s
rural area next to the local hosthe practice?” pital. The largest employers in the area
What is your answer to that question?
are a wire manufacturer, an EHR develUsually it is the same type of generic anopment company, and a hospital. As a
swer that has minimal meaning; “Good,”
primary care eyecare provider, the prac“Pretty good,” “Fine.” tice strives to be the choice for eye care
for every member of the family. It provides eye exams, contact lenses, specialty
lenses, and surgical comanagement, and
– Daily deposits
it provides a lot of medical eye care. Its
– Number of exams
vision is to earn trust by providing the
– Income per exam
highest quality care and products to pa– Capture rate (optical)
tients. It works hard to grow 10 percent
– Collection rate (insurance)
yearly, be a good member of the com– Percentage full (scheduling)
munity, and feed its staff’s passion to
– Write-offs
care for patients. – Patient wait time
Practice 2 has five locations in vari– Net promoter score
ous strip malls around a larger metro
area. This practice strives to create a consistent experience at all of its locations.
But in reality, do you even know how
All of its stores carry the same brands
things are going in your practice? When I
of frames, accept the same insurances,
am at my best, I can tell you my capture
and are priced identically. As a primary
rate, collection rate, cost of goods sold,
care provider, it too provide exams, conand expenditures compared to budget.
tact lenses, and surgical comanagement.
But other times I can judge my practice’s
For the most part, medical care and spestatus only by my ability to pay my bills.
cialty care will be referred to practices
In my consulting work with practices, I
that are more equipped. Growth is parhave found that most of us don’t know if
amount with clear goals of adding two
our practice is doing well or not.
locations per year for the next decade. When we really want to know
how someone is doing, we ask it
differently. We may say, “I saw
on Facebook that you lost your
goldfish. Are you doing OK?”
or, “How have you been dealing with your new situation?” Metrics to watch
It depends
So, how do you know how your practice
is doing? The answer is, “It depends.”
To have any understanding of how your
practice is doing, you must clearly define
have identified your mission and made
it clear to the rest of the team, your practice will just be “fine.” Once you have
identified where you are going, you can
monitor your progress. Then you can
truthfully answer, “We are performing
much better than we thought we would
be at this point.”
There are too many metrics that can
be measured in our practices to remain
effective. If I wanted, I could calculate
the amount of electricity being used per
box of contact lenses sold. I am not sure
of the value of that, so I do not measure
it. Other metrics may be relevant twice
a year, while others need to be monitored daily. I recommend finding five metrics that
help you determine how you are progressing toward your goals, and I recommend
you look at those metrics a lot. Determine
what is “good,” what is “not so good,”
and what is “reaction worthy.” For almost every eyecare practice, the
amount of money being deposited into
the bank needs to be monitored daily.
Find how much needs to be deposited
daily to keep the cash flow going. If you
have several days in a row below that
amount, do something. Other big metrics to watch ones include:
– Number of exams
– Income per exam
– Capture rate (optical)
– Collection rate (insurance)
– Percentage full (scheduling)
– Write-offs
– Patient wait time
– Net promoter score
Don’t compare
Be cautious about comparing these metrics with your colleagues because the
practice vision can dramatically affect
these numbers. Practice 1 is likely to have
higher staff costs than Practice 2 simply
because of the variety of testing. Practice
2 is more likely to garner a higher capture
rate because optical is more of a focus.
The point is to continuing nudging your
benchmarks in the direction you want.
Find out where you’re going
This is just two examples. There is really
an unlimited number of ways that eyecare practices can be operated. Until you
Dr. Rothschild is also a consultant for Alcon, Optos, and
Vision Source; a member of the speakers’ bureau for VSP;
and a clinical researcher for CIBA Vision.
When treating your patients with bacterial conjunctivitis –
Unleash power against
pathogens of concern.
1
2
1,3:
– S. aureus, S. epidermidis, S. pneumoniae, H. influenzae
– Pseudomonas aeruginosa
Indication
BESIVANCE® (besifloxacin ophthalmic suspension) 0.6% is a quinolone antimicrobial indicated for the treatment of
bacterial conjunctivitis caused by susceptible isolates of the following bacteria: Aerococcus viridans*, CDC coryneform
group G, Corynebacterium pseudodiphtheriticum*, Corynebacterium striatum*, Haemophilus influenzae, Moraxella
catarrhalis*, Moraxella lacunata*, Pseudomonas aeruginosa*, Staphylococcus aureus, Staphylococcus epidermidis,
Staphylococcus hominis*, Staphylococcus lugdunensis*, Staphylococcus warneri*, Streptococcus mitis group, Streptococcus
oralis, Streptococcus pneumoniae, Streptococcus salivarius*
* Efficacy for this organism was studied in fewer than 10 infections.
Important Safety Information about BESIVANCE®
BESIVANCE® is for topical ophthalmic use only, and should not be injected subconjunctivally, nor should it be introduced directly
into the anterior chamber of the eye.
As with other anti-infectives, prolonged use of BESIVANCE® may result in overgrowth of non-susceptible organisms, including
fungi. If super-infection occurs, discontinue use and institute alternative therapy.
Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy
with BESIVANCE®.
The most common adverse event reported in 2% of patients treated with BESIVANCE® was conjunctival redness. Other adverse
events reported in patients receiving BESIVANCE® occurring in approximately 1-2% of patients included: blurred vision, eye pain,
eye irritation, eye pruritus and headache.
BESIVANCE® is not intended to be administered systemically. Quinolones administered systemically have been associated with
hypersensitivity reactions, even following a single dose. Patients should be advised to discontinue use immediately and contact
their physician at the first sign of a rash or allergic reaction.
Safety and effectiveness in infants below one year of age have not been established.
Please see brief summary of Prescribing Information on adjacent page.
To learn more about BESIVANCE® call your Bausch + Lomb sales representative today.
References: 1. BESIVANCE® Prescribing Information, September 2012. 2. At 12 hours, the concentration of besifloxacin in tears was >10 μg/mL.
Proksch JW, Granvil CP, Siou-Mermet R, Comstock TL, Paterno MR, Ward KW. Ocular pharmacokinetics of besifloxacin following topical
administration to rabbits, monkeys, and humans. J Ocul Pharm Ther. 2009;25(4):335-344. 3. Comstock TL, Paterno MR, Usner DW, Pichichero ME.
Efficacy and safety of besifloxacin ophthalmic suspension 0.6% in children and adolescents with bacterial conjunctivitis: a post hoc, subgroup
analysis of three randomized, double-masked, parallel-group, multicenter clinical trials. Paediatr Drugs. 2010;12(2):105-112.
Besivance is a trademark of Bausch & Lomb Incorporated or its affiliates.
© 2015 Bausch & Lomb Incorporated. All rights reserved. US/BES/15/0010
BRIEF SUMMARY OF PRESCRIBING INFORMATION
This Brief Summary does not include all the information needed to use Besivance
safely and effectively. See full prescribing information for Besivance.
Besivance (besifloxacin ophthalmic suspension) 0.6%
Sterile topical ophthalmic drops
Initial U.S. Approval: 2009
1
INDICATIONS AND USAGE
Besivance® (besifloxacin ophthalmic suspension) 0.6%, is indicated for the treatment of
bacterial conjunctivitis caused by susceptible isolates of the following bacteria:
Aerococcus viridans*, CDC coryneform group G, Corynebacterium pseudodiphtheriticum*,
Corynebacterium striatum*, Haemophilus influenzae, Moraxella catarrhalis*, Moraxella
lacunata*, Pseudomonas aeruginosa*, Staphylococcus aureus, Staphylococcus
epidermidis, Staphylococcus hominis*, Staphylococcus lugdunensis*, Staphylococcus
warneri*, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae,
Streptococcus salivarius*
*Efficacy for this organism was studied in fewer than 10 infections.
2
DOSAGE AND ADMINISTRATION
Invert closed bottle and shake once before use.
Instill one drop in the affected eye(s) 3 times a day, four to twelve hours apart for 7 days.
4
CONTRAINDICATIONS
None
5
WARNINGS AND PRECAUTIONS
5.1
Topical Ophthalmic Use Only NOT FOR INJECTION INTO THE EYE.
Besivance is for topical ophthalmic use only, and should not be injected subconjunctivally,
nor should it be introduced directly into the anterior chamber of the eye.
5.2
Growth of Resistant Organisms with Prolonged Use As with other anti-infectives, prolonged use of Besivance (besifloxacin ophthalmic suspension) 0.6% may result
in overgrowth of non-susceptible organisms, including fungi. If super-infection occurs,
discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the
patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining.
5.3
Avoidance of Contact Lenses Patients should not wear contact lenses if they
have signs or symptoms of bacterial conjunctivitis or during the course of therapy with
Besivance.
6
ADVERSE REACTIONS
Because clinical trials are conducted under widely varying conditions, adverse reaction
rates observed in one clinical trial of a drug cannot be directly compared with the rates
in the clinical trials of the same or another drug and may not reflect the rates observed in
practice.
The data described below reflect exposure to Besivance in approximately 1,000 patients
between 1 and 98 years old with clinical signs and symptoms of bacterial conjunctivitis.
The most frequently reported ocular adverse reaction was conjunctival redness, reported
in approximately 2% of patients.
Other adverse reactions reported in patients receiving Besivance occuring in approximately
1-2% of patients included: blurred vision, eye pain, eye irritation, eye pruritus and headache.
8
USE IN SPECIFIC POPULATIONS
8.1
Pregnancy Pregnancy Category C. Oral doses of besifloxacin up to
1000 mg/kg/day were not associated with visceral or skeletal malformations in rat pups
in a study of embryo-fetal development, although this dose was associated with maternal
toxicity (reduced body weight gain and food consumption) and maternal mortality. Increased post-implantation loss, decreased fetal body weights, and decreased fetal ossification were also observed. At this dose, the mean Cmax in the rat dams was approximately
20 mcg/mL, >45,000 times the mean plasma concentrations measured in humans.
The No Observed Adverse Effect Level (NOAEL) for this embryo-fetal development study
was 100 mg/kg/day (Cmax, 5 mcg/mL, >11,000 times the mean plasma concentrations
measured in humans).
In a prenatal and postnatal development study in rats, the NOAELs for both fetal and
maternal toxicity were also 100 mg/kg/day. At 1000 mg/kg/day, the pups weighed
significantly less than controls and had a reduced neonatal survival rate. Attainment of
developmental landmarks and sexual maturation were delayed, although surviving pups
from this dose group that were reared to maturity did not demonstrate deficits in behavior,
including activity, learning and memory, and their reproductive capacity appeared normal.
Since there are no adequate and well-controlled studies in pregnant women, Besivance
should be used during pregnancy only if the potential benefit justifies the potential risk to
the fetus.
8.3
Nursing Mothers Besifloxacin has not been measured in human milk, although
it can be presumed to be excreted in human milk. Caution should be exercised when
Besivance is administered to a nursing mother.
8.4
Pediatric Use The safety and effectiveness of Besivance® in infants below one
year of age have not been established. The efficacy of Besivance in treating bacterial
conjunctivitis in pediatric patients one year or older has been demonstrated in controlled
clinical trials [see CLINICAL STUDIES (14)].
There is no evidence that the ophthalmic administration of quinolones has any effect on
weight bearing joints, even though systemic administration of some quinolones has been
shown to cause arthropathy in immature animals.
8.5
Geriatric Use No overall differences in safety and effectiveness have been
observed between elderly and younger patients.
12
CLINICAL PHARMACOLOGY
12.1 Mechanism of Action Besifloxacin is a fluoroquinolone antibacterial [see CLINICAL PHARMACOLOGY (12.4)].
12.3 Pharmacokinetics Plasma concentrations of besifloxacin were measured in adult
patients with suspected bacterial conjunctivitis who received Besivance bilaterally three
times a day (16 doses total). Following the first and last dose, the maximum plasma besifloxacin concentration in each patient was less than 1.3 ng/mL. The mean besifloxacin
Cmax was 0.37 ng/mL on day 1 and 0.43 ng/mL on day 6. The average elimination half-life
of besifloxacin in plasma following multiple dosing was estimated to be 7 hours.
12.
Microbiology
Besifloxacin is an 8-chloro fluoroquinolone with a N-1 cyclopropyl group. The compound
has activity against Gram-positive and Gram-negative bacteria due to the inhibition of
both bacterial DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme
required for replication, transcription and repair of bacterial DNA. Topoisomerase IV is an
essential enzyme required for partitioning of the chromosomal DNA during bacterial cell
division. Besifloxacin is bactericidal with minimum bactericidal concentrations (MBCs)
generally within one dilution of the minimum inhibitory concentrations (MICs).
The mechanism of action of fluoroquinolones, including besifloxacin, is different from that
of aminoglycoside, macrolide, and β-lactam antibiotics. Therefore, besifloxacin may be
active against pathogens that are resistant to these antibiotics and these antibiotics may
be active against pathogens that are resistant to besifloxacin. In vitro studies demonstrated
cross-resistance between besifloxacin and some fluoroquinolones.
In vitro resistance to besifloxacin develops via multiple-step mutations and occurs
at a general frequency of < 3.3 x 10-10 for Staphylococcus aureus and < 7 x 10-10 for
Streptococcus pneumoniae.
Besifloxacin has been shown to be active against most isolates of the following bacteria
both in vitro and in conjunctival infections treated in clinical trials as described in the
INDICATIONS AND USAGE section:
Aerococcus viridans*, CDC coryneform group G,
Corynebacterium pseudodiphtheriticum*, C. striatum*, Haemophilus influenzae, Moraxella
catarrhalis*, M. lacunata*, Pseudomonas aeruginosa*, Staphylococcus aureus, S.
epidermidis, S. hominis*, S. lugdunensis*, S. warneri*, Streptococcus mitis group, S. oralis,
S. pneumoniae, S. salivarius*
*Efficacy for this organism was studied in fewer than 10 infections.
13
NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in
animals to determine the carcinogenic potential of besifloxacin have not been performed.
No in vitro mutagenic activity of besifloxacin was observed in an Ames test (up to 3.33 mcg/
plate) on bacterial tester strains Salmonella typhimurium TA98, TA100, TA1535, TA1537
and Escherichia coli WP2uvrA. However, it was mutagenic in S. typhimurium strain TA102
and E. coli strain WP2(pKM101). Positive responses in these strains have been observed
with other quinolones and are likely related to topoisomerase inhibition.
Besifloxacin induced chromosomal aberrations in CHO cells in vitro and it was positive in an
in vivo mouse micronucleus assay at oral doses × 1500 mg/kg. Besifloxacin did not induce
unscheduled DNA synthesis in hepatocytes cultured from rats given the test compound up
to 2,000 mg/kg by the oral route. In a fertility and early embryonic development study in
rats, besifloxacin did not impair the fertility of male or female rats at oral doses of up to
500 mg/kg/day. This is over 10,000 times higher than the recommended total daily human
ophthalmic dose.
14
CLINICAL STUDIES
In a randomized, double-masked, vehicle controlled, multicenter clinical trial, in which
patients 1-98 years of age were dosed 3 times a day for 5 days, Besivance was superior to
its vehicle in patients with bacterial conjunctivitis. Clinical resolution was achieved in 45%
(90/198) for the Besivance treated group versus 33% (63/191) for the vehicle treated group
(difference 12%, 95% CI 3% - 22%). Microbiological outcomes demonstrated a statistically
significant eradication rate for causative pathogens of 91% (181/198) for the Besivance
treated group versus 60% (114/191) for the vehicle treated group (difference 31%, 95%
CI 23% - 40%). Microbiologic eradication does not always correlate with clinical outcome
in anti-infective trials.
17
PATIENT COUNSELING INFORMATION
Patients should be advised to avoid contaminating the applicator tip with material from the
eye, fingers or other source.
Although Besivance is not intended to be administered systemically, quinolones
administered systemically have been associated with hypersensitivity reactions, even
following a single dose. Patients should be advised to discontinue use immediately and
contact their physician at the first sign of a rash or allergic reaction.
Patients should be told that although it is common to feel better early in the course of
the therapy, the medication should be taken exactly as directed. Skipping doses or not
completing the full course of therapy may (1) decrease the effectiveness of the immediate
treatment and (2) increase the likelihood that bacteria will develop resistance and will not
be treatable by Besivance or other antibacterial drugs in the future.
Patients should be advised not to wear contact lenses if they have signs or symptoms of
bacterial conjunctivitis or during the course of therapy with Besivance.
Patients should be advised to thoroughly wash hands prior to using Besivance.
Patients should be instructed to invert closed bottle (upside down) and shake once before
each use. Remove cap with bottle still in the inverted position. Tilt head back, and with
bottle inverted, gently squeeze bottle to instill one drop into the affected eye(s).
Manufactured by: Bausch & Lomb Incorporated
Tampa, Florida 33637
Besivance® is a registered trademark of Bausch & Lomb Incorporated.
©Bausch & Lomb Incorporated
U.S. Patent Nos. 6,685,958; 6,699,492; 5,447,926
†DuraSite is a trademark of InSite Vision Incorporated
US/BES/15/0019
Based on 9142605(flat)-9142705(folded)
DRY EYE
Focus On
Why you’re missing dry eye in front of you
The risk factors are endless, but we’re still not catching most dry eye patients
As we head into 2016, perhaps you are considering providing specialty services in dry eye or ocular surface disease (OSD). A common barrier to many practitioners is
concern that the practice does not have the patient foundation to make investment profitable. I assure you that
OSD management will profit the patient in clearer, more
comfortable vision, enhancing productivity and wellbeing.
Patients at risk for dry
eye
hormone therapy
Patients with arthritis or
other autoimmune disease
Who are the current patients in
your practice that can benefit
Patients who see another
from your new OSD specialty?
specialty provider for any
How can you identify them?
chronic disease
Where can you find them? The
Patients with blepharitis,
BY KATHERINE M.
following is my stream-of-conMGD, BMD
MASTROTA, MS,
sciousness brainstorm to help
Patients with any corneal
OD, FAAO Center
you recognize patients with or
disease
director of Omni Eye
at-risk for ocular surface disease.
Patients with recurrent “conSurgery in New York
City.
These patients include, but
junctivitis” or patients who
are not limited to all:
have had true conjunctivitis of any etiology
Diabetic patients
Glaucoma patients on topical or oral
Patients whose school or job demands
therapy
include excessive computer or digital device use
Post-surgical patients (cataract, especially femto- assisted, glaucoma,
Patients who wear makeup
ptergium, retina, plastics)
Patients who wear contact lenses
Patients with sleep apnea or continuPatients who work for airlines, hospious positive airway pressure (CPAP)
tals, hotels, or in any environmentallydevice users
controlled buildings (any building
with dry heat or air conditioning),
or in any old building with older
heating, air conditioning or ventilation; have homes or offices with
carpeting; or in the top 20 states for
high allergen count
Patients who cut grass, work around
or use chemicals on a daily basis, or
travel a good part of the time
Patients with Parkinson’s disease
Incomplete blinkers
I hope you are starting to think that
practically every patient you encounter
Patients with allergy, asthma, or
is at risk for OSD. I am a firm believer
atopic skin disease or dermatologic
that we all have some level of dry eye
disease (especially rosacea)
disease—we are only on different places
Patients who receive in-office inin the path to symptomatic and life-altraocular injections (anti-vascular
tering disease.
endothelial growth factor [VEGF])
Patients with pseudoexfoliation
Female patients in menopausal/periTapping into this population
menopausal age range and those on
How do you tap into your patient popu-
I hope you are
starting to think
that practically
every patient you
encounter is at
risk for OSD.
lation to help yourself and your patients?
Here are ideas to get started:
Detailed education of your staff
Detailed educational brochure for
your patients
Detailed educational brochure for referring primary/specialty care doctors (especially endocrinologists, allergists, pediatricians)
Questionnaire designed with specific
questions about occupation, medication, health, and allergy available on
your practice website and at check
in with either Ocular Surface Disease Index (OSDI) or Standard Patient
Evaluation of Eye Dryness (SPEED) or
other verified dry eye screening tool
Manual keratometry on all patients
to observe the tear film/mire quality and topography to identify other
irregularity
Tear osmolarity testing on every patient as a baseline or screening
If possible, digital ocular redness
assessment, tear meniscus height,
tear stability, lipid layer thickness,
and meibography on every patient
as a baseline/diagnostic test
Eyelash rotation on every patient
to identify and quantify demodex
Eyelash photography as baseline
documentation (Can you improve
the health of the eyelashes? I believe you can)
I recommend office-based lid and lid
margin microblepharoexfoliation to
every patient after photo documentation and explanation of blepharitis and its sequelae
In addition to the aforementioned benefits of attention and treatment of OSD,
you and your patients’ efforts will help
ensure successful ocular surgery (including injections) with better pre-operative
data and infection risk reduction. Aesthetics will be improved. Contact lenses
will be worn longer. And you will have
happier patients.
Offer lid hygiene products, omega supplements, and occlusion products (such as
eye masks, specialty eyewear, and CPAP
eye protection) in your office.
Go forth, educate, and treat.
[email protected]
13
14
Focus On
GLAUCOMA
JANUARY 2016
|
How patients perceive glaucoma matters
What I learned when a patient asked when she’d go blind from glaucoma
The other day, I had the pleasure of seeing one of my favorite glaucoma patients for an intraocular pressure (IOP)
check and visual field study. She is an 86-year-old white
female from rural Nebraska who found her way to Georgia many years ago with her late husband in an attempt
to find carpentry work.
serious question. We both sat
She has no family here and is
down, and she asked me how
essentially independent, living
long she had before she went
alone, and still driving. Her mediblind because her mother went
cal history is remarkable for arteblind from glaucoma before seekrial hypertension and high choing ophthalmic care. My mind
lesterol, and her systemic mediimmediately went back to my
cations are Lipitor (atorvastatin
BY BENJAMIN
fourth year at University of Alacalcium, Pfizer) and Tribenzor
P. CASELLA, OD,
bama at Birmingham School of
(olmesartan medoxomil/amloFAAO Practices
Optometry in the ocular disease
dipine/hydrochlorothiazide, Daiin Augusta, GA ,
clinic when a patient asked me
ichi Sankyo).
with his father in
his grandfather’s
the very same thing. I froze up
I have been successfully treatpractice.
at the time because I didn’t reing her IOP with prostaglandin
ally know how to handle such a
analog monotherapy for two
blunt and potentially life-altering question.
years. She first presented with IOPs of
My attending, Dr. Nowakowski, who
28 mm Hg in the right eye and 29 mm
was in the room, sensed the feeling of tenHg in the left eye. After a diagnosis of
sion in the air and immediately jumped
early primary open-angle glaucoma, I set
in by emphatically saying, “No. We’re
her target pressures to 18-21 mm Hg for
not going to let that happen.” He then
both eyes, corresponding to about a 30
went on to briefly say that the patient
was doing everything she needed to do
with her drops and to simply continue
being compliant. I could literally see the
relief appear on the patient’s face. I felt
relieved, as well, and I never forgot about
that short 10-second conversation.
Never pass up
an opportunity
to give a patient
good news,
so long as it is
rational
percent IOP reduction. She has consistently been at or below target since the
initiation of therapy.
The big question
She had just started the Tribenzor and
asked me if I thought it could affect her
glaucoma. I told her that amlodipine, being
a calcium channel blocker, was actually
helping by opening up the blood vessels
feeding her optic nerves. At the completion of the examination, I was getting
ready to walk her up to the front when
she stopped me and said she had a very
Lessons learned
I took two lessons away from that day
in clinic. The first lesson I learned was
the fact that patients tend to perceive information in a much different way than
doctors. Further, in the age of the Internet and its seemingly unending ether of
information, it’s not difficult to search
long enough to convince oneself that a
particular symptom or diagnosis carries
with it an impending sense of doom.
The second lesson I learned on that day
was the fact that many patients tend to
look to their doctors for a sense of comfort. As fiduciaries, doctors have an obligation to explain what is going on with
their patients’ health, and glaucoma can
and often does lead to blindness with no
treatment (or treatment that is ineffective).
Moreover, the “I feel fine, so this must
not be a big deal” mantra is still very
much alive and well in glaucoma, and
some patients truly need to be rattled
about the seriousness of their condition.
However, passing up an opportunity to
give reassurance in the face of paranoia
means passing up an opportunity to potentially make a big difference in one’s
mindset, noting that appropriate levels
of concern and understanding of one’s
condition can lead to better compliance
(and, thus, better overall health). In short,
never pass up an opportunity to give a patient good news, so long as it is rational.
I’m not going to let that
happen
Turning back to my present glaucoma
patient’s sinister question, I simply said,
“You’re not going blind from glaucoma
because I’m not going to let that happen. At this point, you and I are doing
everything we need to do to prevent that
from happening. So, let’s just keep up the
good work.” She smiled and thanked me,
and I walked her up to the front desk to
schedule an IOP check for three months
down the road.
Taking care of patients’ eyes, adnexa,
and visual systems can be challenging
enough. However, the science of what
we do is often one of the easiest parts of
our days. It is the art of conveying information to our patients in an appropriate
manner (and dealing with subsequent
reactions) that can be delicate to handle. I learned much regarding this concept (among many other things) from Dr.
Nowakowski, and I have come to realize
that people tend to get more bad news
than good news from doctor visits. This
notion could be framed to especially reign
true in the arena of glaucoma, when the
goal of therapy, to this date, really isn’t
to improve function, but to just keep
things from getting worse. Again, never
pass up an opportunity to give a patient
good news (keeping in mind the fact that
news of blindness not being imminent
may be just good enough).
[email protected]
Add Avenova® with NeutroxTM
(Pure Hypochlorous Acid 0.01% as a
preservative), the only Rx lid hygiene
product with pure hypochlorous acid,
to the lid & lash hygiene regimen
for all your patients.
AV E N O VA . C O M
Daily lid and lash hygiene.
|
|
R X O N LY
SPECIAL SECTION
16
JANUARY 2016
|
Glaucoma
Glaucoma in women
Gender, hormones may play a bigger role than previously thought
t has been estimated that by the
Secondary glaucomas
year 2020, there will be an inWhen looking at the less common
crease in the number of Ameriforms, women are more likely to
cans living with glaucoma from
be susceptible to narrow-angle
glaucoma. There has been a long60 to 80 million. Given that women
outnumber and outlive men, this
standing theory that shorter axial
will result in a vast number of palength was the physical difference;
BY LOUISE
tients who will require optometric
however, new evidence from Wang
SCLAFANI, OD,
care. As we review risk factors for
using anterior segment tomography
FAAO
this disease, perhaps gender and
reveals that it may also be related
is clinical associate
hormonal factors should be factored
to iris thickening and curvature
of ophthalmology
in to the decision-making process.1
variations.6,7 Many studies in the
and visual science
and
director
of
U.S. and Scandinavia agree that
As glaucoma is a disease of the
optometric services
women are more at risk for pseuaged optic nerve, it makes sense
The University of
doexfoliation syndrome8 and less
that those who live longer will have
Chicago Medicine
an increased risk. With glaucoma
at risk for pigmentary dispersion
being a disease of progression, it is more
glaucoma.2,8
essential to diagnose and treat earlier, espeHowever, because these forms can be more
cially those who may have silent risk factors,
aggressive, so should their management. Of
such as exposure to endogenous estrogen.1
greatest concern is low tension glaucoma because it is the most underdiagnosed form—
There have been a number of epidemioyet according to the Collaborative Normal
logic studies conducted to determine if there
Tension Glaucoma Study (CNTGS), women
is a gender difference in the incidence of
have a higher risk. This is likely due to the
multifactorial causes for glaucoma, such as
vasospasm disorders that women develop
which include low blood pressure, migraine
headaches, and reduced circulation to hands
and feet which may contribute to loss of
blood flow to the optic nerve.8-10
I
As women delay
pregnancy to their
late 30s and 40s and
glaucoma has a
known propensity
to affect us as we
age, the initial
glaucoma diagnosis
may occur during
pregnancy
glaucoma. Due to variances in study designs and populations, there are no conclusive findings for primary open-angle glaucoma. The Baltimore and Beaver Dam Studies showed no difference, the Blue Mountain Study showed an increased incidence
for women, and the Framingham, Barbados, and Rotterdam Studies showed an increased incidence for men.2-5
Effects of pregnancy
It is imperative to look at the pregnant state
both as a factor in glaucoma diagnosis and
treatment. As women delay pregnancy to their late 30s and 40s
and glaucoma has a known propensity to affect us as we age, the
initial glaucoma diagnosis may
occur during pregnancy. However, studies have shown that during the
second trimester, normal patients have a
10 to 20 percent reduction in IOP. Ocular
hypertensive patients have an even higher
reduction, 25 percent during Weeks 24 to
30. There are several theories as to why
this may occur. Perhaps hormonal changes
increase uveo-scleral flow. We know that
other ligaments soften as women prepare
to deliver, and perhaps this mechanism applies to aqueous outflow.11,12
TAKE-HOME MESSAGE As the number
of women with glaucoma is likely to increase,
gender and hormonal factors should be part
of the optometrist’s glaucoma diagnosis and
treatment considerations. Women are more
susceptible to narrow-angle glaucoma, and
pregnancy may be a factor during diagnosis
and treatment. In addition, estrogen may
offer a protective benefit. Dementia plays
a role with incidence, vision loss, and high
intraocular pressure. Ask more questions of
your glaucoma or glaucoma suspect patients,
especially women.
Treatment during pregnancy
This finding offers the patient some protection during pregnancy and may be a safeguard to delay management. If it is decided
that the patient needs to start or continue
treatment, the potential teratogenic effects
need to be considered. As most glaucoma
treatment is topical, recall that 80 percent
of the drop drains into the nasolacrimal
duct and leads to systemic absorption. All
steps should be taken to reduce this, such as
punctual occlusion, wiping excess, and closing eyes for a few minutes after instillation.
The only true Category B glaucoma agent
is brimonidine; however, many glaucoma
specialists concur that the risk-benefit ratio
would allow other medications, such as timo-
43 years
women who had hysterectomies prior to this age
had increased risk to
develop glaucoma
lol, to be used during pregnancy. Many will
discontinue a few weeks prior to delivery
to reduce any potential effects to the baby.
Topical carbonic anhydrase inhibitors may
be indicated, but orals should be avoided.
Theoretically, the prostaglandin category is
contraindicated due to the potential to induce
premature labor, yet these drugs are safe
during lactation. Remember that all drops
will end up in breast milk, so it is best to
See Women and glaucoma on page 18
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SPECIAL SECTI O N
18
JANUARY 2016
Glaucoma
Women and glaucoma
protection, but even within the gender, the
source of estrogen plays a role. In summary,
women who have early menses and late onset
of menopause will have longer exposure to
administer single daily-dose medications
endogenous estrogen, and this is shown to
just before the longest sleep interval for the
be protective against glaucoma.15-18
infant. If multiple doses are needed, recommend the patient breast feed immediately
The results of the Rotterdam Study in the
before instillation. Finally, many women
Netherlands, n=3078, showed that if natural
suffer from severe dry eye, so the use of
menopause occurs before the age of 45 years,
there was a 2.3 times higher risk to
develop open-angle glaucoma even
the number of Ameriwith hormone replacement therapy.19
cans living with glauThe
Blue Mountain Study in Australia
coma by the year 2020
showed that late menarche of onset
>13 years old, or early menopause
beta-blockers may be prohibited, making it
<45 years old, increases risk.20 The Nurses
more difficult to get adequate IOP control
Health Study in the U.S., n=66.417, was a
and needing more surgical intervention for
prospective study that concluded that later
the disease.13,14
menopause, onset >54 years, showed a reduced risk.21 And finally, studies from the
Of concern is the patient at risk for acute
angle closure because labor can precipiMayo Clinic indicate that women who had
tate an angle closure. A laser peripheral irihysterectomies before the age of 43 years
dotomy (LPI) can be safely performed durhad an increased risk to develop glaucoma.22
ing pregnancy with topical anesthesia and
Another consideration is the role of iron,
an upright position during the procedure.
which causes oxidative stress. Women are
For those who have a pre-existing condition
often iron deficient during menses, and this
of glaucoma prior to pregnancy, this may
may have a protective effect.
be a more severe form due to earlier age of
When we look at exogenous estrogen, such
onset. IOP is slightly elevated during natuas in hormone replacement therapy (HRT)
ral childbirth, therefore a Cesarean section
or oral contraceptives (OC), the findings
delivery should be discussed if control is
vary. For those post-menopausal women on
questionable.13,14
HRT, the Heart and Estrogen Replacement
Study (HERS) and Women’s Health Initiative (WHI) studies, published in 1998 and
The role of estrogen
2002, respectively, indicated a 0.40 percent
Numerous studies have looked at the role of
risk reduction for POAG for every month of
estrogen in the development of glaucoma.15-18
therapy.21 Today, in the U.S., HRT is very tarEstrogen has been known to offer neuro-
60-80M
|
geted for those symptomatic women (symptoms include hot flashes, urogenital atrophy, osteoporosis) and therefore the benefit
is limited due its reduced use. Contrary are
pre-menopausal women on OC. The Nurses
Health Study, n=80,000, was a retrospective
study looking at patients from 1980-2006.21 It
revealed that the use of OC for five years or
longer increased the risk for primary openangle glaucoma by 25 percent. The difference in these exogenous sources is likely the
formula, but also the physiologic outcome.
Oral contraceptives contain progestin which
suppresses ovulation, thereby altering the
natural hormonal patterns.
The role of estrogen in the central ner-
There seems to
be a correlation
between ED and
the diagnosis of
glaucoma, not its
treatment
vous system has been well studied, and it is
thought that some of these findings may be
applicable to retinal and optic nerve health.
Retinal ganglion cells express estrogen receptors, and this may contribute to neuroprotection. Estrogen increases extra-cellular matrix production that may protect the
optic nerve head from axonal damage. And
See Women and glaucoma on page 20
IN BRIEF
Dry eye is linked to chronic pain syndromes, says study
MIAMI—Researchers with Bascom Palmer Eye
Institute have found a link between dry
eye and chronic pain syndromes—a finding that suggests that a new paradigm is
needed for diagnosis and treatment to improve patient outcomes. Results were published in Journal of Pain.
“Our study indicates that some patients
with dry eye have corneal somatosensory
pathway dysfunction and would be better described as having neuropathic ocular pain,”
says lead author Anat Galor, MD, MSPH, a
cornea and uveitis specialist and associate
professor of clinical ophthalmology at Bascom Palmer Eye Institute at the University
of Miami Miller School of Medicine.
Corresponding author Roy C. Levitt, MD,
a neuroanesthesiologist, pain specialist, and
geneticist at the Miller School, says, “A multidisciplinary approach used for chronic pain
treatment may also benefit these dry eye
patients.”
Their research team evaluated 154 dry
eye patients from the Miami Veterans Affairs Hospital.
“Dry eye patients in our study reported
higher levels of ocular and non-ocular pain
associated with multiple chronic pain syndromes and had lower scores on depression
and quality-of-life indices consistent with
a central sensitivity disorder,” says Levitt.
“We also suspect that neuropathic ocular
pain may share causal genetic factors with
other overlapping chronic pain conditions.”
“Traditionally, eye specialists have treated
dry eye with artificial tears or topical medications for the surface of the cornea,” said
Galor. “However, even if these treatments
improve some dry eye symptoms, many patients continue to report underlying ocular
and non-ocular pain.”
Reflecting on the implications of the study,
Galor said, “Our highest priority is educating physicians that dry eye represents an
overlapping chronic pain condition. Consequently, a multidisciplinary approach should
be considered in the diagnosis and pain
management of dry eye patients.”
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SPECIAL SECTI O N
20
JANUARY 2016
Glaucoma
Women and glaucoma
because estrogen regulates smooth muscle
control, this may enhance blood flow to the
optic nerve. Another concern is that some
cancer agents are anti-estrogen—careful
monitoring is needed.15-18
similarities between AD and elevation in
intraocular pressure including decreased
cerebrospinal fluid and amyloid plaques
that aggravate in both the brain and retinal ganglion cells.25-27
Lifestyle
We have all heard that 50 is the new 40. In
fact, 70 is the new 60! People of this age
have more active lifestyles than before and
Women as caregivers
strive to stay healthy. This may include acWomen are often the caregivers or mantivities such as yoga, golf, and yes, sex.
age the family health care, so indirectly
Depending on the
level
of activity, inverthe use of oral contraceptives for this
time frame (or longer) increased the
sions in yoga and latrisk for primary open-angle glaucoma eral extension in golf
by 25 percent
have been shown to
elevate intraocular
pressure. On a positive note, sleeping with
they may affect the incidence and detection
the head slightly elevated 30 degrees on
of glaucoma. A recent study in India pubtwo pillows has been shown to decrease
lished in British Journal of Ophthalmology
IOP up to 20 percent. This is a very comrevealed that in 1,259 pediatric glaucoma
mon position for women in the age group
cases, five percent were steroid induced due
because they are likely to make a weekly
to the overuse of steroids for severe GPC or
visit to their salon for an up-do hairstyle,
vernal conjunctivitis. Children are affected
and they like to maintain their style until
by steroids at lower dosing and duration
the next visit.28-30
than adults, so it is important to monitor
IOP and discontinue treatment in a timely
Age does not discriminate for those who
manner. Because mothers might be instilllike to maintain beauty and sex appeal. Erecing the medications and treating recurrent
tile dysfunction (ED) is more commonly
conditions, it is important they know the
discussed as treatment has become more
potential risks.23
effective. More and more seniors are sexually active. It was long thought that erectile
dysfunction was a side effect of the use of
Glaucoma in mature populations
beta blockers systemically or topically for
As our gender thrives into more advanced
glaucoma. On the contrary, there seems to
years, dementia becomes another health
concern. Treatment success for glaucoma
is based on compliance, and the ability for
patients to self-administer their medications
is reduced with memory loss. As cognitive
impairment and glaucoma share a common
vascular risk factor, the relationship between
Alzheimer’s disease (AD) and glaucoma has
been reviewed.
Previous studies in Europe and the U.S.
have not shown a relationship; however, a
be a correlation between ED and the diagnorecently published population-based study in
sis of glaucoma, not its treatment. Because
Taiwan has. The study looked at ICD codes
women often take care of their spouse’s
and co-morbidity factors of over 15,000 pahealth needs, this is a discussion they should
tients. Of interest is that in this population,
be having.31
when compared to the controls, women (not
men) with dementia were more likely have
Ask questions
a prior diagnosis of open-angle glaucoma.
In the past, the pertinent history for glauOther studies have shown that women with
coma included family history, age, race, and
glaucoma have more severe vision loss. This
trauma. Today we need to query further.
may be due to longevity, financial burdens,
As we can see, age of menses, use of OC/
or simply late diagnosis.1,24 This sensory imHRT, and hysterectomy play a key role. A
discussion regarding childbearing may have
pairment and lack of visual stimulation can
been just in passing, but this information
easily contribute to the progression of cogmay now be significant because the choice
nitive loss. This study also discussed other
5 years
|
is delayed and our optic nerves age. Six percent of women enter menopause before the
age of 45,32,33 and although we don’t typically ask this question of our patients, perhaps we should. Many men don’t always
disclose all of their medications or their
diagnosis of ED because they don’t think it
affects their eyes. Perhaps we need to specifically ask them and their partners about
this information.
Lifestyle choices that may be more focused
to our gender should be discussed. Given
some of the findings, future treatment may
be more targeted toward hormonal control.
Globally women live longer and 90 percent
of centenarians are women.34 It is important to keep that in mind when determining target IOP and when to treat.
REFERENCES
1. Vajaranant TS, Nayak S, Wilensky JT, Joslin CE.
Gender and glaucoma: what we know and what
we need to know. Curr Opin Ophthalmol. 2010
Mar;21(2):91-9.
2. Takusagawa H, Mansberger S. Do Ethnicity
and Gender Influence Glaucoma Prevalence?
Ophthalmology Management. Available at: http://
www.ophthalmologymanagement.com/articleviewer.
aspx?articleID=106702. Accessed 12/28/15.
3. The Eye Diseases Prevalence Research Group
Prevalence of open-angle glaucoma among adults in
the United States. Arch Ophthalmol. 2004 Apr;122(4):
532–538.
4. Leske MC, Connell AM, Schachat AP, Hyman L.
The Barbados Eye Study. Prevalence of open angle
glaucoma. Arch Ophthalmol. 1994 Jun;112(6):821-9.
5. Leske MC, Connell AM, Wu SY, Nemesure B,
Li X, Schachat A, Hennis A. Incidence of openangle glaucoma: the Barbados Eye Studies. The
Treatment success for glaucoma is based
on compliance, and the ability for patients
to self-administer their medications is
reduced with memory loss
Barbados Eye Studies Group. Arch Ophthalmol. 2001
Jan;119(1):89-95.
6. Kang JH, Loomis S, Wiggs JL, Stein JD, Pasquale
LR. Demographic and geographic features of
exfoliation glaucoma in 2 United States-based
prospective cohorts. Ophthalmology. 2012
Jan;119(1):27-35.
7. Wang B, Sakata LM, Friedman DS, Cahn YH He
M, Lavanya R, Wong TY, Aung T. Quantitative iris
parameters and association with narrow angles.
Ophthalmology. 2010 Jan;117(1):11-17.
8. Kang JH, Lookis S, Wiggs JL, Stein JD, Pasquale LR.
Demographic and geographic features of exfoliation
glaucoma in 2 United States-based prospective
cohorts. Ophthalmology. 2012 Jan;119(1); 27-35.
9. Wang D, He M, Wu L, Yaplee S, Singh K, Lin S.
Differences in iris structural measurements among
SPECIAL SECTI O N
American Caucasians, American Chinese and
mainland Chinese. Clin Experimental Ophthalmol. 2012
Mar;40(2): 162-9.
10. Kamal D, Hitchings R. Normal tension glaucoma--a practical approach. Br J Ophthalmol. 1998
Jul;82(7):835-40.
11. Tehrani S. Gender difference in the pathophysiology
and treatment of glaucoma. Curr Eye Res. 2015
Feb;40(2):191-200.
12. Razeghinejad MR1, Tania Tai TY, Fudemberg SJ,
Katz LJ. Pregnancy and glaucoma. Surv Ophthalmol.
2011 Jul-Aug;56(4):324-35.
13. American Academy of Ophthalmology. Drugs
and Pregnancy. Focal Points: Clinical Modules for
Ophthalmologists. September 2007
Glaucoma
Of concern is the
patient at risk for
acute angle closure
because labor can
precipitate an angle
closure
PT. Is open-angle glaucoma associated with early
menopause? The Rotterdam Study. Am J Epidemiol.
2011 July 15:154(2): 138-144.
14. Johnson SM, Martinez M, Freedman S. Management
of glaucoma in pregnancy and lactation. Surv
Ophthalmol. 2001 Mar-Apr;45(5):449-54.
20. Lee AJ, Mitchell P, Rochtchina E, Healey PR; Blue
Mountain Eye Study. Female reproductive factors and
open angle glaucoma: the Blue Mountain Eye Study. Br
J Ophthalmol. 2003 Nov;87(11): 1324-8.
15. Pasquale LR, Rosner BA, Hankinson SE, Kang
JH. Attributes of female reproductive aging and their
relation to primary open-angle glaucoma: a prospective
study. J Glaucoma. 2007 Oct-Nov;16(7): 598-605
21. Pasquale LR, Kang JH. Female reproductive factors
and primary open-angle glaucoma in the Nurse’s
Health Study. Eye (Lond). 2011 May;25(5): 633-41.
16. Altintaş O, Caglar Y, Yüksel N, Demirci A, Karabaş L.
The effects of menopause and hormone replacement
therapy on quality and quantity of tear, intraocular
pressure and ocular blood flow. Ophthalmologica. 2004
Mar-Apr;218(2): 120-129.
17. Zhou X, Li F, Ge J, Sarkisian SR Jr, Tomita H,
Zaharia A, Chodosh J, Cao W. Retinal ganglion cell
protection by 17-beta-estradiol in a mouse model of
inherited glaucoma. Dev Neurobiology. 2007 Apr;67(5):
603-616.
18. Vajarant TS, Pasquale LR. Estrogen deficiency
accelerates aging of optic nerve. Menopause. 2012
Aug 19(8): 942-7.
19. Hulsman CA, Westendorp IC, Ramrattan RS, Wolfs
RC, Witteman JC, Vingerling JR, Hofman A, de Jong
22. Vajaranant TS, Grossardt BR, Maki PM, Pasquale
LR, Sit AJ, Shuster LT, Rocca WA. The risk of glaucoma
after early bilateral oophorectomy. Menopause. 2014
Apr; 21(4): 391–398.
23. Gupta S, Shah P, Grewal S, Chaurasia AK, Gupta V.
Steroid-induced glaucoma and childhood blindness. Br
J Ophthalmol. 2015 Nov;99(11):1454-6.
24. Quigley HA, Broman AT. The number of people
with glaucoma worldwide in 2010 and 2020. Br J
Ophthalmol. 2006 Mar;90(3);262-7.
25. Chung SD, Ho JD, Chen CH, Lin HC, Tsai MC,
Sheu JJ. Dementia is associated with open-angle
glaucoma: a population-based study. Eye (Lond). 2015
Oct;29(10):1340-6.
26. McCKinnon SJ. Glaucoma: ocular Alzheimer’s
21
Disease? Front Biosci. 2003 Sep 1;8:s1140-56.
27. Berdahl JP, Allingham RR, Johnson DH.
Cerebrospinal fluid pressure is decreased in primary
open-angle glaucoma. Ophthalmology. 2008
May;115(5):763-8.
28. Weinreb RN, Cook J, Friberg TR. Effect of inverted
body position on intraocular pressure. Am J Ophthalmol.
1984 Dec 15;98(6):784-7.
29. Buys YM, Alasbali T, Jin YP, Smith M, Gouws
P, Geffen N, Flanagan JG, Shapiro CM, Trope GE.
Effect of sleeping in a head-up position on intraocular
pressure in patients with glaucoma. Ophthalmology.
2010 Jul;117(7):1348-51.
30. Seo H, Yoo C, Lee TE, Lin S, Kim YY. Head position
and intraocular pressure in the lateral decubitus
position. Optom Vis Sci. 2015 Jan;92(1):95-101.
31. Nathoo NA, Etminan M, PharmD, Mikelberg
FS. Association between glaucoma, glaucoma
therapies, and erectile dysfunction. J Glaucoma. 2015
Feb;24(2):135-7.
32. McKinley SM, Brambilla DJ, Posner JG. The
normal menopause transition. Maturitas. 2008 SepOct;61(1-2):4-16.
33. Miro F, Parker SE, Apsinall LJ, Coley J, Perry PW,
Ellis JE. Sequential classification of endocrine stages
during reproductive aging in women; the FREEDOM
study. Menopause. 2005 May-Jun;12(3); 281-90.
34. Austad SN. Why women live longer than men: sex
differences in longevity. Gend Med. 2006 Jun;3(2):
79-92.
Dr. Sclafani is president of Women of Vision, past president
of the Illinois Optometric Association, past chair of the
AOA Contact Lens and Cornea Section, and has served as a
consultant for the Chicago Blackhawks.
[email protected]
IN BRIEF
Portable tool being developed to diagnose sideline concussions
BLOOMINGTON—Two Indiana University scientists
continue their work toward a portable sideline device that will be able to quickly detect signs of mild brain trauma.
Since 2010, Nicholas Port and Steven A.
Hitzeman, researchers at the IU School of
Optometry, have gathered baseline data on
the eye movements and balance of IU athletes and have since expanded their work to
high schools and local club and youth sports.
To measure concussion symptoms, Port
devised a system that consists of eye-tracking goggles within a shoebox-sized device
and a balance platform based on technology
in Nintendo’s Wii gaming system. By comparing an athlete’s baseline numbers with
similar tests after a high-impact blow, the
tester can quickly determine whether the
athlete suffered a concussion and should
be withheld from competition.
So far, data on more than 1,000 athletes—as
well as 69 concussions—has been collected,
about two-thirds of which came from football. There is not yet enough information
to produce statistically valid conclusions.
Says Port, “Ocular and motor performance
can be severely impaired during the acute
phase of a concussion, which is the first
10 minutes to an hour after a concussion
occurs. We like to test the affected athlete
within 10 minutes of the event.”
Once fully developed, such technology
could help eliminate scenarios such as what
occurred in the Nov. 22 NFL game between
the St. Louis Rams and the Baltimore Ravens when Rams quarterback Case Keenum hit his head on the turf. Despite the
Rams sending its head trainer on the field
to talk with Keenum and the presence of
an NFL injury spotter, Keenum remained in
the game. Only after the game was it found
that Keenum had suffered a concussion.
“The research being conducted will add
an objective approach to this problem by
developing a device that not only measures
symptoms on-site but eliminates athletes’ ability to fool trainers, physicians, and coaches
into thinking they are fit to play,” Port says.
In some cases, athletes may not be aware
they sustained a concussion until days later,
says Orlin Watson, head athletic trainer for
Bloomington North High School, which has
had about 15 students take part in the study.
“We explain to our student-athletes why it
is important to report symptoms,” Watson
says. “But you’re still dealing with subjective information. A device that can provide
objective information would serve as a valuable tool for athletic trainers in treating and
diagnosing concussions.”
SPECIAL SECTI O N
22
JANUARY 2016
Glaucoma
Glaucoma drainage
ditional glaucoma surgery. It is the smallest
FDA-approved device for mild to moderate
glaucoma. The iStent Inject is being
developed with multiple iStents in
prised of Heparin (heparin sodium,
a preloaded injector system if the
Hospitra)-coated titanium. The iSsurgeon deems it necessary to use
tent is usually implanted nasally
more than one.2
into Schlemm’s canal during cataract surgery and is designed to
Contraindications for iStent use
improve the aqueous outflow and
include primary- or secondary-anBARBARA J.
decrease intraocular pressure (IOP)
gle closure glaucoma, neovascuFLUDER, OD
by creating a permanent opening
lar glaucoma, thyroid eye disease,
has been in practice
in the trabecular meshwork.
Sturge-Weber syndrome, or any other
for 22 years and
The procedure involves insertcondition that may cause elevated
currently practice
ing the iStent through the phacoepiscleral venous pressure. Goniat Williams
Eye Institute in
emulsification incision site past
oscopy should be performed beMerrillville, IN.
the pupillary margin. The angle
fore surgery to rule out peripheral
is viewed with a gonioscopy lens,
anterior synechiae, rubeosis, and
and an approach is made to the upper one
any angle abnormalities or conditions that
third of the trabecular meshwork at an angle
would occlude sufficient visualization of the
of 15 degrees. The trabecular meshwork is
angle that could lead to improper placement
engaged, and the iStent is gently inserted
of the stent.1 Complications can include corinto Schlemm’s canal. The bottom of the
neal edema, posterior capsular haze, stent
inserter is pushed to release the iStent. The
obstruction, early postoperative cells in the
button is released, and the side of the snoranterior chamber (AC), and early postop-
Selection of the device depends on
numerous factors, such as patient’s age,
glaucoma subtype, and treatment goals.
kel is gently tapped to ensure the device is
properly seated. The inserter and viscoelastic are then removed.1
Because the procedure is minimally invasive, it spares tissue damage caused by tra-
1
erative corneal abrasion.1
Postoperative care generally includes the
usual cataract recovery drop schedule as well
as the patient’s currently prescribed glaucoma medications. Commonly used postop-
|
TAKE-HOME MESSAGE Optometrists
comanaging glaucoma surgery or even seeing
glaucoma patients should know their way
around drainage devices. Baerveldt Glaucoma
Implant, Ahmed Glaucoma Valve, iStent, and
ExPress Glaucoma Filtration Device share
commonalities in usage, complications, and
postop care; however, there are differences in
these devices.
erative drops include Besivance (besifloxacin, Bausch + Lomb) tid for one week;
prednisolone tid for one week, then bid for
one week, then qd for two weeks, and Ilevro
(nepafenac ophthalmic suspension, Alcon)
qd for four weeks. If the IOP remains the
same as it was preoperatively, then usually
the patient will continue with his glaucoma
drop regimen. A trial discontinuation of the
glaucoma drops may be used to see how
well the IOP is maintained.3
Baerveldt Glaucoma Implant
Baerveldt Glaucoma Implant is designed for
patients with medically uncontrolled glaucoma or patients who have failed conventional surgery. It is available in three models: 250 mm, 350 mm, and 350 mm pars
plana.4 The 250 mm is the most commonly
used size. Its features include a large surface area plate, single quadrant insertion,
a drainage tube, recessed knot capability,
decreased bleb height, low edge height, and
four fenestrations to promote fibrous adhe-
Figure 1. Insertion of the tube into the
anterior chamber to increase aqueous outflow.
Image courtesy Ike Ahmed, MD
SPECIAL SECTI O N
2
Glaucoma
Figures 2, 3, 4.
Postop after
Baerveldt
insertion.
Images courtesy Brad Sutton, OD.
23
Complications can include a choroidal hemorrhage, hyphema, choroidal effusion, hypotony, flat AC, phthisis bulbi,
retinal detachment, endophthalmitis, tube erosion, tube touch
to cornea, tube block by iris or vitreous, bullous keratopathy, uveitis, and diplopia.5 Corneal patch grafts are used to
prevent tube erosion. The tube is initially restricted with a
suture to prevent early hypotony. Some surgeons make fenestrations in the tube to control pressure early in the poSee Glaucoma drainage on page 24
3
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sions to the sclera, which may reduce bleb height. A fenestrated Baerveldt may reduce bleb height by 50 percent. These advantages allow
for long-term IOP control, easier implantation, decreased surgery time,
less trauma, and faster healing.4
A Vicryl suture is used to tie off the tube before implantation and is
tested with balanced salt solution (BSS) to ensure it is occluded. Some
surgeons also insert a ripcord into the tube to be released later if further IOP reduction is necessary. The superior temporal conjunctiva is
dissected, creating a conjunctival flap between the superior and lateral
rectus muscles. The plate is placed behind the muscles and is secured
to the sclera. If superior temporal placement is not possible, it may be
placed inferonasally. An incision is made parallel to the iris through the
sclera for entry of the tube into the anterior chamber. The tube is cut to
size before being inserted into the AC. The tube should be close to the
surface of the iris without indenting it. The tube is then covered with
a patch graft. Two to three fenestrations may be made into the tube as
well. If a ripcord is used, it is placed in the inferior conjunctival space
and the conjunctival flap is closed.
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SPECIAL SECTI O N
24
JANUARY 2016
Glaucoma
Glaucoma drainage
stop period. Tube touch to cornea can be
avoided by placing the tube in the sulcus
in pseudophakic patients.3
Regarding postoperative care, if an elevation in the IOP occurs early in the postop period and the suture has not broken,
breaking the suture is an option. Using a
ripcord suture gives the surgeon an addi-
10 days. Routinely, patients are seen at one
day, one week, three weeks, and five weeks
until IOP is stabilized.3
5
6
Ahmed Glaucoma Valve
Although there are several models of this
device, the original S2 is commonly used.
The body plate is made of polypropylene, and
the valve is made of polypropylene with a
silicone elastomer membrane to control IOP.
The Ahmed features immediate reduction
Baerveldt Glaucoma Implant is designed
for patients with medically uncontrolled
glaucoma or patients who have failed
conventional surgery
tional choice. Glaucoma drops are continued
during the initial postop period until the
suture dissolves or is broken. Prednisolone
drops are prescribed qid for approximately
two weeks then tapered and Polytrim (trimethoprim/polymyxin B, Allergan) qid for
|
of IOP and a valve system to prevent excessive drainage and AC collapse. There is no
need for drainage tube ligature sutures, ripcord sutures, and occluding sutures. Other
models include a pediatric or small globe
S3, FP7, pediatric F8, PC7, pediatric PC8,
Figure 6. Ex-Press Glaucoma Filtration
Device. Image courtesy Alcon.
and FX1 (with a bi-plate design). The latest model is M4 It is comprised of a porous
polyethylene which allows soft tissue growth
into the pores, promoting integration with
surrounding tissue and vascularization.2
The procedure is performed almost the
same as the Baerveldt Implant; however,
no ripcord or tube occlusion is needed because it is a valved device. The valve needs
to be primed with BSS. A patch graft is also
used to prevent erosion in this procedure.
Figure 5.
Ex-Press Glaucoma Filtration
Device diverting aqueous humor
to a bleb in the subconjunctival
space.
Image courtesy Alcon.
SPECIAL SECTI O N
Patch grafts can be corneal, pericardial or
scleral. Our glaucoma specialist, Tyler Kirk,
MD, prefers a corneal patch graft.3
Complications with an Ahmed Valve are
similar to those of the Baerveldt and can
include hypotony. However, it is usually
transient and often spontaneously resolves.
Postop care includes discontinuation of
all glaucoma drops, prednisolone qid for
two weeks, and Polytrim qid for 10 days.
Patients are seen at one day, one week, and
three and five weeks until IOP stabilizes
and the eye has healed.3
Glaucoma
25
7
ExPress Glaucoma Filtration
Device
ExPress Glaucoma Filtration Device is a
3-mm long non-valved device that, like a
trabeculectomy, diverts aqueous humor flow
from the AC to a bleb in the subconjunctival space. The initial procedure is similar to that of a trabeculectomy as well.
ExPress is preloaded in an injector with a
metal rod fitted through the lumen, which
is attached to the end of the injector. The
Figure 7. Baerveldt Glaucoma Implant. Image courtesy of Abbott Medical Optics.
See Glaucoma drainage on page 26
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on Chronic Dry Eye
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SPECIAL SECTI O N
26
JANUARY 2016
Glaucoma
Glaucoma drainage
shunt is then placed under a scleral flap
into the AC through the incision made with
a 25-gauge needle. The shunt is inserted
all the way into the wound so the plate is
flush with the scleral bed. Like a punctal
plug, the shaft of the injector is depressed,
retracting the metal rod and releasing the
shunt. The scleral flap and the conjunctiva
are sutured. The flow is tested by inflating the AC with BSS through the temporal
paracentesis. A fluorescein strip is used to
check for wound leak.
Complications with ExPress Glaucoma
Filtration Device include hypotony, although
a study by Maris et al6 show a 32 percent
hypotony rate with trabeculectomy and a
four percent rate with the ExPress device. It
is thought that this lower rate of hypotony
is attributed to the resistance to flow due
to the 50 μm lumen of the shunt.7
Postoperative care consists of discontinuation of all glaucoma drops, prednisolone
four to six times per day for approximately
four weeks, and Polytrim qid for 10 days. If
the device is combined with cataract extraction, it is common to add Ilevro qd. Patients
are seen at one day and every week after
for several weeks. Suture lysis may occur at
three weeks as needed. Prednisolone drops
are generally tapered at four weeks.
Choosing a device
Selection of the device depends on numerous factors, such as patient’s age, glaucoma
subtype, and treatment goals.8 There can be
The Centers for Medicare and Medicaid
(CMS) announced in September 2015 that
it will bundle and revalue tube shunt and
patch graft surgeries.
|
considerable pressure volatility in the early
postoperative period with the Baerveldt Implant. However, lower long-term pressure
control is often achieved. The Baerveldt tube
is occluded during the first four to six weeks
after surgery while the bleb forms around
the plate. Flow begins when tube occlusion
dissolves or is removed. This often causes
a quick pressure drop and may cause hypotony-related complications. The Ahmed
device has a built-in valve that allows for
immediate flow postoperatively and thus
prevents hypotony. However, glaucoma medications may be required long term. There
are many other tube shunt devices such as
the Molteno 3 and the Krupin.8
Other postoperative aids may include fibrin glue. Fibrin glue is a biological tissue
adhesive that mimics the final stages of the
coagulation cascade. Fibrin glue incorporates a fibrinogen and a thrombin component, both prepared by processing plasma.
Fibrin glue forms a smooth seal along the
wound and helps reduce hypotony and increase patient comfort. The glue is used
in conjunction with sutures.9 If IOP is extremely low early in the postoperative pe-
IN BRIEF
Transitions Optical names finalists of first innovation awards
PINELLAS PARK, FL—Transitions Optical, Inc. has
named the finalists for its new Transitions
Innovation Awards program, which recognizes both individuals and companies from
the U.S. and Canada for their innovative efforts to support the Transitions brand over
the past year. The finalists will be honored
during Transitions Academy 2016, where the
winners will be announced.
“Innovation exists within all business functions and teams; sometimes it’s the company
culture that supports and sustains this creativity and at times it’s an individual that
inspires a change or idea,” says Jose Alves,
general manager, Americas, Transitions Optical. “All of our finalists have applied smart,
innovative thinking to achieve their professional and personal goals. We are grateful
for their partnership and for all they do to
promote the Transitions brand.”
Transitions Brand Ambassador
This award celebrates an individual who best
showcases their dedication to being an influential advocate of the Transitions brand.
The 2015 finalists include:
– Eric White, OD, Complete Family Vision
Care,San Diego
– George Thomas, Territory Director –
Visionworks, Chicago region
– Rachel Hill, Personal Optical (St. Catherines, Ontario)
Best in Growth Achievement
The Best in Growth Achievement title is awarded
to an individual or company that has demonstrated a strong commitment to Transitions
Optical and photochromic growth. The 2015
finalists include:
– Henry Ford OptimEyes, Detroit
– Insightful Visions, Sechelt, BC
– Vision Arts Eyecare Center, Fulton, MO
and Ontario
– U.S. Optical, Syracuse, NY
– Visionworks
Best in Marketing
This award honors an individual or company
for creative and strategic marketing tactics
to effectively promote the Transitions brand
or Transitions family of products among customers or within their communities. The 2015
finalists include:
– Lunetterie New Look Eyewear, Québec
and Ontario
– Opto-Réseau, Québec
– Visionworks
Best in Patient Experience
Best in Training
This award celebrates an individual, company, or educator that has shown creativity
in developing or offering training and education opportunities that include dispensing
photochromic lenses, the Transitions brand
or Transitions family of products. The 2015
finalists include:
– Lunetterie New Look Eyewear, Québec
This award is presented to an individual or
company for developing a forward-thinking
approach to consistently dispense Transitions
lens products to meet individual patient needs.
The 2015 finalists include:
– Advanced Vision & Achievement Center,
Phoenix
– Vision Arts Eyecare Center, Fulton, MO
– Vision Source Olmos Park, San Antonio, TX
SPECIAL SECTI O N
Glaucoma
27
Figure 8.
8
Baerveldt Glaucoma Implant.
riod, atropine can be administered bid to
deepen the AC and raise IOP. Additionally,
a large diameter contact lens can be applied
to tamponade the flow.3
The Centers for Medicare and Medicaid
Services (CMS) announced in September
2015 that it will bundle and revalue tube
shunt and patch graft surgeries.10 Surgeons
have been placing patch grafts over tubes
for years to reduce the incidence of tube
erosion through the underlying conjunctiva.
Therefore, a patchless technique is now appearing. Dr. Rafael Bohorquez recorded a
video to demonstrate a 6-mm scleral tunnel
used in lieu of a patch graft to cover the tube
on its way into the AC.11 He recommends
inserting a 22-gauge needle parallel to the
iris to create the tunnel. He closes the back
of the tunnel with a Vicryl suture to reduce
the chance of filtration around the tube.12
Looking ahead
There are continually new procedures and
devices on the horizon. InnFocus Micro
Shunt is currently in Phase I FDA trials at
11 U.S. centers and is being implanted either alone or in combination with cataract
surgery in clinical trials outside the U.S.
The company reports that patients are experiencing a “stable reduction in mean IOP
to below 14 mm Hg.” The report states that
70 to 80 percent of patients are requiring
few medications or no medications at all.13
Other procedures include endocyclophotocoagulation, which reduces aqueous inflow by selective ablation of the ciliary body.
This procedure can be done in conjunction
with outflow procedures as well.13
Canaloplasty decreases IOP by creating
a Descemet window and dilation and tensioning of the trabecular meshwork. This is
performed using an iTrack micro catheter,
developed by iScience Interventional, and
a suture placement in Schlemm’s canal.13
Trabectome by NeoMedix uses bipolar
cautery on a disposable handpiece to ablate
a certain number of clock hours of the trabecular meshwork in an effort to increase
outflow. It is approved for mild to moderate glaucoma and can be combined with
cataract surgery.13
CyPass Micro-Stent by Transcend Medical is inserted via a clear corneal incision
and placed in the supraciliary space. Its design is to increase uveoscleral outflow and
it can be combined with cataract surgery.13
The ability of these many options allows
the glaucoma specialist to customize procedures based on the physiological needs of
each diseased eye and meet each patient’s
individualized needs.
REFERENCES
1. Glaukos Corporation website. Available at: http://
www.glaukos.com/istent. Accessed 12/22/15.
2. New World Medical, Inc. website. Available at: http://
www.ahmedvalve.com. Accessed 12/22/15.
5. Sarkisian SR. Going with the flow: Managing tube
shunts. Rev Ophthalmology. Available at: http://www.
reviewofophthalmology.com/content/d/glaucoma_
management/i/1210/c/22807/. Accessed 12/28/15.
6. Maris PJ Jr, Ishida K, Netland PA. Comparison of
trabeculectomy with Ex-PRESS miniature glaucoma
device implanted under scleral flap. J Glaucoma. 2007
Jan;16:14-9
7. Sarkisian SR. The ExPress mini glaucoma
shunt: technique and experience. Middle East Afr J
Ophthalmol. 2009 Jul-Sep;16(3): 134-137.
8. Ahmed IK, Christakis PG. Ahmed, Baerveldt, or
something else? Rev Ophthalmology. Available at:
http://www.reviewofophthalmology.com/content/t/
glaucoma/c/41000/. Accessed 12/28/15.
9. Panda A, Kumar S, Kumar A, Bansal R, Bhartiya
S. Fibrin glue in ophthalmology. Indian J Ophthalmol.
2009 Sep-Oct; 57(5): 371–379.
10. Corcoran S. Glaucoma coding: 2015 brings
changes. Ophthalmol Management. Available at: http://
www.ophthalmologymanagement.com/articleviewer.
aspx?articleID=112312
11. Eyetube.net: Available at: www.eyetube.net/
video/non-extrusion-b-drainage-device-technique/.
Accessed 12/28/15.
12. Myers JS. Tube coverage: Another approach.
Glaucoma Today. Available at: http://glaucomatoday.
com/2014/12/tube-coverage-another-approach/.
Accessed 12/28/15.
13. Noecker RJ. Update on new glaucoma surgical
devices. EyetubeOD. Available at: http://eyetubeod.
com/2011/12/update-on-new-glaucoma-surgicaldevices. Accessed 12/28/15.
3. Kirk, Tyler. Personal interview. 16 Jan 2015.
4. Abbott Medical Optics website. Available at: http://
www.abbottmedicaloptics.com/products/cataract/
glaucoma-implants/baerveldt-bg-101-350-glaucomaimplant. Accessed 12/22/15.
Dr. Fluder is a member of the American Optometric Association
and the Indiana Optometric Association. She has no financial
interest in any of the devices discussed.
[email protected]
Practice Management
28
JANUARY 2016
|
5 tips to prepare yourself
for private practice purchase
So you want to be a practice owner. Do these things first
practice, I suggest conducting demographic
research and obtaining information about
the school systems to nail down your deurchasing a private practice is a
sired area.
big decision and requires thorYou’ll need to weigh the pros and
ough preparation. The
cons of the area for both personal
practice that you purchase
and business reasons. Be sure that
can determine where you live and
the city is a good fit for you, and
where your children go to school,
determine the need for your serand it ultimately shapes the lifevices in your desired area. Durstyle you’ve been dreaming about
ing your search, it is important
your entire life.
to remain flexible—there can be
When the practice purchase is
limited opportunities for a given
conducted properly, it will provide
DIRK MASSIE, OD,
has two practice
city depending on the size and the
a great income throughout your calocations in the St.
number of private practice ownreer. Typically, owners of a private
Louis metro area.
ers who could potentially be repractice can earn considerably more
tiring soon.
than employed practitioners. One of
the best features of owning a private practice is that you build equity in the practice
Determine the type of
(and sometimes also the building in which
practice you want to
you practice). Another big advantage with
purchase
Do you want to purchase a smaller practice for a low price and work hard to turn it
into a full-time practice? There are several
smaller practices coming onto the market
as baby boomers are starting to retire. Several of these practices have annual revenue
of only about $400,000 and can usually be
purchased for under $250,000. With hard
By Dirk Massie, OD
P
2
Be sure that the
city is a good fit for
you, and determine
the need for your
services in your
desired area
owning your practice is total freedom—freedom to care for your patients in the manner that is in line with your philosophy,
and freedom to make your own schedule.
Careful planning is necessary when making such a big investment decision.
Here are five tips you should know before
you take the plunge into practice ownership.
1
Study the area where you
want to practice (and live)
Ideally, practice owners live in
the same city where their practice is located.
While it is not a must, being involved in
the community where you practice has long
been a driver of growth in private practice.
As you are searching for the perfect area to
1M.
Like smaller practices,
larger ones grossing this
can be purchased outright
work and dedication, a young practice owner
can grow the practice rapidly. In fact, I did
that myself. I bought a practice grossing
$375,000 a year, and within five years our
annual sales were over $1,000,000.
If you prefer to not work so hard to turn
around a smaller practice, consider buying
a larger practice. While a large practice
comes at a higher price, there is usually
not much additional investments needed; a
smaller, older practice often needs an office
remodel and updated equipment. A large
practice purchase is often structured as a
junior partnership in which the younger
partner slowly learns about practice own-
TAKE-HOME MESSAGE From carefully
examining the area in which you are hoping
to purchase, to deciding what kind of practice
you wish to buy, to buttoning up your finances,
these tips can help ease your way into practice
ownership. Private practice ownership is big
emotional and financial decision. Make sure
you’re ready before you make the leap.
ership from the senior partner. However,
large practices grossing over $1,000,000
can also be purchased outright just as a
smaller practice.
Ultimately, it comes down to the exit
strategy for the seller and if he wants to
remain working in the practice. Unfortunately, many young prospective buyers have
been promised an opportunity to “buy into
a practice” when they are hired on as an associate only to be led along for years with
the practice purchase never coming to fruition. This happens for various reasons but
mostly because the selling doctor overvalues her practice. The best way to avoid this
situation is to have the practice appraised
prior to ever seeing your first patient. The
terms of the employment contract should
include details of a possible practice purchase if/when it happens.
In my experience, private practices are
as unique as the owner. Each practice has
its own personality, and the buyer (and
his agent) should do his due diligence to
dig deep and find out what the practice is
truly like.
3
Decide if you should you hire
an agent to help you
Do you have spare time to search
for potential practices for sale? Are you comfortable knowing if the terms of the sale
are fair and reasonable? If you answered
“no” to either of those questions, then you
should seek out the help of a practice broker.
A practice broker can be a huge help
with buying a practice. Some of their serSee Practice purchase on page 30
Practice Management
30
Practice purchase
vices include:
Determine the type of practice that is suitable for the buyer
Confidentially search for the practice, freeing up the buyer to
continue working full time
Perform a fair market valuation of
the practice
Negot iate t he
terms of the transaction and assist
the buyer through
closing
Help the buyer obtain financing for the purchase
“You make your money when you purchase” is a longstanding
phrase used by real estate investors and accountants. It is crucial
not to overpay for your new practice, and a practice broker can
help you avoid making that mistake.
Each practice has
its own personality.
Do your due
diligence first.
4
Get your finances in order
Despite having significant student loan debt, practice
buyers are typically suitable for financing, sometimes
for 100 percent of the sale price, for purchasing a private practice.
TIPS FOR BUYING
A PRACTICE
1 Study the area where you want to practice
(and live)
2 Determine the type of practice you want to
purchase
3 Decide if you should hire an agent to help you
4 Get your finances in order
5 Protect your investment
Banks want to see good credit scores, minimal credit card debt,
and personal tax returns showing high levels of income in recent
years. If the prospective buyer has a spouse who works, that is
very appealing to banks who finance private practices.
One variable banks examine is your debt-to income ratio. If you
are serious about buying a practice soon, I recommend saving your
money and limiting your debt. Hold off on buying that new car or
home until after you’ve settled into your new practice. After all,
the car expenses can be paid by your future practice!
5
Protect your investment
The goodwill of the selling doctor can be the largest
portion of your investment when purchasing a practice.
See Practice purchase on page 34
JANUARY 2016 / OptometryTimes.com
Marketplace
PRODUCTS & SERVICES
Advertisers Index
Advertiser
DIGITAL IMAGING
Alcon Laboratories Inc
Tel: 800-862-5266
Web: www.alcon.com
Page
CVTIP, 34, CV3, CV4
Allergan Inc
Tel: 714-246-4500
Fax: 714-246-4971
Customer Service: 800-433-8871
Web: www.allergan.com
29, 30
Bausch + Lomb
Tel: 800-227-1427
Customer Service: 800-323-0000
Web: www.bausch.com
11, 12
Cooper vision
Web: www.coopervision.com
Mibo Medical Group
Tel: 214-507-8091
25
Nova Bay Pharmaceuticals
Web: [email protected]
15
REICHERT
Tel: 716-686-4500
17
Shire ophthalmic
Tel: 415-971-4650
7
TTI Medical
Tel: 800-322-7373
Web: www.ttimedical.com
CONFERENCES & EVENTS
CAREERS
American Academy of Optometry
New Jersey Chapter
NEW HAMPSHIRE
CV2
23
This index is provided as an additional service.
The publisher does not assume any liability for errors
or omissions.
14 t h A n n u a l E d u c a t i o n a l C o n f e r e n c e
April 13-17, 2016
Myrtle Beach, South Carolina
Hilton Embassy Suites at Kingston Plantation
Dr. Joseph Sowka, O.D., F.A.A.O.
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16 HOURS
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One, Two or Three Bedroom Suites
Accommodations Include a Daily Breakfast Buffet
and Evening Cocktail Reception
PACK YOUR CLUBS!
Golf details to follow.
For Accommodation and Additional Information, contact:
Dennis H. Lyons, OD, F.A.A.O.
Phone: (732) 920-0110
E-Mail: [email protected]
Concord Eye Center is currently interviewing
for an Optometrist to join our busy practice of
14 providers, in a multispecialty practice.
We are located in the heart of NH, with only an
hour to the coast, Boston and the mountains.
GmjimYdaÚ]\[Yf\a\Yl]oadd]f`Yf[]l`]aj
overall experience with performing complete
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ENSURES it will be seen
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call 603 224-2020 ext 2117
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Call Joanna Shippoli
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ADVERTISE TODAY!
31
32
JANUARY 2016 / Optometry Times
Marketplace
Content Licensing for
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For more information, call Wright’s Media at 877.652.5295 or
visit our website at www.wrightsmedia.com
Q&A
Mary K. Mercado, OD
33
Digital marketing manager for CooperVision, Inc.
Nail polish, opening a practice, and skydiving
As a chemist, what interested you in the contact lens field? Actually, it
wasn’t contact lenses, it was
polymer chemistry. My organic chemistry teacher told
me that there’s a whole science about just making plastics. It could be from making Tupperware to nail polish
to contact lenses. I thought,
maybe I want to work for
OPI, that’s a famous nail polish. I was an impressionable kid who loved fashion
and beauty. There’s a lot of
polymer chemistry in cosmetics, so I thought that was
something I should go into.
But CooperVision was in
my backdoor. I was initially
hired for polymer chemistry. It wasn’t like I wanted to
be a contact lens polymerchemist genius. Every girl
wants to work for something
she uses, like makeup. That
was kind of me, and then I
grew up really fast working
at CooperVision.
Photo courtesy Mary Mercado, OD
What pulled you into
marketing instead of
optometry? I got accepted to
UC Berkeley. I was super excited. I went to orientation,
then I just thought, “I don’t
think I’m cut out to do this.”
I couldn’t sit in a room for
eight hours a day. There’s a
lot of responsibility. I didn’t
think I was worthy and that I
wouldn’t be the right type of
doctor for someone’s health.
That’s how hard I am on myself. I was devastated. I took
about a month or two to figure out what I wanted to do.
I thought doing my MBA
would be really good. I took
my first marketing class, and
I thought, “Yes, this is what I
want to do.”
Why digital marketing?
How has
the Internet
changed how
products are
sold?
Q
It’s changed significantly because as
we’re seeing millennials becoming doctors—and with people like Alan Glazier—
there’s a whole community online, and it’s
increasing. We can’t
ignore that. If it were
decreasing, I would
have to rethink my career again. We have to
learn where the trend
is. It enables sales—
it almost enables us
to be right there in
front of ODs, whether
they’re at a conference
or in their practice, we
can serve them content and the consumption is at their leisure.
We’re busy people—
you’re busy, I’m busy.
So, if we’re at a restaurant and waiting for
our spouse or date,
of course I’m going to
be scrolling through
Facebook just seeing what’s on Huffington Post —that trend
cannot be denied. So,
it’s a fascinating world
where we can create
content for people to
consume when they
want it.
It’s obvious we live
in a very digital world. If I
was going to go into marketing, it was going to be at the
cutting edge. Print and traditional marketing will always be there. What opened
my eyes was the reach frequency with digital vs. print.
Give me $10,000 for print
and $10,000 for digital—I can
measure an ROI more successfully with digital, and I
can increase my digital footprint by rate-frequency significantly more. We have
Facebook on our phones,
Twitter ads, push notifications—we have to embrace it.
What’s the craziest
thing you’ve ever done?
For me, it’s skydiving. I told
my parents, “Do you want to
go skydiving?” They’re like,
“No, you should never do
that. Why would you do that
to your family? You could
die.” OK, well, I’m going to
go do it. [Laughs] That was
better than getting a tattoo. I
did it with a group of friends,
videotaped it, and bought the
DVD. I shouldn’t have bought
it because that was evidence
to my parents. How old was
I? About 20, still living at
home. [Laughs]
—Vernon Trollingerr
Your husband is an optometrist, and you’re
opening a new practice. How’s
that going? It’s super exciting. It’s kind of hard
to find a job unless
you’re going to be an
OD in a practice. He
just said, “Why not?
Let’s just open practice.” [Laughs] It
just makes perfect
sense. A great OD
with clinical and research skills, and we
also have me who
can market and know
how we want to position ourselves.
Hopefully we
can be successful and give
back to the
community.
To hear
the full interview
with Mary Mercado,
listen online:
optometrytimes.com/
MaryMercado
34
Practice Management
Practice purchase
If the selling optometrist will no longer be
working in the practice, it is important to
have her sign a non-compete agreement
so she doesn’t suddenly become your competitor and take all the patients with her.
In fact, patient retention should be your
primary focus when purchasing an existing
practice. The seller should agree to pose for
a photo with you that you can mail out in
a letter announcing you as the new owner.
The goodwill of
the selling doctor
can be the largest
portion of your
investment when
purchasing a
practice
JANUARY 2016
will result in a successful practice that patients will appreciate and will provide you
with a great lifestyle. Best of luck with your
quest to find your dream practice.
Dr. Dirk Massie is the primary consultant at Premier Doctor
Consultants. [email protected]
@dirkmassie
Drance hemorrhages and quarterly optic
disc evaluation
OptometryTimes.com/drance
Not knowing IOPs can make you a better
clinician
OptometryTimes.com/notknowingIOPs
Is glaucoma a neurological disease?
OptometryTimes.com/neurologicaldisease
Your pet may increase your glaucoma risk
OptometryTimes.com/glaucomapets
Like something we published?, hate
something we published?, have a
suggestion? Send your comments
to [email protected]. Letters
may be edited for length or clarity.
In the offspring of female rats that received travoprost subcutaneously from Day 7 of pregnancy to lactation Day
21 at doses of ≥ 0.12 mcg/kg/day (3 times the MRHOD), the incidence of postnatal mortality was increased, and
neonatal body weight gain was decreased. Neonatal development was also affected, evidenced by delayed eye
opening, pinna detachment and preputial separation, and by decreased motor activity
t.
BRIEF SUMMARY OF PRESCRIBING INFORMATION
A
®
DOSAGE AND ADMINISTRATION
A
The recommended dosage is one drop in the affected eye(s) once daily in the evening.
TRAV
AVATTAN Z (travoprost ophthalmic solution) should not be administered more than once daily since it
has been shown that more frequent administration of prostaglandin analogs may decrease the intraocular
pressure lowering effect.
®
TRAV
AVATTAN Z Solution may be used concomitantly with other topical ophthalmic drug products to lower
intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be
administered at least five (5) minutes apart.
CONTRAINDICATIONS
A
None
WARNINGS AND PRECAUTIONS
W
Pigmentation
T avoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most
Tr
frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and
eyelashes. Pigmentation is expected to increase as long as travoprost is administered. The pigmentation
change is due to increased melanin content in the melanocytes rather than to an increase in the number
of melanocytes. After discontinuation of travoprost, pigmentation of the iris is likely to be permanent, while
pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some
patients. Patients who receive treatment should be informed of the possibility of increased pigmentation.
The long term effects of increased pigmentation are not known.
Iris color change may not be noticeable for several months to years. Typicall
T
y, the brown pigmentation
around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the
iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While
treatment with TRAV
AVATAN Z (travoprost ophthalmic solution) 0.004% can be continued in patients who
develop noticeably increased iris pigmentation, these patients should be examined regularly.
®
Eyelash Changes
TRAV
AVATTAN Z Solution may gradually change eyelashes and vellus hair in the treated eye. These changes
include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon
discontinuation of treatment.
®
Intraocular Inflammation
TRAV
AVATTAN Z Solution should be used with caution in patients with active intraocular inflammation
(e.g., uveitis) because the inflammation may be exacerbated.
®
Macular Edema
Macular edema, including cystoid macular edema, has been reported during treatment with travoprost
ophthalmic solution. TRA
RAVATTAN Z Solution should be used with caution in aphakic patients, in pseudophakic
patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.
®
Angle-closure, Inflammatory orr Neovascular Glaucoma
TRA
RAVATTAN Z Solution has not been evaluated for the treatment of angle-closure, inflammatory or
neovascular glaucoma.
®
Bacterial Keratitis
There have been reports of bacterial keratitis associated with the use of multiple-dose containers of
topical ophthalmic products. These containers had been inadvertently contaminated by patients who,
in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.
Use with Contact Lenses
Contact lenses should be removed prior to instillation of TRAV
AVATTAN Z Solution and may be reinserted
15 minutes following its administration.
®
ADVERSE REACTIONS
Clinical Studies Experience
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 rates in the clinical studies of another drug
and may not reflect the rates observed in practice. The most common adverse reaction observed
in controlled clinical studies with TRA
RAVATTAN (travoprost ophthalmic solution) 0.004% and
TRA
RAVATTAN Z (tr
( avoprost ophthalmic solution) 0.004% was ocular hyperemia which was reported in 30 to
50% of patients. Up to 3% of patients discontinued therapy due to conjunctival hyperemia. Ocular adverse
reactions reported at an incidence of 5 to 10% in these clinical studies included decreased visual acuity, eye
discomfort, foreign body sensation, pain and pruritus. Ocular adverse reactions reported at an incidence of
1 to 4% in clinical studies with TRA
RAVATTAN or TRA
RAVATTAN Z Solutions included abnormal vision, blepharitis,
blurred vision, cataract, conjunctivitis, corneal staining, dry eye, iris discoloration, keratitis, lid margin
crusting, ocular inflammation, photophobia, subconjunctival hemorrhage and tearing.
®
®
®
( avoprost ophthalmic solution) 0.004%
There are no adequate and well-controlled studies of TRA
RAVATTAN Z (tr
administration in pregnant women. Because animal reproductive studies are not always predictive of
human response, TRAV
AVATTAN Z Solution should be administered during pregnancy only if the potential
benefit justifies the potential risk to the fetus.
®
INDICATIONS
A
AND USAGE
TRAV
AVATTAN Z (travoprost ophthalmic solution) 0.004% is indicated for the reduction of elevated intraocular
pressure in patients with open-angle glaucoma or ocular hypertension.
®
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USE IN SPECIFIC POPULATIONS
A
Pregnancy
Pregnancy Category C
T atogenic effects: Tr
Ter
T avoprost was teratogenic in rats, at an intravenous (IV) dose up to
10 mcg/kg/day (250 times the maximal recommended human ocular dose (MRHOD), evidenced by an
increase in the incidence of skeletal malformations as well as external and visceral malformations, such
as fused sternebrae, domed head and hydrocephaly. Tr
T avoprost was not teratogenic in rats at IV doses up
to 3 mcg/kg/day (75 times the MRHOD), or in mice at subcutaneous doses up to 1 mcg/kg/day (25 times
the MRHOD). Tr
T avoprost produced an increase in post-implantation losses and a decrease in fetal viability
in rats at IV doses > 3 mcg/kg/day (75 times the MRHOD) and in mice at subcutaneous doses
> 0.3 mcg/kg/day (7.5 times the MRHOD).
Reduction of the intraocular pressure starts approximately 2 hours after the first administration with
maximum effect reached after 12 hours.
Ideally, the seller stays on for one to two
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can verbally tell all the patients how great
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or two days per week for a period of time,
it makes for a very smooth transition and
a higher percentage of patients will stay
with the practice.
Congratulations if you’re considering owning your own private practice! In recent
years, we’ve seen negativity surrounding
private practice ownership due to the Affordable Care Act (ACA), ICD-10 implementation, and meeting meaningful use guidelines. However, despite some of those challenges, private practices provides a wonderful opportunity to provide a high standard
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|
®
Nursing Mothers
A study in lactating rats demonstrated that radiolabeled travoprost and/or its metabolites were excreted in
milk. It is not known whether this drug or its metabolites are excreted in human milk. Because many drugs
are excreted in human milk, caution should be exercised when TRAV
AVATAN Z Solution is administered to a
nursing woman.
®
Pediatric Use
Use in pediatric patients below the age of 16 years is not recommended because of potential safety
concerns related to increased pigmentation following long-term chronic use.
Geriatric Use
No overall clinical differences in safety or effectiveness have been observed between elderly and other
adult patients.
Hepatic and Renal Impairment
T avoprost ophthalmic solution 0.004% has been studied in patients with hepatic impairment and also in
Tr
patients with renal impairment. No clinically relevant changes in hematology, blood chemistry, or urinalysis
laboratory data were observed in these patients.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
T o-year carcinogenicity studies in mice and rats at subcutaneous doses of 10, 30, or 100 mcg/kg/day
Tw
did not show any evidence of carcinogenic potential. However,r at 100 mcg/kg/day, male rats were only
treated for 82 weeks, and the maximum tolerated dose (MTD) was not reached in the mouse study. The high
dose (100 mcg/kg) corresponds to exposure levels over 400 times the human exposure at the maximum
recommended human ocular dose (MRHOD) of 0.04 mcg/kg, based on plasma active drug levels. Tr
T avoprost
was not mutagenic in the Ames test, mouse micronucleus test or rat chromosome aberration assay.
A slight increase in the mutant frequency was observed in one of two mouse lymphoma assays in the
presence of rat S-9 activation enzymes.
TTravoprost did not affect mating or fertility indices in male or female rats at subcutaneous doses up to
10 mcg/kg/day [250 times the maximum recommended human ocular dose of 0.04 mcg/kg/day on a mcg/kg
basis (MRHOD)]. At
A 10 mcg/kg/day, the mean number of corpora lutea was reduced, and the post-implantation
losses were increased. These effects were not observed at 3 mcg/kg/day (75 times the MRHOD).
PATIENT
A
COUNSELING INFORMATION
A
Potential for Pigmentation
Patients should be advised about the potential for increased brown pigmentation of the iris, which may be
permanent. Patients should also be informed about the possibility of eyelid skin darkening, which may be
reversible after discontinuation of TRAV
AVATTAN Z (travoprost ophthalmic solution) 0.004%.
®
Potential for Eyelash Changes
Patients should also be informed of the possibility of eyelash and vellus hair changes in the treated eye
during treatment with TRAV
AVATTAN Z Solution. These changes may result in a disparity between eyes in
length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth.
Eyelash changes are usually reversible upon discontinuation of treatment.
®
Handling the Container
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye,
surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by
common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of
vision may result from using contaminated solutions.
When to Seek Physician Advice
Patients should also be advised that if they develop an intercurrent ocular condition (e.g., trauma or
infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid
reactions, they should immediately seek their physician’s advice concerning the continued use of
TRAV
AVATTAN Z Solution.
®
Use with Contact Lenses
Contact lenses should be removed prior to instillation of TRAV
AVATTAN Z Solution and may be reinserted
15 minutes following its administration.
®
Use with Other Ophthalmic Drugs
If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5)
minutes between applications.
Rx Only
U.S. Patent Nos. 5,631,287; 5,889,052, 6,011,062; 6,235,781; 6,503,497; and 6,849,253
®
Nonocular adverse reactions reported at an incidence of 1 to 5% in these clinical studies were allergy,
angina pectoris, anxiety, arthritis, back pain, bradycardia, bronchitis, chest pain, cold/flu syndrome,
depression, dyspepsia, gastrointestinal disorder, headache, hypercholesterolemia, hypertension,
hypotension, infection, pain, prostate disorder, sinusitis, urinary incontinence and urinary tract infections.
In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the
eyelid sulcus have been observed.
ALCON LABORATORIES
A
, INC.
Fort Worth, TTexas 76134 USA
© 2006, 2010, 2011, 2012 Novartis
10/15 US-TRZ-15-E-0278
CHOOSE TRAVATAN Z® Solution:
A POWERFUL START
Sustained
%
30 IOP lowering
at 12, 14, and 20 hours post-dose
in a 3-month study1,2*
Not actual patient
TRAVATAN Z® Solution has no FDA-approved therapeutic equivalent available
Help patients start strong and stay on track with
INDICATIONS AND USAGE
TRAVATAN Z® (travoprost ophthalmic solution) 0.004% is indicated for
the reduction of elevated intraocular pressure (IOP) in patients with
open-angle glaucoma or ocular hypertension.
Dosage and Administration
The recommended dosage is 1 drop in the affected eye(s) once daily in the
evening. TRAVATAN Z® Solution should not be administered more than once
daily since it has been shown that more frequent administration of prostaglandin
analogs may decrease the IOP-lowering effect.
TRAVATAN Z® Solution may be used concomitantly with other topical ophthalmic
drug products to lower IOP. If more than 1 topical ophthalmic drug is being used,
the drugs should be administered at least 5 minutes apart.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Pigmentation—Travoprost ophthalmic solution has been reported to
increase the pigmentation of the iris, periorbital tissue (eyelid), and eyelashes.
Pigmentation is expected to increase as long as travoprost is administered. After
discontinuation of travoprost, pigmentation of the iris is likely to be permanent,
while pigmentation of the periorbital tissue and eyelash changes have been
reported to be reversible in some patients. The long-term effects of increased
*Study Design: Double-masked, randomized, parallel-group, multicenter non-inferiority comparison
of the efficacy and safety of travoprost 0.004% preserved with benzalkonium chloride (BAK) to
TRAVATAN Z® Solution after 3 months of treatment in patients with open-angle glaucoma or ocular
hypertension. Baseline IOPs were 27.0 mm Hg (n=322), 25.5 mm Hg (n=322), and 24.8 mm Hg
(n=322) at 8 AM, 10 AM, and 4 PM for TRAVATAN Z® Solution. At the end of Month 3, the TRAVATAN Z®
Solution group had mean IOPs (95% CI) of 18.7 mm Hg (-0.4, 0.5), 17.7 mm Hg (-0.4, 0.6), and
17.4 mm Hg (-0.2, 0.8) at 8 AM, 10 AM, and 4 PM, respectively. Statistical equivalent reductions in IOP
(95% confidence interval about the treatment differences were entirely within ±1.5 mm Hg) were
demonstrated between the treatments at all study visits during the 3 months of treatment.
References: 1. Data on file, 2013. 2. Lewis RA, Katz GJ, Weiss MJ, et al. Travoprost 0.004%
with and without benzalkonium chloride: a comparison of safety and efficacy. J Glaucoma.
2007;16(1):98-103.
© 2015 Novartis 10/15
US-TRZ-15-E-0278
pigmentation are not known. While treatment with TRAVATAN Z® Solution can be
continued in patients who develop noticeably increased iris pigmentation, these
patients should be examined regularly.
Eyelash Changes—TRAVATAN Z® Solution may gradually change eyelashes
and vellus hair in the treated eye. These changes include increased length,
thickness, and number of lashes. Eyelash changes are usually reversible upon
discontinuation of treatment.
Use With Contact Lenses—Contact lenses should be removed prior to instillation
of TRAVATAN Z® Solution and may be reinserted 15 minutes following its
administration.
Adverse Reactions
The most common adverse reaction observed in controlled clinical studies with
TRAVATAN Z® Solution was ocular hyperemia, which was reported in 30 to 50% of
patients. Up to 3% of patients discontinued therapy due to conjunctival hyperemia.
Ocular adverse reactions reported at an incidence of 5 to 10% in these clinical
studies included decreased visual acuity, eye discomfort, foreign body sensation,
pain, and pruritus. In postmarketing use with prostaglandin analogs, periorbital
and lid changes including deepening of the eyelid sulcus have been observed.
Use in Specific Populations
Use in pediatric patients below the age of 16 years is not recommended because
of potential safety concerns related to increased pigmentation following long-term
chronic use.
For additional information about TRAVATAN Z® Solution, please see
the brief summary of Prescribing Information on the adjacent page.
NOW AVAILABLE: PLUS POWERS!
DAILIES TOTAL1® CONTACT LENSES
-10.00D
TO
-0.50D
NOW IN PLUS POWERS
PERFORMANCE DRIVEN BY SCIENCE™
See product instructions for complete wear, care and safety information.
© 2015 Novartis 08/15 DAL15097JAD
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Glaucoma - Modern medicine

Transcription

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