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Transcript
An Open Letter to All Ophthalmologists, Optometrists,
and Oculoplastic Surgeons of Australia
Dear Eye Care Professionals:
We are writing to you today to bring to your attention a fact that is slowly and agonizingly
ruining our lives. It is a fact that has led to undue pain, suffering, and debilitation for men
and women all over the country. The simple fact is this: Treatment of dry eye
(keratoconjunctivitis sicca) in Australia lags far behind the standards in much of North
America and Europe. Eye care professionals in Australia are failing dry eye patients every
single day by not adopting or pursing the best-practice treatments currently emerging or
established in the global medical community. This is not an opinion. It is a fact.
Many of us have spent thousands of dollars visiting countless specialists who, after lengthy
waiting periods, have often dismissed or ignored our symptoms and clinical picture, offering
minimal, out-dated, ineffective treatments not specific to our conditions. It’s depressing
enough to suffer with such a chronic and embarrassing disease. To receive no sympathy,
along with repeatedly hearing the line, ‘It’s all in your head’—it’s demoralizing.
We feel it is time to do something about it instead of sitting back, allowing our symptoms to
worsen, and wasting valuable time and money with archaic treatments. We often find
ourselves educating the doctors we pay to see, who then find it offensive that we know more
about dry eye than they do. We say the above not to demean our eye specialists, but rather in
the hope that it will send a message to all health care professionals that we need additional
help—that there are more sophisticated treatment options than the usual ‘plug and drop’.
As dry eye sufferers, we daily suffer from escalating anxiety and stress, debilitating physical
pain, and an overall decrease in quality of life. It affects our ability to drive, use a computer,
read, work outdoors, or do any fine detail work. This, in turn, affects our ability to support
ourselves in employment or even enjoy basic recreational and social activities, which has a
profoundly negative impact on our mental health.
Many of us are members of the rapidly growing online dry eye support community. We have
immersed ourselves in the many personal opinions, clinical reports, reviews, and wellreceived studies supporting the use of new, advanced, and even experimental treatments for
dry eye. These treatments can help patients in Australia who are unresponsive or
contraindicated to the currently conventional treatments in this country. We hope the
following information will provide some valuable insight into the emerging and established
treatments currently used in other countries, particularly the United States, with the hope
that they may become available to us sooner rather than later.
Every day that passes is a day we lose to this malady. We cannot delay this any longer, and we
need your help.
The Problem with Current Protocols
Dry eye is a multi-factorial condition and must be treated as such. There is no one-size-fits-
all treatment for us. Unfortunately, very few doctors are willing to take a personal interest in
managing the unique attributes of each of our specific cases, or do anything to help us
research different therapies to improve our symptoms. We feel forgotten because our
disease is not properly understood or extensively researched in this country. The consensus
seems to be simply, ‘As long as you can see, then we can’t do anything more.’ This isn’t good
enough—in fact, it is a dangerous and irresponsible practice.
Current first-line treatments typically prescribed to dry eye patients in Australia are artificial
tears, steroids, punctual plugs, basic lid hygiene, and (rarely) scleral lenses. While artificial
tears may provide short-term relief, they do not address underlying pathophysiology, and in
some cases can cause worsening of symptoms rather than improvement due to the lack of
investigation into the original cause of their specific dry eye. In addition, many over-thecounter drops contain harmful preservatives, which patients are often not instructed to
avoid.1 Even if they are preservative-free, dosage of any drops in a chronic fashion can be
detrimental rather than beneficial to the natural tear film structure and corneal epithelium.
Prescription steroids and mass cell stabilizers used to combat inflammation in vulnerable
dry eye patients such as Flarex, FML and Patanol are preserved with benzalkoniumchloride
(BAK), a chemical used in detergents. BAK can puncture the corneal epithelium, denature
corneal protein, and cause irreversible damage to the eye. Steroid drops are usually
prescribed with little concern for their toxicity to the ocular surface, and can cause
significant worsening of symptoms in some cases, even in the short term.2
There are many tests and equipment that can be used to evaluate a dry eye patient’s specific
conditions and severity, such as fluorescein break-up time measurement, meibography,
Schirmer’s test, TearLab osmolarity, evaluation of the lid margin, and bacterial analysis to
determine staphylococcal/seborrhoeic dermatitis—most of which are not routinely
performed in Australia.
Meibomian Gland Dysfunction and Blepharitis
Regardless of whether a patient has an aqueous tear deficiency (ATD) or not, complaints of
dry eye symptoms are usually accompanied by mild, moderate or severe meibomian gland
dysfunction (MGD), a common, under-diagnosed disease of the oil producing glands in the
eyelid. Meibomian gland dysfunction can occur for various reasons, most commonly
blepharitis.3 If there is an ATD, this prevents proper protection for the eyelids, causing a
build up of bacteria on the lid margin. The result is a combination of both ATD and MGD, an
unstable tear film culminating in dry eye syndrome (DES).
Blepharitis takes on two forms: anterior, which occurs when a build-up of excess oil
produced by the meibomian glands develops on the outer lids creating a breeding ground for
bacteria; and posterior, which develops when the meibomian glands become inflamed and a
thick paste-like substance (meibum) is secreted, or no oil is produced at all. This lack of oil
on the tear film causes the middle aqueous layer to evaporate, resulting in a condition called
‘evaporative dry eye’. Each type requires different treatments, and only anterior blepharitis
seems to be the focus in Australia. Posterior blepharitis is far more difficult to treat, but
there are now new technologies available that are proving to combat it.
Instructing patients with ATD and MGD to chronically dose themselves hourly (or up to four
times an hour) with artificial tears and inserting punctal plugs is incorrect and potentially
harmful. Retaining abnormal tears with high concentrations of pro-inflammatory cytokines
can cause further inflammation.4 MGD must be treated vigorously first before punctal plugs
are used.
It is estimated that up to 80% of dry eye sufferers have some form of MGD on top of ATD,
which begs the question, ‘Why are the majority of treatments only aimed at treating the
aqueous layer?’ Many of us have been into numerous ophthalmologists suites, with high
hopes and a price tag to match, only to find out they don’t even know what a meibomian
gland is! This is absolutely appalling and entirely unacceptable.
New Potential Solutions
Current treatment options advised for blepharitis and meibomian gland dysfunction in
Australia are lid hygiene, warm compress, eyelid massage, and oral supplementation of
omega-3 fatty acids. While these may help patients with mild MGD, studies on omega-3s are
largely equivocal. Patients with chronic MGD, moderate to severe evaporative dry eye, and
even aqueous deficient patients can benefit from newer much more effective treatment
options. The following list contains information on some of these options, as well as
supporting research.
Meibomian Gland Related Treatments
LipiFlow: This is a thermal pulsation system that bypasses the tarsal plate to directly apply
heat to the meibomian glands and their contents allowing for easier flow of oil.5 Dr. Jim
Kokkinakis at The Eye Practice in Sydney CBD rented the equipment on a trial basis in June
2012. Following this news, he immediately began taking frantic appointments from over
40 desperate patients, from all over Australia and even New Zealand, indicating our
widespread desperation and the travel-burden required for better treatment.6,7 The use of
LipiFlow to treat MGD is vastly superior to home remedies like lid massage and warm
compress, of which the latter can be dangerous due to potential overheating.
Meibomian Gland Probing (MGP): Dr. Colin Chan at the Vision Eye Institute in Bondi, New
South Wales, is the only doctor in Australia that offers MGP. The procedure and equipment
were developed by Dr. Steven L. Maskin in Tampa, Florida.8 It has been proven to be highly
successful as an initial treatment to unclog blocked meibomian glands along the lid margin.
In chronic MGD patients, inflammation causes periductal fibrosis, and only an MG probe can
‘pop’ open these scars that wrap around the ducts, allowing oil to flow naturally.9,10,11,12,13
This procedure is widely used across North America and Europe. It has become standard
practice to help chronic MGD patients. There is a misconception that probing is ‘dangerous’
or ‘painful’, but, in fact, many patients with MGD find it extremely relieving. Maskin Probes
are simple to use, inexpensive, and can be purchased from Rhein Medical or their Australian
Distributor, Ellex.14
Meibomian Gland Expression: This is the easiest and most cost-effective option to help
patients with chronic MGD. As of this writing, we are not aware of any doctors that utilise
meibomian gland expression in their toolbox of treatments for MGD patients. Dr. Malcolm
McKellar from Christchurch, New Zealand, has performed this treatment in-office with great
success. His eye centre website offers instructional information on how to perform the
procedure. The idea is to massage the eyelids with forceps to express solidified contents in
the meibomian glands, which will encourage production of newer thinner secretions. In
McKellar’s words: ‘It’s not sexy, but it does work.’15
There are adjunct tools developed by doctors in the US such as the Mastrota Paddle and
Gulden Expressor Kit, which have been designed specifically for in-office expression. They
recommend that expression is a first line of treatment, and subsequent conventional
treatments such as omega-3 supplementation, warm compress, etc., can form part of a wider
long-term strategy. Meibomian gland expression is also regularly practiced across North
America and Europe. The technique can and should be adopted by all eye care professionals
treating patients with MGD.16,17,18,19
Haemotherapy Related Treatments
Autologous Serum Drops: Serum drops are prepared from a patient’s blood and can be
used in different solutions (20–100%). It should be prepared under sterile conditions in a
certified laboratory unit. It contains several growth factors, vitamin A and fibronectin, and
also has an anti-inflammatory effect. Therefore, it has been beneficial in advanced and
severe cases of dry eye.20
Serum drops are usually reserved for patients with significant corneal problems. This is a
misguided approach, as many dry eye patients benefit from the non-allergic nature of the
drops and also find the properties that help promote a healthy tear film, leading to a
reduction in dry eye symptoms.
Eye Platelet Rich Plasma (E-PRP): Goblet cell density is low in dry eye patients, particularly
in cases of aqueous tear deficiency and cases with chronic inflammation.21,22 Known as the
‘ball bearings’ of the tear film, it makes sense that, with a deficient goblet cell density, we
experience a gritty sensation. Low goblet cell density is also associated with a mucin layer
problem in the tear film. Artificial tears do not treat this layer of the tear film.
Similar to autologous serum, E-PRP has shown to be highly effective in treating dry eye
patients. Clinical studies report significant improvement on lachrymal meniscus and
conjunctival hyperaemia and a decrease of corneal fluorescein staining. Post treatment,
impression cytology reveals significant increases in conjunctival goblet cells.23 E-PRP has
been extensively researched by Dr. Edward Jarka and Dr. John Crane, in St. Louis, Missouri,
in the United States. Renowned Australian Ophthalmologist Dr. Brian Holden has also worked
with these doctors on this therapy.24
To obtain PRP for therapeutic use, a small amount of blood is collected from the patient. The
sample is then centrifuged for several minutes to separate the red blood cells, platelets, and
serum. The platelets are then removed and prepared for use in eye drop form. Importantly,
when platelets are ‘activated’ (either by coming into contact with collagen, heating to body
temperature, or mixing with thrombin), hundreds of anti-inflammatory molecules are
released into the local tissue environment. While the very complex mechanisms of
interaction between these growth factors, cytokines, hormones and other molecules are just
beginning to be elucidated, they are proving to work in concert to restore tissue homeostasis
in cases of chronic inflammation. 25,26,27,28
In correspondence with Dr. Jarka, he stated:
‘We believe that the concentrated growth factors that are released when the platelets are
activated on the ocular surface have the ability to restore the normal cellular structural
architecture that may have changed from a number of environmental or internal factors
that deplete these components over time. The result is a continuous intracellular and
intercellular signalling that culminates into a chronic dry eye.
‘The procedure involves the collection of your blood and concentrating it in a cell
separator. We use the Harvest Smart PReP system.[29] We then prepare a concentrate
into a solution form to be applied to the eye at least twice a day.
‘We have had enough success with this procedure that we now receive referrals from
local physicians and ophthalmic surgeons. We have treated people from many states
including Oklahoma, Arkansas, Virginia, and an American citizen currently working in
Afghanistan. The cause of these dry eyes has usually been from many contributing
factors.’
Amniotic Membrane Related Treatments
Amniotic Membrane (AM) and ProKera: It is widely regarded that one common theme
throughout all dry eye patients, regardless of the type, is that we all suffer from recalcitrant
inflammation of the ocular surface. As such, anything that possesses anti-inflammatory
actions could help us, and should be investigated. The use of amniotic membrane in
ophthalmology dates back to the early 90s, where it was discovered that the foetal wound
healing strategy could be applied to the eye to help reduce inflammation and minimize
scarring.30
World renowned pioneer Dr. Scheffer Tseng in Miami, Florida, developed the use of AM to
heal damaged ocular surfaces after acute chemical burns, Stevens-Johnson Syndrome and
even pterygium removal patients with very high success rates. Due to this success, Dr. Tseng
now treats moderate to severe dry eye patients with a self-retaining contact lens containing
AM, called ProKera.
ProKera is listed by the FDA as a Class II medical device.31 As per his correspondence, Dr.
Tseng has successfully treated patients with dry eye using ProKera. He states:
‘Yes, ProKera can help dry eye patients in several ways. I have used it successfully for
them. In short, its potent anti-inflammatory action can surpass steroids and Restasis and
more importantly circumvent the potential side effect known to both of them. The
membrane also contains abundant nerve growth factor that is known to promote
innervations that may help correct the ocular surface deficit caused by dry eye and
inflammation so that the neuronal reflex can be improved. The hydration of the
membrane instantly helps maintain the preocular tear film stability. For those eyes where
the eyelid blinking is incomplete, it also prevents exposure-induced dryness. Once
improved, the patient will normally have a “prolonged” period of remission. Because the
underlying causes of dry eye are multiple and may not be fully corrected, dry eye can
return later on. Nonetheless, the treatment can be repeated.’
Dr. Allan Panzer of Houston, Texas, has also treated dry eye patients with ProKera, claiming it
relieved their pain immediately. One long-term dry eye patient was interviewed by Fox
News in the US, stating, ‘It felt like I took a pain pill.’32 Numerous other ophthalmologists
such as Dr. Steven Maskin and Dr. Arun Gulani in Jacksonville, Florida, have been using AM
for many years to help dry eye patients.
While it may be difficult to ship cryopreserved AM from the US, the Centre For Eye Research
Australia (CERA) located at the Royal Eye & Ear Hospital in Melbourne has been distributing
amniotic membrane tissue every year, primarily in corneal transplant patients.33 Attempting
this type of treatment for dry eye is just a matter of harnessing the material for modification
for a different purpose. If not used in a self-retaining contact lens, AM can be easily
temporarily sutured with nylon stitches or fibrin glue to the eyelid margin for the same
effect by covering the ocular surface as a ‘biological bandage’.34
Amniotic Membrane Extract (AMX): AMX is a novel method of applying amniotic
membrane to the eye without the need for surgery or contact lenses. Inventor Dr. Emliano
Ghinelli, from Rome, patented the use of lyophilized amniotic membrane for topical
application promoting the same biological factors, corneal epithelial regeneration, and
inflammation suppression.35 AMX contains an abundance of growth factors, neurotrophins,
interleukin antagonists, plus fibronectin and collagen.
In correspondence with Dr. Ghinelli, he states:
‘As inventor I would certainly recommend you AMX to increase your Conjunctival Goblet
Cells Mucin secretion and in this way “hold tighter” the aqueous part of your few tears
on your ocular surface. Regarding availability: FDA does not allows AMX to be on the US
market yet. On the EU field, AMX its currently under evaluation to have the green light.
Regarding ProKera: AM or PROKERA are both clever and innovative ways to approach
the same diseases.’
Dr. Kenneth R. Kenyon from the Massachusetts Eye Infirmary has worked closely with Dr.
Ghinelli, stating AMX has application in moderate to severe dry eye.36,37,38,39,40
The use of AMX has also been clinically studied in the US by Dr. Hosam Sheha in Miami,
Florida. His studies confirm that:
‘Although one may attribute AMX’s effect in relieving pain to its anti-inflammatory action,
we suspect that such a rapid action in pain relief might be mediated by a yet unknown
anti-pain action that deserves further investigation. Ocular surface inflammation was
markedly reduced in all cases after treatment. Although the exact action mechanism
remains to be determined, the aforementioned effect may be associated with early
delivery of AM’s anti-inflammatory active ingredients, which are retained in AMX.’ [41,42,43]
Other Treatment Options
Tetracycline: Oral tetracycline exhibits antibacterial, anti-inflammatory and anti-angiogenic
properties, and can be used systematically.44 The dosing varies between 20 and 100 mg/day
and usually lasts for three months in an intermittent modality. Studies confirm that low dose
doxycycline improves Schirmer’s and Tear Break-Up Time Scores (TBUT).45 A common side
effect is stomach pain, but many patients have claimed this to be far less than the pain
experienced by their dry eye.46
AzaSite: The use of AzaSite, topical azithromycin, has proven to treat eyelid inflammation in
both anterior and posterior blepharitis patients, with results indicating more than 50%
effectiveness over conventional lid hygiene and warm compresses therapy.47 The presence
of lid margin telangiectasias is commonly overlooked. Many eye doctors do not even perform
lid eversion tests. AzaSite as well as Lotemax (loteprednol) have also shown to reduce the
inflammation in lid wipers commonly seen in patients with lid margin disease.48
Testosterone Eyelid Cream: This has been studied for over a decade in the US by Dr. David
A. Sullivan, Dr. Charles G. Connor, and the now retired Dr. Charles Haines. Transdermal
application of 3% testosterone to the eyelid twice a day promotes both tear production and
reductions in meibomian gland dysfunction leading to improved tear film stability. The
research has found that testosterone regulates both lacrimal and meibomian glands and
direct application to the eyelids allows for direct treatment of both glands.49,50
Not currently FDA approved, testosterone cream is only used off-label in the US with
impressive results in Schirmer’s tests, Ocular Surface Disease Index (OSDI), and contact lens
wearing time. Many doctors in the US currently prescribe this cream for their patients,
including the renowned Dr. Boxer Wachler in Los Angeles, California, and Dr. Allan Panzer in
Houston, Texas. 51,52
Dehydroepiandrosterone (DHEA): Administered in drops, DHEA works along similar
principles as testosterone, since we know that androgens play a role in the function of
lacrimal and meibomian glands.53,54 Although DHEA has substantially less androgenic activity
than testosterone, a study by C.G. Connor and J. Fender demonstrated that 1% DHEA drops
produced improvement in TBUT and Schirmer’s test results. In fact, participants felt that the
DHEA drops were more effective at relieving symptoms than either plain artificial tears or
1% testosterone drops. 55
Whilst it’s not registered with the TGA, we can use a compounding pharmacy to produce the
medicine for us as long as a prescription is provided. While we’re aware of the potential risks
of using a compounding pharmacy, we believe that as long as we choose our pharmacy with
care (with the help of our doctors), we can get safe, effective medicine.
In Closing, a Solemn Plea
This writing is the culmination of years of experience and research from many individuals,
sufferers and advocates alike. We are pleading that you take the time to read our references,
gain an understanding into the collective mind of a dry eye patient first hand, connect with
each other, and bring much needed attention to our plight. We cannot treat ourselves at
home. We need your help so we have a chance of having our lives back.
None of the aforementioned treatments are regularly practiced in Australia, and we believe
they should be. We cannot afford to travel overseas for treatment, as we are already under
huge financial pressure because of our dry eye. Australia has great scientific and medical
capacity, and we can overcome any bureaucratic or technological stumbling blocks with the
right focus, creative problem solving, participation, and faith from our eye care
professionals.
The Digital Revolution seems to have caused a new epidemic of Dry Eye Syndrome across
the developing globe. An estimated 50 million people in the US alone suffer with dry eye of
varying severity. The potential market for proper dry eye treatments is vast, and most
of us are willing to spend whatever it takes and to risk ourselves as guinea pigs in the hope
a particular new treatment can help us. If we have this open mind about treating ourselves,
why shouldn't our eye care professionals allow us to pursue it?
The severe impact of dry eye is very real to us, not theoretical. It impacts our lives as much
as other, better-studied ophthalmological conditions. We want some recognition, and we
want the best help available. We’re tired of reading about patients in other countries with
easy access to these treatments, fantasizing about the possibilities. The US and Europe are
leading the way in helping dry eye patients. We must adopt the same strategies, and even
form our own innovative methods to counteract this disease before it leads to a spike in
mental health problems and disabilities like blindness down the road.
We might consider the formation of specialised ‘Dry Eye Clinics’ (similar to Dr. Colin Chan in
Bondi), located in each capital city, where doctors with an interest in this particular field can
work together to manage patients. In this setting, doctors would have access to the correct
tear film diagnostic equipment on a regular basis and thus would be able to help patients
attain the latest best-practice treatments. Even if it is an intermittent clinic that operates
once a month, this is still better than nothing. We would gladly pay to have a few
professionals taking an interest in us, helping us try newer more advanced options and
monitoring our progress.
If there are any ophthalmologists, optometrists, oculoplastic surgeons, or general
practitioners that would be able to help dry eye sufferers try any of these treatment options,
please contact us: [email protected]. There are many of us who suffer together, and we rely
on each other for hope, support, and solutions. Let us rely on you, too.
Thank you,
—Dry Eye Suffers of Australia
References
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50
51