Doctors share their successful strategies in treating this condition.
BY JOHN PARKINSON, ASSOCIATE EDITOR
According to The Schepens Eye Research Institute, approximately 6 million women and 3 million men in the United States have moderate or severe symptoms of dry eye, and scientists estimate that an additional 20 to 30 million people in this country have mild cases of dry eye. However, until recently, dry eye was considered difficult to treat and too demanding of valuable chair time. This led many patients to tolerate dry eye and many ophthalmologists to shy away from actively seeking out and treating them.
This is changing for all parties involved. The emergence of several new-generation artificial tears, a prescription dry eye medication, and new dietary supplements has made the ailment much more manageable. According to the ophthalmologists interviewed for this article, patients can be treated effectively -- and efficiently -- and making sure of that is also advantageous for the practice.
The opportunity will only get bigger. The largest generation of people in the United States -- the baby boomers -- number 76 million according to one estimate, and in the coming years they'll need more eye care, including help with dry eye. Also, a general public awareness of dry eye has arisen. Pharmaceutical company media-marketing campaigns and medical information on the Internet have not only publicized the condition, but have informed people on potential treatments. These factors have made the climate even more hospitable for physicians to actively seek out and treat dry eye patients. In this article, several ophthalmologists who are doing just that share their strategies and rationales.
Streamlining Chair Time
Traditionally, one of the chief complaints about dry eye care was the amount of chair time it took. But many practices are fine-tuning their process to narrow that down.
Shachar Tauber M.D., says that about 25% of his patients suffer from dry eye and ocular surface ailments, so he uses the waiting room to start screening patients. There, first-time patients fill out a form containing five dry eye specific questions. This allows the doctor to focus on symptoms immediately during an office visit.
When seeing all patients, regardless of the reason for the visit, Joe Mussoline, M.D., begins by asking if the patient's eyes are burning or scratchy. "Once I have started the discussion, I ask about specific symptoms, which helps me narrow down the diagnosis, and then I take a history," states Dr. Mussoline. "The amazing part is that it does not take a long time for all of those things, and I think this is one of the fears of most ophthalmologists -- that they don't want to take the time to elicit those things because of the time factor fear." After questions, and securing a patient's history, Dr. Mussoline begins the physical exam to verify the diagnosis, then he moves on to treatment. Dr. Mussoline estimates that 50% of his practice deals with treating dry eye patients.
Conversely, some doctors feel the initial office visit and diagnosis should be more time-consuming. Eric Donnenfeld M.D., uses the first visit to question a patient, conduct a comprehensive exam to confirm diagnosis, and explain treatment. Consequently, this leads to shorter follow-up visits.
"Once I have given them the initial information, explained what will likely happen, and given them reading materials, subsequent visits are much quicker. They are among the faster visits I have in the office." Dr. Donnenfeld estimates that 15% to 20% of his patients have dry eye.
Marguerite McDonald, M.D., estimates that 80% to 90% of her patients suffer from mild to severe dry eye, including preoperative laser vision correction patients. With that many patients, Dr. McDonald also spends a lot of initial chair time -- several minutes per patient -- explaining the diagnosis and treatment. The extra time adds up, she says, and decreases her patient load. In an effort to streamline office visit times, she is working on creating a video that will explain how one of the therapies she often recommends works.
Pinpointing the Diagnosis
Effective diagnosis is key to realizing the patient and practice benefits of treating dry eye. Nailing down the diagnosis takes place during several parts of the patient visit:
History. In looking at patients to determine whether they have dry eye, Robert Latkany, M.D., says that history is most significant. "Most patients present in the same fashion," says Dr. Latkany. He says doctors should obtain a list of all the medicines patients are taking, history of surgeries, and confirmation of contact lens usage because they all point to the type of dry eye to be treated. "History will help guide you to what type of dry eye they have." Dry eye can come in many forms. Some patients may suffer from it because the tears evaporate too quickly, others may have an aqueous deficiency. There are multiple causes for the ailment.
Dr. Latkany is founder and director of the Center for Ocular Tear Film Disorders with offices in Manhattan and White Plains, N.Y. He says about 90% of the patients he sees have dry eye/ocular tear film disorders.
Chief complaint. Dr. Donnenfeld says patients often come in not knowing what it is exactly that is bothering them and he begins by asking probing questions. "They come in complaining of excessive blinking around air vents, contact lens intolerance, or they can't look at their computers for a long time. When they come in with those symptoms, I then ask them questions related to dry eye. I specifically ask if their symptoms are worse at night or in the morning. Usually, patients who do have dry eye have worse symptoms at night."
Physical exam. Dr. Mussoline moves very precisely through his exam to confirm his diagnosis. "I look on the slit lamp exam for the classical signs such as superficial punctate keratitis (SPK), an increase of tear film breakup, and possible conjunctival and corneal staining," explains Dr. Mussoline. "I will do an ocular protection index or the symptomatic noninvasive tear breakup time. By this time, I have clearly made the diagnosis and move on to treatment."
Elements of Effective Treatment
Dr. Latkany gets to the crux of what has been a paramount problem for doctors treating dry eye: "Even today, the mainstay treatment is the use of artificial tears. These tears are not really addressing the source of the problem."
Nonetheless, Dr. Latkany does use several therapies in his practice, and acknowledges the next generation of medicines in the pipeline will address the various biomechanisms that create dry eye, thus attacking the source of the problem and not just supplementing tears.
Doctors are having success in treating dry eye. Here is a glimpse at some of their methodology:
Education. All the physicians who provided input agreed on the importance of providing patients with information and specifically using literature to educate patients on their condition. Some doctors are using materials from the American Academy of Ophthalmology (AAO); others are working with pharmaceutical companies to provide pamphlets; and others are creating hybrid brochures, combining what is available and personalizing the pamphlets.
"We do provide our patients with the traditional AAO pamphlets at this time. We are in the process of customizing our brochures to reflect our practice's special interest and expertise with dry eye diseases," says Dr. Tauber.
Treatment pyramid. As there is no set pattern for dry eye care that's been proven 100% effective, doctors treat different patients in different ways. "I adjust the treatment to each patient based on their history, symptoms, and the type of dry eye they have," reports Dr. Latkany.
Dr. Latkany starts conservatively with artificial tears and lid hygiene. At the next visit, he sees if he needs to add anything to the treatment. If he does need to add something, it might be cyclosporine ophthalmic emulsion 0.05% (Restasis) or flaxseed oil or fish oil vitamins or punctal plugs. He adds to the treatment until the patient is satisfied.
Eventually, a set pattern for how dry eye patients are treated might emerge. "There is an algorithm that dry eye specialists are developing that is evolving with drugs and our experience with drugs," states Dr. Tauber.
An inverted treatment pyramid has many doctors starting with an over-the-counter tear. If that is not effective, then a progression of medicines, supplements, and plugs is implemented. This leads to a combination of treatments.
Combining treatments. There isn't a consensus on what combinations work best together. No one medicinal tandem works for every patient, and it really comes down to personal preference for the patients and the doctors. One newly considered combination is Systane eye drops with Restasis.
Dr. Mussoline uses Systane for 6 to 8 weeks. If that is not working, and symptoms have not subsided, he uses Systane and Restasis together. However, when patients use this combination, he waits 2 months for a follow-up visit because it can take some time for the Restasis to take effect. Dr. Tauber explains when he uses this combination. "If it is a tear breakup issue, it is a very easy decision to treat the patient with Systane. If it is truly a deficiency and there is some degree of inflammation -- whether it be Sjogren's or a thyroid patient -- then it makes sense to start Restasis and Systane at the same time. There is a tremendous benefit in treating with an anti-inflammatory in these specific patients."
Dr. Donnenfeld treats patients with menopausal dry eye and patients with tear deficiency in a similar fashion. Starting with a regimen of nonpreserved tears, he uses TheraTears or Refresh. He will schedule a follow-up visit in 1 to 2 months. If the patient is not better, Dr. Donnenfeld recommends an ointment at night or Restasis twice a day. However, if a patient is complaining of burning or irritation, he will modify treatment by adding a steroid like loteprednol etabonate (Lotemax) twice a day for a month and Restasis twice a day. He says it all depends on patient feedback and how a person is responding to treatment.
As far as cultivating a dry eye patient population, Dr. Latkany says you need to look no further than your own practice. "They are right in front of you. The patients you are treating probably have dry eye and you are not addressing it."
Dr. McDonald concurs. There are times when a doctor sees one ailment in a patient and the patient is concerned about another. "It's a great practice-builder if you actually address the patient's complaint," Dr. McDonald says. "A patient comes in because her eyes feel bad. Why? Because they are dry. The doctor decides she has cataracts, schedules removal, and ignores her chief complaint."
Practical factors also play into the significance of dry eye treatment. As LASIK-induced dry eye complaints are quite common, doctors need to treat it, so why not become proficient dry eye practitioners?
When dry eye is treated effectively, patients will not only be satisfied, but will speak about how their doctor successfully treated their previously annoying and painful ailment. With word of mouth comes other patients seeking dry eye relief. Referrals or focusing more of your practice's efforts specifically on dry eye can be hugely beneficial.
"You've got to address the condition, educate the patients, and once they become involved in their condition, they listen. They can see the benefit of treatment and they come back to you and they start referring patients to you," explains Dr. Latkany.
Dr. Mussoline claims word of mouth is his best advertisement. "You have to remember that many of these patients I have treated have been to numerous eyecare specialists and have been misdiagnosed or treated improperly with poor or no relief of their symptoms," states Dr. Mussoline. "So when I have a satisfied and happy patient, he or she is thrilled to tell someone with similar symptoms. And before you know it, you are a busy ophthalmologist."
Marketing a practice to dry eye patients can come in traditional forms, too. Dr. Tauber's practice advertises on National Public Radio because Dr. Tauber and his partners realized public radio appeals to an audience that fits the demographic of patients they treat.
Dr. Donnenfeld, who is a partner in a multilocation practice, has advertised in the health section of local magazines. His practice, Ophthalmic Consultants of Long Island, initially didn't like the idea of advertising dry eye care, but changed their minds because the advertising serves another purpose as well.
"We felt that by marketing dry eye, we could market ourselves ethically and do a significant service to the patients of Long Island by talking to them about new developments in dry eye. We could provide therapeutic options that could help their conditions that they may not have heard of before. We felt this was providing a public service, as well as marketing a practice at the same time."
Ophthalmic Consultants has also employed a consulting company to help it develop a multimedia campaign and teach employees how to communicate effectively with patients. "We had extensive internal training of staff with PowerPoint presentations and a roundtable of our doctors for the staff during a dinner meeting geared entirely towards education on this matter to handle patient inquiries properly," explains Tom Burke, CEO, Ophthalmic Consultants.
Using Ocular Nutrition to Fight Inflammation
Dietary supplements have become a major component in treating patients with dry eye. Doctors can help patients by passing along their knowledge.
Spencer Thornton, M.D., co-founder and president of Biosyntrx, a nutritional supplement company, believes that there is increasing recognition that dry eye is a chronic inflammatory condition and that it needs to be treated as such. Specifically, Dr. Thornton reports that lactoferrin and the omega-3 and omega-6 essential fatty acids in black currant seed oil address dry eye inflammation. The company reports that these compounds promote the natural metabolic sequence of events set in motion at the beginning of the inflammatory process. Omega-6 essential fatty acid, gamma-linolenic-acid (GLA) found in black current seed oil along with specific vitamin and mineral co-factors included in Biosyntrx's BioTears Oral Gelcaps produce potent site-specific (mucosal tissue) anti-inflammatory hormone-like substances -- the series one prostaglandins (PGE1s).
Dr. Thornton advocates full spectrum formulation supplements for dry eye patients as opposed to large amounts of any one vitamin. "One should not forget the importance of nutritional balance and how supplementing with just a few nutrients or antioxidants can deplete the body of other nutrients," says Dr. Thornton.
Dr. Thornton says that a supplement regimen should become a permanent part of all patients' daily routines in order to continue reaping the benefits. "Patients need to think of supplements as food," states Dr. Thornton. As further evidence of such thinking, Dr. Thornton points to the AMA's decision on supplements. "All epidemiological studies show that less than 20% of the U.S. population even comes close to eating a well-balanced diet. This information led the AMA in 2002 to recommend that everyone take multiple vitamin."
According to Dr. Thornton, eating a well-balanced diet including more fruits, green leafy vegetables, and small cold water fish is only one half of the equation. He stresses that it is equally important to cut down on various processed foods. "Because five fruits and vegetables [recommended daily allowance] do not include enough of a number of nutrients necessary to address the metabolic pathway responsible for controlling the inflammatory process, most diets should include less sweets, less hydrogenated fats, and a bit less red meat." This will help to bring up the natural omega-3 intake and decrease the unnatural omega-6 intake.
Dr. Tauber offers a caution about a lack of consistency he's seen in the efficacy of some supplements. "We started adding flaxseed oil pills. Some patients were very knowledgeable on it, some grind their own flaxseed, some had results that were very surprising. It all depended on where they got their flaxseed." Dr. Thornton attributes this to some flaxseed oil caplets being sold already oxidized, thus depleting the efficacy of the supplement. Physicians should recommend patients go to stores that are reputable.
Jeffrey Gilbard, M.D., founder and CEO of Advanced Vision Research, a pharmaceutical company responsible for TheraTears line of therapeutic tears and nutritional supplements, also believes that dry eye inflammation can be addressed with nutritional supplements. "It has been shown that long chain omega-3s, specifically EPA, block the gene transcription of the pro-inflammatory cytokines including tumor necrosis factor-alpha and interleukin 1-alpha and 1-beta, that have been implicated with playing a central role in decreasing tear production in dry eye," explains Dr. Gilbard. "TheraTears Nutrition provides the long-chain omega-3 essential fatty acids from fish oil, as well as the short-chain omega-3s from flaxseed oil, that not only suppresses inflammation in the lacrimal glands and lids, but also suppresses inflammation throughout the body."
Although definitive research showing why omega-3s are helpful is still needed, Dr. Gilbard believes what is known about the health benefit is too great to ignore. "Given the health benefits of omega-3s, let's treat the dry eye patients, and at the same time, watch for the research that works out in detail the mechanism of action."
Punctal occlusion is the most popular minor procedure in ophthalmology, says Kevin Corcoran, C.O.E., C.P.C., F.N.A.O., president of Corcoran Consulting Group. Utilization of this procedure has been steadily increasing for a number of years. During that time, reimbursement rates have changed, but in a complicated fashion. Prior to Jan. 1, 2002, separate reimbursement was made for the silicone punctum plugs as well. From 1996 through 1998, procedure volume increased while reimbursement remained constant. Then Medicare began raising reimbursement in 1999 and procedure volume increased dramatically. In 2002, Medicare reversed course and reduced reimbursement from $264 to $163 and utilization slowed. Since 2002, reimbursement has stayed pretty much the same. However, for 2005, reimbursement has declined 23% to $140.
The effect of all these changes has been leveling off of the amount of money Medicare spends for this procedure at about $55 million per year, down from a peak of $80 million in 2001. For those doctors who have embraced this procedure, Corcoran provides a few recommendations. Make sure medical documentation can stand up to postpayment review. The exam must show the need for a surgical procedure in light of the failure of other less-invasive treatment options. Doctors can follow the standard of care outlined in AAO's Preferred Practice Patterns.
As a point of reference, Medicare pays for one punctal occlusion for each eye exam performed on a beneficiary. So if your practice includes many more procedures proportionally, then questions will arise. "Being above average isn't necessarily wrong," he says, "but it means you have to have a response to the reviewer who asks why you are different from your peers. The response could be 'my patients are sicker or more of my patients are referred to me from other doctors who didn't treat their dry eye.' The response could be many things, but the point is the doctor has to be prepared to defend his care protocols," Corcoran explains.
The Next Generation of Treatment
Clearly, dry eye has made a transition from being an ailment tolerated by patients and perhaps avoided by ophthalmologists in the past, to a manageable condition today.
"We understand the pathophysiology and we have more treatment options available to us than we did before, and we have new medications on the cusp of being approved in the next couple of years to add further to our ability to treat these patients," says Dr. Donnenfeld. "The future of the management of dry eye actually looks much better than it did 5 years ago."
Q&A on Using Restasis
At the joint meeting of the American Academy of Ophthalmology and the European Society of Ophthalmology in October, Terrence P. O'Brien, M.D., professor of ophthalmology at the Wilmer Eye Institute at Johns Hopkins University in Baltimore, delivered a presentation on Restasis and ocular surface disease. Below are some of the questions he was asked by audience members and his responses:
Q: How can I distinguish between my dry eye patients who should use an over-the-counter artificial tear preparation from those who might benefit from a prescription therapy?
A: Many of my colleagues struggle with the decision of when to prescribe Restasis and when to recommend artificial tears. The answer is that artificial tears are fundamentally palliative while Restasis targets the underlying pathological mechanism of dry eye. The goal of dry eye therapy is to restore tear volume, composition and stability.
A patient's own natural tears are clearly far more physiologic than artificial tears. They are the only thing that provides the long-term quality of life and relief of symptoms of chronic dry eye. By increasing a person's own natural tear production, Restasis has been shown to restore the normal functioning of the ocular surface, thereby improving both the quantity and quality of tears.
Therefore, when patients come to me with daily symptomatic discomfort, or if they are frequently using artificial tear drops without relief, I know they need a therapy that goes beyond just palliative treatment and restores the body's ability to produce its own natural, healthy tears. In fact, if artificial tears are needed too frequently, the natural composition of tears is further diluted. Since Restasis became available, many clinicians, including myself, have seen improvement in tear production and stability, ocular surface epithelial health, and a decrease in irritation symptoms in as early as 1 month after initiating regular use.
Q: I see a lot of patients who wear contact lenses. Can I prescribe Restasis for these patients?
A: With the availability of Restasis, we have a tool to restore stability to the ocular surface, improving the tear film with the production of natural tears and creating an environment conducive to wearing contact lenses. It's important to note that Restasis is safe to use in patients who wear contact lenses. In fact, there has been some data showing that patients can increase their wear time and use less rewetting drops if they use Restasis. I advise patients to wait about 15 minutes after putting Restasis in before inserting their contact lenses to avoid potential blurring related to the oil-based vehicle.
Q: How can I assess whether Restasis is working in my patients?
A: Since Restasis increases a patient's own native tears, I look for signs of improvement in tear production. I ask my patients if they have decreased the frequency of artificial tear use and ask them if tasks such as reading and using the computer have gotten easier. It is important to remember that there are no magic elixirs; relief with Restasis may start to be experienced within the first 4 to 5 weeks. Continued use helps the patient make more of his/her own tears.
I also repeat the same diagnostic tests I used initially to evaluate tear production, tear stability and the integrity of the ocular surface to determine how well the drug is working. The most commonly used tests include the Schirmer test, tear break-up time (TBUT), and corneal and conjunctival dye staining. Restoring the natural tear film composition by treating with Restasis helps re-establish the stability of the ocular surface and return the TBUT to normal levels.
Q: What are the contraindications of Restasis?
A: Restasis helps my patients increase tear production which may be reduced by inflammation on the eye surface in chronic dry eye. The most common side effect seen in the FDA trials was a burning sensation upon installation, but very few of my patients complain of it if provided with a pre-warning that this transient effect may occur. Other side effects seen in the FDA clinical trials included eye redness, discharge, watery eyes, eye pain, foreign body sensation, itching, stinging, and blurred vision.
In clinical studies, this increased tear production was not seen in patients using topical steroid drops or tear duct plugs. Restasis should not be used by patients with active eye infections and has not been studied in patients with a history of herpes viral infections of the eye. Because ocular herpes is a T-cell lymphocyte-mediated disease, Restasis should probably be avoided.
Q: Several studies tout flaxseed oil for dry eye. Do you recommend flaxseed oil for your patients?
A: While some studies show that nutritional supplements such as flaxseed oil and essential omega-3 fatty acids could help maintain a healthy ocular surface, Restasis is the only FDA-approved treatment that gets to the root of the problem and actually increases tear production. Because of my concern about progression, I use Restasis to treat moderate and severe dry eye patients and those suffering from regular symptoms or who use tears frequently. Mild patients typically find that their symptoms and signs are controlled by artificial tears. Restasis can be used in combination with nutritional supplements to reduce inflammation and restore the natural composition of tears.