Article Date: 2/1/2006

dry eye
Matching Dry Eye Patients To the Proper Therapeutic Approach

A continuum of care approach can achieve optimal patient outcomes.
BY PAUL KARPECKI, O.D., F.A.A.O.

Chronic dry eye is one of the most common complaints we see, accounting for nearly 25% of all office visits, according to Canadian and Japanese studies. Until recently, there was little we could do for these patients other than offer palliative therapies: artificial tears to temporarily relieve symptoms and tips to modify exacerbating lifestyle and environmental factors.

All this has changed over the last decade as we've learned more about the complex pathophysiology of chronic dry eye, especially its inflammatory com- ponent. This in turn has led to the development of therapeutic approaches that target the underlying disease state to restore ocular health. Before we can take advantage of these new treatments, however, we must undertake the rather challenging task of diagnosing this condition.

The forecast is for growth

Recent developments mean eye care specialists can now make a real difference for these patients — and that's no small matter. Millions of people throughout the world suffer from eye discomfort due to inadequate tear film quantity or quality. Dry eye affects up to 11% of people aged 30 to 60 and up to 15% of those 65 years and older, according to a study at Johns Hopkins. It's been estimated that as many as 12 million Americans have moderate to severe dry eye — a number certain to increase as the population ages.

The impact of dry eye on patients' quality of life can be significant. The condition increases the risk of problems during vision-related activities, including reading, computer use and night driving. Studies confirm that many patients alter their daily routine to manage their symptoms. A recent survey at the Henry Ford Health Care System showed that people with moderate to severe dry eye experience levels of disease impact comparable to patients who suffer from moderate to severe angina and similar medical conditions. So it's not surprising that the patients we treat for dry eye are some of the most satisfied — and grateful — patients we work with.

Recognize chronic dry eye

Effective treatment of chronic dry eye requires accurate diagnosis to determine the specific cause of symptoms. This can be a challenge, however, as our own experience makes clear. When dry eye patients first come to our clinic, many have been using artificial tears or taking allergy medications for some time, or have stopped wearing contact lenses in an effort to ameliorate symptoms. But they've never received specific treatment for dry eye.

One reason diagnosis can be difficult is that common dry eye symptoms easily masquerade as other things — itching is easy to mistake for allergy, ocular fatigue for eye strain and discomfort for contact lens intolerance. Compounding this is the fact that dry eye symptoms do not correlate well with clinical signs. A patient can experience the classic symptoms of dry eye — itchiness, burning, redness, stinging — and yet show no evidence of conjunctival or corneal involvement; indeed, the eye can appear com- pletely normal. It's also possible to examine a patient and plainly see corneal or conjunctival staining, or thin tear meniscus height, yet the patient reports being asymptomatic. This can happen when a patient has had dry eye for a long time and experiences a loss of corneal sensation.

This conundrum is one reason there's no generally accepted symptomatic definition of dry eye. Instead, diagnosis depends on our ability to assess cumulative evidence (including signs and symptoms), a thorough patient history to identify causative or ameliorating conditions and risk factors, and appropriate diagnostic testing to confirm the diagnosis and gauge disease severity.

■Key symptoms and signs. Frequently reported symptoms that should lead you to suspect dry eye include dryness, discomfort and irritation, itching, sensitivity to light and grittiness. This is especially true in the presence of other symptoms like pain or foreign body sensation; ocular fatigue; tearing or mucus discharge; transient blurring, which may last as long as one to two hours (or perhaps just minutes or seconds until the next blink); symptoms that worsen late in the day; and contact lens intolerance.

External examination often reveals clinical signs in the lids (e.g., blepharitis, meibomianitis, lid laxity, ectropion), and in the tear film, conjunctiva, cornea and vision. Physical examination of the patient's hands may reveal signs of autoimmune disease (e.g., rheumatoid arthritis) or the face may show signs of rosacea, both of which are associated with dry eye.

■Patient history. The patient history is extremely important for eliciting information to support a dry eye diagnosis, including insights regarding:

Severity and duration of symptoms;

Exacerbating environmental or lifestyle conditions (e.g., wind, sleeping with a fan on, air travel, low humidity, smoking or smoky environments, prolonged visual efforts associated with decreased blink rate such as reading or working at a computer);

Topical medications used for symptom relief (e.g., artificial tears, antihistamines, glaucoma medications, vasoconstrictors, corticosteroids);

►Systemic medications associated with decreased lacrimal gland secretion (e.g., antihistamines, diuretics, oral contraceptives and hormone replace- ment therapy, beta blockers, psychotropic drugs, antimuscarinics)

Other risk factors (e.g., advanced age, female gender, menopause, autoimmune diseases, genetic predisposition, pollution and particulate exposure).

In our clinic, we use two simple instruments to assist us in taking the history: the Ocular Disease Severity Index (ODSI), which is particularly useful for assessing disease severity in terms of symptom frequency and level of disability; and a patient questionnaire designed to reveal possible predisposing or other risk factors.

■Diagnostic tests. Several diagnostic tests are useful to confirm a dry eye diagnosis, evaluate disease severity and, increasingly, to assess therapeutic response. These include:

Tear break-up time (TBUT), to assess the stability of the tear film;

Ocular surface dye staining using lissamine green, fluorescein or rose bengal dyes to assess the ocular surface;

Tear meniscus height via slit lamp examination, a valuable assessment of tear volume; and

Schirmer test to evaluate aqueous tear production (useful for diagnosing Sjogren's syndrome, but gives variable results and shouldn't be used as the sole criterion for diagnosing dry eye).

The continuum approach    

It is increasingly recognized that the management of dry eye disease requires a continuum of care approach, with disease severity as the determining factor guiding treatment decisions. The American Academy of Ophthalmology and the American Optometric Association each pub- lished treatment guidelines in 2002. More recently, an International Task Force (ITF,) consisting of 17 international dry eye experts, met under the auspices of the Wilmer Eye Institute last year and developed a dry eye severity scale based on symptom frequency and quality of life impact (see table, page 60).

Homegrown wisdom

Similar to the ITF recommendations, we've implemented an approach to the management of dry eye focused on reducing signs and symptoms, and on treating the underlying pathophysiology to improve the quantity and quality of tear production.

■The mild to moderate patient. We initiate treatment with non-preserved or dissolving preserved artificial tears, depending on the individual patient and symptoms. It appears that gel products work better in patients with corneal staining.

ITF GUIDELINES: LEVELS OF DRY EYE SEVERITY

LEVEL SIGNS & SYMPTOMS RECOMMENDED TREATMENT
Level 1 •   Mild to moderate symptoms,no signs

•   Mild to moderate conjunctival signs

Patient counseling, preserved tears, environmental management, allergy eye drops, use of hypoallergenic products, water intake
If no improvement, add Level 2

Level 2

•   Moderate to severe symptoms

•   Tear film signs

•   Mild corneal punctate staining

•   Conjunctival staining

•   Visual signs

Unpreserved tears, gels, ointments, cyclosporine A, topical steroids, nutritional support (e.g., flax seed oil)
If no improvement, add Level 3
Level 3 •   Severe symptoms

•   Marked corneal punctate       staining

•   Central corneal staining

•   Filamentary keratitis

Tetracyclines, punctal plugs
If no improvement, add Level 4

Level 4

•   Severe symptoms

•   Severe corneal staining

•   Erosions

•   Conjunctival scarring

Systemic anti-inflammatory therapy, oral cyclosporine, moisture goggles, acetylcysteine, punctal cautery, surgery

We educate patients about the chronic nature of the disease, the importance of complying with therapy (possibly long-term) and modifying environmental and lifestyle factors. In fact, we've seen excellent results in many patients simply by identifying changes they can make in their lives. Turning off the fan at night, using a room humidifier, avoiding wind, or adjusting the height and visual angle of a computer screen can all make a big difference. So can smoking cessation. We recommend that patients with diets deficient in essential fatty oils increase their fish intake or take flax seed or fish oil supplements, and that they stay hydrated by drinking plenty of water during the day and avoiding excess caffeine consumption.

Follow-up with patients in two weeks to a month to evaluate their progress. First, ask how frequently they're using artificial tears. Use more than three times a day suggests artificial tears are not working. Second, how long does the relief from artificial tears last? If the answer is 30 minutes or less, therapy at the next level is likely warranted. And certainly any symptoms of inflammation merit an immediate step up in the continuum of care. Early, aggressively treatment of a chronic disease like dry eye is more likely to achieve better patient outcomes.

■The moderate to severe patient. How do you quantify which patients fall into this category? We start these patients on cyclosporine A (Restasis, Allergan) to inhibit infiltration of pro-inflammatory T-cells that disrupt normal tear production in the lacrimal glands. By improving the function of the lacrimal glands, cyclosporine A helps patients produce more of their own tears — a central goal of therapy. These patients should continue to use artificial tears (preservative-free, dissolving-preservative, or gel formulations for patients with significant corneal staining) as necessary.

We may also start the patient on concurrent therapy with a topical steroid to treat the inflammation. With this approach, patients are provided with the short-term relief of the steroid during the two to four weeks before cyclosporine A takes maximum effect. After two weeks, we taper the steroid over the course of four to six weeks. Patients on cyclosporine A therapy continue for a minimum of six months, with follow-up visits at two months and six months to assess compliance and therapeutic response.

■The very severe patient. If after three months signs and symptoms do not sufficiently improve, we continue with cyclosporine A but also may recommend punctal plugs, so long as any inflammation or allergy is under control. Plugging the punctal ducts before this may trap inflammatory material on the ocular surface.

Alternatives to explore if these therapies do not produce the desired outcomes include oral tetracycline, which may need to be given in lower doses to avoid side effects such as stomach upset. This also provides good results but with fewer side effects. After one month, taper to once daily as you see improvement. Note that these drugs cannot be used in women who are pregnant or nursing, or in children. Some patients find that moisture goggles that prevent some evaporation or spectacles with moisture chambers are helpful.

Ensure patient compliance

As our ability to offer more effective treatment approaches for dry eye has improved, so has a historically common problem in the management of these patients — that is, low patient satisfaction and poor compliance with therapy. Artificial tears for the temporary relief of symptoms have always had a clear role to play in dry eye management, and they remain a foundational therapy for these patients. But therapy with artificial tears is palli- ative and does not treat the underlying pathophysiology. It's no wonder that many patients end up with recurring symptoms and, frustrated, do not follow up with their treatment plans — or with their eye doctors.

The likelihood that patients will comply with treatment and achieve good outcomes has increased with the availability of new treatment options. But achieving good compliance is not a given. We need to educate patients about the nature of chronic dry eye and the fact that it must be managed on an ongoing basis. Make detailed discussion of aggravating environmental and lifestyle factors and their modification a basic first step in managing any dry eye patient.

Work with patients to set appropriate treatment expectations at each level of care. Patients initiating cyclosporine A therapy, for instance, should understand that it will not provide immediate relief. It may take several weeks for patients to start producing more of their own tears and for their frequency of artificial tear use to decline. Also emphasize that proper dosing (twice a day, every day) is essential. Finally, advise patients on what to expect regarding potential side effects (the most common one is a burning sensation, seen in 17% of patients in clinical trials) and how to handle them. The concurrent use of a steroid, loteprednol etabonate 0.5% (Lotemax, Bausch & Lomb), as an initial treatment has been shown to decrease the incidence of burning by 75%.

It's an exciting time as new treatments and new therapeutic strategies make it possible to treat the underlying disease in chronic dry eye and prevent disease progression.

It's incumbent upon us to recognize chronic dry eye for what it is: a serious disease that can cause our patients suffering to a life-altering degree. More than ever, we have the ability to treat dry eye as aggressively as our patients deserve.

References are available upon request.

Dr. Karpecki is Director of Research at Moyes Eye Clinic and runs a large ocular surface disease clinic in the Midwest. He is a paid consultant for Allergan and Bausch & Lomb, but has no financial interest in the products mentioned in this article.



Optometric Management, Issue: February 2006