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Algorithm devised for classification, treatment of dry eye
Lids, tear film, conjunctiva, cornea and vision are considered when classifying the severity of dysfunctional tear syndrome.
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Artificial tears are rarely enough to achieve lasting and effective results for chronic dry eye patients, according to Steven E. Wilson, MD, director of corneal research at the Cole Eye Institute at the Cleveland Clinic Foundation.
Dr. Wilson, along with colleagues on a Delphi Panel, a group of experts formed to evaluate a specific issue, developed the Consensus Treatment Algorithm to identify the stages and severity of patients’ symptoms and recommend concise corresponding treatments. He presented the new algorithm at the Ocular Drug and Surgical Therapy Update meeting.
“We’ve known for a long time that somehow the way we were diagnosing dry eye in the past has just not been adequate,” Dr. Wilson said. “It comes from the highly variable nature of the patients that we see.”
The researchers first aimed to redefine chronic dry eye, considering the evolved understanding of the disease. They renamed the disease dysfunctional tear syndrome (DTS). The name encompasses the symptoms of decreased tear volume, abnormalities of tear film composition and the presence of molecular factors that do not support a healthy ocular surface, Dr. Wilson said.
“Basically, the new algorithm is an acknowledgment that there is no individual sign or symptom that really allows a clinician to say, ‘This is dysfunctional tear syndrome,’” he said. “There are many different presentations that patients can have that encompass chronic dry eye or dysfunctional tear syndrome.”
Before the Delphi committee devised the algorithm over a year ago, there were no established guidelines to assess dry eye, Dr. Wilson said.
“Everybody had their own approach. That was one of the problems,” Dr. Wilson said. “There was no real consensus approach. Some people would treat only based on Schirmer regardless of what the signs looked like. If a patient had 12 mm [of moisture in a Schirmer test], no matter what their signs were, they would say it couldn’t be dry eye. That’s where the realization of tear quality became important.”
Dysfunctional tear syndrome
“Over the past 5 to 10 years there has been an increasing appreciation of the importance of the components in the tears, not just the volume,” Dr. Wilson said. “In fact, I think many of us feel that’s really the most important factor.”
Dr. Wilson said sometimes patients have symptoms of dry eye, including grittiness and dry sensation, but their Schirmer test reveals that they have plenty of aqueous tear production.
“A lot of patients don’t fit into categories and they have what would be considered a normal aqueous production, yet they still have all the symptoms and signs, otherwise, of dry eye,” he said. “It [the algorithm] basically came from a realization of the importance of the composition, but also this new understanding of an underlying inflammatory pathophysiology to the disease in a large proportion of patients.”
Dr. Wilson said, “It is important to emphasize that DTS is not an inflammation such as iritis or conjunctivitis, which can be detected at the slit lamp. Instead, it is something detected on conjunctiva or lacrimal gland biopsy.”
“[DTS] tends to be low-grade but over a long period of years can do serious damage to the tear film system and the ocular surface,” he said.
Dry eye is common
“The important point is these symptoms are common in not only refractive practice, but also in cornea practice and general practice,” Dr. Wilson said. “A clinician has to be aware of the symptoms and signs and be looking for them.”
Although his practice is primarily devoted to refractive surgery, Dr. Wilson said dry eye is common among his patients because they tend to be unable to wear contact lenses.
“They don’t know specifically why they’re having trouble wearing them, but they have them in for an hour or two and have to get them out,” he said. “We find they have DTS … and this makes them a difficult candidate at that point in time to wear contact lenses, until the DTS is treated.”
There are two reasons why DTS should be treated before LASIK, he said. First, DTS patients are at a higher risk of having a hard time with dry eye postoperatively. Second, if the patient has punctate epithelial staining on the cornea, it can confound wavefront analysis used in custom corneal ablation.
“I would have to say I have at least four or five new patients like that every week,” he said.
Typically, Dr. Wilson said he prescribes Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan) and re-evaluates the patient’s condition after 1 month of treatment before he continues with LASIK.
“I’ve pretty much committed them to a 6-month course when they start, but if they come back in a month and their corneal surface changes have resolved, then I’ve had a lot of success in going ahead with surgery, but stopping Restasis starting with the day of surgery and then resuming it 3 days postop,” he said.
Restasis
Dr. Wilson said 75% to 80% of patients seem to respond significantly to Restasis treatment.
“Some respond within a few weeks, sometimes it takes 3 months to see a significant improvement, and sometimes it takes 6 months,” he said. “So I tell my patients right up front that we need to get them through a 6-month course, even if they’ve responded within 1 month.”
For patients who do not respond, compliance should be taken into consideration, he explained.
“If they are in compliance, that could be telling us something about their pathophysiology,” he said. “These may be patients who don’t have an underlying inflammatory component to their dry eye, and we just don’t understand completely yet what the factors are in those particular patients.”
Dr. Wilson said he is convinced that a Restasis treatment regimen may halt progression of DTS and, in some rare cases, provide a cure.
“I’d say that’s less than 10% of my total patients, but I’d hate to not give a person an opportunity to be one of those people,” he said.
“Realizing that this is such a variable presentation disease, you can never completely pidgeonhole people who have this,” Dr. Wilson said.
DTS severity guide
A patient suspected of having DTS should be classified on his initial visit into one of three categories — DTS with lid margin disease, DTS without lid margin disease (the most common form), or DTS with altered tear distribution and clearance.
To determine the appropriate treatment, the severity of the disease must then be measured, he said. Each patient with DTS should meet two primary criteria and one secondary criteria.
There are five categories of primary criteria — lids, tear film, conjunctiva, cornea and vision — and there are several symptoms in each category. Lids can pose symptoms such as hyperemia or lash loss; tear film can pose decreased tear meniscus or foamy or oily tears; conjunctiva can have staining or hyperemia; cornea may present punctate changes, erosions or ulcerations; and vision could be blurred.
“They can have any two of these, and you then grade the severity on a scale of 1 to 4,” Dr. Wilson said.
The secondary criteria includes tear breakup time, Schirmer test, corneal sensation, impression cytology, tear composition and reflex tearing.
Four levels of severity
In the new treatment algorithm, DTS severity is divided into four levels.
In the first level, Dr. Wilson said patients have mild to moderate symptoms and no significant signs. They are typically successfully treated with unpreserved artificial tears.
The second level includes patients who exhibit tear film signs, mild punctate staining, conjunctival staining and visual signs. Patients may have moderate to severe staining and some blurring of their vision. They can be treated with cyclosporine in addition to unpreserved tears.
The third level includes patients who have corneal signs, central corneal staining and possibly filamentary keratitis. These patients are treated with Restasis and, if they are very symptomatic, a corticosteroid for 10 to 14 days. Punctal plugs may also be used, but not at the beginning of treatment because that would plug up bad tears. Oral tetracyclines are also prescribed at this level.
The fourth level, the most severe, includes patients who have severe corneal staining and conjunctival scarring. They have almost no tear production. These patients are treated with an anti-inflammatory medication and environmental modification.
“Restasis is not always successful in these patients. Sometimes they may think of moving out of their environment, such as away from dry locations like Denver or Phoenix,” he said.
Patients can continue to take unpreserved artificial tears in conjunction with the other treatments in levels 2 to 4, but use of these palliative agents tends to fall off in patients who have a successful response to Restasis, Dr. Wilson said.
Moisture goggles may be recommended and punctual cautery may be helpful if Restasis is not effective.
“If they’ve been on Restasis for 6 months and they still aren’t producing tears, they’ve probably damaged their lacrimal gland so severely that they’re just not going to respond to the therapy,” Dr. Wilson said. “Then you can do more aggressive things like punctual cautery or tarsorrophy — closing the side of the opening between the eyelids.” For Your Information:
For Your Information:
- Steven E. Wilson, MD, can be reached at Cole Eye Institute, 9500 Euclid Ave., I-32, Cleveland, OH 44195; 216-444-5887; fax: 216-445-8475; e-mail: wilsons4@ccf.org. Dr. Wilson is a speaker for Allergan and has served as a consultant to Allergan.
- Allergan, maker of Restasis, can be reached at 2525 Dupont Drive, Irvine, CA 92612; 800-433-8871; fax: 714-246-5913; Web site: www.allergan.com
- Daniele Cruz is an OSN Staff Writer who covers all aspects of ophthalmology.