Point-of-Care Testing for Ocular Allergies

With Doctor’s Allergy Formula, ophthalmologists can improve diagnosis, treatment decisions and outcomes — without disrupting the flow of the clinic.

A GOOD FIT IN ANY PRACTICE

ROBERT J. WEINSTOCK, MD: We’ve been using Doctor’s Allergy Formula for approximately 6 months and I’ve learned a great deal about integrating it into a practice. As many of us would agree, designating a person, or specific technicians, to be trained — with the help of the Doctor’s Allergy Formula team — to administer the test is a smart place to start. Also, having the doctor present in the building is paramount, especially in the beginning, and having the doctor spend time with the patient to explain the results is important.

What have you found to be crucial in integrating this testing into your practice?

JOHN D. SHEPPARD, MD, MMSC: It’s amazing how prevalent allergy is, and how often it is overlooked as one of the “big three” of ocular surface disease: dry eye, meibomian gland disease and allergy. Allergy is an integral part in the pathogenesis of so many of my patients’ problems. I need to be aware of that so I can prioritize my therapeutic approach. Not only do I have to recognize the condition, I have to decide whether allergy is a significant contributor to a patient’s problems. For the first time, Doctor’s Allergy Formula gives me an objective way to do that.

However, I also must be able to take advantage of this test without interrupting or slowing patient flow in the clinic. I’ve accomplished this thanks to a single strategy: Our entire practice is on board. From schedulers to staff at the checkout desk, everyone knows about the test and how we use it. We’ve added it to our checkout sheet alongside the LipiFlow consultation and the various products, such as cold masks and nutraceuticals, that we offer for ocular surface disease. Every Wednesday afternoon, we have a dedicated clinic, which is run by an LPN and one of my chief technicians and supervised by our optometrists. No one is in the retina clinic that day, so we have dedicated office space for administering the test. The optometrists make a report on the charts of the patients who are tested so the next time I see them, I have the results. The data is waiting for me, along with a tear osmolarity test result, the visual acuity, and so on, so I can make a diagnosis.

None of this absorbs my time, I have an income stream, and I’m addressing not only ocular problems but also systemic problems for patients who also may have eczema, asthma, rhinitis or sinusitis. I’m doing it in my office, which is convenient and familiar for them, thus more comfortable than sending them to an allergist’s office. The test is totally integrated into the practice, takes no extra time for me and provides me with an additional chance to deliver state-of-the-art care.

JODI LUCHS, MD: A strategy we use in our practice is to bring patients back strictly for allergy testing subsequent to their initial consultation or regular exam. Practice flow isn’t interrupted on that initial day, and when I see patients at the next visit, a technician has already performed the test. I review the results with the patients, who often feel I’m providing a great deal of specialized attention to their ocular surface disease and allergies in an effort to tailor a therapeutic plan specifically for them.

JAI G. PAREKH, MD, MBA: You can choose how you want to incorporate Doctor’s Allergy Formula into your practice. In our mindset, ocular surface disease is very important; therefore, we think just like other tests such as visual fields and OCT scans, this test deserves its own session. I’m in the building when the allergy test is performed because, technically, we’re administering an antigen that can cause an adverse response. Along with me, we have on hand EpiPens and Benadryl.

A couple of days per month, we devote four or five hours and schedule six to eight patients per hour to have the test done by two technicians. During that time, I complete some dictation, perform some minor plastics procedures or see post-op cataract patients. When the allergy-tested patients are ready for me, I spend about 5 minutes with each, explaining the results and adjusting their treatments as needed. I see them again in 4 to 6 weeks to assess how they’re doing. It’s a nice, relatively quiet day for me, and it’s rich with information. We’ve tested about 600 patients and have had zero resistance to this protocol.

MITCHELL A. JACKSON, MD: We have two doctors and four technicians in our practice, and we’ve taken a similar approach. We created an allergy/ocular surface clinic. We also have a glaucoma testing clinic and a cataract advanced diagnostics clinic. In our electronic health records system, we’ve created all of these different tabs, including one for Doctor’s Allergy Formula. When I want a patient to undergo the test, I use the tab to note this. He or she returns on allergy/ocular surface clinic day, which we schedule once a week. My associate and I alternate weeks.

On my week, I sit with each patient and review their findings, which are always useful. Armed with the data, I may be able to eliminate eye-drying allergy medicines they don’t need. Or I may learn what specific time of year to treat their allergic response. I can also tell them that the objective results support a preauthorization for allergy medication if they need it.

JAY S. PEPOSE, MD, PHD: We use more of a hybrid model because I find that patients seem to fall into one of two groups. One group knows they have allergies, but don’t know what they’re allergic to. Many of them don’t want to come back for testing, so we offer them the test on the spot, unless they’ve been taking antihistamines. They’re often grateful to finally learn what sets off their allergic response.

The other group consists of patients who are the diagnostic dilemmas. They come in with the overlapping symptoms of itching, burning and foreign body sensation. For them, we’ve created a combined intake form that includes allergy and dry eye. We explain that they need to discontinue antihistamines for 5 days, so we can have them return for a combined allergy/dry eye evaluation. At that visit, they undergo a complete ocular surface disease workup, performed by one of our optometrists. The allergy test data goes to an ophthalmologist who has a follow-up visit for counseling.

DR. WEINSTOCK: Sometimes when we’re seeing patients, we’re focused on their main reason for seeing us, such as cataracts or a retinal problem. To help keep a broader focus, we’ve trained our technicians to talk to patients about whether they have itchy, watery, red, uncomfortable eyes. When they do, the tech flags the intake form with a red sticker. That alerts me to delve into that subject, along with any other ocular findings when I’m with patients. I tell them we have a great test that helps us find the cause and best treatment for their symptoms.

DR. LUCHS: We’re able to see from the explanations that Doctor’s Allergy Formula can be implemented into a busy practice in different ways. Some practices segment their time into specific disease subcategories and bring patients back for testing on those days. Others have integrated the testing into the regular visit. Still others have created a hybrid of the two, and all of the methods are working well.

IN-OFFICE DIAGNOSTICS ENABLE HIGH-QUALITY CARE

HOWARD J. LOFF, MD: What percentage of patients who say they’re allergic to something truly are?

DR. PEPOSE: I wouldn’t say 100%, but a very high percentage.

DR. JACKSON: In my experience, many people who say they have allergies do, but don’t know whether they’re seasonal or perennial. That makes a big difference because people are self-treating with medicines that are aggravating their condition when they really need to use a treatment in only the spring or fall. It’s significant when I can tell them we’ll treat their dry eye year-round, but they only need allergy treatment seasonally.

DR. LUCHS: All of us have integrated into our practices the latest diagnostic and therapeutic advances in order to deliver state-of-the-art care, and this new allergy diagnostic test should be no exception. It represents exactly how we want to manage patients with ocular surface disease complaints. We utilize all of the available tools to help us sort out what’s going on so we can make the appropriate therapeutic choices.

DR. PAREKH: This kind of test is commensurate with comprehensive medicine as it relates to, for example, lipids. If a patient is told he has high cholesterol, what does that mean? Well, today, triglycerides, LDL, HDL, LDL/HDL ratio, all of these components are measured. I’ve tested about 600 patients with Doctor’s Allergy Formula, and I would feel remiss had I not tested them. This tool provides me with so much useful information; I would be upset to have it taken away from me at this point.

DR. SHEPPARD: All of the new point-of-care tests, such as LipiView, tear osmolarity, InflammaDry and Doctor’s Allergy Formula, enhance one another, and this segment will continue to grow.

DR. PEPOSE: Yes, and if a patient has high tear osmolarity and corneal staining, it doesn’t mean he doesn’t also have ocular allergies, and both need to be treated.

DR. SHEPPARD: Another advantage of having quantitative analysis is it helps recruit patients as their own advocates. When I tell patients they have superficial punctate keratopathy, they have no idea what I’m talking about and may or may not take the drug I prescribe for them. On the other hand, if I tell them they react positively to three specific antigens, their tear osmolarity number is X, and they need to avoid a certain exposure and use this treatment, they tend to become my ally. Next time I see them, their tear osmolarity score is lower, they no longer have that elm tree in their front yard, their eyes itch less and are less red. We all know that with chronic conditions, compliance is the biggest enemy of therapeutic success. When we make patients their own advocates, we improve our ability to help them.

DR. JACKSON: When you have objective data, self-motivation to continue therapy and compliance definitely improve.

DR. WEINSTOCK: Does anyone have any thoughts about administrating the allergy test for kids?

DR. SHEPPARD: Some of the most difficult patients to deal with are children because they really don’t understand. If we can at least recruit the parents to help with some of the behavior modifications, therapies are likely to be more successful. I practiced pediatrics for 5 years after medical school in the Navy. This type of test is more successful in children than the traditional pin prick testing. There’s no increased risk of anaphylactic response, but the immunogenic response in a child is much more vigorous than in an adult. We’ve tested several kids and they’ve done very well. They benefit from a lifelong approach of preventive care to arrest a clinically significant disease before it can become advanced and cause damage, which contributes to an improved quality of life over many decades.

DR. PAREKH: We’ve tested kids as young as seven or eight. Also, we test every keratoconus patient in our clinic because nighttime itching and aggressive scratching can exacerbate the cornea and astigmatism, which can push someone into a state of full-fledged keratoconus. We’re testing all of our contact lens patients who have a history of giant papillary conjunctivitis (GPC), too. In some cases, what I thought was GPC wasn’t; it was pollen allergy. The contact lens itself can be a reservoir for the allergen.

DR. WEINSTOCK: Doctor’s Allergy Formula is reimbursable through medical insurance and Medicare, which is very helpful to the patient. However, copays can be a burden. Is it important to have this discussion with patients up front?

DR. JACKSON: This is one of the reasons we don’t test on the spot. We schedule it for a different day and then alert our coding and billing folks. We have two people who are dedicated to pre-authorizations and finding out whether there is a deductible or copay because we don’t want any hidden surprises for our patients. Due diligence ahead of time means our patients know their costs ahead of time. More than 90% of the patients agree to have the test. For some, I have to explain why I think it’s really important they have the test even if they have to pay $50 or $100 out of pocket. It’s important to have that discussion, especially in this health insurance climate.

DR. LOFF: You can approach the issue from a cost-containment perspective, too.

DR. WEINSTOCK: That’s a good point. Having the test may end up saving them money in the long run if we learn they’re spending on drops they don’t need or only need at certain times of the year.

DR. PAREKH: Many of these patients are pretty uncomfortable, eyes constantly itching and/or red, so when we give them a diagnosis, they’re thrilled. I’ve had zero push-back with this test.

DR. LUCHS: Nor have I. Whether patients have the test on the spot or come back to have it done, they’re very happy and grateful to have the results. They get a sense that even if they have to pay something, they’re getting something in return. They can actually take that piece of paper and see they’ve gained knowledge. Doctor’s Allergy Formula is one of the few new initiatives for which I’ve seen nothing but acceptance.

TESTING GUIDES — AND SOMETIMES CORRECTS — TREATMENT DECISIONS

DR. WEINSTOCK: Can you share a case that illustrates how treatment was dictated or different than expected based on Doctor’s Allergy Formula?

DR. SHEPPARD: We looked closely at our first group of Doctor’s Allergy Formula patients. Our selection criterion for testing was a doctor’s suspicion of ocular allergies. That meant virtually all of them had used some form of topical antihistamine or steroid, which aren’t inexpensive medications. Out of our first 40 patients, 15 had no reaction to the test panel. They had no pathophysiologic reason to be using antihistamines. That surprised me. Because of the variety of presentations and phenotypes among our patients, we truly need some assistance in categorizing the primary instigator of their problems, be it type 2 sensitivity, meibomian gland dysfunction, hypersecretion, neurotropic disease or a combination of factors.

DR. LUCHS: One of my patients who originally presented with all of the symptoms that are so difficult to differentiate — itching, foreign body sensation, burning — we had been treating for ocular allergy. His Doctor’s Allergy Formula results were negative, suggesting that either we’re completely missing the antigen, which I doubt, or allergy really isn’t a component of his ocular surface disease. When I know the latter with any patient, I can focus on the other aspects of ocular surface disease, dry eye and/or blepharitis. A tighter focus usually leads to better relief of the symptomatology. Consider, too, that a patient who has dry eye may not have adequate ocular surface lubrication to flush out antigens or irritants that get into the tear film. That may produce a local response that creates their symptoms, but they don’t rise to the level of skin-test-positive allergy. We treat their dry eye and they get better.

DR. SHEPPARD: Many of our patients use oral antihistamines, which can be purchased over the counter. In many cases, they’re overmedicated and making their dry eye worse. If I can prove they’re not allergic, I can take that out of the equation. When these patients are convinced to stop taking the oral antihistamines and don’t subsequently get worse, they see they don’t need to take those drying, sedating medications.

DR. LUCHS: Another good example of the benefits of Doctor’s Allergy Formula is the patient who comes in saying he always wakes in the morning with swollen eyes, so he takes an oral antihistamine. He’s noticing his symptoms in the morning so that’s when he takes the pill. When we perform the allergy test, we find he’s actually allergic to dust mites or feather pillows. We instruct him to get rid of the pillows, get dust-mite resistant bedding, or wash the bedding in hot water, and, low and behold, his symptoms go away. He’d been taking a pill in the morning for a symptom that was developing overnight, which of course was to no avail.

DR. PEPOSE: The positive predictive value of the Doctor’s Allergy Formula test is very high, but we should be cautious in how we interpret a negative test and how we relate that to the patient, because we’re not testing for thousands of antigens. We’re testing for 60. It’s important to explain to patients they don’t seem to have a systemic response to these 60 antigens, but we can’t say with 100% certainty that they aren’t allergic to anything or that they don’t have a local ocular immune response that hasn’t reached the point of systemic immunity. I’m sure there are groups of patients like that. So I think we have to be cautious in the way we interpret a negative test where there is great specificity in the positive.

DR. WEINSTOCK: So perhaps in some cases you may get a negative allergy test, but based on the strong clinical signs and symptoms, you may still consider treating for ocular allergy? Certainly you wouldn’t treat systemically if the patient isn’t reacting to the test.

DR. PEPOSE: Right, because we’re not really doing a local provocative test here. As more diagnostics become available, such as for IgE, chymase or tryptase, we’re going to become more like internists. We’re going to have a tear profile, and it may turn out we learn more about those patients who do have a local immune response vs. a systemic immune response.

DR. LUCHS: The scenarios in which we’re using a test like this aren’t cut-and-dried. They’re not just positive or negative and that’s it. We still need to be clinicians and rely on our clinical acumen to decide whether another component of allergy is playing a role for an individual patient and whether we need to treat it. Doctor’s Allergy Formula is an additional data point we can add to our diagnostic algorithm.

DR. SHEPPARD: There may be some gaps in the testing. Obviously we’re advanced in this science but we do have farther to go. For instance, food allergens aren’t included in the panel, and they’re very difficult to test with cutaneous hypersensitivity analysis. One test that would be very valuable to me would be one that determines whether a patient is reacting to the benzalkonium chloride (BAK) in a medication or to the medication itself. As the science progresses further, I’m certain we’ll have access through Doctor’s Allergy Formula to analyze these most important panels. In addition, maybe we need a secondary panel for the patients whose results don’t look as we expect them to look on the first pass with the first 60 antigens.

DR. LOFF: The company has been researching and developing tests for preservatives, such as BAK and Polyquad, and should hopefully have them commercially available in the next few months.

AN ASSET FOR THE OR IN ADDITION TO THE CLINIC

DR. WEINSTOCK: In a high volume surgical practice, how are you able to identify patients who need allergy testing in light of the fact that many of them are surgical patients?

DR. PAREKH: I think the reason we’ve been so successful with this is that we require every patient to complete an allergy/ocular surface disease intake form. I’m not eager to defer a patient who is ready to schedule for surgery, but I want to be sure whether I should pre-treat someone who has severe ocular surface disease before proceeding with a procedure. I need to be confident that the biometry will be accurate. A tear osmolality test and corneal staining are part of our routine pre-testing for every cataract patient for this reason.

DR. SHEPPARD: The surgery-related algorithm for allergy is going to change just as it has for dry eye. In past years, it was anathema to delay cataract surgery even if the patient had dry eye. Doctors are stepping back from that because of premium IOLs. We looked at our own data 2 years ago and virtually all of our unhappy multifocal lens patients had ocular surface disease. What has happened is we’ve reduced the number of cases in which we choose a multifocal lens, from approximately 15% to about 9%. The 9% are happy, and it’s a much happier environment for the doctors and staff as well. So why should we treat ocular allergy any differently?

For refractive surgery, the Boorstein article from 2003 clearly shows that oral antihistamines protect atopic patients from diffuse lamellar keratitis after LASIK. Therefore, allergies should be a key component of the pre-LASIK screening. Consider this as well: The highest concentration of mast cells in the eye, and therefore in the body, is in the choroid, not the conjunctiva, and those cells are very highly reactive in atopic patients. I’m following a cohort of atopic patients in which I expect to find a significant statistical difference in the incidence of at least anatomical cystoid macular edema (CME) with routine cataract surgery. In my cohort of patients who have had skin testing, those with atopy test positive for 28 to 32 antigens, whereas my average reactors have 3 to 7 antigens. About a half to three-fourths of my patients don’t react to anything on the test panel. So we have almost a tri-modal distribution. The folks with the rubbery, leathery, lids and the puffy eyes and the keratoconus and asthma and the eczema are reacting to everything. They clearly need sublingual immunotherapy, and we can postpone their cataract surgery until the ocular surface is under control. I treat them aggressively for CME prevention, too, and I give them a bolus of intravitreal corticosteroid at the time of cataract surgery. This is a small group of patients, but a relatively large group in a practice like ours where we see a great deal of cornea patients.

THE VALUE OF ALLERGY TESTING FOR OPHTHALMOLOGY PRACTICE

DR. WEINSTOCK: I have little doubt that Doctor’s Allergy Formula will become a standard part of ophthalmology practices. When I first heard about it, it seemed a little out of the box to use skin testing because it’s not something we learned in residency or have had much, if any, training or experience with. We had done other seemingly tangential things in our practice in the past, such as integrate hearing services, and some worked and some did not. I tend to be skeptical.

However, when all the physicians in my practice — the retina specialists, the glaucoma specialists — discovered how valuable the allergy testing was in making decisions about topical therapies, they began showing up to have themselves tested and ordering testing for their own patients. That made me realize how completely germane to ophthalmology this is, especially in an ocular surface disease clinic, a dry eye clinic and an allergic conjunctivitis clinic. It really is integral and makes me wonder why we haven’t been doing this all along. It was a paradigm shift for me to understand the value of point-of-care allergy testing in my practice. I’m certainly glad I came to the realization.

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