The Dry EyePublication Exclusive

Building a dry eye clinic, part 3: The advanced dry eye practice

A three-part series explores the idea of developing a dry eye service in your practice.

Are you still here? That is fantastic! That must mean you made a conscious, all-in decision to start a dry eye practice, as discussed in part 1, and you have adjusted your existing protocols to include a directed evaluation of the anterior segment looking for clues to the presence and type of dry eye using our traditional exam techniques, as discussed in part 2. You have started to use the information you have gathered to treat patients who suffer from dry eye symptoms using a combination of artificial tears, mechanical therapy and prescription medications. Guess what? Your patients have noticed, and they feel better.

I promised you that treating dry eye would make you cool, like our up-and-coming thought leaders Elizabeth Yeu, MD, and Christopher Starr, MD, but you probably were still a bit skeptical, weren’t you? Right up until you walked by the Abbott Medical Optics booth at the American Academy of Ophthalmology meeting and noticed that the longest line was not for the sweets or the sweet lasers, but to sign up for Blink samples. Admit it, that is kind of cool. Now it is time to take the next step like Liz and Chris and become an advanced dry eye practice.

The advanced dry eye practice is all about the utilization of point-of-service testing. Herein lies the magical intersection of industry and better medical care. While there are quite a number of tests available, and new ones coming on line seemingly every month, there are three well-established diagnostic tests that comprise the high-tech diagnostic suite: tear osmolarity (TearLab), MMP-9 testing for inflammation (InflammaDry, RPS) and meibomian gland imaging (TearScience). Let’s look at them in the order in which they have become important.

Tear osmolarity

For my mind, tear osmolarity is an indispensable test that simply must be part of any advanced dry eye practice. Originally launched as a binary test — negative or positive — practices such as ours have long held that the data obtained with tear osmolarity is much more helpful than that simple view. It is much better to consider tear osmolarity as either low or high; each measure tells us something important when we combine that value with the information we have gleaned from our patient and our traditional exam findings. We also learn valuable information by examining the similarity, or lack thereof, between the readings from each eye.

While the limit of “normal” is 308, anything above 320 is a clear indication that your patient has dry eye. Full stop. We have found that a difference between the measurements of the two eyes greater than 12 is just as diagnostic, although one should be aware that 8 is the upper limit of homeostasis, so 8 and higher should be viewed with suspicion. By the same token, 300 is the upper limit of normal; a reading under 290 means that there is a low likelihood of classic, single-modality aqueous-deficient dry eye. Note that even here, in the low range of results, asymmetry between the two eyes is a sign of pathology.

How do we put this data into play in the office? A high tear osmolarity means that we are going to be leaning toward including some sort of treatment for abnormal aqueous production in our plan. The higher the tear osmolarity, the more likely we are to consider long-term anti-inflammatory treatments such as Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan). In addition, a high tear osmolarity is a prompt for the “prescription” of a hypotonic artificial tear such as TheraTears (Akorn) or Blink, which a patient can use for additional symptomatic relief. A low tear osmolarity makes us look much more critically at the lid margin and typically drives the “prescription” of an oil-based tear such as Retaine MGD (Ocusoft). Because tear osmolarity is a number, it is easy to use it as a measure of success (or lack of success) on follow-up visits.

The business of tear osmolarity is at once both straightforward and murky. Tear osmolarity is CLIA-waived; you do not have to have a qualified lab to do the test. TearLab will provide you with handsets, and you purchase single-use test “chips.” Your cost is determined by volume. By and large, all insurance carriers reimburse more per test than you pay per chip. Recent guidance from commercial carriers and at least one Medicare carrier looks like they have accepted this test as medically necessary both for diagnosis and follow-up evaluations.

MMP-9 testing for inflammation

Next in the lineup comes InflammaDry, a test that provides a qualitative measurement of MMP-9 activity, and therefore inflammation, on the surface of the eye. Once again, the early guidance on this test was that it, too, was a positive or negative toggle switch. Quite frankly, we struggled with this one for months at SkyVision. We thought we were getting solid results, but looking at them as a standalone test, we (meaning I) simply could not figure out what to do with them. This changed when we decided to apply InflammaDry primarily as a treatment toggle: a positive InflammaDry drives us in the direction of anti-inflammatory treatment.

When we couple this with tear osmolarity, we start to get a pretty sophisticated, actionable treatment matrix. A positive InflammaDry coupled with a high tear osmolarity is a pretty clear runway to launch Restasis (as an aside, this will probably be similar for lifitegrast from Shire if it is approved). On the other hand, a positive InflammaDry in the face of a low tear osmolarity gives us strong support for the addition of corticosteroids, most often Lotemax Gel (loteprednol etabonate ophthalmic gel 0.5%, Bausch + Lomb). Anyone who has used InflammaDry in its present form is anxiously awaiting a version that will give us an analog result telling us how much MMP-9 is present.

Like tear osmolarity, InflammaDry is CLIA-waived and has been relatively well received by both commercial and government insurance carriers. The single-use tests are purchased in bulk from RPS. Once again, the volume of your purchase determines your cost. The math is not quite as beneficial with InflammaDry as it is for tear osmolarity, but in general, your reimbursement will always be higher than your costs. Follow-up testing is understood to be a medically necessary part of treatment.

Meibomian gland imaging

Last, but certainly not least, the new “sexy beast” of dry eye care, LipiView meibomian gland imaging. You are going to shell out some bucks for this one, but if our experience is any indication, dynamic meibomian imaging is to dry eye what OCT is to macular degeneration. You still have to be a doctor here. The meibomian gland analysis using the Korb evaluator tells you what is coming out of the meibomian glands in a repeatable, standardizable way. However, if you think your patient suffers from MGD and the two of you look at images of gland obstruction and/or destruction, your job of educating that patient on the “why” of their dry eye is pretty much done for you. Whether you choose to treat your findings with traditional mechanical treatment, prescription medications such as AzaSite (azithromycin ophthalmic solution, Akorn) or nutraceuticals such as re-esterified fish oil, or true physical therapy with LipiFlow is beyond the scope of this column, but you will for sure know that you are going to treat them. And so will they.

Becoming an advanced dry eye clinic is all about adopting and embracing the point-of-service tests of tear osmolarity, MMP-9 levels and meibomian gland imaging. These three tools are the last steps in your journey to being at least as cool as guys like me, or even my friend Dave Hardten, MD, one of the true pioneers in the dry eye world.

I just can’t promise you will look as good as Liz or Chris do while you are at it.

Disclosure: White reports he is a consultant for Bausch + Lomb, Allergan, Shire and Eyemaginations and on the speakers board for Bausch + Lomb, Allergan and Shire.

Are you still here? That is fantastic! That must mean you made a conscious, all-in decision to start a dry eye practice, as discussed in part 1, and you have adjusted your existing protocols to include a directed evaluation of the anterior segment looking for clues to the presence and type of dry eye using our traditional exam techniques, as discussed in part 2. You have started to use the information you have gathered to treat patients who suffer from dry eye symptoms using a combination of artificial tears, mechanical therapy and prescription medications. Guess what? Your patients have noticed, and they feel better.

I promised you that treating dry eye would make you cool, like our up-and-coming thought leaders Elizabeth Yeu, MD, and Christopher Starr, MD, but you probably were still a bit skeptical, weren’t you? Right up until you walked by the Abbott Medical Optics booth at the American Academy of Ophthalmology meeting and noticed that the longest line was not for the sweets or the sweet lasers, but to sign up for Blink samples. Admit it, that is kind of cool. Now it is time to take the next step like Liz and Chris and become an advanced dry eye practice.

The advanced dry eye practice is all about the utilization of point-of-service testing. Herein lies the magical intersection of industry and better medical care. While there are quite a number of tests available, and new ones coming on line seemingly every month, there are three well-established diagnostic tests that comprise the high-tech diagnostic suite: tear osmolarity (TearLab), MMP-9 testing for inflammation (InflammaDry, RPS) and meibomian gland imaging (TearScience). Let’s look at them in the order in which they have become important.

Tear osmolarity

For my mind, tear osmolarity is an indispensable test that simply must be part of any advanced dry eye practice. Originally launched as a binary test — negative or positive — practices such as ours have long held that the data obtained with tear osmolarity is much more helpful than that simple view. It is much better to consider tear osmolarity as either low or high; each measure tells us something important when we combine that value with the information we have gleaned from our patient and our traditional exam findings. We also learn valuable information by examining the similarity, or lack thereof, between the readings from each eye.

While the limit of “normal” is 308, anything above 320 is a clear indication that your patient has dry eye. Full stop. We have found that a difference between the measurements of the two eyes greater than 12 is just as diagnostic, although one should be aware that 8 is the upper limit of homeostasis, so 8 and higher should be viewed with suspicion. By the same token, 300 is the upper limit of normal; a reading under 290 means that there is a low likelihood of classic, single-modality aqueous-deficient dry eye. Note that even here, in the low range of results, asymmetry between the two eyes is a sign of pathology.

How do we put this data into play in the office? A high tear osmolarity means that we are going to be leaning toward including some sort of treatment for abnormal aqueous production in our plan. The higher the tear osmolarity, the more likely we are to consider long-term anti-inflammatory treatments such as Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan). In addition, a high tear osmolarity is a prompt for the “prescription” of a hypotonic artificial tear such as TheraTears (Akorn) or Blink, which a patient can use for additional symptomatic relief. A low tear osmolarity makes us look much more critically at the lid margin and typically drives the “prescription” of an oil-based tear such as Retaine MGD (Ocusoft). Because tear osmolarity is a number, it is easy to use it as a measure of success (or lack of success) on follow-up visits.

PAGE BREAK

The business of tear osmolarity is at once both straightforward and murky. Tear osmolarity is CLIA-waived; you do not have to have a qualified lab to do the test. TearLab will provide you with handsets, and you purchase single-use test “chips.” Your cost is determined by volume. By and large, all insurance carriers reimburse more per test than you pay per chip. Recent guidance from commercial carriers and at least one Medicare carrier looks like they have accepted this test as medically necessary both for diagnosis and follow-up evaluations.

MMP-9 testing for inflammation

Next in the lineup comes InflammaDry, a test that provides a qualitative measurement of MMP-9 activity, and therefore inflammation, on the surface of the eye. Once again, the early guidance on this test was that it, too, was a positive or negative toggle switch. Quite frankly, we struggled with this one for months at SkyVision. We thought we were getting solid results, but looking at them as a standalone test, we (meaning I) simply could not figure out what to do with them. This changed when we decided to apply InflammaDry primarily as a treatment toggle: a positive InflammaDry drives us in the direction of anti-inflammatory treatment.

When we couple this with tear osmolarity, we start to get a pretty sophisticated, actionable treatment matrix. A positive InflammaDry coupled with a high tear osmolarity is a pretty clear runway to launch Restasis (as an aside, this will probably be similar for lifitegrast from Shire if it is approved). On the other hand, a positive InflammaDry in the face of a low tear osmolarity gives us strong support for the addition of corticosteroids, most often Lotemax Gel (loteprednol etabonate ophthalmic gel 0.5%, Bausch + Lomb). Anyone who has used InflammaDry in its present form is anxiously awaiting a version that will give us an analog result telling us how much MMP-9 is present.

PAGE BREAK

Like tear osmolarity, InflammaDry is CLIA-waived and has been relatively well received by both commercial and government insurance carriers. The single-use tests are purchased in bulk from RPS. Once again, the volume of your purchase determines your cost. The math is not quite as beneficial with InflammaDry as it is for tear osmolarity, but in general, your reimbursement will always be higher than your costs. Follow-up testing is understood to be a medically necessary part of treatment.

Meibomian gland imaging

Last, but certainly not least, the new “sexy beast” of dry eye care, LipiView meibomian gland imaging. You are going to shell out some bucks for this one, but if our experience is any indication, dynamic meibomian imaging is to dry eye what OCT is to macular degeneration. You still have to be a doctor here. The meibomian gland analysis using the Korb evaluator tells you what is coming out of the meibomian glands in a repeatable, standardizable way. However, if you think your patient suffers from MGD and the two of you look at images of gland obstruction and/or destruction, your job of educating that patient on the “why” of their dry eye is pretty much done for you. Whether you choose to treat your findings with traditional mechanical treatment, prescription medications such as AzaSite (azithromycin ophthalmic solution, Akorn) or nutraceuticals such as re-esterified fish oil, or true physical therapy with LipiFlow is beyond the scope of this column, but you will for sure know that you are going to treat them. And so will they.

Becoming an advanced dry eye clinic is all about adopting and embracing the point-of-service tests of tear osmolarity, MMP-9 levels and meibomian gland imaging. These three tools are the last steps in your journey to being at least as cool as guys like me, or even my friend Dave Hardten, MD, one of the true pioneers in the dry eye world.

I just can’t promise you will look as good as Liz or Chris do while you are at it.

Disclosure: White reports he is a consultant for Bausch + Lomb, Allergan, Shire and Eyemaginations and on the speakers board for Bausch + Lomb, Allergan and Shire.