The Dry Eye

Looking back at a year of LipiFlow

Initial results at one practice showed that most patients had improvements in their dry eye symptoms and gland scores.

There I was on the podium at a small winter meeting, escaping the snow and once again keeping company with Sheri Rowan and Alan Crandall, talking about dry eye. A year ago, almost to the day, the “Great LipiFlow Ambush” took place in the same setting. The only thing missing this year was Patti Barkey. Last year, my three colleagues, all LipiFlow evangelicals in the Church of Chirillo, ganged up on me, the nonbeliever, in an effort to get me to see the light about the benefits of TearScience’s offering. Even though I was tipped off that it was coming, it is always a little bit daunting to be put on the spot in front of an audience of your peers.

Thankfully, I survived to tell the tale.

Here we are, a year later, and SkyVision is simply hitting one patient success home run after another with both LipiFlow and LipiView 2. What changed? TearScience stepped up to the plate and developed a diagnostic that was worthy of its treatment, and then it totally changed its business model, making the entire program much more affordable. SkyVision jumped in with both feet, and we have been sprinting around the bases ever since.

As I have written in the past, we have a process-driven dry eye practice, one in which we are constantly evaluating all aspects of our diagnostic and treatment modalities not only for efficacy, but also for how they fit into our rabidly patient-centered philosophy. We now have a solid 6 months of data that I can share from our collective experience of what we are calling LipiFlow v1.0.

Would this patient benefit from LipiFlow?

Let me start by outlining our process to determine if a patient would benefit from LipiFlow. Remember that we are an advanced dry eye center. SkyVision sees not only the common types of dry eye patients seen in most eye care practices, but also some of the most difficult and frustrated dry eye patients imaginable. With the active involvement of our entire staff, including patient service, tech and counselor, a new type of exam was created, the Advanced Dry Eye Evaluation (ADE). We all felt that having up-to-date data on all aspects of a patient’s profile would allow us to best help our patients understand our recommendation.

A dry eye syndrome patient is scheduled for an ADE by the front desk agents and is flagged as such on the daily schedule. After being brought into the clinical areas of the office by a technician, the patient is asked to fill out a SPEED form. A directed history on her symptoms is then obtained. Tear osmolarity (TearLab) is performed at this point. Every other test in the process will invalidate the tear osmolarity, and the test itself has no effect on all other tests performed. Just before the doctor examines the patient, a test for inflammation (InflammaDry, RPS) is performed, followed by IOP measurement. If a Schirmer test is necessary, it is done just after measuring the IOP.

The magic of the process occurs in the middle of the ADE: LipiView 2. We do parts 1 and 3 of the ADE in whatever lane might be available. The patient is escorted into our diagnostic room for a measurement of the frequency and effectiveness of her blink, a measurement of the level of oil in the tear film and imaging of the meibomian glands themselves. Because this all occurs on a massive high-resolution screen, our patients can see their results in real time. When they return to the lane, they already know what their glands look like and whether they might have a pathologically low level of oil in their tears. The self-educational aspect of this part of the exam cannot be overemphasized. All patients watch an educational video explaining LipiFlow while waiting for their InflammaDry to percolate.

There is still some real, live doctor stuff you have to do in an ADE. Once the patient is at the slit lamp, we do all of the stuff I talked about in the basic dry eye practice article. The lid margins are examined for clinical signs of meibomian gland dysfunction. The tear meniscus is measured, and fluorescein dye is applied to look for both staining and tear breakup time. At this point the meibomian glands are evaluated by applying uniform pressure just below their orifices using the Korb evaluator. Secretions are recorded as none (0), inspissated (1), cloudy (2) or clear (3), with values assigned to each.

After all those data are accumulated, who then needs LipiFlow? You would be surprised at the number of patients who come into this last part of the exam already self-diagnosed after seeing their glands. For the rest, a gland score of less than 18 is abnormal and warrants consideration. A lipid level of less than 60 is always abnormal. Greater than 80 may be normal; there are just too many other ways to get non-meibomian oil into the tears (lotion, makeup, etc.) to declare a high level as “normal,” and we explain the LipiView to patients in exactly this way. Destruction, truncation and obstruction (with associated ductile dilation) are obvious on imaging. The “perfect triad” of candidacy is low oil, long, healthy glands and obvious obstruction; it is quite obvious that opening up those glands will lead to improved symptoms. At this point, approximately 75% of patients who are determined to be candidates for LipiFlow have opted to have the treatment.

Initial results

How have we done so far? Pretty darned well, I have to say. In our first 6 months with LipiView 2/LipiFlow, there were 120 eyes for which we have initial follow-up data. Two of our measured outcomes have met or exceeded expectations, and as is so often the case when you let a new technology loose in the wild, we had one very curious result. Consistent with the FDA data submitted by TearScience, 86.5% of our patients had an improvement in their symptoms as measured by SPEED, and 94% showed an improvement in their gland scores on the meibomian gland evaluation performed by the doctor. Interestingly, we found no understandable effect on tear breakup time: one-third of eyes were better, one-third were worse and one-third had no change.

Now it is back to the drawing board for us as we digest this information and start to develop v2.0. I think we have been a little conservative in making recommendations for treatment, especially in light of our fantastic results. Now that TearScience has cut the price of activators in half, we have been able to lower the cost of treatment, and I think we would be justified in offering it to more patients. One of my optometric partners is developing a program for the newly contact lens intolerant that would involve LipiFlow, and I am considering adding it as a standard part of our advanced IOL program. As it has always been, both before and after my ambush in 2015, the trick is to be diligent in the “who and why” of choosing patients for treatment.

My staff and I, and every single one of our LipiFlow patients, owe a great big “thank you” to my friend Dee Stephenson who insisted — nay, demanded — that I participate in that 2015 panel. She may or may not have been the little birdie that whispered in my ear before I took the stage; she definitely reminded me that I am never daunted.

Disclosure: White reports he is a consultant for Bausch + Lomb, Allergan, Shire and Eyemaginations; is on the speakers board for Bausch + Lomb, Allergan and Shire; and has a financial interest in TearScience.

There I was on the podium at a small winter meeting, escaping the snow and once again keeping company with Sheri Rowan and Alan Crandall, talking about dry eye. A year ago, almost to the day, the “Great LipiFlow Ambush” took place in the same setting. The only thing missing this year was Patti Barkey. Last year, my three colleagues, all LipiFlow evangelicals in the Church of Chirillo, ganged up on me, the nonbeliever, in an effort to get me to see the light about the benefits of TearScience’s offering. Even though I was tipped off that it was coming, it is always a little bit daunting to be put on the spot in front of an audience of your peers.

Thankfully, I survived to tell the tale.

Here we are, a year later, and SkyVision is simply hitting one patient success home run after another with both LipiFlow and LipiView 2. What changed? TearScience stepped up to the plate and developed a diagnostic that was worthy of its treatment, and then it totally changed its business model, making the entire program much more affordable. SkyVision jumped in with both feet, and we have been sprinting around the bases ever since.

As I have written in the past, we have a process-driven dry eye practice, one in which we are constantly evaluating all aspects of our diagnostic and treatment modalities not only for efficacy, but also for how they fit into our rabidly patient-centered philosophy. We now have a solid 6 months of data that I can share from our collective experience of what we are calling LipiFlow v1.0.

Would this patient benefit from LipiFlow?

Let me start by outlining our process to determine if a patient would benefit from LipiFlow. Remember that we are an advanced dry eye center. SkyVision sees not only the common types of dry eye patients seen in most eye care practices, but also some of the most difficult and frustrated dry eye patients imaginable. With the active involvement of our entire staff, including patient service, tech and counselor, a new type of exam was created, the Advanced Dry Eye Evaluation (ADE). We all felt that having up-to-date data on all aspects of a patient’s profile would allow us to best help our patients understand our recommendation.

A dry eye syndrome patient is scheduled for an ADE by the front desk agents and is flagged as such on the daily schedule. After being brought into the clinical areas of the office by a technician, the patient is asked to fill out a SPEED form. A directed history on her symptoms is then obtained. Tear osmolarity (TearLab) is performed at this point. Every other test in the process will invalidate the tear osmolarity, and the test itself has no effect on all other tests performed. Just before the doctor examines the patient, a test for inflammation (InflammaDry, RPS) is performed, followed by IOP measurement. If a Schirmer test is necessary, it is done just after measuring the IOP.

The magic of the process occurs in the middle of the ADE: LipiView 2. We do parts 1 and 3 of the ADE in whatever lane might be available. The patient is escorted into our diagnostic room for a measurement of the frequency and effectiveness of her blink, a measurement of the level of oil in the tear film and imaging of the meibomian glands themselves. Because this all occurs on a massive high-resolution screen, our patients can see their results in real time. When they return to the lane, they already know what their glands look like and whether they might have a pathologically low level of oil in their tears. The self-educational aspect of this part of the exam cannot be overemphasized. All patients watch an educational video explaining LipiFlow while waiting for their InflammaDry to percolate.

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There is still some real, live doctor stuff you have to do in an ADE. Once the patient is at the slit lamp, we do all of the stuff I talked about in the basic dry eye practice article. The lid margins are examined for clinical signs of meibomian gland dysfunction. The tear meniscus is measured, and fluorescein dye is applied to look for both staining and tear breakup time. At this point the meibomian glands are evaluated by applying uniform pressure just below their orifices using the Korb evaluator. Secretions are recorded as none (0), inspissated (1), cloudy (2) or clear (3), with values assigned to each.

After all those data are accumulated, who then needs LipiFlow? You would be surprised at the number of patients who come into this last part of the exam already self-diagnosed after seeing their glands. For the rest, a gland score of less than 18 is abnormal and warrants consideration. A lipid level of less than 60 is always abnormal. Greater than 80 may be normal; there are just too many other ways to get non-meibomian oil into the tears (lotion, makeup, etc.) to declare a high level as “normal,” and we explain the LipiView to patients in exactly this way. Destruction, truncation and obstruction (with associated ductile dilation) are obvious on imaging. The “perfect triad” of candidacy is low oil, long, healthy glands and obvious obstruction; it is quite obvious that opening up those glands will lead to improved symptoms. At this point, approximately 75% of patients who are determined to be candidates for LipiFlow have opted to have the treatment.

Initial results

How have we done so far? Pretty darned well, I have to say. In our first 6 months with LipiView 2/LipiFlow, there were 120 eyes for which we have initial follow-up data. Two of our measured outcomes have met or exceeded expectations, and as is so often the case when you let a new technology loose in the wild, we had one very curious result. Consistent with the FDA data submitted by TearScience, 86.5% of our patients had an improvement in their symptoms as measured by SPEED, and 94% showed an improvement in their gland scores on the meibomian gland evaluation performed by the doctor. Interestingly, we found no understandable effect on tear breakup time: one-third of eyes were better, one-third were worse and one-third had no change.

Now it is back to the drawing board for us as we digest this information and start to develop v2.0. I think we have been a little conservative in making recommendations for treatment, especially in light of our fantastic results. Now that TearScience has cut the price of activators in half, we have been able to lower the cost of treatment, and I think we would be justified in offering it to more patients. One of my optometric partners is developing a program for the newly contact lens intolerant that would involve LipiFlow, and I am considering adding it as a standard part of our advanced IOL program. As it has always been, both before and after my ambush in 2015, the trick is to be diligent in the “who and why” of choosing patients for treatment.

My staff and I, and every single one of our LipiFlow patients, owe a great big “thank you” to my friend Dee Stephenson who insisted — nay, demanded — that I participate in that 2015 panel. She may or may not have been the little birdie that whispered in my ear before I took the stage; she definitely reminded me that I am never daunted.

Disclosure: White reports he is a consultant for Bausch + Lomb, Allergan, Shire and Eyemaginations; is on the speakers board for Bausch + Lomb, Allergan and Shire; and has a financial interest in TearScience.