Informed Consent
Episode 11

Neurostimulation for Dry Eye

John Berdahl, MD; Elizabeth Yeu, MD; and Patti Barkey, a certified ophthalmic executive, join Marguerite McDonald, MD, to discuss neurostimulation as a treatment for dry eye. The three eye care practitioners share their experience with the TrueTear (Allergan) neurostimulator and explain how they educate patients about this treatment.

Speaker 1: Informed Consent: Getting to Yes, is editorially independent content supported with advertising by Alcon.

MARGUERITE: Welcome to another edition of our podcast, Informed Consent: Getting to Yes, where we focus on the fair and balanced words that leading eye care professionals use to get their patients to say yes to their recommendations. I’m your host, Marguerite McDonald of Ophthalmic Consultants of Long Island, in Lynbrook, New York.

Today’s edition features conversations I had with three leading eye care practitioners about neurostimulation as treatment for dry eye—specifically the TrueTear neurostimulator.

My guests are Patti Barkey, a Certified Opthalmic Executive at Bowden Eye and Associates in Jacksonville, Florida and the director of Bowden’s unique Dry Eye University. Welcome Patti.

PATTI: Hi. Thank you for having me.

MARGUERITE: It’s my pleasure. Next is Dr. John Berdahl, who participated in our podcast on LipiFlow. He is a partner at Vance Thompson Vision in Sioux Falls, South Dakota and an associate professor of ophthalmology at the University of South Dakota. Welcome back John!

JOHN: Thanks Marguerite. It is fun to be here.

MARGUERITE: And finally, our conversation also includes Dr. Elizabeth Yeu, a cataract and refractive surgery specialist with an international reputation. She is a partner at Virginia Eye Consultants and an Assistant Professor at Eastern Virginia Medical School. Thanks for being here Elizabeth.

ELIZABETH: Thanks, Marguerite; I'm excited to be able to do this with you.

MARGUERITE: So, I’d like to start by asking what each of you thought when you first heard about this technology. John, your practice was involved early on in this technology, so I’ll begin with you.

JOHN: So, here is something that seems really goofy, and you say, wait a second, you're going to put a little electrode on both of my nostrils, and then I'll push a button, and that's going to cause me to tear and make my dry eye better?

We were approached to be in the study, and I said that sounds crazy, sign us up because I love it when people take a really different approach to solving a disease.

But I was skeptical, but I felt like the risk profile was going to be low for these patients so let’s participate in the trial.

PATTI: I can honestly say I thought, "What? We're going to have patients stick something up their nose. I don't know if this is going to work."

ELIZABETH: When I first heard about the concept of neurostimulation I thought of reactive tearing, which is all that it was going to be, and I was a little skeptical about its efficacy and what kind of tears that this would actually be producing. Are these actually going to be good and healthy tears? Or are these reactive ones going to be comprised of more pro-inflammatory mediators and not have the same kind of efficacy. I've been sorely mistaken, thankfully so.

JOHN: I remember it vividly. The first patient that I went in to see in the trial ... I walked in, I leaned back, I folded my arms, and gave them every permission to tell me how much they disliked it. And I said, "So, how's this going?" She said, "Please don't take this away from me. I haven't been able to read a book at night for seven years. Please let me keep it."


JOHN: And I said, "No kidding." And she said, "Yes." So then the next five patients I saw that day, all had a variation on that theme. and I went from being a skeptic to a believer in those five patients.

PATTI: I can honestly tell you that patients have embraced this. My physicians on staff with dry eye and our actual staff with dry eye have all embraced it. And they're just so proud to use it, and they're so proud to be one of the first practices to offer it. For the particular patients, the embracement has been amazing. We've had very few patients push back. Any pushback we do have is more on the line of a simple understanding, and they can't get through the fact that they're going to put something up their nose. And then of course, the pricing is the other pushback.

MARGUERITE: So, let's pretend for a moment that I'm a dry eye patient. I'm Mrs. Smith and you and Dr. Bowden have decided that I need to be on neurostimulation, how would you explain it to me and encourage me to say yes?

PATTI: Well, gosh Mrs. Smith. We have a device available for you. We've had you using multiple eye drops to lubricate and moisten those eyes during the day, but we now have a device that you can use two to three times a day for about 30 seconds, and it will make your own natural tears. So, no more bottles to squeeze. No more drops to mess up your makeup. A simple ... you'll put this up your nose, it will actually touch the trigeminal nerve within the nose, and that will cause it to produce your natural tears from the lacrimal and meibomian glands.

MARGUERITE: John, what do you say to Mrs. Smith?

JOHN: Mrs. Smith, you know, you've got dryness, and we've been battling it with kind of conventional means. But there's a new device that's approved, and I think that it might be able to help you. So let me tell you about it, and keep an open mind, because it sounds really goofy at first. This is a little device that actually goes up your nose and has two little electrical stimulating currents that provide neurostimulation.

That stimulates the nerves that cause tearing. Just like if you got punched in the nose, and you wanted to tear, this does this in a much more controlled way with different levels. The nice thing is I've seen dramatic responses from folks that didn't have anything else that could work for them.

So, I think that we should give it a try here in clinic. What do you think?

MARGUERITE: I would love that Dr. Berdahl, so what do we do next? What's the next step?

JOHN: So, let's go get one, and let's see how it works for you. Then I come back into the room, and we try it, and when we try it, then she says, "Oh, wow," and she gets tearing that occurs. I say, "Okay, now the next step is to take it home."

MARGUERITE: Let’s continue talking to Mrs. Smith.

Dr. Yeu, I see that in your hand. How far up my nose do I put this thing?

ELIZABETH: As you can see here, I myself, I can demonstrate it for you, but I will also have Alexia sit with you and if you are interested, this is going to be like about a 10-minute educational process. It does take a few tries to really know exactly where to place it. It does not go too far, but it is kind of up and forward. You will know, because it's almost like a tickle.

MARGUERITE: Can I use it as much as I want?

ELIZABETH: Absolutely. It can be ... there are patients who use it upwards of 10 times a day. With each setting, you'll probably not need it more than 5 to 10 seconds at a time. You will feel the tears actually being made, and it's not an uncomfortable tear now, this is very different from when you get like a burst of air, or if you, let's say, take in too much wasabi and you get that tearing that also causes the burning. This is not like that at all. It will help to, and you will feel, almost immediately, that your symptoms are also improved after the utilization and that's what the studies have shown that the symptoms and the signs of dry eye very readily do improve with the use of this device.

MARGUERITE: Is it going to hurt?

PATTI: No, actually, gosh it's just like a tickle. We tell patients often, if you've ever stuck a 9-volt battery to the end of your tongue, which we all did as kids, it's almost like a little stimulation. And it's not painful at all. There's five levels of effectiveness that you can use; we suggest most people start with one or two. If you want to go stronger, you simply push a button, and you make it stronger. We've seen people use a level as high as five. Me personally, I think two is plenty.

MARGUERITE: Well, my sister has dry eyes too, but she broke her nose when she was 16. Will she be able to use it?

ELIZABETH: That's a great question, and it kind of depends. If the structures of her nose and the passageway of her nose are relatively open and normal, and if the sensation is relatively normal, then absolutely. It may be that we have to take a look and have that evaluated first to make sure that the actual passageway can support it, but the device itself, as you can see here, is a very thin pronged device. There are concerns about what these side effects or complications could be. The great news is, there are really none. It can be irritating, and it may make you sneeze, but in terms of burn, like a mucosal burn of the inner lining or something like that, that is not going to happen. There have been reports, very rarely, where there's like light spotting, but again, this is not something that is going to cause a thermal damage or damage to the inner lining of the nasal passageways.

PATTI: You know some of the contraindications are patients who've had a lot of nasal surgery. Patients with pacemakers are not ideal patients. So in the consenting process and the informed consent process, we obviously credential the patients to make sure that they are candidates. We use a consent process because we want to emphasize that to patients, because you can only assume that this would be naturally and inquisitive item to have at home, where your family and friends would want to try it. And the last thing we would want is for a family member to take that home and have grandma with a pacemaker use it. Right?

MARGUERITE: Yes. Smart. Do you find that some patients overproduce, like women who suddenly have smearing makeup?

PATTI: No. We haven't seen that at all. You don't get the effect of reflex tearing where it's running down your cheeks. It just fills the eye with tears, nice thick tears.

MARGUERITE: And is this covered by insurance?

JOHN: It's not reimbursed by insurance yet. We talk about the cost, but I also say, if this isn't working for you within the first 30 days, you're able to return it. And that's really a nice thing for patients.

MARGUERITE: That really is. Do you find that some people do return it, or do most people keep it?

JOHN: We haven’t yet. We have not had people returning them yet.

PATTI: If you're a Medicare patient or a government insurance plan right now, the pricing's $1,000. That's for the unit and the first 30 day supply of tips. The tips are disposable, so they're good for 24 hours each, and that's because there's a silicone tip on it that will ... well, I think it's silicone ... but it's a tip that will erode over the 24 hours. So we need to change that for sterility and for effectiveness.

ELIZABETH: With commercial insurances, the base unit will end up being about $200, and then every month it's roughly $50 for the disposable tips. So, the insurance company definitely takes care of the majority of that.

MARGUERITE: Have you found anyone who develops tachyphylaxis, where over time, they're just not getting the same effect?

PATTI: Not yet. We haven't. We know we've had the devices in our practice since May. We've had two patients return the device, and they return them to Allergan. One was a ... she specifically could not get over the fact that she had to put it up her nose. It had nothing to do with the device. And the other patient, it was ... she didn't even open the box. She felt like she couldn't get past the thought process. So we've had no one with an adverse effect, or a dissatisfaction with the effect of the actual unit.

MARGUERITE: Patti, at the moment, I think Allergan has two separate business models for doctors who want to sell it out of their practice and for those who don't. Can you explain that a little bit?

PATTI: Yes. We chose to do the model where we could sell it straight out of our practice. So we order devices and we order tips, and we keep them on inventory and for that there's a profit margin you can make by doing it that way. If you don't want to have the inventory, and you don't want to handle keeping track of it and the expense of the overhead, then you can just enroll the patient online. Allergan will contact them, and Allergan will make the transaction with the actual patients themselves.

ELIZABETH: Sowe, just because of how many locations we have and that it can be a little bit more difficult right now to track, since we're just getting started with it over the last month and a half, we've opted to utilize their specialty pharmacy, we submit everything to them, allow them to act as the insurance, and they take care of all of it, including the payment from the patient, etc.

MARGUERITE: That sounds like almost exactly what we've decided to do, and maybe in the future we can revisit it and go back and start stocking it, etc.

JOHN: We're starting by selling it out of our practice because we want to learn as much about the process as possible. It provides a small but real revenue stream for the people that are teaching them how to use it. And so, I think that that, and combined with the fact that we want to control all of the process and see where this is going to fit in, that allows us to really keep our finger on the pulse. If it turns out that the rigmarole of doing it through our clinic is too much, then we go to the online approach.

MARGUERITE: It’s nice to have options. And now I’m going to exercise my option to conclude this episode of Informed Consent: Getting to Yes. I’d like to thank my guests and invite them to come back to discuss another topic: Patti Barkey…

PATTI: I would love to. Thank you.

MARGUERITE: Dr. John Berdahl...

JOHN: See you later.

MARGUERITE: And Dr. Elizabeth Yeu.

ELIZABETH: /// Thanks, Marguerite. I look forward to seeing you soon.

MARGUERITE: And, as always, thanks to our listeners. I hope you will join us again next time.

Speaker 1: Informed Consent, Getting to Yes, is editorially independent content supported with advertising by Alcon.

11/29/2017 | 15:32

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