Informed Consent
Episode 6

How to Approach Patients Regarding Inlays

Marguerite McDonald, MD, invites Stephen D. Klyce, PhD, to describe the physiology and history of corneal inlays. Gregory Parkhurst, MD, and William Wiley, MD, also share their experiences with inlays and discuss how they educate patients when making a recommendation for this technology. Drs. Parkhurst and Wiley further describe the ideal candidates for inlays and how they approach this procedure.

ANNOUNCER: Informed Consent: Getting to Yes is editorially independent content supported with advertising by Abbott.

MARGUERITE: Welcome to another episode of our podcast, Informed Consent: Getting to Yes. I’m your host, Marguerite McDonald of the Ophthalmic Consultants of Long Island, in Lynbrook, New York.

RANNA: And I’m Ranna Jaraha of EyewireTV.

MARGUERITE: On this podcast we talk to leading ocular surgeons about the specific words they use to honestly and ethically get patients to recognize the value of new technologies in cataract surgery and say yes to making an investment in their vision.

RANNA: Today we’re going to be talking about corneal inlays with three leading ocular surgeons. We expect to cover a lot of information about how our guests use inlays, but the focus is always on the words they use with patients to make their recommendations.

MARGUERITE: So, with that being said, I’d like to introduce our guests. First is Greg Parkhurst, MD, who is the founder of Parkhurst NuVision in San Antonio, Texas and President of the Refractive Surgery Alliance.

GREG: Thank you so much Marguerite for inviting me to participate. This is an exciting series that you're doing and we appreciate it.

MARGUERITE: Thanks, Greg. It’s our pleasure. Next is Dr. Bill Wiley, the Medical Director of the Cleveland Eye Clinic. Thank you so much for taking the time once again.

RANNA: Your perspective on ORA was great, so thanks for talking with us about inlays.

BILL: Thank you. Thanks for having me.

MARGUERITE: And our third guest is Dr. Stephen D. Klyce.

RANNA: That’s Dr. Klyce, PhD, not MD.

MARGUERITE: Correct. Steve isAdjunct Professor of Ophthalmology at Mount Sinai University, the Medical School in New York. His specialty is physiology of the eye.

STEVE: Well, thanks, it's a pleasure to be here Marguerite.

RANNA: Marguerite, why don’t we start with Dr. Klyce and get a little history and an explanation of inlay physiology?

MARGUERITE: That’s a good idea. Steve, why don’t you tell us a little bit about why the inlays we have now are successful compared to all those that have failed in the past?

STEVE: There is quite a long history. In fact, you were involved in one of the first inlay experiments in humans. Physiologically, one of the most important aspects that inlays have to deal with is nutrition of the cornea. Most inlays are fairly impermeable. There implanted fairly deep within the corneal stroma. As long as they’re permeable enough to allow nutrients to pass through, then they seem to be very well tolerated by the cornea for basically for years and years.

MARGUERITE: The two types, the kind that have an aperture versus the kind that change the interior corneal curvature, what are your thoughts?

STEVE: Well, in terms of physiology, each of those two types of inlays solve the problem of nutrition in different ways. The Acufocus inlay has a large, 1.6-millimeter hole in the center. Obviously, that allows nutrition as well as light to pass through and because the skirt for the surround of the inlay is impermeable to nutrition, there is actually a multitude of holes that are randomly placed though the material. That's how that particular inlay solves the problem in nutrition.

Other inlays don't have holes so they change the shape of the cornea where they have a refractive power built in to them. They are either very thin or very permeable to allow this nutrition to occur so that they can be sustained for many, many years.

MARGUERITE: Dr. Greg Parkhurst, what has been your experience with inlays?

GREG: I've been involved in some of the FDA clinical trials with the inlays for about five years now. As you know, the KAMRA inlay was approved by the FDA about two years ago whereas the Raindrop inlay was the second corneal inlay to get approval going on about eight or nine months ago now. These are two relatively new procedures to our mix to help our patients. The way that I present basically all vision correction procedures, whether it be Lasik or inlays or lens-based refractive surgery, I'm basically always trying to get to the bottom of what the patient's issue is and what their need is.

MARGUERITE: Bill Wiley, same question to you—your experience with inlays?

BILL: Sure. So we started with inlays with the Presbia Trial, through the FDA trial, and we've enrolled about 38 patients in the Presbia Trial. That kind of sparked the whole inlay mindset for our practice. We saw some great results. We saw very happy patients and so, soon after we had experience with Presbia, KAMRA was released, commercially in the U.S. Since then, we've had a great result with KAMRA as well. Then more recently, Raindrop has been released and we've got some early experience with that. Not quite as broad as we have with KAMRA, but we're excited about that technology.

MARGUERITE: So Presbia, as of this taping today, is not yet available in the U.S., but you have the two others.

BILL: Correct.

MARGUERITE: So now let’s talk about the type of patients you’re getting who might be candidates for inlays, or even those who came in looking for them. Greg?

GREG: It's interesting to me that still most people out there, if you ask them, "What does vision correction mean?" They typically just go straight to the word 'Lasik.' There are so many myths out there about what Lasik can and cannot do, but I'd say one of the biggest ones is people think that Lasik wears off. The reason they think that primarily is because of presbyopia. For the first time now, we have a couple of procedures with the FDA indication of treatment of presbyopia. It's a really exciting time to be able to talk to our community and talk to our patients to let them know that we do have options. In many cases, it's to their surprise and to their delight. Just getting the message out to the community that something exists to get rid of reading glasses or reduce the need for reading glasses has been a major benefit in terms of bringing patients into the practice to look at the set of procedures that we have.

We approach vision correction in the overall context of the three milestones of vision development, the first one being ocular maturity, the second one being presbyopia, and the third one being cataracts. We talk to every patient who comes in, whether they're a 25-year-old patient seeking laser vision correction or a 55-year-old seeking solutions for presbyopia, we let them know about these milestones. One of the biggest reasons we do that is to emphasize and to educate around this presbyopic condition that a lot of our patients just don't understand or don't know about. They definitely don't realize that there are surgical solutions to it. Once we educate the patients about what their problem is and listen to what their pain points are, we can then start to fit the procedure to them.

The way that we approach our presbyopic refractive surgery patients is actually to ... Well first of all, check what their refraction is. Second of all, do scans of their anatomy. Looking at corneal topography, similar to how we would with any laser vision correction patient. We also use the AcuTarget HD scan, specifically looking at the optical scatter index to determine what the clarity of the crystalline lens is. For patients that have clear crystalline lenses and good OSI scores, this is a group of folks that we start talking with about corneal inlays.

MARGUERITE: Do you find with the increased awareness in your region that you're actually getting older cataract patients who had surgery, phaco, years ago who would now like to have an inlay? Has that happened?

GREG: We have seen some of that, but really the biggest group that's been coming in are the 40s and 50s. They're people who've been thinking about refractive surgery for awhile, but they've put it off because they've always been under the impression that, "Oh, I'm just trading my distance glasses for my reading glasses." Once the community is educated that that is not true, that there is a solution for both near and far vision, we're finding that those patients in their 40s and 50s are coming in that probably weren't before. For those patients oftentimes in their late 50s or early 60s, we're in many cases finding that they've got early lens changes, which is showing light scatter. In many cases, those patients are adopting a refractive lensectomy. In those patients that have perfectly clear media and excellent or minimal optical scatter, we're discussing corneal inlay approaches with them.

MARGUERITE: Let’s talk about how you decide between the two currently approved inlays, KAMRA and Raindrop. Bill?

BILL: Sure. It's interesting, in general we try not to market or discuss individual technologies. We like to discuss outcomes. It's interesting, we sort of fell in the trap when it was first Kamra, we got used to talking about Kamra and then Raindrop was released. They did a great job with PR and patients came in looking for the Raindrop and maybe they weren't a candidate for that. We had to sort of change gears or change mindsets and put them back into maybe another technology. So in general, we'd like to discuss inlays as a broad topic and then, individually, try to choose which inlay fits that patient's needs best. What we found is, we started using Kamra as almost like a LASIK upgrade, that many of the patients that are coming in with LASIK, that are presbyopic, maybe have tried mono vision and didn't like it, are not excited about that technology, we offer them inlays, particularly the Kamra inlay in that instance, as sort of an upgrade to LASIK where they can get great distance vision but then at the same time if we place the corneal inlay, it can keep that near vision for them. We've had success with that.

A very similar discussion that we have, with let's say upgrade to cataract surgery, so when patients come with cataract surgery, we can discuss what we can do. The traditional technology and the glasses, probably for distance but definitely for near, or we can do an upgrade where we can, you know, do a presbyopic lens to give distance and near vision. The same sort of mindset occurs with inlays and LASIK. Patients can come in and we say "Okay we can do LASIK, give great distance vision or we can do, you know LASIK plus an inlay and give distance and near vision. Patients seem to latch on to that. A mindset to be having less dependence on glasses and this sort of coattails into that nicely.

MARGUERITE: So you have made the decision beforehand which of the two is most appropriate. So basically, the AcuFocus, the Kamra inlay, if they're headed for LASIK and they're myopic, in particular.

BILL: Correct, correct.

MARGUERITE: Whereas the Raindrop isn't the best match with LASIK because of the alteration in the anterior corneal curvature.

BILL: Correct.

MARGUERITE: So it's much better just on its own?

BILL: Correct.

MARGUERITE: For a low hyperope plano, low hyperope?

BILL: Correct, yeah. We see the sweet spot for Raindrop is somewhere between let's say +1 and plano. More recently we've expanded that to -0.5 if we place the inlay, the Raindrop, a little deeper or if we place it under a pocket, that tends to dampen the effect. So we're comfortable using it in the low myopsis as well but I would say, sort of within the FDA guidelines, under a flap, the sweet spot for Raindrop would be right around +0.75.

GREG: We use both KAMRA as well as Raindrop. With our initial discussion, we don't talk about one versus the other.

RANNA: This is Dr. Greg Parkhurst.

GREG: We've actually designed in our office a really helpful handout or patient education piece that we designed internally. We discuss each of these milestones of vision and then we have all on one sheet the procedures that are applicable to each milestone. In the case of presbyopia, we generally have three options. We've got blended vision or monovision laser refractive surgery, we've got corneal inlays and we've got refractive lens exchange. We present those three surgical options together all as legitimate solutions for presbyopia. Then once we understand the patients' refractive air and their anatomy, we start to narrow down which of those three general approaches is going to be best. Then if it's the case of a corneal inlay, we talk about that generically. If the patient is myopic, we're generally heading them more towards the KAMRA inlay. We can combine with laser vision correction, put in a pocket. For those low hyperopes, those are the ideal Raindrop patients.

MARGUERITE: Steve, as a PhD. scientist you're not often sitting right in front of the patient talking about inlays. But let’s say you have a patient, Mrs. Smith. Put yourself in the position of having to condense all that you know about inlays down into just a few sentences, to explain to Mrs. Smith what you've chosen for her—knowing that she wants to see up close and far away. How would you quickly, but honestly, get her to yes without skipping over the risks and benefits? Pretend I'm Mrs. Smith.

STEVE: Okay, Mrs. Smith, it's good to see you today, I hope you're well. Today we're going to talk a little bit about how we're going to give you better vision. You’re presbyope, that is you’re farsighted hyperope and we need you to use your reading glasses less. It'll enable to see more clearly up close, read the paper and so on. To do that there're a number of alternatives. Two of these include inlays that are placed in your cornea. One has a little pinhole in it that allows you to see very clearly over an extended range of vision. Others have a refractive power that changes the power of your cornea that allow you to also see more clearly close up. There's a difference between the monofocal vision, that is maybe using one contact lens to see clearly and these inlays. The inlays allow you see clearly or fairly clearly over a large range. That is the eye that is corrected for near can also see fairly well at distance, but that’s called multifocality.

MARGUERITE: Are there any risks, Dr. Klyce?

STEVE: These implants have undergone very extensive clinical trails. They're FDA approved and while every surgery has a certain amount of risk, the risk for these devices is very small.

MARGUERITE: I understand you can reverse them? How do you do that?

STEVE: Yeah. As a matter of fact, these implants are actually put under a flap of the cornea and centered and allowed to heal. If, for example, for some reason you don't like the implant, it doesn't give you the kind of vision you were expecting, the implant can always be removed by lifting the flap, taking the implant out and letting the cornea recover.

RANNA: Why don’t we ask the same question of Greg?

MARGUERITE: Greg, let's pretend I'm Mrs. Smith. I've read about inlays. I'm 48. You have selected me. You've looked at my anatomy and you know what my desires are to get rid of readers. What would you say to me in the exam lane?

GREG: Marguerite, I understand it's the reading glasses I see you taking on and off your head right now. That's the issue, right? Most people are telling me they have about 15 pairs of those. There's one in the dashboard. There's one by the computer. The glasses seem to be everywhere except where they need to be when you need them. A lot of my patients are telling me about how they're frustrated with this on/off business, where if they want to look in the distance, they have to take them off. Anything they look at up close, it's like, "Where are my cheaters?" The fact that we actually call them reading glasses I think is in many ways a misnomer because reading glasses implies the only thing we need them for is reading, but the truth of the matter is there's hundreds of things in our near world. Everything from the food on the table to price tags and shopping labels where this problem becomes frustrating.

In the past, we haven't had very many options to fix this. If we did have a surgical option, it meant there was a trade off. We had to trade some distance to get some near and vice versa. With the advent of the corneal inlay procedures, the beauty of it is we don't have the trade-offs anymore. We can help you restore your near vision and you don't have to give up significant distance vision to get that. We've been working with the corneal inlay for a few years now. We've found great results for patients that are hoping to reduce their need for reading glasses. You look like a great candidate for this.

MARGUERITE: Bill, how do you get Mrs. Smith to yes while covering all the bases and risks?

BILL: I'll say "Mrs Smith, you know, for all refractive surgery, there's risks and benefits and some of the risks are infection or inflammation. With inlays, there are some unique risks where there maybe the body doesn't tolerate the inlay and there's a chance of removal. Thankfully, it is easily removed and we've seen the vision recovers back to its preoperative state so it can be advantage. For some reason, if you don't like the vision or if you don't tolerate the vision, we can remove that inlay and go back to your preoperative state." We find that the patients really like that option of removabilty.

MARGUERITE: Does it have to be removed very often doctor?

BILL: Thankfully, in our experiences, the risk of removal is less than two percent.

MARGUERITE: Great. The few that need it removed, how soon afterward do you realize that it has to come out?

BILL: This is a journey that we'll take together and it's very important that you have your follow-ups with me. You follow the postoperative instructions. In particular, if the body is not tolerating the inlay, we need to know about it. So if you have changes in your vision, you need to call and come in. I don't want you just to have the inlay and disappear so it's important that we work together through the postoperative journey. There are other things that we need to work together on. We have to control the eye's surface in the tear film and so we'll be managing that with maybe some artificial tears. Sometimes some prescription strength tears. Sometimes an oral supplement, so we'll work together with that. I don't want you to just think it's in and then I won't see you again. You need to be comfortable with me and I need to be comfortable with you and we'll work together through this.

MARGUERITE: So Dr Wiley, what's going to happen to my distance vision? I know my near vision is going to get a lot better, that's what I want, but what'll happen to my distance vision?

BILL: So with any of the refractive surgery, there are some compromises. Thankfully, for example let's say with LASIK, we tend to deliver great distance vision but sometimes it can compromise near vision. What we see with the inlays, there is a give and take. For example, one inlay that we may choose is called KAMRA. What we see is that it does dim the distance vision. You tend to still maintain a good distance vision on the chart but you'll see things are a little bit more dark that's why we wouldn't recommend it in both eyes, we just do it in the one eye. So I'd love to tell you it's perfect vision for distance, intermediate and near. It's functional but not perfect and there is some compromise. Some patients do notice some glare or halo or nighttime driving symptoms so if you're an airline pilot or a truck driver or a police officer, I'd probably not recommend this is an option for you.

We all do nighttime activities and most of my patients find it reasonable. They might notice a little bit of a glare or halo but in general, that they enjoy that decreased need on glasses. With that said, other things I tell all my patients is, the goal, this is decreased dependence. You may not have complete independence. I don't want to think that is a failure. You know, I myself, I had refractive surgery over twenty years ago, but I still keep a light pair of glasses in my glove box that I sometimes use to drive at night with yet most times I don't need any glasses but I still have that pair if I'm in a situation where need a little bit better vision. Don't look at that as a failure. We want to give you a functional vision, decrease the need for glasses but you still may need them for certain tasks.

MARGUERITE: Continuing my role as Mrs. Smith. How do you perform the procedure, Dr. Parkhurst?

GREG: The corneal inlay procedure is done on the nondominant eye only. It takes about 10 minutes to do. It's an in office procedure. It doesn't hurt. Most patients are finding that they can see better up close within about 24 hours. There's not much downtime with this procedure. In fact most people can go back to work and drive even by the next day. It is really important to use the prescribed eye drops, which we're going to let you know about. There are some that are used and necessary for a couple of months. We also discuss what the expectations are going to be around the early healing period. In the case of the Raindrop inlay, what a lot of people find is that even by the day after, the close-up vision is dramatically improved.

However, the distance away from the eye where you see clearly is going to be different. You've been used to holding things out and stretching your arm to the point where your arm is not long enough anymore, but in fact what you need to do the day after your Raindrop is actually bring things in closer. The near point is often up around maybe even 10, 14 inches away from your eye. What we've found is that people can easily read their text messages and look at even pretty small print within 24 hours. Over time, that near point will shift out to a more comfortable reading distance, like you're used to. In your lap, for example. The postop appointments are important. We see everybody back on one day out, just to make sure that the inlay is positioned where it needs to be and things are healing properly. Then there's another checkup that one week and one month and then three months out.

MARGUERITE: Are there any possible complications or things that could go wrong, Dr. Parkhurst?

GREG: There are. As you know, there's no such thing as any surgical procedure anywhere on the body that comes with zero risks. Corneal inlays are certainly no exception to that. Thankfully, the complications that have been reported in the literature as well as the few that we've seen are primarily able to be treated rather simply. Probably the worst thing that could go wrong with this is if for some reason you were to develop an infection in the first week after healing. It's really important to keep your eyes clean, not to rub them and to use all the prescribed eye drops to prevent that. I've actually not seen that happen in my career to date. One of the things that's unique about corneal inlays is that while we intend to leave this there forever, we intend it to be a permanent solution, it is possible to remove the corneal inlay.

If for whatever reason there's something about the inlay that you don't like, it is possible to remove it and go back to the way you were with reading glasses in the past. That's unique to corneal inlays, which is a significant advantage. Some of the other things that we've seen in terms of risks of corneal inlays include temporary dryness of the eyes, which is typical of most corneal procedures, but like others, it tends to go away after a couple of months. It's rare that this is a long-term complication. Another potential risk of corneal inlays is the potential for the body essentially rejecting the implant and developing an inflammatory reaction or immune response to the inlay.

If we see that, patients often notice their vision becomes a little bit hazy and the first treatment is to use some antiinflammatory medications. In many cases, that'll solve it. However, if inflammation persists, that would be one of the reasons that we might recommend having to remove the inlay. Thankfully, the removal rate has been very low. In published studies, it's only about two percent of the cases that inlays need to be removed or even less.

MARGUERITE: Well I think, Greg, that is an incredibly well balanced explanation to Mrs. Smith. Do you find that you do all of this? Do you do the important parts and let your coordinator do some of it or does the coordinator just repeat it because we know our patients are nervous and they don't remember absolutely everything the first time?

GREG: Well I make it a habit to meet all of my patients and examine them and have pretty extensive discussions with them preoperatively. We talk about all the potential upsides and how great it is to have the freedom of not needing reading glasses anymore. We talk about all those advantages and we talk about different alternatives. In many cases, patients have already experienced the alternatives. The frustrations of reading glasses, the downsides of monovision contact lenses. They're familiar with other solutions. We talk about risks as well. After that long discussion, patients feel pretty comfortable in terms of the opportunity to experience a life of better vision and less dependency on glasses and contact lenses.

MARGUERITE: In your practice, do you find you have more females than males or is it equally split?

GREG: It's been pretty equally split, actually. I haven't looked at that data, but just anecdotally, I don't think that there are more women versus men. It's interesting. One of the things that I find quite common is we're seeing a lot of executives and professionals. What's going on, they'll describe a situation where they're in a boardroom. They're in a situation where they need to look at some sort of spreadsheet or some sort of numbers and process the data quickly in order to make a decision to lead their organization. When they're slowed down by their ability to focus on what they need to see, it's almost as if they're not mentally processing as quickly as they feel they need to be. This can really be a motivator for patients to prove that they've still got it and that their mind is still there. It's just their vision is slowing down. Giving them a solution where they can see fast and think fast and process the information and move their company forward has been a really significant benefit.

MARGUERITE: Well that is fascinating. I mentioned briefly before about people who had phaco years ago. They were corrected for distance in both eyes. You're just beginning to see that patient come in now?

GREG: Yeah, we are. In our center, we're actually enrolling in a clinical trial for that with Raindrop. There's not much published data out on this yet, but the patients we've done have done great actually. In fact, we're now using Raindrop in the corneal pocket. Especially for these patients that are by definition a little bit older and might have a more compromised ocular surface, being able to place the inlay in a pocket rather than under a thicker flap has been advantageous for the ocular surface.

MARGUERITE: Wow.This was wonderful. Your thoughts are very complete and considered Greg.

RANNA: Yes, I learned a lot and I’m sure our listeners did too.

MARGUERITE: Without a doubt—from all our participants. Thank you all so much, from Ranna and myself. I would also like to thank you for listening and to ask you to keep an eye out for the next episode of Informed Consent: Getting to Yes.

6/29/2017 | 29:28

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