Speaker 1:

Gary Wörtz, MD:

Dr. Wörtz: Ophthalmology off the Grid is supported by Centurion from Alcon.

Open. Outspoken. It’s Ophthalmology off the Grid, an honest look at controversial topics in the field. I’m Gary Wörtz.

By the year 2020, presbyopia will affect 2 billion people worldwide, presenting a unique challenge to eye care providers. In this episode of Ophthalmology off the Grid, Dr. George Waring IV discusses the enormous opportunity to help those with this ubiquitous condition and shares insight into how he currently educates and treats presbyopic patients. Tune in for this State of the Union: Presbyopia Edition.

Today we have with us Dr. George Waring IV, a great surgeon and probably even better friend of mine from South Carolina. George is going to be talking to us today about presbyopia. Actually, this is kind of the State of the Union Address for presbyopia, and I couldn’t think of a better person to talk to than George Waring, someone who’s really been crafting this micro-subspecialty of presbyopia correction, not only lens-based but looking at a lot of different technologies that are going to help patients who have lost their near vision and are frankly quite disturbed by that.

George, without further adieu, thank you for coming on the program today, and I’d love to get your thoughts on where things are now and maybe where things are going.

George O. Waring IV, MD, FACS: Hey Gary, it’s great to be here and thanks for the opportunity to speak. Love the format, and I think this is just great. The opportunity with presbyopia is a big one. When we think about this in terms of how many people can we help this, we want to think in terms of demographics. Simply 2 billion people will be presbyopic in 4 years worldwide. In the year 2020, there are going to be 2.1 billion presbyopes, and everybody’s got two eyes. That’s 4 billion eyes that we can help.

In terms of opportunity to help people, it’s big. Everybody knows this is a ubiquitous disorder. When we speak to industry about where are the opportunities, you want to think about areas of need. Macular degeneration, dry eye, cataracts, have all been an important part of the ophthalmic industry for all the great reasons but presbyopia has gained a lot of traction in the last few years in terms of interest. Mostly because this is a real issue.

Gary: No, you’re exactly right. It’s interesting that, as ophthalmologists, as we were probably both going through training, the first ReStor lens came out, and I think ReZoom was kind of coming out around the same time. It really was this sort of novelty and, in my residency, wasn’t really looked upon with tremendous favor. It wasn’t looked upon as this is the Holy Grail, but it was something that was very interesting to me because, exactly as you stated, the opportunity to help people in our industry, there’s probably no greater opportunity in terms of numbers and desire than patients who have presbyopia.

I can’t tell you the number of times I’ve had either friends or new patients frankly call in a panic and almost demand to be seen immediately. You get the chart from the technician and they’re plano and they are J3 or J4, and you walk in and you’re kind of scratching your head but you know what the conversation is going to be. It’s that they’ve just realized that they’re presbyopic. I’m sure you’ve had those exact same interactions. It’s really that first sign that people are no longer as young as they may look or feel, and it’s sort of grappling with the idea that they’re facing some changes that are age-related and that can really throw people off, don’t you think?

George: Yeah, absolutely—particularly in patients that are hyperopic. It’s funny, it’s hard for people to truly understand how debilitating presbyopia can be, and, as you just described well, we have countless patients that come in truly desperate because something’s changed and now they can’t see anymore. This is a disturbing process for a subset of patients that truly feel that they’re visually debilitated. This is something that my feeling is that we owe it to our patients to show them the opportunities to, whether it’s surgery or not, how we can help them.

It’s just really interesting because there are so many things we can do now. We’ve kind of developed this algorithm for the treatment of presbyopia. In the past, it really was historically monovision, and actually that’s still the most widely used procedure to address presbyopia, is still monovision. We’ve mapped out all the different ways we can help patients, and it’s quite sophisticated now. When I compare it to other subspecialties that require fellowship training, I think glaucoma’s a great example and there’s more and more now with minimally invasive glaucoma surgery, more and more are our options, but there’s just as many options for the correction of presbyopia.

Gary: Like we’ve stated, the correction of presbyopia does not seem like it’s a foundational element that’s stressed in residency and, for a number of years, if a patient was 20/20 at distance after cataract surgery, for example, I really just felt like I did the patient the hugest favor. It wasn’t until a patient held their hands about 12 inches or 14 inches from their face and said, “You know Doc, I can’t see. Why can’t I see?” I tried to explain to them what a tremendous job I just did with their cataract surgery, now they can see off in the distance and they don’t have to drive with glasses and they said, “No, but I can’t see.” To the patient, this is a former myope, someone who was used to taking their glasses off to read, their definition of seeing was different than my definition of seeing.

The reality is, sometimes as ophthalmologists we like to put people in boxes. We like to push the easy button, and, with presbyopia, it sounds like with your algorithm you’re trying to develop a new, maybe a dashboard of easy buttons for patients who want to see differently and really going through that learning phase so that you can help guys like me and guys who are perhaps around the country, really trying to figure out the right solution for different subsets of patients.

George, with that being said, walk me through your approach to a patient who comes in, and there’s probably different subsets of patients, so walk me through what you would do with someone who’s maybe just hit presbyopia—maybe they’re in their early 40s and how that approach might be different than someone who’s in their middle 50s, and then maybe someone who’s a true cataract patient down the road in their 60s.

George: You frame that perfectly because that’s the clinically relevant scenarios that we deal with on a day-to-day basis. It’s really, there are two primary considerations. One is that of educating your patients on what their best options are and the other is surgical decision-making or just clinical decision-making in the management of presbyopia. They really go hand in hand. To that end, we help describe essentially a syndrome of the aging crystalline lens that is called the dysfunctional lens syndrome.

We felt like there was a real need for better understanding and characterizing these aging changes for multiple reasons. About a decade ago, when we were doing LASIK routinely for presbyopes in their late 50s, early 60s and then something was happening on a regular basis in that they were coming back 5 years later, tugging at your coat saying, “Hey Doc, my LASIK wore off.” Well, we know that wasn’t the case because we look under the slit lamp and see that their lens had changed, and then we performed a lens-based procedure. It was during my fellowship that Dan Durrie and Jason Stahl and I sat down, and we came up with concept of taking … Harvey Carter had referenced a lens as being dysfunctional, and we said it is dysfunctional but it’s syndromatic.

There’s a syndrome of these dysfunctionalities that occur through someone’s life with the internal lens, and the first stage of it is presbyopia. The second stage is worsened presbyopia, but now we’re starting to lose some clarity in the internal lens, and then the third stage is when that clarity is lost so much and there’s so much opacity that it’s affecting someone’s daily activities that would warrant an insurance-based procedure, ie, cataract. The aim in this was to, number one, help us better understand how to educate our patients on, does it make more sense to operate on the outside lens, the cornea, or the internal lens, the crystalline lens, and to help ourselves and others make better decisions for intrinsic surgical decision-making on which lens to operate on.

Gary: That makes a lot of sense. We always need to think about the risks and benefits of every procedure and how it’s going to ultimately impact the patient. You really don’t want to do a procedure on someone in, for example, 2016 and then turn around in 2018 and realize that maybe you had recommended the wrong procedure, and now you’ve got to do a more invasive procedure like a lensectomy or a cataract surgery.

Again, when you’re thinking about the early presbyope, I think maybe that’s an easier conversation, although with the inlays that conversation has really gotten a little bit more interesting. For a long time, I would tell my patients, “Let’s do a monovision contact lens trial, and if you like that then we can perhaps operate on one eye if you’re a plano presbyope or both eyes if not.” That was sort of my algorithm, my go-to. We’re going to see if you can tolerate monovision. If you like it, we can make it permanent.”

Now with the advent of an inlay, that conversation is actually really changing. I just spoke to our mutual friend Bill Wiley and Jim Mazzo at a dinner recently, and Bill is a guy who I think we both very much respect his opinion. He’s definitely a thought leader in this space as well as you are, being the medical monitor on a lot of the trials. This seems like a technology that’s really gaining some traction, so how is your conversation changed with your early presbyopes, maybe now the advent of inlays, or how do you think it’s going to be changing moving forward?

George: This fits into the category of stage 1 dysfunctional lens syndrome. Now, as you alluded to, it’s not just monovision anymore, although monovision still has a place in our practice. This is really a corneal-based procedure or even drops in some cases. There are drops for nonsurgical treatment that are actually proving to be effective as well. That is for somebody like myself who is just on the precipice of just becoming symptomatic; drops make a lot of sense. Then, if that becomes more manifest, then we start thinking about a corneal-based solution because the internal lens is still clear but it’s just not focusing as well as it used to. Then a surgical intervention may become warranted. We use advanced diagnostics to show that the internal lens is clear and then that gives us the confidence and the patient the confidence to move forward with a corneal-based procedure.

Inlays, as you’ve alluded, to gain traction as a kind of top opportunity for corneal-based solution. There are five corneal inlays for the surgical correction of presbyopia going through various stages of development and clinical trials. Recently there was a big win for ophthalmologists in the US. Last April, the Kamra inlay was approved by the FDA for the surgical correction of presbyopia. Now, we have advanced technology for stage 1 dysfunctional lens syndrome correction. You kind of think of this like a premium procedure for the cornea-based solution.

Why? Because this is a technology that’s relatively straightforward, where we implant a small-aperture corneal inlay that’s been shown to be safe and effective in clinical trials into the, classically the nondominant eye, and it does something that monovision can’t do. It gives you distance vision, intermediate vision, and near in the nondominant eye, so you have a true through focus, which is how small aperture technology works. It’s very, very different than a set focal point at near in the nondominant eye because patients are more functional overall, but there are subtleties to it that are very real, ie, you retain stereo acuity when you retain binocularity, and that’s been also published in the peer-review literature.

Furthermore, it is resistant to the aging progression of presbyopia in that you’re not losing that near point over time because of the through focus so when you look over time you’re not losing, even though internally you’re losing accommodation. The small aperture is resistant to that and continues to provide that through focus.

Lastly, it fits really nicely into when the lens does go onto the different stages, into stage 2 and/or stage 3, and you perform a lens-based procedure. You can put in a monofocal lens and create a beautiful optical system that still gives you depth of focus and utilize the small aperture in the cornea.

Gary: One thing that Bill mentioned to me, and this really makes sense because you’re really talking about a hyperfocality when you’re talking about a small aperture, you’re elongating the depth of focus, the depth of field. What Bill is doing, and I’d love to hear your commentary on this, he’s actually not going for a plano or even a -0.25 D or -0.50 D. He’s actually shooting for about a -0.75 D in the eye he’s going to put the Kamra in and obviously trying to get plano in the other eye, either through refractive surgery or some patients are lucky enough to be pretty close to plano.

That really made sense to me because, if you’re looking at a -0.75 D, for example, you’re really elongating the depth of field in both directions, so you’re going to actually improve the distance vision so that you’re getting great distance vision, but you’re also not working so hard to get that near vision. That really was something that resonated with me.

In your experience, being a medical monitor for the Kamra, what are your thoughts on being a little bit closer to maybe a -0.50 D, -0.75 D in the eye you’re going to put the Kamra in?

George: First let me just clarify, I served as the world surgical monitor for a number of years, where we actually looked carefully at these endpoints. I’m sorry, I wasn’t the medical monitor; I was world surgical monitor. It was in the commercialization of this outside the United States and the studies that we did outside the United States that we identified the improvement in outcomes if we went for a little bit of myopia in the inlay eye. This work really was done at the Shinagawa Clinic in Tokyo, where the vast majority of these inlays were put in in Japan over the last number of years, where we could learn how to optimize the procedures. We carried out a number of clinical trials there and published most of these results.

Think of it a little bit like shifting your A-constant with an IOL. I think that’s the best way to think about it. Now that we’ve got a new optical paradigm of small-aperture technology, it performs differently than diffractive optics or spherical aberration induction and other ways that we can improve depth of focus. The small-aperture technology is very forgiving in that even though you have some defocus, you may actually give up a line or a few letters of distance to a degree, but you gain a lot of near. You can actually push it a little bit more to the minus side or a little bit more on the plus side, but the happy medium where you really did not give up distance but gained near was about -0.75 D. Again, that’s because of the pinhole effect. Just like an aperture F-stop in your camera, hence the name.

It’s a recommendation through the teaching, and when we taught doctors how to do this all over the world, that’s the recommendation from the company is -0.75 D, and that’s been the teachings in the United States commercial rollout since FDA approval as well.

Gary: Excellent. I think we see where the Kamra fits into the armamentarium—really feels earlier presbyopes or sort of the phase 1, category 1, dysfunctional lens syndrome. Let’s move into category 2. These are the patients who are coming in and are really having a little bit more lenticular issues but not quite a cataract that would be considered ready for surgery based on insurance criteria. Walk me though your conversation you have with a patient who’s coming, maybe coming in for a LASIK evaluation because they recognize something is not quite right. They want to see better without glasses and then all of a sudden the conversation becomes different than maybe what they were expecting.

George: That is said so well. This used to be the most difficult conversation we had with patients, and this really was one of the most difficult consultations that we used to have in general—the 60-year-old presbyope coming in for LASIK to get out of their bifocals. We now in our center, Gary, we have what we call an Advanced Ocular Analysis Center. It’s an all-digital analysis center that the patients kind of go through a digital track, and we image their internal lens. It’s a dedicated digital lens analysis where we’re looking at functional imaging as well as objective measurements. To look at the quality of their lens, the clarity, and we can actually capture the light scatter with technology like the double-pass wavefront by Visiometrics—this is distributed by AcuFocus as the AcuTarget HD—a very important advanced functional diagnostic test that shows us quality of vision in light scattering ways that we could never see it.

We’ll couple that with things like densitometry, taking a picture of the internal lens, and we will take a patient on a tour of their eye. We can actually show them instead of using animation, we’ll actually show them the different lenses in their eye. We’ll show them how they’re functioning by showing them the light scatter coming from the different sources. We’ll assign a score to their vision. Herman Snellen described Snellen visual acuity in the 1800s, and so things have changed. We know that there’s good quality 20/20 and bad quality 20/20.

Once we make a determination that this patient would be better served and we explain to the patient that their dysfunctionality has progressed and now is at a stage 2 dysfunctional lens syndrome, the first thing I say once their eyes get big because they look scared is, “Guess what. It’s okay. Congratulations, you’re normal, normal for your age.” I say, “By the way, you don’t have to do anything. There’s nothing worrisome about this. It’s just part of aging.” We don’t want anybody to feel scared and that feeling like they have to have a procedure, but remember, they came to you for surgery to get out of glasses.

Gary: Right. They came for a solution. They came seeking an answer.

George: They came for LASIK. In the past, when I said well, it makes more sense to do a lens exchange instead of LASIK, they’d walk out thinking that this was crazy talk. They want to operate on the inside my eye and take out my lens. Now the conversation is changed. When I explain to them, I showed them the dysfunctionality, I showed them the point-spread function of light falling on their retina with double-pass wavefront with the Visiometrics device. When I then say, “Oh and guess what, there’s one other big benefit here that this also can prevent you from going on to have cataracts.” Then that’s when the bells go off for the patient.

Gary: I think that’s a really huge benefit because especially if somebody’s going to be investing in advanced technology, the longer they’re alive to utilize it, the more value they’ve actually given themselves. I think that’s a conversation. When I talk to patients about their choices for upgrading their vision, upgrading to a premium lens, whether that’s a toric or whether that’s multifocal, my one thing I leave them with is I say, “Investing in your vision is the one investment you’re guaranteed to use for every moment you’re awake the rest of your life.”

When you think about that, what’s that worth on a daily basis to someone—$1, $3, $20? The value that you provide is always way more than the price that we charge no matter you’re charging. I think we don’t always recognize that but especially in those younger patients, they’ve got a long time to live and a long time to take advantage of the technology they’re investing in.

George: I totally agree. I actually have a degree in economics, and we’ve studied this concept that was new at the time, of passive use value. It was trying to assign a value to something that really you can’t assign a value to. These are things that are very difficult to quantify, and it’s a perfect example of the value that you can add to somebody’s life and lifestyle, make really a wonderful change.

The neat part of this conversation too, Gary, is that now we have access to femtosecond lasers for lens surgery. These patients—and it’s not just that they’re coming in for LASIK—they’re coming in for laser vision correction. I just kind of put it in their terms when I’m taking them on their digital tour of their eye. I point to their cornea on the big screen, and I’ll say, “In the past, if you’d come in 15 years ago, 10 years ago, we would have done laser here and that’s what you came in thinking about, but now we do laser here,” and I’ll point to their internal lens, that’s now dysfunctional, stage 2 dysfunctionality, and so we can do laser on both levels. And then, “Guess what. By the way, this is permanent. It can also prevent cataracts. You won’t need another procedure. If we did LASIK, we would need to do another procedure here in the future.”

Now the conversation is completely flipped to the point where I actually can’t talk a patient out of it, and I have to be a little careful because if a patient has stage 1 and LASIK is indicated and if I start talking about stage 2 …

Gary: … they’re going to want to jump.

George: Right. I think it’s actually safer for them and less expensive and makes more sense to actually have LASIK or an inlay, and so, at the end of the day, we’ve got to be mindful in not giving them too much information and keep them focused. It’s just been wonderfully effective, and, in the ophthalmic community, I think there’s been some low controversy around using the term dysfunctional because of the worry about patients getting concerned, but it’s like all other things in medicine. There’s a responsibility that we reassure our patients. We help them make the best decisions. We do what’s best for them, but ultimately these patients are coming in for surgical correction, and my strong feeling on this is that if they have a stage 2 dysfunctional lens, or whatever you want to call it, you’re doing them a disservice by performing LASIK on them, then bringing them back and doing a second surgery in the future, where they may actually have limited selection for IOLs at that time or are more difficult to hit their target or whatever.

There were close to 30 papers and courses on dysfunctional lens syndrome this year at ASCRS, and we were fortunate to get the Best Paper of the Session for their grading scale that we just discussed for a paper at ASCRS this year in New Orleans.

Gary: That’s very well deserved, George. You’ve really been the champion for this, and, to be honest, it’s made my conversation with patients so much easier, basically leaning on the tips and pearls that you’ve passed along to me in conversations like this but in different formats. I think, to be honest, we basically just conceded defeat or accepted failure treating presbyopia in the past to the point that we really just lowered the bar for ourselves as ophthalmologists in terms of what we considered to be appropriate care or successful treatment.

With the new technology, as things have advanced like what you’ve mentioned, the Visiometrics technology with the double-pass wavefront, looking at scatter, looking at the dysfunctional lens index, for example, and the iTrace machine, which I found to be very helpful, looking at other things like internal opacities—these are all things that ophthalmologists in the past didn’t have access to, and, therefore, it made those conversations a little bit more grey. It wasn’t quite as black-and-white. We have so much better technology now, and we also have better solutions with better multifocal lenses, and I think better solutions are coming down the road.

To be honest, I’m so happy with the AMO Tecnis ZKBOO, their low add. I really feel like we now finally have multifocal lenses that will live up to the hype. I don’t hesitate offering that to patients who are in this category, and I really do feel like they can live up to the hype.

I want to thank you for the work you’ve done in not only figuring out the diagnostics but helping shape the conversation. It’s made it much easier for doctors like myself taking care of patients who are in this category.

George: Gary, thanks so much. I think, at the end of the day, it’s the data number one and, number two, it’s doing what’s best for our patients. For years, to patients, we basically said, “Well, it’s okay. You’ve got a pre-cataract. It’s not ripe enough to do anything,” so they would wait for a decade and wear their glasses and not see great and not do anything. When they’re coming to you asking for help and we can improve their quality of vision and reduce their dependence on spectacles like they’re asking for, this whole dismissive concept of a pre-cataract just really did not make sense in terms of what we feel is best for the patient.

That’s, again, where the concept of dysfunctional lens syndrome came into play. We set forth to try to build a database to show that this works, and we’ve been able to show and we presented this in numerous abstracts that we can improve quality of vision with dysfunctional lens replacement or refractive lens exchange because these are not clear lenses. This is not clear lensectomy. These are not cataracts. These are not patients that have their daily activities affected.

Compared to LASIK, we’re able to improve quality of vision and still meet the primary objectives of reducing their dependence on glasses, but now we’re improving visual performance and we can measure this subjectively with image quality on the retina in ways that we’ve never been able to think about before. The conversation is evolving, and we sure appreciate the interest and the opportunity to talk about this exciting new sub-subspecialty. We’re actually looking at starting a fellowship in the surgical correction of presbyopia.

Gary: When you start that fellowship, please send me an application. I would love to learn from you, to be honest. It would be an incredible experience.

Listen, George, with that being, said I think the State of the Union is very, very bright for presbyopia correction. I think that, going forward, we’re going to have even more options for all the stages of presbyopia, and maybe we can have another conversation next year and do this on an annual basis where we sort of go through what’s new and what’s coming. How does that sound?

George: That sounds fabulous, particularly with the extended depth of focus lenses that are just around the corner. That’s going to take this to a whole other level, where the contrast is not being sacrificed and the visual performance is enhanced at all different distances. I think we just have so much to look forward to. I totally agree with your assessment that the future is very bright for what we’re doing and helping our patients.

Gary: Awesome, George. Thank you so much for talking to me today about presbyopia. This has been Dr. Gary Wörtz for Ophthalmology off the Grid. Thank you.

Thanks for listening to this episode of Ophthalmology off the Grid. Send us your thoughts on this episode by tweeting @Eyetubenet or emailing us at ootg@bmctoday.com. Until next time …

Speaker 1: Ophthalmology off the Grid is supported by Centurion from Alcon.