SMILE Like You Mean It

John Doane, MD, joins Gary Wörtz, MD, to share his thoughts on the safety and efficacy of small incision lenticule extraction (SMILE). The two surgeons discuss how this procedure compares to LASIK and how to achieve the best outcomes possible when treating patients. Dr. Doane also discusses IOL technology in the current era of refractive cataract surgery.

Gary: Open. Outspoken. It's Ophthalmology off the Grid—An honest look at controversial topics in the field. I'm Gary Wörtz.

Thanks to the recent FDA approval of the VisuMax Laser for treatment of myopia, the team at Zeiss is surely smiling. However, I wanted to get some real-world insights into the SMILE procedure. Will this challenge LASIK for correcting myopia, and where will it fit into our refractive tool belt? Today I sit down with Dr. John Doane to get his opinions about the safety and efficacy of the procedure and how it stacks up against LASIK, and also which patients might respond best to the treatment. If you know John, you know we'll be talking about a host of interesting topics—from IOL technology in the era of refractive cataract surgery, to the question of the holy grail of lenses—and finally we'll wrap up with thoughts on managed care and the so-called skinny networks. Listen in. This is going to be a good one.

Speaker 2: This episode of Ophthalmology off the Grid is supported by Centurion from Alcon.

Gary: This is Dr. Gary Wörtz with Ophthalmology off the Grid, and today I have with me Dr. John Doane from Kansas City. John, I just want to say thanks for spending a little time with us. For those who don't know, give us a little blurb on where you're practicing and the focus of your practice, and then we'll talk a little bit more.

John: Thank you for having me, Gary, pleasure to be here. I am, obviously, in Kansas City as you've mentioned. Been there just starting my 20th year. Let me take that back, It's my 19th year in Kansas City.

Gary: Who's counting?

John: Yes. Fellowship-trained refractive surgery, that's really kind of my love—doing refractive surgery, be it initially at the cornea or now at IOL. That’s kind of everything that drives me, but in doing that I still have a pretty broad practice. I still do transplants, still do posterior transplants, and do just standard cataract surgery as well.

Gary: Excellent. As you have been really passionate about refractive surgery, I know you're really seen the evolution. You've been through, I would assume, the RK days. Did you do much RK back in the day?

John: Yeah, great question. I was right at the precipice of laser vision correction coming to the forefront. During my fellowship, excimer lasers were approved in the US. I started in July in fellowship, and first laser summit was approved in October, and then VISX was approved in March of ‘96. I never had to do RK.

Gary: That's awesome.

John: Yipee yay.

Gary: Yeah. You've been through laser vision correction, it sounds like, from the beginning, and as we've talked over the past few days, in the past also, I know you've had an experience in what may be the next evolution in refractive surgery with the femtosecond laser from Zeiss. Give us a little bit of your experience about the SMILE technique. I'd love to hear why you feel this is a compelling technology, what patients you like to treat with this, and maybe the pros and cons of this versus what we're doing now with LASIK and PRK.

John: Yeah, great question. I think that the paradigm is always going to shift. If there's anything I learned over 20 years, it’s that surgeons, but maybe more importantly patients, will always migrate to a better technology, a better technique. What can be better than LASIK? LASIK right now is fantastic. It's absolutely incredible. Are there are any shortcomings? I would say—you're creating a flap. I love LASIK. I had LASIK on myself. There are some limitations with LASIK. The flap is still an issue. Not that I'm going to be joining the MMA, but anything combative, anything contact-sport wise, people have concerns of that.

For me, where SMILE comes in, if you just look at it, it appears it could be safer because you have, again, a small incision. The structural integrity of cornea essentially remains. That is a huge selling point. Then when you say, "My area of surgery is actually a smaller diameter than LASIK," that means I'm incising fewer corneal nerves. Hey, maybe we can get less dry eye. That, again, seems very appealing. Not just short term, let's say that first 3 to 4 months after lamellar surgery, but what about the rest of the patient's life?

I think that they may be a benefit. Where I really got my socks knocked off with SMILE, is when I looked at the outcomes for the highers. The higher corrections were just as, let's say on target, or as predictable as the lower corrections. I think the reason is, is we're doing the surgery in a vacuum. With excimer laser we have to worry about what happens at the end optical train, the last lens in a corneal surface. Humidity, barometric pressure, particulate matter, temperature, dehydration of the cornea—that's where the higher correction we lose that predictability. We simply don't see that with the higher SMILE corrections.

Gary: You basically have flat dose response, if you will, with SMILE, whether it's a 1.00 D treatment or 10.00 D. The response to the treatment is essentially flat, where you're getting the same predictability. Whereas we know that the higher ends of the spectrum with LASIK really have the potential to fall off.

John: That's exactly right. Then the next question for me was, "Well, can LASIK do as well as," correction, "Can SMILE do as well as LASIK does on, let's say, the 1.00 and 2.00 D." That had to be proven to me, and, in the FDA trial, it was proven to me that they can do just as well.

Gary: You bring up a good point about the flaps. IntraLase and Ziemer, I think, kind of changed the game. I didn't ever really like cutting flaps with the keratome. Just didn't like it. I know it's a safe technique and it's something you can get beyond, but I really enjoyed using the femtosecond laser for creating flaps. It just seems to be a pretty noninvasive technique. If you have a bad flap, you can leave it, come back, do PRK, re-cut a flap. It just seems like an extra safety measure. When we're doing LASIK, putting that flap back down, I'm always concerned about interface debris and making sure that I'm getting the gutters equal, and making sure that everything is symmetric. I do worry about patients coming back the next day and having rubbed their eye, and having striae. That happens sometimes.

The thing I love about PRK is, I don't have to really worry about that, but again, I'm shifting an easier surgery potentially with a more difficult postoperative course, potential for haze and other things. When I look at SMILE, I almost see this in-between procedure, where you have some of the advantages of PRK and some of the benefits of LASIK, in terms of quick recovery time. What do you think about that?

John : I think one, being a little stand-offish with the microkeratome, you are not alone. A person that's now a partner in our practice, that was a fellow of mine, as soon as he started practicing he really didn't want anything want anything to do with the microkeratome. Even though he was right over my shoulder, and we did cases together. He absolutely wanted the femtosecond laser. It really opened my eyes. He watched me, he was in a fellowship for a year, so he saw it. He saw how to manage things, really didn't want to do anything with the mechanical microkeratome. Believe me, you are not alone in that.

How do you compare the PRK and the LASIK? I think I would be remiss without saying, many people have heard, "Well, SMILE, it's, it's a longer postop recovery." We all know that PRK is. We know the beauty of LASIK is you treat, 4 hours later, you're done. There is a little bit of a difference in the recuperative phase for SMILE. Early on, when actually it was the FLEX procedure—so it was the femtosecond lenticule extraction—a flap was created, you peeled off the lenticule from the surface. It was fully exposed. Those results were a longer recovery. That's changed with SMILE. Now with a higher hertz-rate laser, the recovery time said to be in the, let's say, equal at a day, they're equal at a week.

Gary: I think that's very acceptable. I wasn't necessarily implying that it's similar to PRK in terms of a delayed healing; I was more saying that I like the safety of PRK, the fact that we don't have a flap to really worry about. That comes with the consequence of a longer healing period. I'm excited about SMILE because you're getting the best of both worlds in some ways. That's what I envision. I've done the SMILE wet lab, I've done that, was kind of curious how it would be, and it's really not that hard. It really was pretty intuitive. I'm fairly excited about it.

One other question I have, and you can educate me on this—what do you see in terms of induction of higher-order aberrations? Are you seeing less induction of higher-order aberrations with SMILE as opposed to traditional LASIK? We know that when you cut a flap, and we do LASIK, we're inducing some higher-order aberrations. Have you seen any differences there? Is that something you've looked at?

John: I have personally not looked at that, but internationally, it has been looked at. The great thing about the SMILE technique is that lenticule can be an aspheric lenticule that you remove. Everything that we've learned about lamellar surgery with a excimer laser, we have now just shifted that knowledge base to SMILE. We can cut something that looked like a 1995-96 refractive ablation, but we don't. We do essentially what we do in 2015, with an excimer laser. We learned that aspect of it. Looking at the higher-order aberrations, they're equal to or less than what we see with a standard LASIK procedure.

Gary: If you were counseling a surgeon, say someone has been doing refractive surgery for a while, maybe had a roll-on, roll-off platform, hasn't really invested in technology, and were thinking about really doubling down on getting some technology, how would you counsel them? Just honestly saying, this is your experience, you've had excimer experience, now you have SMILE experience. What kind of advice would you give a surgeon who is looking at the future of refractive surgery?

John: Great point. I like to look outside the US a lot. We are a little bit cloistered in the sense that we don't have full availability. A lot of technologies that are used elsewhere. Last summer, I did a symposium in Europe, and the topic came up. I was leading the panel session, had five experienced SMILE surgeons from Europe and India. Every one of them, when I said, "Okay, person comes up with a X refractive error, that you could treat with SMILE or LASIK, what are you going to do?" Every one of them, except for one, "I'm doing SMILE." The one that said he was not, he only had the laser for a month or 2.

Everybody was already transitioning. What most people outside the US are doing, -1 to -10 sphere with up to 4.00 D of cylinder—they're treating that with SMILE. Those people essentially have converted already to 100% SMILE.

Gary: I think that's really powerful. You see the wave and the winds of change happening overseas, and it usually is pretty telling as to what's going to be happening and what trends are going to be coming to the US in the next 5 five years. And while we're on that topic, let's talk about IOLs. I know that's another thing you're passionate about and have a real interest and keen understanding in IOL technology. Where do you feel like IOLs are now? We're entering, and have entered, the era of refractive cataract surgery, so give me a little bit of your experience and thoughts about the Calhoun lens, and some of the lenses that were coming out, that maybe, are potentially changing things for us on the cataract side?

John: Yeah, I think the biggest problem we have right now with cataract surgery is it's still not refractive enough, meaning that after a single surgery, we don't have a high enough percentage of patients literally being plano sphere. Typically, that's what we want. If we leave any residual astigmatism, even half a unit with a multifocal IOL, a large percentage of those patients are going to say, "No, thank you." Sometimes it's incredibly small. I've literally had a patient—I didn't think this person could exist—that was -0.25 plus 50. 20/70 uncorrected. I put the lenses in front him, and he went to 20/15. I said, "This, this is not possible. There's no way somebody could be like this."

I just put the cylinder in front of him, and he was 20/30. I didn't even talk about his near vision. Once I put a -0.25 in front of him, he's 20/15. I did not think it was possible. You cannot do that same refractive error in front of a person with a monofocal IOL or a person that's had LASIK and have that type of uncorrected acuity. The telling point is, it's inherent with multifocal technology that there are some patients that you can't be anything but perfect.

The point being, even if we look at our monofocal data, 50% or 60% of the eyes are going to be inside plus or minus 0.50 sphere and cylinder, but 40% are not. Those people, historically, have gone to the optical shop. Now we're trying to tell them, "Oh, you're really doing pretty good, but blah, blah, blah." A lot of surgeons, I think, are not getting those people across the finish line. If you don't get them across the finish line, they're not going to be happy. You might say, "Well, why is, or why are, only 7% of the IOLs implanted in the US, or outside the US?" In Europe, it's the same number, roughly 6% to 7% of all IOLs implanted are multifocal.

As I mentioned earlier to you, we do not have the “perfect cheer,” just like Cheri Oteri and Will Farrell, we do not have the perfect IOL yet. Maybe let's talk about the Calhoun lens. That's one lens, from a refractive standpoint, my experience in FDA trial, it is refractively more predictable than LASIK. It's a tighter grouping. We don't talk about plus or minus 0.50. We talk about, are you inside or outside a 0.25 D of sphere or 0.25 D cylinder. It's another factor of accuracy that we simply don't have. That, in my mind, is a game changer. If you want to do refractive surgery and nail it, the Calhoun just seems like such a wonderful technique.

Gary: I agree. I think the Calhoun is really exciting technology, and talking to people who have had experience in the clinical trials, your experience is very similar to things I heard from them also. The only downside is, it is another procedure. Even though it's not invasive, it does require more chair time, more visits, potentially the purchase, or lease, or rental of a UV light source. Those are some of the barriers to getting patients happy potentially early. That's what I look at as a cataract surgeon who's doing refractive cataract surgery, or doing the best job that I can at refractive cataract surgery.

I really want one procedure and one lens that I can use over and over again, that's going to make all of my patients 20/20, or in that range, under 0.50 D. Like you said, we're just really not there yet. We've talked about this in the past also. My thought is that effective lens position is something that is really that last hurdle that we haven't really gotten over. The fact that biometry really ... every biometric formula just takes bits and pieces of data and crunches and weighs it differently to determine effective lens position. At the end of the day, we're just guessing.

You've got a 5-mm cataract, and you're putting in a 1-mm lens that can sit in a variety of locations when it's all said and done. That, to me, is something that ... you know my background. I'm working on something to try and help solve that problem, which is not here yet. I really am excited about the future when we talk about better technologies with biometry, and new lenses that are coming out. I think the Calhoun is going to be a fantastic addition. But the holy grail, as you said, is having the perfect lens, or, in my mind, having one procedure in the operating room where you can really nail people right there, and before they leave the OR, you know they're going to be good.

That's something I think we're both really looking forward to, and hopefully in our lifetimes we'll be able to get that done. John, I know you also have some interest in practice development and looking at the landscape of managed care. We try to be surgeons, but we also have to keep our pulse on the changing elements of health care. I'd love to know what's going on in your market, what kind of changes you're seeing. Give me what you think some changes are going to be that maybe other ophthalmologists need keep their eye on going forward.

John: Yeah, it’s interesting. When I left residency, I was reading these articles about PPMCs. The topic of the day in 1994, 1995, was physician practice management corporations. I said, "I want to get so far away from that, that I can't even scream loud enough." I didn't want anything to do with that. I really didn't want anything to do with managed care. Again, I'm a refractive guy. If I was solo, I would want nothing to do with any of that. Turns out, I'm now part of a group of 40 doctors. We have combined MDs and ODs. I can't run away with it, because it's part of a practice that I'm deeply involved with over the last 19 years.

What I see on the horizon is we know right now that roughly 75% of, let's say, MEDSURG is fee-based. Fee for service. 25% is in these advantage Medicare programs.

Gary: Kind of a capitated situation.

John: There're trying to balance their financial risk, and so forth. We know, and everybody's telling us, that that number is going to go to 50/50. How are they going to do that? We're going to, again, we're going to have to do more, probably for less. Probably getting paid less per procedure, but that's just the way it's going to be, because there's such a large volume of people that need to be treated. What we're seeing in Kansas City, and I'm sure it's no different than any other metropolitan in the US, is something called skinny networks. The insurance companies are trying to get providers that aren't “surgerizing” and expensing every patient out the wazoo, if you will.

I think providers are going to be less apt to do that. They're going to do things that are appropriate, they're going to take good care. They're going to make the number of providers in the panel smaller. When they do, they can control the amount of revenue that it take to take care of patients.

Gary: That to me just seems like maybe a good way to control cost but a bad way to take care of patients. If I'm a doctor, and you're paying me a certain number of dollars to manage the care of a group people, the incentive is to not provide care. It really deincentivizes surgeons and physicians from potentially recommending treatments, when patients could be living a healthier or better life. When I look at cataract surgery, and I know I'm preaching to the choir here, but when you look at the value of the procedure, in terms of the quality of life for the patient, in terms of impact—decrease the hip fracture rates, and decrease mortality—compare that to the actual cost of the procedure, it's probably the single-most valuable procedure in medicine right now.

Just to think about having to have a group of patients who are going to be managed by ophthalmologists, who are essentially going to be incentivized to hold on to those patients for longer and let those cataracts develop and get worse. It just doesn't sit right with me. It doesn't seem right to me. Am I wrong here?

John: Gary, you're an American. It's oxymoronic: managed care. In some ways, when you look on the financial side, if you're a bean counter, you really want to manage to not care. We're on the same page. Hopefully, just like the HMO days were very, very short in the US, and very few capitated contracts lived long term. Maybe we're going to learn that there will be a fight back from patients that, "No, I will not accept this."

That being said, we have had a capitated contract in Kansas City now for 15 years.

Gary: Interesting.

John: The company has absolutely loved it. The patients have gotten great care. We've had great reviews from the patients. It can work. Again, when the providers are taking financial risk at the end of the year, they gave you, let's say, they gave you $1 million. End of the year, you spend $1.1 million, that means you actually paid somebody $100,000 to do their care. That's a really bad place to be. We have to find something that's acceptable to all.

Gary: This is a complex topic. No one really has the answer at this point, but it is important for us to be considering all sides of these issues. John, I just want to say thank you so much for coming in and giving us your thoughts and opinions on, not just refractive surgery, but cataract surgery and also managed care.

That's it for another episode of Ophthalmology off the Grid. Like what you hear? Visit us at eyetube.net/podcasts to download more episodes. Thanks for tuning in; until next time. This is Dr. Gary Wörtz.

Speaker 2: This episode of Ophthalmology off the Grid is supported by Centurion from Alcon.