Informed Consent
Episode 1

Getting to 'Yes' With LASIK or SMILE Patients

Karolinne Rocha, MD, PhD; John Doane, MD; and Ron Krueger, MD, speak with Marguerite McDonald, MD, about how they present LASIK and SMILE to their patients in order to obtain informed consent for surgical procedures. Listen as the physicians share specific pearls for helping patients reach educated decisions about the surgical procedures that can improve their vision.

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

Marguerite M.: Welcome to our podcast, Informed Consent, Getting To Yes. I'm Marguerite McDonald of the Ophthalmic Consultants of Long Island in Lynbrook, New York. Our podcast is designed to pick the brains of key opinion leaders and successful high volume surgeons to see how they talk to patients, how they get to yes quickly, efficiently, ethically, but with a high conversion rate.

Ranna Jaraha: I'm your co-host, Ranna Jaraha. In this podcast series, we're going to focus on how to explain risks and rewards of premium and elective technologies to your patients. Today, we're going to look at LASIK and SMILE. Marguerite, aside from yourself, who I'd like to point out did the world's first laser eye surgery on a human in 1988, a PRK, who are your refractive surgery experts for this inaugural edition?

Marguerite M.: Ladies first. We have Dr. Karolinne Rocha. Dr. Rocha is Director of Cornea and Assistant Professor of Ophthalmology at MUSE, Storm Eye in Charleston, South Carolina. Welcome, Karolinne.

Karolinne R.: Hi, Marguerite, thank you for having me. This is great.

Ranna Jaraha: USC stands for the Medical University of South Carolina.

Marguerite M.: Right. We also have Dr. John Doane.

Dr. Doane: Great to be here, Marguerite. Loved the invitation and really excited about helping out here.

Marguerite M.: Thank you. Could you tell us a little about yourself?

Dr. Doane: I am from Kansas City, worked with a practice for the last 20 years called Discover Vision Centers. We have about 36 doctors, do ophthalmology, optometry. Also I'm on the clinical faculty at University of Kansas Department of Ophthalmology, where I lecture about once a month to the residents, have a great time there. Also I'm the incoming president, starting in January, for the American-European Congress of Ophthalmic Surgery, or AECOS, as we know.

Ranna Jaraha: Finally, we have Dr. Ron Krueger.

Marguerite M.: Could you please tell the listeners about yourself?

Dr. Krueger: Sure. I'm a professor of ophthalmology at the Cleveland Clinic Lerner College of Medicine and a Director of Refractive Surgery at the Coal Eye Institute of the Cleveland Clinic.

Marguerite M.: I know you've had a wonderful experience with topography-guided LASIK. How do your patients feel about it?

Dr. Krueger: They're pretty enthusiastic about it. It's something that was approved last year in 2015 and here we began in about February of 2016 and very quickly adapted a high conversion rate, offering to our near-sighted patients. It's really approved for near-sightedness up to about eight or nine diopters with astigmatism up to three diopters, so it gives us a fairly broad range. The key caveat is really capturing high quality topography maps that are in close agreement to each other.

Marguerite M.: Do you think that it is an improvement over standard wavefront-guided LASIK?

Dr. Krueger: Yes, and I previously have done virtually 100% of all my cases as a wavefront-optimized ablation pattern with very good results. I had done a lot of pioneering work with wavefront-guided treatments in the past, kind of made the conversion to wavefront-optimized because of just how good that was, but those subtle aberrations, especially at the level of the cornea, is not something I could treat up until now. One of the simplest things I can tell my patients is, what I used to do with really good success, is treat your prescription dead-on and get the right profile that gives you good quality vision day and night. Here, I can actually treat something more than just your glasses prescription. There's the potential to get you even better than glasses vision.

Marguerite M.: Do they find it hard to understand the technology or do they ask you a lot of questions about exactly how contour vision LASIK works?

Dr. Krueger: Yeah, I think a lot of times when they're getting new information you can't overwhelm them with too much. I tell them what it's called, I say it's contour vision because it treats the contour of your eye, and especially custom treats the contour of your eye. Then I'll also indicate I'll often have a map right in front of me and I'll say this is a map of the front surface of your eye, which bends most of the light that gives a good focus, and there are subtle irregularities on this map, which is your specific signature or fingerprint of what your curvature is like, and we're going to custom treat that curvature in addition to your prescription to get you the ideal post-op result. In many cases, 30 - 40 percent of patients, can actually gain a line of better vision than their best pair of glasses.

Marguerite M.: You blend the contour vision advantages into your basic LASIK informed consent, if you will.

Dr. Krueger: Yes. Usually when I talk to them and say you're a candidate for LASIK, I'll go over all the details of what's involved with LASIK, that we're using two lasers, a laser to make a flap, a laser to reshape your eye. I'll talk about the categories of risk associated with it and how we mitigate the risk in order to get a good outcome. Ill talk about side effects that in the past, there are things like halos and glare and dry eyes. Now those things are much improved, significantly reduced with the newer technologies and given them an idea of what they might be able to expect post-op. Then I'll tell them, and we're doing something new in the last eight months or so, and the majority of our patients are being treated this way, and I'll tell them what's involved and give them an opportunity to respond if this is something they'd like to pursue.

Marguerite M.: Do you find that when you describe it as new technology that they find that reassuring, or does a certain percentage say, "Ugh, that's scary, I don't want anything new?"

Dr. Krueger: I try to make a point to say that the LASIK procedure that I do has not changed. All the steps that I do during surgery, when I'm operating on them, are exactly the same. It's not like I'm doing something new they have to be worried about. It's just a profile of what's coming out of the laser is now different and that's due to things that we're doing before the surgery starts, that we're doing extra planning and lining up and orientation and sort of verifying, to make sure they get the right overall treatment.

Ranna Jaraha: Isn't topography-guided LASIK also called TCAT, and doesn't Dr. Rocha also have a lot of experience in this area?

Marguerite M.: Yes. It's called TCAT for topography-guided custom ablation treatement, and Dr. Rocha was intimately involved in the study that led to FDA approval.

Karolinne R.: The results were fantastic. The patients, they're definitely seeing 20-15 day one after surgery. We know the outcomes are even better than the wavefront-guided clinical trial.

Marguerite M.: I think we were all shocked at how excellent the results were in normal patients and, of course, everybody is hoping to use TCAT on abnormal patients, people who can't wear a contact lens after a penetrating keratoplasty, or people who had RK a long time ago with irregular astigmatism. We all have lots of patients, patients who've had a corneal ulcer that left a scar, and irregular astigmatism. What do you think the chances are that this technology will be used for those people?

Karolinne R.: I think topography-guided is great for patients with small optical zones, patients that had refractive treatments, refractive ablations a few years ago and they have small optical zones and the centered ablations, those are the easiest cases, I would say, to start in highly abraded eyes. In patients with scars, post-transplant [ectasia 00:08:09], it's important to explain to the patients that it's a stage treatment, let's put this way. You may need to do that first treatment, that I call just therapeutic TCAT ablation, just you make that surface better. Then sometimes you need to plan a second treatment to correct the residual refractive error.

Marguerite M.: As part of your informed consent, you mentioned the possibility of a second treatment, do you tell that normal patients or just the folks who have highly aberrated eyes?

Karolinne R.: Yes, absolutely. I think it's for patients with highly aberrated eyes. It's all about patients' expectations, right? In patients with high abraded eyes it's important to explain, "Yes, you may need a second treatment." In normal eyes, because the results are so amazing, sometimes I don't mention, "Oh, you many need an enhancement." However, patients with really high astigmatism corrections and sometimes even hyperopic patients, it's important to explain, "You may need an enhancement just to correct the residual refractive error."

Ranna Jaraha: It's interesting that both Dr. Rocha and Dr. Krueger are proponents of TCAT. What about Dr. Doane?

Marguerite M.: Dr. Doane is on the forefront of SMILE.

Dr. Doane: Yes. We were involved in the FDA study for SMILE over the last five-six years. Been involved with SMILE as at least a concept since 2009. As you mentioned, it was recently approved for myopia up to minus 10.

Marguerite M.: Since you've been doing it in Kansas City for a while as part of the clinical trial, there must be a lot of awareness. Do you get people asking, "Doctor, should I get LASIK or SMILE?"

Dr. Doane: I think we're not quite there yet. We haven't been pushing it internally or externally outside of education we did early, right after approval. Right now I think it's good that there's not a ton of awareness because you don't want to have something that you're talking about but you can't deliver. When it becomes available, that's a different decision.

Marguerite M.: I know we talked about the fact that you, like myself, have sort of simplified the choices. Everybody in your practice, you said, gets a Femtosecond LASIK flap and also gets a wavefront-optimized LASIK. Can you sort of tell us what your informed consent sounds like for a patient?

Dr. Doane: Sure. Obviously, me being a prior laser vision correction patient, is so helpful, and I think having people in the practice and on your refractive team that have had prior laser vision correction is wonderful. Once they've had it, it just takes the educational level so much higher. I think it would be like being at a travel agency trying to tell somebody to fly or take a trip and they've never been on that trip. Once they've been on that trip, they become so much more, I think, not just passionate about it, but become a reliable resource for whoever is planning on the next journey, that journey being laser vision correction.

Marguerite M.: Certainly, your coordinators, I'm sure, are providing them with written material, websites to go to. The probably show them short videos on an iPad. The doctor, of course, has to have a short, concise, little pitch, if you will, informed consent that explains everything and is fair but has some marketing value, because you want the conversion rate to be good for the appropriate well-selected patient. If you pretend I'm Mrs. Smith, tell me what your informed consent for a LASIK would sound like.

Dr. Doane: We try to figure out what is that person's problem. What do they want solved? Why are they there? Very quickly, if they come in and they say, "My friend sent me in. I'm not quite sure why I'm here," we say, "Are you having any problems with your glasses and contacts?" and they say, "No, I love them," we say, "There's really nothing we're going to solve for you." If they come in and say, "My problem is this. I want to see without glasses," then we work through what's the problem, what's the solution and what are the chances of success. We tell them very clearly, "X percent chance you're going to be done single surgery; there's always a chance you might come back and need additional help." We obviously want to educate them based upon where they are in relation to presbyopia.

Ranna Jaraha: That's interesting. Discussing LASIK is done in relation to presbyopia.

Dr. Doane: If they're 20, there's hardly any discussion of presbyopia outside of something that happens at age 40. If they're age 38, we start talking about monovision or what their alternatives are, obviously reading glasses. We're going to be very clear what our goals are for their specific situation and I think that's what patients need to know. You don't want to, I think, put everybody in a certain pigeon hole. You want to talk about what their problems are, what you want to solve and how you're going to do it. For us, the vast majority of the time it's going to be laser vision correction.

Marguerite M.: Some surgeons use actual statistics, like your chance of needing an enhancement is X percent. Others will just say your chance of needing an enhancement is low. Some surgeons will mention virtually every single possible complication short of alien abduction and others will just say, "This is a safe and effective procedure and the chance of something going wrong is very low." Where do you fall in that category, would you say, John?

Dr. Doane: I'm probably more, and once it's more of a [inaudible 00:13:58] I told myself 20 years ago I would never say zero percent or 100 percent. That means I can predict the future. If you're a minus 1, the chance of you needing enhancement is as close to zero as we can get. If somebody's a minus 10, I'll tell them there's maybe a four or five percent chance you may come back, even if it's a very, very small correction, you will need an enhancement.

Ranna Jaraha: Karolinne Rocha.

Marguerite M.: Marguerite, I usually go over every single one, but I think because our results are so good right now, I explain to patients there may be night symptoms, the rainbow glare, but it's interesting that sometimes patients don't complain on rainbow glare, they're just so happy with their visions that they don't complain but if you ask, they say, "Oh, yeah, that's true, I'm seeing different lights." I mention, but I'm not, especially for LASIK now, I don't go over every single one.

Dr. Doane: I tell them the most important thing that I'm thinking about is doing the correct surgery that day and the numnber one thing that I's most concerned about is getting them on target. If they're not on target we do enhancement. I do not go through all of the issues of infection and so forth that are virtually nonexistent but the know that they're there. If the patient brings it up, I will talk about it but, by and large, I tell them I'm swinging for the fences. If we need to enhancement, the chances are very low and we'll address that three months post-operatively.

Karolinne R.: With LASIK, patients love to hear the next day they can see fantastic. One thing I don't talk too much about, creating the flap, I'm cutting your cornea, because some patients, they get like, "Oh my goodness, what are you doing?" Some, of course, they go online, they look at videos, but I just try to be very relaxed and always finalize with, "Do you have any questions?" Sometimes I talk a little bit about dry eyes. We always try to treat dry eyes before refractive surgery. I think that for all refractive surgeons, premium surgeons, ocular surface optimization, is number one. Then you have happy patients.

Dr. Doane: Diagnosing and measuring dry eye is a critical part of the laser surgery process, as Dr. Rocha just mentioned.

Marguerite M.: Absolutely. An upcoming episode will be focused exclusively on dry eye.

Ranna Jaraha: We didn't talk as much about SMILE as I thought we would.

Marguerite M.: That's coming right up, so SMILE.

Patients spend a lot of time on the Internet before they even come to see their surgeon and a lot of them know about SMILE, which was approved not long ago. Have you been faced with questions about SMILE and how do you compare LASIK versus SMILE or make suggestions to them about SMILE?

Dr. Krueger: SMILE approval is only a month old now in the U.S. and the questions are just starting to come where a few people have sort of asked about SMILE and we told them we're going to be starting this process in the next three months or so. There's a little roll-out phase by which we can get started. We do have the laser. One of the conditions for using the laser is that you have to do a certain number of LASIK flaps with that laser before you're comfortable enough to dive into SMILE, and we've done all that so we're kind of poised and ready to go. Probably the best way to phrase it in layman's terms, it's almost like a laparoscopic LASIK. You think about laparoscopic surgery where you're making a small incision to do some abdominal surgery or something along those lines and, of course, people like it because they heal faster.

Here you're making a small incision to do the refractive change, much less than, say, the full extent of a LASIK flap, so although the visual recovery is slower with SMILE than with LASIK, the comfort that patients experience is quicker with SMILE. That's because there's just that small incision. There's a potential for less dry eyes and if someone has a tendency for dry eyes, this might be a good procedure for them.

Probably one of the words of caution I would say about SMILE is it's not the kind of procedure you can say because we're going to preserve those front layer anterior fibers of the cornea by going inside, because of that, now we can do more higher risk eyes. I'd still be cautionary because ectasia has been seen after SMILE. It's one of those things that even though those anterior fibers are still there, you still need to be very cautious about the kind of patients you're recruiting.

Marguerite M.: Besides people who have dry eyes to a significant degree, are there any other differences in patient selection between LASIK versus SMILE?

Dr. Krueger: Right now with the FDA approval it really is for myopic patients without astigmatism because the approval process is such that it's going to be another two years or so before astigmatism will be included. I think at this point I might select patients who have a little higher level of myopia, have pure spherical correction without astigmatism, are looking for a comfortable, fast recovery in terms of comfort and ease, maybe those who are more prone to dry eyes, or other ocular surface issues. If they are more prone to allergies or meibomitis or something along those lines, I think the small incision would be favorable for the ocular surface.

Marguerite M.: John Doane.

Dr. Doane: While we're on the topic, if you're incising less cornea, all the studies that have been done, and now I think there are 190 peer-reviewed articles on LASIK, the biomechanical structure of SMILE has to be better than making a LASIK flap. It's been proven in study after study.

Ranna Jaraha: That was very interesting. Even is we strayed a little from strictly Getting to Yes.

Marguerite M.: Patient selection and our evaluation of the technologies we believe in is also part of the process of deciding what we want our patients to understand in their decision making. I guess the emphasis is really on "informed," more so than "consent."

Ranna Jaraha: We certainly hope you were informed. I'm Ranna Jaraha.

Marguerite M.: I'm Marguerite McDonald. Please watch for the release of our next podcast and join us again.

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

1/26/2017 | 20:50

More Episodes: