 Our next speaker, our own Mejid Moshepar, we're grateful to have banked with us to give a talk on small incision lenticular extraction and I'm assuming we're not talking about the lens. Dr. Moshepar. Thank you. It's my pleasure. While they're putting this up I want to thank everyone and also Elaine and Dr. Crandall, Dr. Boratsko and Dr. Hoffman for organizing this and thank you for having me here for this next 20 minutes. What we were talking about was smile, which is going to be a talk on cornea, specifically talking about myopic correction with small incision lenticular extraction and smile. And I don't have any financial interest or disclosures to reveal. I just want to thank Jordan DeSuttles for helping me with preparing this talk. As you all know, smile was approved in September of 2016 but the system and the software and the program was not released until end of March of this year. And we all started doing them around the country in April of 2017. Can you hear me better now? Yes. So we all started doing this in April of 2017 once the software was unlocked and the sensors and the energy influence was said to be safe and effective for the patients. This basically consists of using only one laser. We don't use two lasers as you all know in Lasik, which is called femtosecond assisted in cytokarotomalusis. We usually use a femtosecond laser in order to create a corneal flap and then we use an eczema laser or excited dimer laser in order to do the ablation of the corneal tissue in order to resolve the refractive error for the patient. This is only one laser which is only a femtosecond infrared laser that we use with a low energy beam and it creates first a posterior lenticule cut, then it creates an anterior lenticule cut which is basically more superficial and then it creates a small incision for you to remove the lenticule. It is approved for being provided right now in the United States for minus one to minus eight diopters with minimal amount of astigmatism. That means you really cannot do this for patients who have more than 0.75 diopters of cylinders, so it's for simple myopia at this point. Although the correction can be done up to minus 10, but the safety and efficacy beyond minus eight has not been proven in this country. The FDA efficacy is quite comparable to what we used to have with the third generation eczema lasers. However, the data is still not as great as our topography guided Lasix or what we call now fourth generations. As you can see that the 2040 range is quite impressive, but when it comes to 2016, most of the wavefront guided technology or the optimized technology can provide close to 78 to 81% 2020 visual acuties and higher. Predictability based on the result has been quite impressive in the country. There are a few under corrections, but predominantly please it's usually between plus minus a half a diopter and also between plus minus one diopter. Of course the stability after one year has not been looked at at this point in this country yet, but it shows that there is a small amount of regression for those of you who have been familiar with Lasix. There is a regression of Lasix between 0.1 to 0.3 diopters every three years. And we think that Lasix can be actually slightly more or comparable. In terms of safety, nobody has lost vision. Nobody had induction of stigmatism in these eyes and they've done overall very well. Contrast and sensitivity is actually slightly better with smile than Lasix. And that has to do with the fact that the procedure removes even though more microns per diopters, but since the actual lenticule that is extracted is not a blended zone like we have with Lasix, so you're actually having a larger optical zone of 6.5 to 7 millimeter. So that's why the spherical aberrations and the hyoid aberrations with smile for higher level of myopia is actually advantageous over Lasix. In terms of cylinder, we do know that there is still under correction for cylinder. That's why it's still not approved in this country. There's almost about 12 to 13 percent under correction for low myopia and for higher, I'm sorry, for low cylinder and for higher cylinder, it can be between 23 to 25 percent under correction of the cylinder at this point. So the under correction for more than 2.5 diopter of cylinder has made this a challenging situation for atoric treatment with smile at this point. Now the advantage of smile over Lasix in some ways has to do with the fact that you don't create a flap that is 8, 8.5 or 9 millimeter. Your actual cap that you're creating is more like a 7 or a 7.5. And also the fact that you don't create an 11 o'clock hour of flap but you're simply creating a 2 o'clock hour of incision, you are theoretically cutting less of those nerve plexies superficially. So that's why perhaps there is more advantage there. Now this is my own case that I'm just simply showing you in steps. I have done 24 cases since April. And the first cut is the actual lenticular cut. That's what determines the minus 8, minus 4, minus 6. This is the deeper cut that you do shown in the red line over there. And then once that cut is performed, then you perform the superficial cut which you can call it flap or cap. And that is usually set at 120 micron or 130 micron. So that is the superficial cut that has no lenticular power to it. And then eventually the suction comes off. This is my case number 3. It took me 8 minutes to do this. So I fast forwarded it at this point for you. First you simply make the anterior dissection. Then you do the posterior dissection. And then after that you basically use special devices to go in there and do your dissection. It feels like you're doing almost like a dull, but much easier, dull deep anterior lamellar keratoplasty. And it's important to make sure that we take all the remnants out. This patient was a minus 450 diopter myope. And now the posterior dissection is being done. There are people who can do this in 20, 25 seconds. But with time people can get fast. And the beauty of it is that you don't have to move the patient between two platforms of femtosecond and excited dimer. You actually can do everything in one. So internationally this may be easier for people that they don't have to have two separate laser technology, femtosecond and excited dimer. They can have a femtosecond to do it. And you can see that in this case when we take these lenticules out, I usually like to look at them. So we try to untangle this. And for lower corrections, like minus 2 and minus 150, it is quite challenging because that lenticule is quite thin. I'm hoping that I would be able to work with Dr. Mamoulis on analyzing these. Right now I'm putting these on a balloon. I'm looking at them at pentacamp in order to see the refractive powers of it. But it would be better to do something beyond that. I am preserving these right now in formalin, just for my own internal studies that I'm doing with them. The period that we have to throw these out. These are my own 16 eyes that I show you here for one month result. As I said, I've done 24 cases. And nobody has lost best corrective vision. For me as a refractive surgeon, I don't want to lose best corrective vision. None of my patients have lost any. And this is one month result. And there is this theory that most likely they will even have some gain of vision because smile takes longer to heal. In terms of predictability, without any nomogram adjustment, there is under correction that I notice on patients. Meaning that sometimes when you're doing a minus 6 or a 7, you may actually end up 0.75 or 1 diopter under corrected. And what are we going to do for these patients? Certainly you don't want to go back and remove a 0.75 diopter lenticule because it is quite difficult to remove those. So then they end up getting a PRK enhancement. And now there is this theory that this bar graph is going to shift more toward the zero as the months go by because gradually the cap is going to collapse over the residual stromal bed and there would be thinning of the cornea and flattening of the curvature. And thus this myopic appearance in the beginning may become less over the course of the next two or three months. In terms of predictability and attempted versus achieved correction, you can see that there is more under correction. However, 55% of the patients were still within the 0.5 diopter and almost 90% are between plus minus 1 diopter in our patients. The reason Smile is here is not because it's going to take over LASIK or PRK. LASIK and PRK have been with us for 25 years. They are superb procedures. They've shown their efficacy and safety. But I think Smile, maybe for certain patients, would be advantageous. You know, the patients who may have some mild ocular surface problems with some dryness that you don't want to do PRK on them because they have confluent superficial puncture keratopathy or for patients that are in certain professions, they are martial artists, they are in contact sports of some form. Again, this may be more advantageous. But if somebody does a proper LASIK with expertise or PRK, we cannot say that this procedure is going to take over. But for a high level of myopia, perhaps there is a biomechanical advantage. Because right now the philosophy is that we have to relieve a residual stromal bed of 250 micron. 250 micron was the residual stromal bed. And sometimes in the 2000, we went to 300 micron residual stromal bed after finishing your treatment. Now the concept is that, well, with Smile, you do not impact the anterior one-third of the cornea because you don't create a flap. You're creating a little small incision. So the anterior corneal stroma, the entire lamellis are intact from limbis to limbis, 360 degree meridian. So if you have a cap of 130 micron, if you remove that 50 micron of epithelium, you still have 80 micron of your stroma anteriorly that you really didn't disturb. And then when you do your ablation, theoretically you can go as low as 220 micron residual stromal bed because 220 micron of residual stromal bed along with the 80 micron of your cap creates the 300 micron total untouched lamellis. So the concept is that maybe we would be able to use Smile for those corrections that are 7 and 8 and 9 and 10 where we shouldn't be doing lacycondum. And also since you're going below that 130 micron cap, you have a less chance of removing those nerve plexies. So not only the anterior stroma, which is the strongest part of the cornea, is going to be intact, but also you can go deeper because the posterior corneal stroma doesn't have the tensile strength of the anterior and so you would be able to create a niche for Smile patients. So that is why we think Smile can be added to the armamentarium. I did one patient with Bell's policy and I just want to tell you that I think it was a good thing. I did lacycone eye and on the other eye I did Smile. And I think this is the niche that we can have for certain patients. Smile has already been shown to Cosectasia so we shouldn't think that Smile cannot Cosectasia. But yes, the dryness is definitely improved with this concept. But there is one other thing that we have to give a credit to Smile. Why is it Smile perhaps has less high order issues in terms of spherical aberrations and coma. The fixation with the Smile is not based on the center of the pupil. The centration and the fixation is with respect to the patient's percinct reflex or supposedly center of sight. So if we can create this treatment not with respect to the pupil, but actually with respect to the percinct, because that's how the machine works, you're actually closer to the patient's sight. So if somebody has an angle kappa, then this makes it even better. We all know that myops have a very small angle kappa, but it's still present, 3 degrees, 2 degrees, 5 degrees. It's very hard to see somebody with 8 or 9 degrees of angle kappa. But if you can put a centration with respect to the percinct, maybe that is why there is less chance of getting coma in these patients. If you're looking at the topography of a Smile patient, many of us may see that the treatment is slightly nasal or perhaps infranasal, and that's because you're not going with the center of the pupil, but mainly with the center of the patient's fixation. There is suction loss issue with this technology, the same way there is a suction loss with LASIK. After all, you're doing a treatment, you're doing basically two lamellar cuts, posteriorly and anteriorly, whereas with LASIK you're doing just one. During that time of 25 seconds, you are 12 seconds or so, you are doing the posterior cut, you're 12 seconds or so, you're doing the anterior cut. So there is a chance of losing suction, and you can lose suction in these patients. This is basically my own complete smile procedure. This is one of my recent ones that I have done. First, the docking happens, and you are not centering this with respect to the pupil. This is the patient actually fixating, and you can actually see the fixation light up to this point. So usually during the posterior cut, they can see it, but when the anterior lamellar cut is being performed, patients have a hard time seeing that light, and that's when sometimes the suction can go off because the patient can see and they can move. Whether you're doing a minus-6 or a minus-5 or a minus-2, the time interval is the same. The two cuts still take about 25 to 32 seconds, depending on the software. Here, again, the dissection is being done. This is a patient that was minus-7, and average time for people is now about three minutes for me. For me, I can do this in three to four minutes from the beginning to the end, and we have been looking at the timers, and we can tell that the faster we do this, there is a quicker recovery on patients afterwards, and we think the less stroking that we do, there is less chance of inflammation. Again, right now, we are not preserving these for any shape or form, but potential is there. Again, I'm trying to basically dissect this tissue, and it's important to check to make sure there is no remnants because sometimes you may leave a remnant in these patients inside, and then you have to go back and take them out. I'm checking it, making sure that there is nothing like that. I'm going to stop it and move to this one. So you can have the interruption of your suction cut during the cap, during the posterior cut, and if that happens, sometimes you can repeat the procedure, which I will show you, and sometimes, unfortunately, you have to reverse to lacy and abort. This is a patient of mine, a case that I did, and you can see everything is going nice here. I made my posterior cut for about minus-5 diopters. At this point, the patient starts to lose the vision. They don't see it. It's important to coach the patient. I'm making the anterior cut, and if you look closely, I lost suction right there. So what I did, I immediately went back, and I aplenated immediately, and I complete the anterior cut one more time and made the incision, and you'll see that in this one right now. So I'm going down again, and that is why femtosecond is so valuable for those of you who use the femtosecond for lacy flap. You'll see that sometimes you may lose the suction during that cut. Even in the lacy flap, you can immediately aplenate and cut again. So I completed the last part, and then I made the incision. Yes, you can get something called black spots. These are not OBLs that you get with lacy flap. That is, in that area where those dark spots are shown in the red arrow, there is actually no dissection, meaning that there was never anterior passage and when it gets to those, you actually have to physically use your disector, a dark disector or some form of disector to cut through that, and sometimes you can actually have some imperfection in your incision. So dark spot is a new phenomenon that is with us. The other thing is that you can cause some damage at the edge of your smile incision and cause ingroth. That's why it's important to usually place a bandage contact lens on these to prevent erosion and ingroth. You can also inadvertently cut through the edge of the smile cap and come through the epithelium. If that happens, we need to usually put a bandage contact lens and it's usually self-limiting, but you can perforate the cap and sometimes you can leave a remnant in there. If you leave a remnant in there and we have submitted a little short correspondence to the cornea journal that if you put a little bit of a tri-pan blue inside these eyes under the regular microscope, you may be able to stain these and be able to go back and pull them out. And you can see that on topography it can reveal itself too. This is a case that actually has been published that shows that if a lenticule is placed in... is still in there a remnant of it, you can create some stippening and when you go and take it out, then the cornea becomes more regular. If you look at 1A and 1B, you can see that there was a remnant of lenticule in the infratemporal aspect of the left eye and when it was removed, that red spot became a lot better. You can have high energy and low energies and get OBL, which is one of the challenging things that needs to be controlled. Yes, you can get undulation and wrinkles. The same way you can get with LASIK flap, because after all, if you take 100 micron of tissue for somebody who is like minus 8 diopters, you can get kind of these undulations and sometimes the epithelium is forgiving and makes you get rid of them, but they look very similar to the mud crack patterns that we see after high myops who undergo myopic LASIK. Yes, you can also get Sanzo-Sahara or Diffuse-Lamellar keratitis and you can also get Transient Light Sensitivity Syndrome. There is a case that's being published in Smile that I'm one of the co-authors on it. However, you cannot get rainbow glare with this technology. You can get rainbow glare with LASIK, but not with this technology. And the reason being, you cannot get that... I don't know, I think the timer went off on this. Let me see if I can get that. Should I close this? Close it? It says start. Yes. Oh, yes, I see what you're saying. That one is MINDO. No, maybe not. Sorry about that. Rainbow glare can only happen if you have a raster pattern. And most of us that we do spend to second LASIK, we have this bubble configuration that goes from north to south in the cornea. In Smile, because the treatment is in this form, you will never get a rainbow glare prismatic effect. And that's one thing that actually is a fact. Hyperopic Smile is being conducted right now in the other part of the world. We're going to see if we can create a donut kind of lenticule, centrally less, peripherally more, so you can move more tissue peripherally, and you can have this donut configuration. But I personally think that this is why I'm interested in Smile, because I think those minus fours and fives that we are removing from myopic patients, if we can learn how to preserve them, or if our iBank can have a Smile technology to create lenticules of minus one all the way to minus ten with different powers and different optical zones of six to seven, and then we preserve these. We can take a child who is plus three or plus four or plus nine and be able to actually put this lenticule inside their pocket, inside their cornea, and resolve that, and there is no issue of regression. So trying to do those sort of lenticular implantation with Smile is, I think, very promising, not only for iBanking, but also for a lot of high-hyperopes with no issue of regression. Yes, we can use it also in perhaps keratoconics. Imagine if our iBank can create large tissues for us so that we can create a lamellar dissection and put them in there. Maybe we can make these thicker so we can put them thicker in the periphery and thinner in the middle so that you can make the central aspect of the keratoconics flatter, but then the periphery would be much thicker, and if we do it tectonically, they are much more stable. And this is a case of a Bowman membrane transplantation. What if we can actually, instead of trying to harvest the tissue or sell from a cadaver, have our iBank create a large 200, 300 micron for us so that we can actually put it inside the eye? Let me just show this. So this is basically the regular lamellar dissection that we do in Bowman membrane transplantation, and once we do this huge dissection, we usually have to go and use the cadaver tissue, which is very irregular, very non-uniform, and the diameter is not always completely normal, and we try to put it inside if we can learn through the iBanking. iBanking now does a beautiful DMEC. If they can do DMEC, it's a piece of cake for them to do that. So I became interested in smile knot from the myopic treatment aspect of it, but the potential that it may offer lamellar procedures in future. So imagine if that tissue can be prepared by the iBank with great accuracy and great thickness and great profile for palusids or for other effective treatments. And what about inlays and unlays and all those? You know, raindrop this hydrogel that we put in. What if we can actually take the donor tissue that minus seven I just showed you that we pulled out and we punch it that two or three millimeter, which they do in other part of the world. What if the iBank can prepare for us a plus three hydrogel lenticule to put right there instead of using a synthetic material that causes haze? Right now we have to use mytomycin C with that. Otherwise the patient develops a certain haze. What if we can actually put a cadaver tissue over there? There would be less chance of haze. There would be less chance of other issues with that. So of course I'm simplifying it, but I think that we can develop inlays that can help us do this and not use synthetic material because I still think anything foreign that goes into the cornea can cause issues and haze and other problems in the long run. So the studies have been already launched in other part of the country and world too about taking these refractive lenticules, putting them in special medium, the DMSO and other medium, try to cryopreserve these and have them in the iBank for future. And the interesting thing is that they stay viable. You can see that's a fresh lenticule, that's a cryopreserved lenticule. And the interesting thing is that in rabbit models they have shown that you can take this tissue out of the cornea, put it back into the cornea, and these tissues stay viable afterwards. So if we can show this in a rabbit model I'm pretty sure it can be shown in humans as well. And more importantly, you can create multiple pancake of this. Right now we do amniotic membrane. Imagine if we can create one minus one diopter lenticules, like 15 or 16 micron levels, and try to put them, stack them on top of one another there, and put some synthetic epithelium on it. You can theoretically create these glorified membranes that you can use for perforations or for that matter for the glaucoma surgeons and other purposes. So it is something that can be used for tectonic purposes and melt and other things as well. So I think there is a lot of potential for this using this sort of a smile procedure. I want to thank you for giving me the chance to be here to share with you things on the smile in that regard. Thank you. You know I was after something. So where you think the anterior cut to get into the lenticule looks to me like it's about 60 degrees that you're cutting. The incision is 90 degrees. 90 degrees. So doesn't that flatten that Viridian? No, it has not caused, actually we have to look at it, but right now vector analysis does not show that it causes induction of a stigmatism in these patients. However, in Europe and other places, they put that incision, which is at 7.5 meridian, and remember it doesn't go all the way through. Whenever we do LRIs, we tell our residents and fellows that you need to go at least 90% to get some efficacy. And even in femtoseconds when you do those incisions, they have to go to certain depth. This is 130 or 120 micron, too superficial to create that effect. But in Europe and other places, you can place those incisions at the depth and the meridian of the patient's astigmatism. Let's say somebody has one diopters at axis 170. You can put it at axis 170. Now in the United States, you're limited to the superior incision. I wish we were not. So when you do that, you go deeper then to correct some of that? Right, but if that's the issue. Now we have looked at camera inlay and the incisions because camera inlay incisions are 250 to 275. And we've shown actually it's coming out vector analysis that it does not cause flattening. It seems that you need to go a lot deeper in order to cause that flattening. I have a question. Yes. On tech point. On tech point? On a technician, healing time, is it the same as LASIK, any difference? Another question, rejection rate on the corneas, the transplants, basically transforming that tissue and do we know any studies on the rejection rate? Is it the same? Is it different than anything else? Do you like all the transplants? Yeah. So, you know, in terms of the first question, even if you look at the FDA results and others, the vision the first day or two is not necessarily for everyone 2015 and 2012. And you see a lot of patients who are 2030, 20, 25, even though they're happy. But when you look at them one week out and one month out, they really catch up very nicely with the LASIK patients. So you have to understand that we use the best software right now in the country, in the world because they all worked on it. But in the beginning, in the literature, they were reporting 2030, 20, 40, for one day was very normal. So you should most likely see patients who are in the ranges of 2030 or better that they want, even for the high myopes. With regard to the second question, you have to understand there's only seven or eight cases of lenticule implantation. So I can't comment about the risk of rejections on these. But I would say it's very similar to other venues like Boman membrane transplantation. Thanks very much. Thank you.