 It's my pleasure now to introduce one of our old colleagues, Majeed Moshefar, who's now back in the Salt Lake Valley and so one of our clinical faculty members. And Dr. Moshefar is gonna talk about PRK-LASIK and patients who have had corneal inlays and some of the issues that are involved in that. So we'll go ahead and we'll get, Randy needs his reading glasses. So once we get macular degeneration cured, the next step we're gonna have to do is cure presbyopia. So Dr. Moshefar, welcome. Thank you for coming in and joining us today. Good morning. It's good to be back here with my Moran family. I missed you all and it's good to see some of you and say hello to you. Now that we had two great speakers talking about very sophisticated concepts, I should say that it was way above my level of understanding, we're gonna go to more like a kiddie stuff and talk about simpler things. The purpose is to simply talk about, can we mix and mishmash eczema ablative procedures such as PRK and LASIK with the concept of corneal inlays? As you know, in the last month, a new inlay has been approved, which is called Raindrop. Last year, camera inlay was approved. So we know that these inlays are coming down the pike and we wanna know if we can offer them to our patients. I would like to acknowledge my colleagues who have helped me throughout this last six months working on this project. And I do not have any financial interest in any of the products that are mentioned here, in any of the lasers. And I also want you to know that most of my co-authors also don't have any financial interest, except Dr. Deryl who does have stock in the AcuFocus. AcuFocus is a small aperture corneal inlay which is 3.8 millimeter on the outside diameter and 1.6 in the central pinhole area. The size of it is almost the size of a red blood cell which is about five microns. And the material is very similar to the material that you see in the haptics of your three-piece lenses. The concept is very simple to the concept of pinhole effect. It simply increases your depth of field. It doesn't have a power. It doesn't have one doctor app or two doctor app. It simply uses the pinhole concept that we're all familiar with in order to increase the depth of field. Theoretically, it should not impact your distance vision. And this is a good demonstration of that. How we can increase depth of field by using the pinhole effect. The way it's inserted is with the assistance of a femtosecond machine. It creates a pocket, not a flap. You create a pocket along certain meridian and then you insert this with your special inserting device. The FDA approved this technology in 2015 in April based on six-year result, primarily on the safety issues. The labeling is primarily for patients who are between 45 and 60. And these patients need to be metropic. That means they shouldn't be wearing any glasses for distance. They should be in the ranges of 2025 to 2015. And they should be basically dependent on reading glasses. Now let's face it. In our refractive world, most of the patients will knock on our doors and ask for vision correction surgery. It's hard to find somebody who's purely metropic with a very small refractive error. Many of our patients can have one or two doctors of refractive error in terms of sphere. They may have some stigmatism which is more than 0.75 dioptics. So when the patient comes to us and they ask us with enthusiasm for inlays of some form, and we have to tell them that you are not in this window of population. What can we do for them? And this is where a lot of the European authors have looked and said, well, can we ametropize these patients? Can we take their myopia down? Can we reduce their stigmatism to this level, bring them to this sort of refractive error and then put the inlay in their eyes? When I looked at the data that has been provided to us by the FDA and you look at the bar graph, it shows that 91.9%, 92% of the patients who are slightly myopic, that means there were patients between minus 0.75 and zero. These patients did a lot better when it came to near visual acuity compared to the other bar, which is 76% for patients who are slightly hyperbolic. So when it comes to the camera inlay specifically, I personally think it works better on patients who are slightly myopic. But when it comes to raindrop, if anything, it's better for the patients who are slightly hyperbolic. And based on this, and based on a lot of the European experience, many of us who are interested to use inlays in our presbiopic population lean toward the camera pinhole aperture inlays for patients who are slightly myopic. And this is nicely shown here. So how does this help us? This helps us to understand that if you have a patient who is minus eight or minus four and has two or three doctors of stigmatism, and if you're trying to bring this patient to a level that can benefit from the camera inlay, bring their non-dominant eye and leave them approximately minus 0.5 to minus 0.75 myopic in their non-dominant eye. And many of these patients could be 57, 58 years old and then implant the camera in them, either consecutively or simultaneously. This is a defocus curve, which is simply showing that if you shift the defocus from plano to minus 0.75, it can actually increase the amplitude of the patient's capability of seeing by 2.75 doctors in terms of depth of focus. So the two questions that many of us have is can we combine this? Can we mishmash it? And is it going to be safe? And should we do PRK or should we do LASIK? Which one is better? And this is simply a preliminary result based on about 42 to 45 patients in each arm of the study that I've had for the three months and six months. The six months beta actually has an attrition and it goes to less than 12, 10 patients in the LASIK arm and about 36 patients in the PRK arm. But before I go there, I think that it's important to talk about centration. Centration has always been a challenge in refractive surgery. From the time that Dr. Casebier was teaching us the RKs and from the time that we went to use eczema lasers, this first generation eczema lasers where we didn't have an eye tracker, we really don't know where is the right place to place the ablation? Or where was the right place to put the RK incision? Is it the Purkinje Reflex One? Is it the center of the pupil? And this dilemma has been with us but when it came to eye trackers, we simply learned that we should just focus on the pupillary aperture and we should simply ablate with respect to the pupillary aperture. And even now that we have gotten sophisticated with the femtosecond assisted cataract surgery and we see all these multifocal lenses, many of us have learned that when it comes to large angle capo, sometimes between 0.5 and 0.7, the multifocal lenses, if they're not placed with respect to the angle capo and the Purkinje Reflex One, you may not have a good result. So now we're realizing that centration is becoming even bigger issue than ever before. And that also applies to hyperlopic lacy with large angle capo. So when it comes to the camera intake, where are we going to put it? Are we going to put it with respect to the pupil? Are we going to put it with respect to the Purkinje Reflex One? And it's been shown that there are some studies that it is better if you actually place this with respect to the Purkinje Reflex One but many of us that still feel uncomfortable to do that, try to center these things somewhere between the pupil as well as the Purkinje, goes back to intax and hyperlopic lacy, the same concept applies. Centration is primarily done somewhere between those two spots. And there are different techniques for that. There are different diagnostic devices. Many people have an OPD scan, schioscopy, some people have a ray tracing technique by Sherry's principle. So you can use these machines in the practices and I don't have any financial interest in any one of these things, but you can use this in order to see where the angle capo is and where is the entrance pupil and where is the reflex. And by using that, you can actually have the data in a snapshot, take it to the operating room and use it for your multifocal, use it for your camera intake, your press period intake, et cetera, et cetera. And this is a good example of topography guided centration with a vario. And it actually shows you both mesopic and photopic and also the purkinje reflex. So this is another device that people use, which is called the Aki Target. Again, another device that helps us to have a numerical understanding of where the center of the pupil will be with respect to this is the center of that and this is the center of the pupil. And in this area, we're lucky because these two are very close. But if somebody had a more nasal angle capo, the purkinje reflex would have been here and then the center of the pupil entrance is here and where would you put that? And it is recommended that it should be between them. And the beauty of such multitude of diagnostic devices is, for example, Aki Target or the others. When you put the camera in there, later on you can go back and you can actually see how off you are with respect to the pupil and how off you are with respect to the purkinje and where it becomes significant. And again, you can take a snapshot of these, take you to the operating room, whether you sit temporarily and superiorly, you can use this for your multifocal implantation, your inlay, whatever. I like the mastel ring personally, myself. It's a very simple device. You don't need a huge diagnostic machine, an expensive one, but it gives you a fixation point that you can use throughout the procedure and patient can fixate on that and can give you an idea of in terms of your centration. The machines, the eczema lasers that some people use in order to tell them where the center of the site is. This is another one when the patient is looking in there, they are fixating. This is the Visex laser. We can use what we have at hand in order to help us in terms of centration. I simply want to show that what we're doing here is I am placing some ink mark trying to have where the limbus is so that we're not put the femtosecond on I would know exactly where the limbus is because you want the incision to be as temporal as possible so you do not induce the stigmatism and then the centration is done with a heavy mark because you do want this heavy mark to be on the right place for the duration of your surgery so it doesn't dissipate so you know exactly where it is. There are three different platforms that can create pockets for the inlay insertions. And this one is the most common one used by the interlaced or AMO company has it. Again, it creates the pocket for us. The other one is the FS 200. FS 200 has the capability of creating your pocket at 180 meridian, 90 meridian, 75 meridian and the beauty of that is that if somebody has 0.75 or one doctors of the stigmatism you can actually place the FS 200 along the meridian that you like. So that's one advantage for the Alcon FS 200 in a second because it gives you the ability to create your pocket in whichever meridian you want and that can also help with the stigmatism as well. Instruction, again you do have your heavy mark from before hopefully it has dissipated and then you simply place your inlay. And the reason here you cannot rely on the patient is because at this point the patient is quite distorted and the patient cannot see. That's why the original centration becomes critical. So in my study design we had one group that had the PRK and the inlay at the same time in their non-dominant eye aiming for minus 0.75 doctor and in the group two they had LASIK and the inlay in their non-dominant eye aiming for minus 0.75 refractive error with the LASIK part of it. The dominant eye of course got LASIK or PRK accordingly. 44 patients in each arm and 45 in the other and 10 patients in my LASIK group six months follow up and 42 in the six months follow up for the PRK. Demographically these patients overall are very similar pre-operatively in terms of cylinder and myopia or hyperopia. And in terms of PRK technique, very simple centration you create the pocket you insert your inlay and then you go to your laser and you do your PRK. And I'll try to show that here. This video has been already on an iTunes website under the inlay section. The centration is done based on the information you gathered pre-operatively based on whatever diagnostic device you prefer. The pocket is being created using whatever femtosecond modality you like to have. The pocket size is approximately 4.7 because you need to have enough wiggle room in order to place this because if you don't then you won't be able to center it. After the placement of the inlay, patient is being taken to the eczema. We do not need to place this underneath the eczema laser. We use the microscope, the surgical microscope that you use for your cataract or your other procedure. We think the view is so much better in order to place the inlay and have the fixation. So after the inlay is placed, you have to actually physically move the patient to the eczema laser so that you can use that optics for your PRK treatment aiming for your undercorrection of 0.75 diatours. The 20% ethanol is used here in order to remove the epithelium and then subsequently the ablation is being applied. The challenges that we have when you are doing simultaneous surgery, especially in the beginning, is if for any reason your X-Y coordinate of your camera inlay implantation is not perfectly centered with respect to the purkinje or the pupil, your ablation is going to be de-centered. So if I was not careful and I did not put this in the right place, the eye tracker is not going to track the pupil. The eye tracker is going to actually track this inlay. So you can see that the ablation can become de-centered if you don't know where to put the inlay. That is why many people advocate, you do the PRK, you aim for minus 0.75 diatours, you come back three months later and you put the inlay because you don't want to put a de-centered inlay and have the ablation also de-centered. That can be very problematic. And this is where some people believe it is better to do them consecutively first the ablation pattern done and then three months later the inlay. And we do have a small subgroup of that and I'd like to see what the data is available to know whether consecutively is better than simultaneous. The rest of the procedure is very similar in terms of the corticosteroid treatment. I will briefly talk about that momentarily after we finish with the lacing part of the procedure. When it comes to the lacing part, initially we all thought, well, that's not a problem. We create our lacing flap, we do our lacing and then we put the inlay and we close the flap. Why, we don't even need to have a pocket. Well, studies after studies has shown over time that if you do that, you actually cause a hyperropic shift because the flaps are only 100 microns or 125 microns whereas the pockets are usually placed at 200 or 250 microns. If we place these pockets, these inlets underneath the flap that we usually do for lacing, you will have some optimal result and you create huge hyperropic shift over course of time. This is the way that has been described in Europe in many places to do and it's quite simple. You lift the flap, you do your ablation and then there you go, you put that at the same time. But this has been abandoned over time because it has been taught that this is not the right way to do. Looking at the literature from Asia as well as Europe. So we are now placing the pockets deeper as long as the residual stroma bed is more than 250 micron and then the pocket is at that depth then you actually go back and you make your flap either simultaneously or consecutively at a different time. Here, this is the technique that has been described by others and we don't advocate this but I would like to show you this is a good colleague of ours who does simultaneously flap creation and pocket creation within a matter of a minute with their femtosecond device places the camera inlay underneath that 250 micron pocket then lifts the flap, does the treatment underneath the 100 micron flap. So there's only 100 micron of space between the two planes and places the treatment over the camera. The problem I have with this technique and we did this on some kebab rice is the bed is not regular. If you create two cuts one after the other. And also, again the challenge is what if your centration of the inlay is not proper? Your ablation is also going to be de-centered because that's all the machine understands. Although they have shown some good results with that we believe that it should be done differently. First, the pocket is created. Then we wait a good five to 10 minutes to make sure all the bubbles are gone whether they are OBLs or not. Then we go to the contralarrow eye we make the flap in the contralarrow eye. We come back to the eye of interest almost 10, 15 minutes later and then you make your lamellar cut. Now I'm hoping that this will come in time. This was the, I think I cannot see it here but we'll figure it out, it's okay. Maybe it's here, let's see. It usually takes a few seconds. And for some reason it's not doing it but if I get it I'll show it to you guys. Going back to this and coming back to it. So I'll try to see if I can get that shown but getting back to the results if you look at the FDA result and this is the communication that people lack to do for when they're talking to their presbyterian patients when you look at the FDA result for the camera in there 91 to 92% of the patients achieve visual acuity of 20, 40 for near or some people call it J5. Then arguably most of the time with both eyes open. In terms of J2 or better which is 20, 25 or better only about 50 to 60% achieve that and that's the communication that has a surgeon you need to have with your patient because when you look at the data that FDA has provided that is the reality of it. The 91 to 92% of the patients see J5 which is 20, 40 and about 50 to 60 see J2. And if you communicate with the patients that and explain to them this is the outcome some patients may say well I don't want this this is not what I was expecting. So that's what if you go with that standard and that's the FDA labeling the result that we got for both of our groups whether it was for distance or near is quite comparable to what the FDA has right now for the hematropic patients. And we show that of course the LASIK patients always start better than the PRK patients but then they eventually reach almost the same endpoint even though we had 10 patients in the LASIK and about 36 patients for the PRK but here they were more comparable. And that is the binocular uncorrected mirror vision that means both eyes open looking through the inmate and non-dominant eye. And this is the monocular distance vision and it shows that the distance vision is not compromised at the end and majority of these patients still in their non-dominant eye still maintain a good distance vision despite the fact that they have an inmate that helps them with their near. In terms of safety, none of our patients lost two line of vision and as you know FDA says 5% or less can lose two lines of best corrected vision. 11% of our patients lost one line of corrected distance vision and that is still within what they call FDA parameters. 58% saw J2 and 89% saw 2040 or what people call J5. And when we look at the LASIK camera group, again 91% saw 2040 at near, 62% saw 2025 at near. And in terms of safety again, nobody lost two line or more but there were 12% that lost one line of potential vision in that eye. That means if there were 2020, not there 2025 or if there were 2015, not there 2020. In my opinion as long as this communication takes place there are some patients that can have the surgery done and the concept of doing them simultaneously if somebody's experienced maybe they can do it but consecutive within three months of one another is a very justifiable way of approaching this. PRK is always slow in healing but that's the case whether if you're doing a pure PRK or you're doing PRK with another modality. So whether you're doing PRK camera or LASIK camera the healing time is still the same. That does not change. I thank you for your attention. Questions for Dr. Moshe? Same depth, exact depth for both for all your PRK and all your LASIK patients. Did you adjust it? Of course it has to be adjusted. The question is what about the depth of the camera? You have to understand if you have somebody who's minus eight diapdos and the patient has 550 micron cornea and you create a flap of 100 micron for the flap part and do that minus eight diapdos. Minus eight diapdos is almost going to be another 96 to 100 micron. So you have 100 micron, another 100 micron. So you really need to put your inlet at the depth of 340 micron. That is beyond the 250 micron reserve. So if somebody is minus eight and they want to get camera and even if their cornea is 550 micron, you cannot do it with the LASIK. You have to do it with PRK. On the other hand, if somebody is 550 micron and they're minus four diapdos, you can do it. So you have to respect the residual stromal bed. Based on the level of myopia, there are some patients that if they want to get their inlet, it has to be done with PRK and not LASIK. G, fast end is always your, you always possess this great material of, it would seem to me that just trying to handle the physics of this, like I said, there's almost always a downside. Do these people notice that potentially their mesopic vision isn't quite as good? I mean, you are blocking a certain amount of that paracentral light in order to get the pinhole effect, or is this really subclinical? You really don't see patients noticing that there is a difference in that lower light situation. In order to answer that question, I will just say something. We've been all in this business long enough to see Hyperion, LTK came by, CK came by, Intax came by for many things, and many of them are gone and dead. And let's look at it, Hyperion, LTK is not here anymore. CK is here, but we use it for a different thing. We're using it for what? We're using it for Kertoconis patients. Intax, we're not using it for myops anymore, we're using them. So I use that disclaimer to say that here I am discussing camera in there, not to say that the camera in there is the best thing after the discovery of other things. The answer to your question is definitely it affects it. As a matter of fact, that eye is dimmer. So if something goes by, they can actually get effect from that. So my opinion is that if somebody says less photons are getting through that area, absolutely. And I think there's diminution of quality of vision in mesopic, and then of course we will know and they know that they show you the contrast sensitivity monocularly and there's no impact. But if you monocularly look at it, there's definitely diminution, contrast sensitivity not only mesopic, but also infotopic environment. But the thing is, the camera in there, despite all of the stuff that it has, and despite the fact that it can affect the night vision, for some patients who have learned to have a suppressed image for whatever model vision they have in the past, it doesn't bother them as much. With regard to the distance vision, I was surprised to see that many of these patients, unlike the model vision when we do, when we do model vision, patients go in their non-dominant type to 20, 40, 20, 50, or 20, 60. These patients still maintain that 20, 25, 20, 30, even though they have their J2, J3 range. Majority of my patients are J4 and J3s. There are some that are J1 and J2, maybe because they're younger and they have some accommodation reserve. But as I said, this is a technology for people who want to have their Saturday morning vision for reading their paper. This is not for somebody who wants to sit down and read the War on Peace novel. But the answer to your question doesn't matter. Thank you. That's it. Thank you.