Congenital and acquired defects of the iris may have a marked negative impact on vision and quality of life. Some defects, particularly those that are small and peripheral may be managed by suture closure, custom contact lenses, or perhaps, corneal tattoo. However, larger defects require use of artificial iris implants. Those devices will be reviewed. In particular, the Humanoptics custom device affords excellent cosmesis and may be placed in the capsule bag or ciliary sulcus. Management of iris defects is most gratifying as it has great positive impact on patients’ lives.

Lecturer: Dr. Samuel Masket, Advanced Vision Care, Clinical Professor, David Geffen School of Medicine, UCLA, California, USA

Transcript

DR MASKET: Well, good day to everybody. We’re going to cover the important subject of iris defects, and the impact that they can have on the lives of individuals, and how we can help them. We’ll do this in a PowerPoint format. As you know, you will have the opportunity to ask questions. And hopefully we’ll have enough time to cover the subject well. And please don’t hesitate to let us know if there are concerns. So this is an important subject. And the reason is that the loss of iris tissue — can have a very significant impact on the individual. It not only affects the quality of vision, because you don’t have the pupil to modulate size and the amount of light that comes in. It causes horrific glare, can have a cosmetic defect varying with the color of the iris, and all of these things can have a significant impact on quality of life. Now, we can help some individuals with this problem in non-surgical means. Some irises can be repaired by suture, and others may require the use of an artificial iris device. So I have a question that I would like to have you pay attention to. And that is: How can we help some people non-surgically? So question one: Non-surgical options for defects include dark glasses, custom use of contact lenses, corneal tattooing, which I will consider non-surgical, or all of the above? Well, I think the answer here should be all of the above. And most people should agree with that. Given what technologies are available, dark spectacles may be the only device available, but I think all of those can be helpful. Now, when we think about suturing a defect in the iris, how many clock hours do you think we can reliably close by sutures? Question two: One, two, three, or four clock hours? I’m curious to see your response to this question. So how many clock hours of iris defect can reliably be closed with sutures? One, two, three, or four? So many of you voted for significantly more than one clock hour. Let’s take a look at some examples, then, and we’ll ask the question a little bit later. So this is a patient born with a congenital coloboma. An incomplete coloboma of the iris. Now, in this instance, as a phakic eye, it’s a little bit risky and tricky. It can damage the lens. You can see in this photograph, we can reliably close one clock hour. Let’s take a look at this example. This is a roughly two-hour defect from prior trauma. And we can see here that this patient was subjected to suture closure, but we still had an insignificant notch in the pupil. But unfortunately a large area still here, present where light comes in, and even though the aesthetics are improved, the function may still be somewhat difficult. So let’s talk about iris suturing. Our indications would be to repair peripheral and pupil margin defects. We also use iris suture fixations to fixate IOLs, either primarily or secondarily, we can do cerclage for the atonic pupil, a somewhat tricky surgery, but it can be done, and we can also do iridodialysis. Now, this may repair several clock hours of iris defect, whereas a full thickness defect can really be only done reliably barely up to two. And there are certain methods. The McCannel technique, where the iris suture is drawn out through a common paracentesis and tied externally, the Siepser sliding knot method, where the sutures are tied internally, and by and large the most widely available and probably best suture material for closing iris defects is 10-0 polypropylene. Also, it would be nice to have 10-0 polyester, but that has unfortunately been taken off the market, for lack of use. 9-0 suture material for the iris is a little bit rigid, and can tend to cheesewire iris. Particularly damaged iris. So we should really limit it to 10-0 material. Unfortunately 10-0 nylon tends to biodegrade, so 10-0 polypropylene is the material of choice. Here is just an example of a postop cerclage. It’s tricky to get good cosmesis and appropriate pupil size, but it’s a useful technique. Here is an example of a patient who has an obvious malpositioned IOL. It’s a three-piece lens, inferiorly malpositioned. We can see that there’s already an opening in the posterior capsule, and what we’re gonna do in this instance — we’re going to grab the lens through a paracentesis, after we do a bit of an anterior vitrectomy. Any vitreous that’s coming through into the anterior segment should be removed initially, so that you’re not dragging on the vitreous base. And then with some protection of OVD and OVD also to try and prevent further vitreous prolapse, the lens is then grabbed with microforceps, and then lodged into the pupil plane, leaving the loops posteriorly, and then with miotic, the pupil is brought down, the lens is then captured, in the anterior chamber, where the loops are in the posterior chamber. And then the goal here is to suture fixate these loops to the iris. Now, we really have the option of whether to use McCannel or Siepser. In this video, we’re going to demonstrate the Siepser method. So a long 10-0 polypropylene suture then comes through a paracentesis, goes underneath the iris, and then underneath the loop of the lens, out of the iris, and then it can either come out a paracentesis, or just punctured through the corneal tissue. So we now have the same procedure, repeated on the nasal side. So now we’ve got these long sutures, and now we need to make a knot. Now, unfortunately, 10-0 material is a little difficult to see, but you can get the idea. Here I’m using a Bonn hook to reach across, and I’m going to bring the long end of the suture out the paracentesis, so we have three pieces of suture here. We’ve made a loop of the distal suture, and we have the proximal suture end. So I’m going to make three loops here, I’m going to grab the proximal suture end, and then from the opposing puncture, I’m going to tie the suture gently, watching the tension on the knot here, around the loop of the lens. Now, recently Agarwal has published that if you just make four loops, you don’t have to make any other knots. Many of us make a 3, 1, and 1 or sometimes a 3, 2, and 1 approach. We take a loop of suture material from the part of the suture that’s tied or from the iris, and then again slide the knot inside the eye. And then the knots are cut with a microscissor, because we do not have any large incision. And they’re cut internally. And then the optic will then be prolapsed behind the iris, and with a little bit of manipulation, we’ll make sure that we create a round pupil. So that is the Siepser sliding knot technique. Now, iris suturing does have a tendency to cause the pupil to be a little bit ovoid, or cat-eye-like. But it can be fixed by stroking the iris that’s entrapped superficially in the knot. As we’re gonna do here. You can also do this with microforceps. And then the surgery is essentially completed. We have the iris fixated, to the loops of the lens. And let’s move on then to the next example. So here’s an example now of a patient who has a malpositioned anterior chamber lens, and a defect in the sphincter from prior surgery. So in this situation, just as you’ve seen before, we’re going to repair the defect at the iris sphincter using a Siepser sliding knot. And again, you’ve seen us do that. We withdraw the loop of the suture. Tie it then to the proximal end. Now, unfortunately, it’s a little bit difficult to see 10-0 suture material, but Alcon has a wonderful teaching video using a large piece of paper and rope. And it’s available for you, if you contact Alcon. This is the McCannel technique. We’re going to go through a puncture, under the iris, under the loop of the lens, in this case an anterior chamber lens, and we’re going to bring both ends out through a common paracentesis. And this is tied externally 3, 1, and 1, at the level of the paracentesis, and then it is cut. The same thing here — both ends of the suture are brought out, and then this anterior chamber lens has been fixated to the iris with McCannel suturing. Here’s an example also — this is a patient who sustained 20 years earlier an injury at the limbus. And the iris drawn into that area, and postoperatively, we can see by doing suture repair and a little bit of a pupilloplasty, we can create a central round pupil. So I’m gonna ask the same question again. How many clock hours of iris defect can reliably be closed by sutures? 1, 2, 3, or 4? And for the purposes of discussion, it’s gonna be a complete from the sphincter to the limbus — how many clock hours can reliably be closed by sutures? And I can see I have influenced you, which is very good. That’s very good indeed. Again, when it comes to an iridodialysis, we can close five, six hours, even more. But once you involve the sphincter, reliably you can only do 1 to 2 clock hours. Very good, thank you. Here’s the example we showed before. We couldn’t get good suture closure, and this is an artificial iris device made by Morcher. Had I had that, it would have fit perfectly in here. While the aesthetics of the black PMMA are not very good, the function is excellent. So Morcher makes a variety of PMMA devices that can go inside the capsule bag at the time of surgery. This is an original device, and two of these are placed inside the bag, overlapping. I refer to these as the piano keys, but people call them a variety of names. I modified it so that these fins, so to speak, would be longer to create a smaller pupil. In this, the original Rasch-Rosenthal device, a 6 millimeter pupil is created, but I modified it to 3.5 because we needed to cut down more light. Here’s an example. We can see this is an atonic pupil from a prior injury, and at cataract surgery we placed an artificial lens, and two of those devices inside the capsule bag. And we can see we still have this atonic pupil. So aesthetically, the black PMMA doesn’t really improve the eye, but functionally, it has a marked improvement for the patient. And here we can see how this can be accomplished surgically. So at surgery, the cataract has been removed. There’s an intact anterior capsulotomy, circular tear. You can only do this if you have an intact posterior capsule and an intact circular anterior capsulotomy. And I’m enlarging the incision to 4 millimeters, which is what’s necessary, to place these fins. As I mentioned, these are done in pairs. The black PMMA from Morcher is very, very brittle. And these are available to you, except in the United States. But these are available otherwise worldwide. They have not been FDA approved, because they have not been subject to appropriate study. You can see here the first one goes in the bag. And again, it looks like piano keys to me. The second one is a little bit trickier to place, because the fins can get hung up with the original one. However, under copious visco agent, and if you put the second one underneath the first one, you can then position the two of these inside the bag and rotate them around so these little fixation holes are underneath the upper lid, and then the artificial lens is implanted on top of that. Silicone. Because it’s much easier to place the lens over the keys, rather than underneath them. Alternatively, you could place the intraocular lens first. However, that becomes a little bit more tricky, as the artificial iris devices could get hung up with the loops of the lens. And here then at the close of surgery, we’ve made sure that we’ve separated the fins. So that we have this complete vignette and then an incision of 4 millimeters should be closed. So let’s move on now to a few other examples. Here’s an example of a patient who had significant subluxation of the lens. And here with a variety of devices, including the artificial iris, we can improve their appearance. Now, these patients could have been helped by cerclage, but I don’t like to do it at the same time as complex cataract surgery, because there’s a risk of damage, and then all these devices might have to be removed. Morcher makes a combination device with a black artificial iris and central optic, with loops — and these little eyelets in the loops of the lens, so they can be suture fixated, and here’s an example of one going into this eye, where we had this defect in the iris, all the way out to the limbus, and this is the optic and the artificial iris here. And here the aesthetics are fine, because the patient has a dark brown iris. Now, from the standpoint of aesthetics, Ophtec — Morcher is a German company. Ophtec is a Dutch company. Ophtec makes artificial lens-iris combinations in three colors. Green, blue, and brown. They tend to be very vivid, not really true colored, and a little bit smaller than our needs to block all of the peripheral light. Nevertheless, they are available worldwide except in the United States. This is the Ophtec model 3-11. And again, varying with the color of the patient’s fellow eye or fellow iris, these can be satisfactory. But not the absolute aesthetics that we would like. And again, because they’re a little bit small, some light can come around, bothering the patients. And because these — just like the Morcher devices — are rigid PMMA, they do require large incisions. So here’s your next question: Limitations of the Morcher and Ophtec devices for aniridia include: Less than ideal cosmesis, large incision size, poor color matching, inadequately sized to block all light. So these are the limitations of the Morcher and Ophtec devices. These would include less than ideal cosmesis, large incision size, poor color matching, inadequate sizing, or all of the above. And yes, the majority of you agree with me that all of the above is appropriate. So let’s take a look at a more recent development in artificial iris devices. This is the HumanOptics silicone foldable artificial iris. It does not come with a lens. As we can see here in a cross section, it is very thin material. A quarter of a millimeter at the edge. And 0.4 here, at the pupil margin. It comes 12.8 millimeters in diameter. And we trephine it to the size we want, and all of them have a central 3.35-millimeter pupil at the plane of the artificial iris, and with magnification, as you see, the entrance pupil seems to be somewhere between 3.8 millimeters, varying with the depth of the chamber and the curvature of the cornea. These are matched to the fellow eye or to photographs, in case the patient needs two artificial irises. So the patient could have any color iris he or she wants, and notice these markings are really quite natural in their appearance. It is silicone, rollable and foldable, so we can insert it very much like we insert an artificial lens. It also comes in two basic varieties, of just pure silicone, for implanting into the capsule bag, or into the ciliary sulcus on top of an existing lens. Or it has a fiber mesh that’s put into the stroma, so that, should we need to sew it to the sclera with heavy suture material like Gore-Tex, the sutures won’t cheesewire the artificial iris. So when we order them — as we will see later on, we can order them with or without the fiber meshwork. And we’ll take a look at some examples of how we can fixate this to the eye. There are five basic ways. We can put it inside the capsule bag, either at the time of cataract surgery or subsequently, if we can reopen the capsule bag, just like putting in capsule tension rings, or other in-the-bag devices, you must have an intact posterior capsule, and you must have an intact 360-degree circular tear anterior capsulorrhexis. But the capsular bag will be the most desirable place if we have an opportunity to do that, if the patient needs cataract surgery at the same time. Or we can put it in the ciliary sulcus, underneath an existing iris or an existing defective iris. We can sew it to an IOL and implant that at the same time, we can sew it to the sclera, or to a native iris remnant. Notice here I never recommend placing it in the anterior chamber. Artificial irises should never be implanted in front of the existing iris into the angle. And we’ll talk about why that’s a problem later on in the presentation. And we’ll take a look at examples of each of these methods. Let’s take a look at bag fixation. This is a patient who had an attack of angle closure glaucoma, and infarcted her iris. So you can see this transillumination defect. She developed a very significant cataract. And unfortunately also required glaucoma filtration surgeries on two occasions. I used a femtosecond laser to make the anterior capsulotomy and to subdivide the dense cataract, because she also had endothelial cell loss, and I wanted to be as protective to the eye as I could. We’re teasing out the laser capsulotomy, and now we’re using a chop method to remove the pieces of the lens that the femtosecond laser helped to predivide for us. In dealing with eyes with compromised endothelium, we want to make certain that we add OVD — a retentive type, dispersive type, to protect the endothelium on several occasions during surgery. Here now, where the capsule bag has been emptied, I’m removing the subcapsule lens epithelial cells, and a capsule tension ring is being placed. We always place a ring with the in-the-bag artificial iris, so that later on we can fixate it to the sclera, should it be necessary. As you just saw, I stained the anterior capsule, so we can see it when we’re placing the lens. And I’m gonna trephinate this artificial iris down to 9.5 millimeters, which is typically what we’ll place inside the capsule bag. We want to make sure that we’re trephinating a perfectly round piece in the center, and then that periphery is not used, but I give it to the patient. They enjoy that. This device is then folded, kind of like Napoleon’s hat, in a trifold, and this is placed inside a silver series cartridge, with OVD. The artificial lens and CTR are already in the bag, and then the iris is then gonna be implanted into the capsule bag, underneath copious OVD, to protect the endothelium. So additional OVD is used to help unfold the iris, and then I’m gonna tuck it underneath, and you can see the stain of the capsule, which is why we stain the capsule just before placing the iris inside the bag. And now with manipulation, the iris is now inside the bag. The OVD is removed. And I’m suturing this incision because of the filtering bleb, and then surgery is completed. Notice the artificial iris is lighter than the residual iris, but matched to her fellow eye. And here the cosmesis is excellent. And she was returned to 20/20 vision. This is another example. Here’s a two clock hour defect, and a cataract is present. This was a work-related injury. Had a primary repair. Induced horrible glare to this highway patrolman, who we can see postoperatively — an excellent aesthetic as well as functional result. This is a patient who sustained an injury 30 years earlier, and had this laceration here. She lost much of her iris. This could not be repaired by sutures. Very dense cataract. This is what the eye looked like postoperatively. And then if we compare this to the uninjured fellow right eye, and the involved left eye here, you can see what a remarkable job the artisans in Germany do, in matching the new iris to the patient’s existing iris. And you can only imagine how elated patients are with both their appearance as well as their functional outcome. As I mentioned, bag fixation is the most desirable, but not always the most possible. We also can place it in the ciliary sulcus. Here’s an example of a patient who had cataract surgery, with a temporal incision, but due to floppy iris syndrome — she did not tamsulosin — she had a large transillumination defect and was very, very unhappy. Now, we have two choices here. One, and I’m measuring the white to white. Typically I make the artificial iris in the sulcus 1 millimeter less. And we can see here this is fiber free. It comes as 12.8, and I believe I trephinated her to 11.5, half to 1 millimeter less, and we want to make sure we trephinate it centrally, and the peripheral part is not used, but given to the patient. The same thing here. The trifold. And you want to make sure you don’t get OVD on the artificial iris. It gets very slippery. Here you do place it under OVD into the silver series cartridge. This requires a 3 millimeter incision. And if you fold it in that fashion, it’ll open up right side up inside the eye. Another option in this case might have been to open the capsule bag and place it inside. But that would have been difficult, given that she had capsule contraction. So here the artificial iris is implanted underneath the existing iris. And kind of teased into the ciliary sulcus, or posterior chamber. And sometimes it’s helpful to use microforceps. Coming from an opposing paracentesis. As you can see here. And then it’s just a matter of removing the OVD, and the surgery is then completed. And you can see here the patient chose — I gave her the option of actually having me remove this tissue, with a vitrector, but it was her preference to leave the iris. She was just interested in a functional result, and she was thrilled not to have the excess light coming from the temporal side. Here’s another series of examples. This is a patient who had ICE syndrome. Already had a tube, cataract surgery, corneal transplantation, but has this very, very unsightly iris, and glare inferiorly, and this is his fellow left eye. So he was very unhappy with the appearance, as well as the function. And then here that was placed underneath his existing iris, and you can see again an excellent cosmetic result. We can also sew the artificial iris to the intraocular lens. And implant them as one unit, into the eye. This requires sewing to the sclera. This is an example of such a patient. Sustained an injury at age 1, loss of lens, loss of iris, corneal scar. This was a perforating cat scratch at age 1. It’s interesting. The patient is a 50-year-old male. And yet, when we talk about his problem, even now, postoperatively, he still gets very emotional, even cries when he thinks about it, even though he was only a year of age and has no recollection of the injury itself. Just the residual problem associated with the eye. Loss of vision associated with aphakia and amblyopia. And glare. And here we elected to repair the iris and lens at an initial setting and to do a corneal transplant as needed later. This is a method called the Hoffman Scleral Pocket, where we make a groove in the peripheral cornea, and then notice, by the way, this iris is with fiber. And we dissect toward the equator, creating a partial thickness scleral pocket, so we can suture to the sclera without taking down the conjunctiva. Useful in patients with blebs or scarring. So here a lens is going to be sewn to the iris. This is a Bausch and Lomb MX60, and we choose it because it has these little eyelets. And I’m gonna use 9-0 polypropylene to sew the lens to the artificial iris. After the artificial iris has been cut to appropriate size. Again, half to one millimeter smaller than white to white. Although there are intraocular calipers that can be used to measure more precisely. And once we’ve sutured that, we then have to attach some Gore-Tex suture. Notice that the lens was placed upside down, because now when we revert it, it will be right side up. So we’re very careful to make these sutures as symmetrical as possible. So that we will get good centration of the iris-lens combination inside the eye. And this is Gore-Tex suture. It is off-label. It is really not approved for ophthalmic use. But it’s an excellent material. And hopefully in the future, that labeling will allow us to use it in any setting. And now after we’ve prepared the iris and lens combination, in surgery, we’re gonna separate the iris from the existing lens remnant. So that we have room in the posterior chamber to place the iris-lens combination. So we have to do this for 360 degrees. And I’m placing dilute triamcinolone to stain vitreous, and we’ll do an anterior vitrectomy. Also try and remove some of the residual iris with the vitrector, because it’s just really not necessary. Now, through the Hoffman pocket, we’re going to use the trocar to make an entrance into the globe, about 2.5 millimeters posterior to the limbus. And the purpose of this is so that we can reach in and get our sutures. A frown-shape incision has been made on the temporal side. We’re going to enlarge this to about 8 millimeters, so that we can place the lens-iris combination. And then here we’re gonna reach through the Hoffman pocket, with microforceps, and take the free ends of the suture so that the sutures are passed into the pockets, before we will bring the device into the eye. And one has to learn how to do this with care, so that you don’t twist the sutures. That creates what I like to call “a world of hurt”. So now the sutures have been placed. We make sure they’re not twisted or knotted or looped, and then under copious visco agent, we’re going to place the iris-lens combination, tuck it behind the existing iris, and then reach into the Hoffman pocket to internal use the suture ends. So that now the sutures are inside the pocket. And then we will adjust the suture tension and we’ll tie these gradually, so that we have nice centration of the iris-lens combination, and then do a little bit more vitrectomy. Just to be certain that we haven’t brought vitreous forward. I like to remove existing Soemmering’s rings. Once I’ve placed the iris, I don’t have to worry that my manipulation will cause them to fall into the posterior segment, where they will be very difficult to manage, and they can cause inflammation. They leak protein once you’ve opened them, so I tend to remove them. And then we’re going to tension our sutures, and the knots are cut and then tucked into the Hoffman pocket. And this is one method of fixating to the sclera. So now we have to close, obviously, an incision of this size has to be closed, but then at the end of surgery, we’ve got a marked improvement in function and cosmesis. I’m using fibrin adhesive to seal the pockets and seal down the conjunctiva as well. So that’s an example of sewing the lens and iris in combination. This patient had also decompensated cornea, much iris missing, and here postoperatively, we can see he’s had a DSAEK, as well as an iris lens, and you can see these are the 9-0 prolene sutures that have fixated an iris and lens together. And this is the uninvolved eye for that patient and the involved eye. And again, I’m overwhelmed by the cosmesis. Note that the residual iris is always darker, and it’s a mystery as to why. And today I probably would have removed more of this with the vitrector, for cosmetic purposes. We can also sew a lens to the sclera. Now, here’s an example of a patient who’s lost her iris about three months following cataract surgery. Blunt trauma. The iris all escaped through her temporal incision. So she’s now aniridic but still pseudophakic. And in a situation of this nature, once we place the artificial iris, it’s going to be difficult to fix the lens. So I’m doing endocyclophotocoagulation, because she also had a little bit of uncontrolled glaucoma. What I’m doing initially is I’m going to sew the existing IOL loops to the iris, so that should the zonular fibers weaken late, I won’t have to worry about a malpositioned IOL behind the artificial iris. And given the fibrotic nature of the anterior capsule, I didn’t think that we could successfully reopen the capsule bag, and also her posterior capsule was open. So the loops — and this is a three-piece lens — the loops are going to be fixated with a lasso of 9-0 polypropylene, after which we’re going to fixate an artificial iris above the artificial lens here. So let’s move this along just a little bit. So now we’re going to trephinate the iris to the desired size. And I’m making marks about 2 millimeters apart. And a millimeter back from the edge. And the double armed Gore-Tex suture, just as we saw earlier, in a horizontal mattress fashion, and we’re marking 180 degrees apart at the limbus, to make certain that we are central. 4 millimeters apart, 2.5 millimeters back. Where we’re marking, and just placing some OVD on the cornea. Here now using an MVR blade, we’re gonna tunnel anteriorly, so that we create a little scleral pocket to hold the sutures, and just as you saw in the previous example, we’re going to reach through the sclerotomies to have the sutures attached to the sclera, before the iris is implanted. Now, I know it’s very difficult to learn this technique in a short video. But this webinar will be available, and you’ll be able to study it more carefully at your leisure. Also I have a YouTube channel under my name, Sam Masket, and a lot of these videos are available for you there, and you can study them again. Also, at the end of this presentation, I’ll give you my email address, and you can feel free to send questions to me. So all four sutures are passed in, again, with care taken not to twist them, tie them, knot them. And then since the iris is going without a lens, it can be implanted through about a 3.5 to 4 millimeter incision, which we’ve made here. And then it’s gonna be implanted into the eye. The sutures will be drawn up, and again, there’ll be tension. And they can be adjusted. You can make slipknots in a 1, 1, and 1 fashion, so that you can adjust the tension to make sure that you create excellent centration of the artificial iris device. Here again, the sutures are being tensioned. And once they’re tied, we’ll then bury them into the sclera. The knot will be buried. And once the knot is buried, we can then cut the sutures and bury the knots in the ends, in those little scleral tunnels that we created with the MVR blade. And here you can see the patient postoperatively. The aesthetics are truly remarkable. And these are the Gore-Tex sutures, holding it to the eye wall. And then there’s one final method. We can sew it to the native iris remnant. This is a patient who sustained a fish hook injury at age 5. You can see he lost a significant amount of the fellow iris. Once again, darker than the fellow eye. But you see this white spot in the lens. Unfortunately this probably was a defect in the capsule, so that at cataract surgery, he’s got this partially resorbed cataract — at surgery, the capsule tore out, the anterior capsulotomy. So we couldn’t implant the device and the lens inside the capsule bag. So in this situation, we decided to sew first an artificial lens to the eye wall, and then the artificial iris also would be then sutured to the existing iris. Creating a little groove and pocket to suture the lens to the sclera. And once again here, we chose a B&L MX60 IOL, because it has this little eyelet that allows us to hitch — make a cow hitch — of the Gore-Tex suture. And these ends are then pulled out through the sclerotomies, and again, if you make your markings properly, you’ll have a nicely centered lens. So the Gore-Tex suture is then buried in that groove. And now we’re measuring, again, white to white for the appropriate sizing. And once again, you’ll see fiber-free, because this is going to go into the ciliary sulcus. Now, I did need to pass a suture through it. But I’m not gonna use Gore-Tex in this situation. And therefore I’m significantly less concerned about cheesewiring. So this is then placed underneath the patient’s existing iris. And we’re gonna use a Siepser sliding knot method. Just as you saw much earlier in the presentation. So this is 10-0 polypropylene. We’re gonna pass it through the paracentesis. Through the iris. The natural iris. Underneath the artificial iris. And then back out through the native iris. And then out a paracentesis here. And then we’re gonna draw out the suture, just like I showed you earlier. And we’re gonna tie it in a sliding knot fashion. Three loops in one direction. And then it is fixated to the existing iris. And the main incision closed. And then once that’s done, we can cut the sutures. And we’ll bury the knots of the Gore-Tex and close those conjunctival flaps. So this is now what that patient looked like postoperatively. And of course, excellent aesthetics, and excellent function. We need to talk a little bit about congenital aniridia. This is a very difficult disease, because it affects virtually every part of the eye. It’s a mutation of the PAX6 gene. As you know, one out of 70 patients will have a Wilms kidney tumor. Because there’s macular underdevelopment or hypoplasia, often they have nystagmus, horrific photosensitivity, I think the biggest problem is the corneal stem cell deficiency, where they will lose corneal clarity, ulceration, scarring, et cetera. Their cataracts are extremely difficult to manage, because the capsule is very, very thin. They often have zonulopathy, glaucoma, a small percentage will develop aniridic fibrosis syndrome as a result of surgery, so virtually every aspect of the patient’s eye and life can be affected by this, and often these are the types of eyes that we have to operate, and they can be very challenging, but the same principles apply. This is a patient with congenital aniridia in between surgery. Fortunately his corneas were similar to normal. Just a little bit of stem cell deficiency peripherally. So here the one eye has been operated. And this is just prior to the fellow eye surgery. He chose to have an eye color very much like his mother. So let’s take a look at question five. Advantages of the HumanOptics artificial iris include: Variable size implant, excellent cosmesis, able to be implanted through small incisions, may be attached to eye tissue in a number of locations, or all of the above. So variable size implant with where you want to place it, outstanding cosmesis, able to be implanted through small incision, may be attached to several eye tissues, iris, sulcus, sclera, or all of the above. And yes, the great, great majority of you said all of the above. And I surely agree with that answer. So that’s why we like that device. I need to talk to you, however, about a device that is implanted into the anterior chamber and fixated in the angle, and there are a couple of products out there. The most common one is BrightOcular. This device is implanted here solely for the purpose of cosmesis. If you remember I said very carefully the HumanOptics and Morcher and Ophtec devices are never placed in the anterior chamber, never fixated in the angle. You can see here the cornea is decompensating. There’s a very hazy view. These devices will destroy virtually every tissue in the anterior segment. They cause the cornea to decompensate, iris atrophy, horrific glaucoma, most often requiring tube implantation, and cataracts. So we see patients who have had this surgery outside of the United States. Who come to us really with significant vision loss, pain, and what have you. It’s so unfortunate. These are placed only for cosmesis. So I don’t want you to confuse this device with the HumanOptics device, which, again, is designed to be attached in the eye, but never in the anterior chamber, never angle-fixated. So if you see those BrightOcular devices in patients, please let them know that at some point they need to be removed, probably the sooner the better. And if you can do anything in terms of public education, please do not allow patients to have those devices implanted. There is a growing body of literature indicating a difficulty. Now, before we take any questions, I just want you to have my personal email here. If you have questions, I don’t mind if you write to me. Or if you would like me to send videos, we can do that as well. But you can have this webinar available to you. And also under my name of Sam Masket, you can go on my YouTube channel, where many of these videos are present. I’m happy now to take questions. We have just a few minutes remaining in the webinar. So that if you have questions for me, I’m happy to take them.

>> Thank you very much, Dr. Masket. I don’t see any questions in the queue right now. So what I’m going to do is share my screen with the questions that were asked at the time of registration. And perhaps we can go through those, as we’re waiting for some live questions to come in.

DR MASKET: Sure, excellent. Let’s do that.

>> So you should have my screen now with those questions.

DR MASKET: I’m doing a little — here we go. I can see them now. So first question: Ways of preventing uveitis after artificial implant. Well, as I mentioned, if the device is placed inside the capsule bag, which would be the most desirable location, it’s not going to occur. And perhaps this question was related to the BrightOcular device. Which if implanted in the anterior chamber will definitely cause uveitis. But if the other devices are placed appropriately, uveitis will not occur. Now, if there’s ischemic optic atrophy around iris defects, how do we repair it? If it’s an old injury, it’s not necessary to remove it. However, if you’re talking about a very fresh injury, where the iris is atrophic and unfortunately open, through an open incision, that tissue must be removed, because it could be infected. If you have a significant degree of iris atrophy, then suturing is not going to work. So you can attempt suture closure, but if it’s significantly atrophic, more likely than not the sutures will cheesewire. How does color of the iris affect vision? It really doesn’t. So I’m not sure that matters, unless we’re talking about patients who have albinism, where there’s a significant loss of the iris pigment epithelium, where they’re going to have significant photophobia. Are there iris implants available for aniridia? And indeed, we’ve looked at three different devices, Morcher, Ophtec, and HumanOptics, that can be used in the aniridic, either congenital or acquired forms. There are also devices made in Russia, but I have no personal experience with them. And next question is: How can iris defects affect vision? Well, as I mentioned to you, terrible glare, loss of focusing are the primary things that iris defects will induce. Question here on optical correction in patients with eccentric pupils. Will surgery be indicated? You know, actually it is remarkable to me that eccentric pupils rarely cause vision defects, unless they are markedly off to the side. It does create some issues with angle Kappa, and the type of lens you would implant. I would not use a multifocal lens in a patient who has an eccentric pupil. But we can fix eccentric pupils. We have suture opportunities, we can use the vitrector, and we can even use intraocular light cautery to position and move the shape of the pupil. How is the accessibility of the HumanOptics device? It is available worldwide. It is now FDA approved in the United States. The problem is that it is an expensive device. And we participated in our practice in the FDA trial, and even in that trial, patients had to spend $5500 US for it. Now that it’s been approved, the device now costs $7700 in the US, and that’s a sizable amount of money. Axenfeld-Rieger syndrome. Here in this condition, you will have many, many problems with the front of the eye, including the iris. You can replace the iris at the time of cataract surgery. Notice that I mentioned that the iris can only be placed at the time of surgery, for cataract, or if the patient is already pseudophakic or aphakic. These are never placed in phakic eyes. Option for mydriatic iris by trauma? Yes, as I mentioned, depending on the nature, if you have an atonic iris, you can do cerclage, or you can also implant an artificial device. 360 degrees of iris damage, I think, can only be helped with an artificial iris. I showed you an example of the coloboma. We also looked at traumatic iris loss. Now, when suturing in the inferior scleral defect, do I prioritize closing the peripheral defect or the pupil? Well, that’s a very good question. But the answer is really both. If you leave a large inferior defect, light from below will come in and be very bothersome to the patient. So that I really think you need to prioritize both, and if the sector is large enough, two clock hours or more, I’m going to want to use an artificial iris device. I think melanoma is really not a topic for conversation here. Now, what causes an iris defect? Well, iris defect can be either congenital — we spoke about congenital aniridia. There are also conditions such as ICE. Or iridocorneal endothelial syndrome. Which can cause progressive loss of iris tissue, or what we used to refer to as central iris atrophy. And then there’s any form of trauma. Be it surgery, as we saw in an example of tamsulosin-type defect, perforating injuries, blunt trauma. So there’s no shortage of ways in which we can have defective irises. Are there any live questions?

>> Dr. Masket, I see two live questions in the Q and A queue. If you look at the bottom of your screen Q and A.

DR MASKET: All right. Let’s take a look at those in the remaining couple of minutes. How can we manage mild inflammation? Well, again, varying with the cause, if it is due to the artificial device, then it’s unlikely. We’ve not seen that frequently. But the device would have to be removed. If it’s very mild, one can always use steroids, cycloplegics, and NSAIDs. But it has to be limited in time. If it’s an ongoing chronic problem, that can lead to glaucoma, that can lead to cystoid macular edema, so it depends upon the etiology. And if it’s due to a device that is rubbing on tissue, then it should be removed. And I just have a — I see a comment from a doctor — it looks like a Russian name, thanking me for my lecture. I thank everybody for their attention. I think we’re virtually out of time, but remember, I did give you contact information, and I really don’t mind if people contact me. So I hope this has been useful to you. And I appreciate your attention to the subject. And again, feel free to contact me. And I wish everyone luck in dealing with these patients. They can be very difficult, but among the most rewarding patients that you’ll ever have, because you’ll really make an impact in their lives.

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December 28, 2018

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