Ab-Interno Canaloplasty: The Most Promising, FDA-Approved, Glaucoma Surgical Treatment? Part 12 of 12 of “What’s New In Glaucoma Surgery” Presentation, a continuing education course for Optometrists presented by Patient-Focused Ophthalmologist, Dr. David Richardson on May 20, 2015.

Ab-Interno Canaloplasty: The Most Promising & FDA Approved Glaucoma Surgical Treatment?

What do I consider the most promising? Interestingly enough, this is something that was just presented at a conference a month ago and I do you think this is the most promising of the minimally invasive glaucoma surgeries and its FDA approved and it’s essentially Canaloplasty but with a really elegant twist. Whereas Canaloplasty in the traditional method that it’s been performed using Dr. Stegmann’s approach, requires making an external incision (a flap) and is a very long tedious surgery. And one of the reasons why it’s not taken off (even though it works as well as it does). It’s not taken off because it just takes too long to do. Ab-Interno Canaloplasty or minimally invasive Canaloplasty surgery, does all of the things that Canaloplasty does with the exception of leaving the prolene suture in the canal. So you get Trabecular Meshwork treated – an openings created with ab-interno. Schlemm’s canal is dilated. Collector channel systems are also re-opened. You get better aqueous outflow and for those who are worried about leaving things in the eye, even if it’s just a prolene suture (and I do have patients who don’t want the prolene suture) I” say, “I think it works better if you stent it open”, and they say, “I don’t want it in the eye. I want nothing in the eye.” This is going to be a really great option.

So, this is Dr. Mark Gallardo. He actually develop this technique and let me show you this video. It’s a really elegant. He’s just-completed cataract surgery. Injects a viscoelastic in the eye. Normally Canaloplasty (now), we create an incision right here, open up the conjunctiva, start creating a flap but he’s going to do is he’s just going to create an oblique incision at the limbus through the cornea into the anterior chamber. You’ll see why he makes it in this direction rather than our usual kind of tangential. What he’s going to do shortly is insert the catheter place a gonio lens sorry I could have probably sped this up a bit. I believe that this is actually a real time video. I can’t remember whether he said it was or not. There’s the catheter. The same catheter that we use for traditional Canaloplasty he places it through that small little incision and he’s going to place up in the angle here. This here is where the catheter is actually going to enter the canal. Again instead of cutting down and entering the canal from the external approach you’re going to see in this video just a moment how he’s going to get this catheter into the canal from the internal approach and actually dilate the entire canal from the inside. Gonioscopic surgery. Put a little viscoelastic you have to tilt the head, there are couple little a maneuvers that you have to perform. Yeah I do believe that this is a real-time video. What he’s showing you there is– that’s just a a pair of I believe the Capsulorhexis forceps or Bent Needle Cystitome. It’s a piece of surgical equipment that every cataract surgeon out there has. You don’t need to buy special equipment for this. So, unlike, say Trabectome or something, there is no expense for equipment to buy. He take that he is going to create a tiny little opening in the Trabecular Meshwork and you see how it immediately get reflux. This is visual proof. Whenever you see this minimally invasive surgeries and you see that, that to me is just to prove that yes it is the Trabecular Meshwork. That’s the problem. Now he’s taking some micro forceps and just threading that catheter through the canal. He’s going to thread it all the way around and you could see… Here it is. You’re looking through the sclera at the blinking tip of the micro catheter as its passing around Schlemm’s canal. Not every surgeon has this micro forceps but you know they’re $600 – $1000. So it’s not like you’re paying $50,000 for an instrument to do something. So now he’s got the tip right there and what he’s going to do at this point is he’ll place– he’s going to reorient so he see what he needs to at the microscope. He’s going to place another instrument right here to act as a fulcrum. So this instrument will keep the catheter from ripping through the Trabecular Meshwork as he pulls it back out and dilates the canal. There’s the blinking red tip of the catheter. And it actually is, I think, pretty cool to see. This is real time, unedited. This is really fast. It’s something that any skilled cataract surgeon could do. It’s technically “that” challenging. If you can put an iStent in, you can do this. But as I show you, you would expect significantly better result. At least from the early studies. Now, he’s just removing the catheter and as he’s doing so, his technician is slowly injecting viscoelastic to dilate that canal and re-open the collector channel system and that’s it. He’s done. And that’s pretty much it. In terms of what there is to see on that video.

How Does It Work

So, how well does it work? Well this is Dr. Gallardo’s results here. And this procedure is something that’s just been developed as an enhancement of Canaloplasty. Canaloplasty has been available for a number years. We have long-term results with the Ab-Externo Canaloplasty. They look really good. At least three years out. The Ab-Interno Canaloplasty actually looks really good early on. He’s only been doing this for about six months. He’s only got a few patients, out six months. He’s got a total of 70 patients here. They started out with pressure around 20, on over two medications. And you can see it one month, around 40 mmHg on 1/2 medication. Every other person had none versus 1. Three months out, maintained at 13 mmHg. And six months, 12.3 mmHg. The 3 – 6 month points are really important points because most glaucoma surgeries, there’s still some healing going on for the first three months. I generally tell my patients we don’t really know whether your surgery was a success or failure until we’re three months out. Once you get three months out we could feel pretty good about it. And you can feel even better six months out. He’s actually taking a look to see, of these patients how many patients actually ended up with no medications at all and what were their pressures. And you can see that a fair number of these patients – 54 out at the 70 patients, ended up, in his study so far with no medications and you can see that now their pressures are doing very well in the 11 to 13 and change range. So, it’s still very, very early in terms of, “knowing will Ab-Interno or minimally invasive Canaloplasty work as well as the Ab-Externo Canaloplasty?” But if we can get the results that are even near the Ab-Externo Canaloplasty with something that’s minimally invasive, fast, doesn’t require now $50,000 up-front investment from the surgery center, my sense is that this could really change the field of how we treat our patients with glaucoma. How early we take them to surgery, could even impact all these things that are not yet FDA-approved, are something that we’ve want to consider if everyone of these stents that aren’t approved comes out we know what they’re all going to cost. Everyone of these stents is going to be at about a thousand dollars if not more to implant and these are things that fortunately, I’m not going to be the one that has to make these decisions in terms of what’s covered and what’s not but it’s nice to know that we have all of these potentials. Some of which will be FDA-approved others not. Even the ones that are FDA approved are going to take years before they come across our shore.

In the meantime I’m hoping that our patients can benefit from Canaloplasty whether it’s myself doing the surgery for somebody else, makes little difference to me. I would just like to see this pick up and I know that Canaloplasty has not been as popular among surgeons simply because at the time constraints and how technically challenging it is. So this to me is just incredibly exciting because there’s so many patients out there with open-angle glaucoma who could benefit from a minimally invasive, effective surgery that doesn’t require a huge upfront investment by either the surgery center, the surgeon or the patient, or the patient’s insurance. And as of today, most insurances including Medicare, do now cover Canaloplasty. They don’t specify whether it’s ab-externo or ab-interno. That’s not in the coding, as far as I understand. The only ones that we still have trouble with – and this will come as no surprise to anybody, is Blue Cross. But other than Blue Cross – patients who have other insurance including Medicare, Canaloplasty is covered.

Anyway, I hope that you share some of my excitement for many of these glaucoma surgeries. I hope that the more exciting, more effective surgeries will become FDA-approved. In the meantime I think it’s important to recognize that there are things that we can offer to our patients that are not – right now, as of today, as risky as Trabeculectomy or glaucoma drainage devices. I’ll now open it up for questions. By the way, one thing before questions is — just about all of the devices that I mentioned tonight, I have more detailed references including what the current studies that are available show, in terms of how effective they are, on my website: New-Glaucoma-Treatments.com. Anybody who does want to research a bit more, I’ve done all I can to summarize the currently available research. I haven’t yet added the results from the latest conference which was BAERVELDT® but I’m working on all right now.

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