Sean Ianchulev, MD, MPH, Professor of Ophthalmology, Director of Ophthalmic Innovation and Technology, New York Eye and Ear Infirmary, Icahn School of Medicine, Mount Sinai, New York, NY, talks about a new, less invasive, cataract surgery procedure that boasts a faster patient recovery time, using a system called miLOOP.
Interview conducted by Ivanhoe Broadcast News in October 2018.
I want to start by asking about cataracts. For patients who are struggling, can you give me a quick description of what is happening in the eye and what patients are going through?
Dr. Ianchulev: Sure. Cataract surgery and cataract is a problem, it’s very common today in society. In the US we do about four million cataract surgeries every year. I think by now a lot of our patients are very educated about cataract surgery. They’ve either had somebody in the family already have cataract, and for many the advancements that have happened over the past fifty years in cataract surgery have really simplified the procedure to make it something that one can solve over a day. You don’t have to be admitted in to hospital and for many people this is more of a procedure rather than major surgery. Cataract really is a process where the optical system of the eye, the one that focuses the image around us and which has to be as a focusing or lens system a very clear transparent medium. Over time just like our hair turns white, the lens of the eye becomes cloudy. When it becomes cloudy we are starting to experience blurry vision, very often the first symptoms are when people drive at night they see a glare, when they read they have more difficulty with the smaller print. Of course in the old days when we didn’t have the surgery, and if you go back almost fifty to a hundred years ago, patients went blind from cataracts. We still see that, actually it’s a tremendous problem worldwide because the burden of this disease is about twenty five million patients are blind from cataracts, worldwide. This is something today we can solve with a thirty-minute procedure, but not everybody is as lucky as we are here in Manhattan or in the US and the developed world. There is a big burden of blindness out there where people cannot see their children, they cannot see their food, somebody has to take care of them because they have cataracts. For us here in the developed world it’s something that we can solve easily. Patients have cataract surgery using technology that in fact, the modern day cataract surgery is something that developed out of here, out of New York and New York Pioneer. New York Pioneer is the oldest specialty hospital in the US, we’re going to turn about two hundred years, bicentennial, in a couple of years. And in New York with Dr. Kelman invented the phacoemulsification technology, which is what we currently use for cataract surgery.
How is cataract surgery performed? What is the traditional way?
Dr. Ianchulev: The traditional way, the way we used to do cataract surgery fifty years ago was to create a very large incision, which opens up about half of your eyeball because the cataract is pretty big, and then you take it out through that ten or eleven millimeter incision, which in ophthalmology speech is huge. Because we work with microns, when you talk about ten, eleven millimeter it’s almost half of your eye where you open the eye to remove the cataract and put a clear lens implant. Today, the standard of care in the developed world is phacoemulsification, we use an ultrasonic probe to go into the eye to break up the cataract. Phacoemulsification allows us to do minimally invasive cataract surgery – we can do this through a 2-3 millimeter incision which causes less trauma. We’ve been doing that for the past fifty years since Dr. Kelman first invented phacoemulsification here in New York City. The problem is that this phaco technology is very complex; it requires a lot of equipment that’s not available worldwide. Also it’s very difficult to train surgeons to do phacoemulsifications. So even though the technology has made a tremendous difference in the developed world where we have invested a lot in physician training, education and also technology it’s actually made a very small difference for global cataract blindness to this day. We’ve seen great improvements in infant and maternal mortality rates in Africa and other countries but we haven’t really made a big impact for cataract blindness unfortunately. Partially because the technology is complex and the training is difficult. In the developing world people still do the old surgery where you open a big incision – that is, if one is lucky to get surgery at all…. Now we can change all that with this new technology, it allows you to go through the same two, three-millimeter incision and break up the lens without using heat, without using the ultrasonic vibration, without the very, very expensive equipment. And it allows you to break up the lens with the help of a super elastic thin NitiNol filaments used in interventional cardiology and radiology. The same type of memory shaped alloys and filaments that we use in stent technology for heart stents or for brain stents. We’re able now for the first time to utilize this modern alloy technology, to allow us do micro-interventional ocular procedures using memory shaped, super elastic elements such as the miLOOP. The miLOOP can easily wrap around the lens and break it into many pieces without using heat or thermal/ultrasonic energy. Again as you saw with Beverly, my patient we did the surgery on, we used very minimal ultrasonic vibration and heat. She was seeing literally on day one twenty/twenty. We’re entering a new age in cataract surgery just like fifty years ago when we were using rotary phones and today we use smart phones, I think we’re trying to minimize the energy and the heat that we deliver inside the eye. This miLOOP is actually the first step in what I call micro-interventional cataract surgery where we’re using the same micro-interventional technology that transformed the field of cardiovascular stenting, technology and interventional radiology. We’re using the same tools to break up the cataract and minimize the impact of tissue damage from heat and the ultrasonic’s that we’ve been using for fifty years. I think that opens up a whole opportunity for not only the developed world but also the developing world because the technology as you can see does not involve major equipment. It’s actually a pen like device, and this miLOOP device comes with a very sophisticated super elastic memory shape thin filament that you can literally put in your pocket as a surgeon. A lot of our surgeons who go to do humanitarian outreach now use this to help them in the surgery, and that’s just step one. I think there’s going to be a lot more innovation that will happen in this type of micro-interventional technology to make us better surgeons, to improve outcomes, and also to bridge the gap ultimately between the developed world and the developing world where we still have a big deficit of surgical interventionists. Twenty five million people blind from cataract surgery worldwide that’s a tall order that we need to address.
I want to ask about the benefits for the patient, using the MiLoop?
Dr. Ianchulev: Yes. The patient that we interviewed Beverly, of course she doesn’t know how we do the surgery because ultimately the patient is under the drapes and completely in the hands of the surgeon and it’s up to us to use the best technology. Where we find this technology really helpful is in the more advanced cases where we would normally have to use a lot of heat-based vibrational energy with the ultrasound to break the cataract. Because not only does the cataract get cloudy but it also gets hard over time, almost like having a stone inside your eye. Breaking that up sometimes requires a lot of energy and that energy is not good to the eye because it causes swelling of the delicate ocular tissue. Very often what the patient sees after the surgery is the vision is still blurry for a few days to a week, even sometimes a month depending on how much intervention we use. In the case of Beverly when we did the surgery she had a pretty advanced cataract and with the miLOOP we were able to break it up before we used the standard heat based vibrational ultrasonic’s. As a result, she was seeing almost twenty/twenty on day one. A lot of my colleagues now are using it here at New York Eye and Ear. Dr. Manusis had an illustrative case, where she had a patient with bilateral cataracts, cataracts in both eyes that were exactly the same. Here is an illustration of how the benefit translates to patient. She did the first eye with the standard technology, Phacoemulsification, because we didn’t have it approved here at New York Eye and Ear. The patient took about one month to recover because it was a very advanced cataract; we actually published that case report. Interestingly then she did the second eye and for the patient that’s exactly the same surgery but she used the MiLoop. The patient achieved perfect vision within one day and one week. To the point that the patient was worried that the first eye surgery was not done well or had a problem. This wasn’t the case; the first eye was done exactly how we normally would do it. Even in the hands of a skilled surgeon when you face the more difficult challenging cases the patient has additional time to recover. But with miLOOP the patient experience was great, they were reading on day one. Again for us it’s not necessarily that we need it to be fast and we need to translate immediately the surgical outcome of success, but as it comes to the eye; heat, manipulation, and energy inside the eye is not a good thing and the more you minimize it the better it is. In my case when I see the outcomes and talk to/train some of the other surgeons in this new technology, the reason they use it is because it not only impacts the patient and they can deliver more immediate better outcomes but also it impacts them. Their heart rate goes down when they have to do more difficult cases where the miLOOP makes those cases much easier.
Can you tell me where you’ve been, where your doctors have been with the miLOOP and what kind of a difference it has made?
Dr. Ianchulev: Yes, absolutely. That’s one of the pleasures of my career and my professional life is when we do outreach. I have done that for the past decade. I’ve probably done twelve maybe thirteen humanitarian outreach missions. The last one I just got back two weeks ago from Panama where we did a miLOOP outreach and for all these missions now that we have this technology the company actually donates the technology for free. A lot of the humanitarian outreach surgeons now use that technology because it allows them to do cataract surgery in a way they haven’t been able to do that. Because in those countries you don’t have the benefit of the very advanced technology you have with the machinery here. Even if you do, those cataracts are so advanced that the complication rate is much higher than we see here. With the miLOOP it simplifies the case and it really creates an advancement that the developing world hasn’t seen for a long time. I just got back from Panama when we did a hundred and twenty cases over two days. The surgeons there who also are miLOOP surgeons now, we’re saying that they’ve never, since the introduction of the miLOOP their complication rate has dramatically dropped on those missionary outreaches, and also the speed with which they can do the cataract surgery has dramatically increased. They can do not just seventy or eighty cases; they can do a hundred and twenty. Because when you go to the third world and the developing world, in those countries and you’re there for two, three days it really matters if you do fifty or you can help a hundred patients. I think we’re working now with organizations such as the American Society for Cataract and Refractive Surgery and the foundation of that society which has embraced the technology for the developing world and we’re collaborating for missionary outreach there. We are working with a lot of organizations like See International, that have been doing that outreach for years and I’ve been working with them on that. Everybody is excited because usually innovation takes time to trickle down to the developing world. Here because I am a public health person as a founder of that technology, I was very interested to make sure that when something that is relevant to the developing world we don’t hold back. We do have a very aggressive donation program to all the missionary outreach surgeons who are really coming in and constantly requesting now even a year after the introduction that technology, because it makes such a big difference when they go out. It’s great, in this case literally one year after we introduced it here in the US, we’re now introducing it in countries like Ethiopia, Panama, Topanga, it’s been all over the world like Tanzania. Dr. McDonald is doing a lot of cases so we’re really seeing a footprint now happening globally, which is really what you want to see for technology. You don’t want it to be exclusive to just a few countries where we have access. Because we do have a big chasm, a big separation between how we do surgery in the developing world and how we do surgery in the developed world. In the developed world we’re using this Phacoemulsification technology now for fifty years. And that hasn’t really been embraced; eighty or ninety percent of cases are still done in the old manual intervention way which we’ve been doing more than fifty years ago. I think it’s time that we bridge the gap and this is the type of technologies where we reduce complexity, easy training of surgeons and lowering the adoption threshold, we can make a difference in the world.
How does the miLOOP work?
Dr. Ianchulev: It looks simple because it’s been designed to be simple. When you have something very complex, it’s hard for surgeons to use and train. But at the same time the engineering that went into this is tremendous. What you see is a very thin filament. It’s a micro-thin filament that is memory shaped and you can fold it, go through a two-millimeter incision, and you can unfold it to almost ten to twelve millimeters. Now that filament always keeps the same shape, that’s very important because we have to wrap around the cataract which is a stone that’s wrapped in a cellophane, in a very thin capsule that’s only four microns thick. How do you break up a stone wrapped in cellophane that’s four microns thick without breaking the cellophane because that’s a complication? miLOOP is able to do that by using a super elastic alloy called nitinol and memory shaping that alloy so that it always preserves its contour and shape. Then when you retract the button you actually cut the cataract immediately. It’s not very different of how we cut cheddar cheese. When you think about the hard cheeses that we cut they’re not cut with ultrasonic’s and even knives, they’re cut with very thin filaments. That allows you to eliminate all heat during the process. This doesn’t generate thermal energy inside the eye and doesn’t generate any ultrasonic’s and vibrational energy. It’s a completely different paradigm of how we break the cataract. That’s only the beginning because this is the very first instrument. There is now one with two filaments that cut twice at the same time. Then there’s other technology we’re developing where we can completely eliminate the Phacoemulsification vibrational thermal energy that goes into the eye and reduce cataract surgery from equipment the size of a vending machine to the size of a pen.
Are patients under general anesthesia?
Dr. Ianchulev: No. We use topical anesthesia.
They are awake?
Dr. Ianchulev: They are awake. We can put you under general too but we rarely do that.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
If you would like more information, please contact:
Ilana Nikravesh, PR Mt. Sinai
347-852-3382
ilana.nikravesh@mountsinai.org
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