 Let's go ahead and get started everybody. We're going to go ahead and get things started. Morning everybody, thanks for coming. So we are going to get things going here with just a few slides and kind of an introduction and then we'll get to the discussion and introduction of our panelists that we're lucky to have with us discussing this topic this morning. So thanks all for coming. So we have pretty much everybody here, which I'm glad about, that is generally involved in the management of our surgical patients from the surgeons, residents, fellows, but also a lot of the operating room staff and nurses, anesthesia staff and scrubbed techs and also a lot of clinic staff and clinic technicians. So I think this is going to be an interesting discussion for everybody. Probably everyone is okay and willing to voice their opinions and we're looking for a lively discussion this morning on simultaneous bilateral cataract surgery, which can be a little misleading in the terminology. So I want to just go through the terms and kind of tell you exactly what that means or what I think it means, but probably the better way to describe it is actually immediately sequential bilateral cataract surgeon. I didn't really think about that until yesterday. One of the residents who I'm not going to name, but came up to me and was asking about this Grand Rounds and was trying to figure out how you get both microscopes and both surgeons over the patient at the same time, whether you do one with the right one with the left like Dr. Olson said. So even though, you know, for simplicity's sake and to match what they call it in the literature, we're going to call it SBCS or simultaneous bilateral cataract surgery. It's probably better described as immediately sequential. So this is cataract surgery performed on the same patient in the same operative setting on one eye shortly followed by the second eye. So that's what we're talking about now. There are certain scenarios where that is performed commonly and it's not really controversial and that's not what we're going to be discussing today. So these simultaneous or immediately sequential surgeries have historically been performed either primarily in developing countries or pediatric patients or patients requiring general anesthesia and so that's not what we're going to be talking about. We're going to be talking about this in, you know, quote unquote normal patients, patients with bilateral visually significant cataracts who don't have any of the customary indications to want to have this done on both sides at the same time. But we can look at lessons applied from the literature where those patients who have had it for other indications have been looked at. So what we're going to do is kind of start off with everyone participating and helping us come up with a list of the good and bad pros and cons to the simultaneous bilateral cataract surgery and then we're going to move on to a discussion with our panelists and so we're happy to have our panelists here. So I'm going to introduce them one at a time. So Dr. Ambadi, he is someone who incorporates simultaneous bilateral cataract surgery into his practice at times and he has some experience with that and so we're going to be interested to hear his thoughts and his experiences on that. And likewise Dr. Crandall does a fair amount in certain settings as well and so both of them have experience with these patients and will be interested to hear their thoughts. Dr. Jacobson is the chief of the division of medical ethics and humanities and you guys know him from our previous discussions on ethics here and so we're happy to have him to sort of frame this discussion. And Dr. Mamelis and Dr. Olson are both well qualified to participate in the discussion also both as a result of their roles on the editorial boards of various ophthalmic journals but also they both helped shape the most recent preferred practice pattern put out by the American Academy of Ophthalmology on cataract in the adult eye. So we're happy to have them to help discuss this as well. So those of you who are at Resident Alumni Day may remember participating, the seven of you who participated in my poll. We're going to try this again. There's way more than seven people here so we have to get more than seven. So we're going to start off. So the way this works is if you pull up on your phone, I know you're all going to be playing on your phone anyway so you might as well just make this part of the morning. If you pull up on your mobile phone or your laptop, this website so polev.com slash moran or you can use a text message in which case your standard text rates will apply but you text to this number 22333 and then you text the number that corresponds to your answer choice. And so this poll is basically do you think simultaneous bilateral cataract surgery is a reasonable thing to offer and this is sort of all patients considered. So to all bilateral cataract patients, to most, to some, all the way down to not even your dog. We'll come back to that in just a second while you guys are... Well maybe I'll leave it up so you can see the numbers. So if you... Those of you who did this with the website, if you leave that website up, there's going to be a few more polls throughout the morning so as I switch to the new poll, it'll automatically refresh on your screen so just leave that website up if that's how you're doing it. I don't really think this is going to be a problem but if we get to 40 responses it'll tell the 41st person that we're full. I don't know. We have 26. Okay. So we're kind of getting there and it looks like there's at least a sizable percentage that say that this is rarely, at least so far, this is only the rare patient with bilateral cataracts who may benefit from this and so we'll see... We'll come back to this and see if the discussion this morning helps sway anybody. You can keep voting by the way. We'll pull that up in a second. Yeah. So it doesn't sway the other... Yeah. That's right. You know, I don't know how to do that so maybe. Well then you have to memorize what the number is that you want to vote for. If you do it on the website then yeah but if you have to text in the number then maybe I could just write the numbers on a slide or something. Sorry. People are getting swayed by the majority here. Okay. So I don't know what everyone's experiences are with simultaneous bilateral cataract surgery but what I want to do at this point is just take a few minutes to take suggestions from anybody and everybody about what the thoughts are on the pros and cons of... Not quite yet because when we turn this off we'll have you... It's that way it's not shining in your face. So we're going to go basically just whoever wants to throw something out there one at a time will... Whatever you think that the pros of simultaneous bilateral cataract surgery are versus the cons. So the goods and the bads. So Dr. Crandall, is Randy in here? Otherwise known as a dartboard. It just kind of threw up. It wasn't quite that bad but... For refracting. Many may remember when Randy wrote an editorial where we're looking at the data just putting in a 19.5 or 20.5. I don't remember what the number was. But still 90% correct. 95%. If you gave yourself a fairly broad range which was what our broad range was that there was a certain power in regards to a fairly standard patient that got you just about as good as a result as what biometry was at that time. And then the big fear that everybody talks about even though it's statistically not common is endothemitis. There's been one or two reported cases in the Indian literature bilateral endothemitis. And that of course would be devastating. The real fear that I worry most about if you figure out the statistics on that which isn't too high is not bilateral but task. Toxic anterior segment syndrome. That could be a real... That's a reason why when we talk about one of the things that we do differently in this subset of patients to help at least avoid that possibility. And then another really big one and it depends on where you live is that the second eye is only reimbursed half price. And that has been studied in Canada and in the provinces where the reimbursement was half on the second eye then the number of cases done compared to the parts of Canada where it was reimbursed same as both eyes was considerably less. I must admit we didn't accept that paper at least initially. So that would seem to be a pretty big incentive for some surgeons is financial. Yeah. So Dr. Crandall's point so sorry we didn't have the microphone at first and I don't know maybe you guys would be able to sit up here without the screen shining directly in your face. I'm not sure Jeff do you want to try it out? So Dr. Crandall's point to begin with is that historically this hasn't even been a thing that we think about because with intercapsular cataract extraction and even extracapsular the recovery is so long and there's prolonged coronial edema induced astigmatism and basically a long period of delayed visual recovery that I don't even think about this. You wait at least initially a couple of months before the second eye and even with extra cap and then early FACO or even now with FACO at least a week or two before the second eye and so it's only been with the development of small incisions and FACO modification and pretty quick visual recovery that we're even to the point where we can talk about this as a possibility because there's just in the vast majority of patients there's not a delayed recovery and then your point with TAS is that with endophthalmitis I mean it's rare, TAS is rare also but with endophthalmitis it's more of a sporadic event where TAS has much more of a likelihood of being an epidemic almost where it happens in quick succession and if that's the case on your OR day when you're doing unilateral cases then you'll have one eye I have a lot of patients who have TAS but if you happen to be doing bilateral cases then it might be both eyes of the same patient and that outcome can be just as bad as endophthalmitis. I actually let, well can we Dr. Maemmels we have an expert in here I don't think they want to hear my thoughts. This is our course for 20 years right? 20 years worth. You know basically TAS is a sterile anterior segment inflammation following cataract surgery it's by definition non-infectious sometimes the symptoms and the signs will overlap between an infectious endophthalmitis and TAS but TAS stands for toxic anterior segment syndrome and basically TAS people will be seen within 12 to 48 hours after surgery so an immediate onset of inflammation they'll have corneal edema they'll have a lot of inflammation in the eye they'll have fibrin in the eye and they'll have blurred vision usually not so much pain whereas endophthalmitis, you know we were taught it occurred four to seven days after cataract surgery nowadays it's out nine even 13 days after cataract surgery and endophthalmitis 75% of them will have pain they'll have anterior segment inflammation they'll have vitreous involvement they'll have corneal edema still but not the diffuse edema you see with TAS and it is due to a bacterial infection although the hard part is when you do cultures and endophthalmitis you know up to a third of all cultures are negative so you have to go on on the clinical history well the prognosis depends and in terms of TAS it depends on the severity of the insult that causes the TAS and so you know TAS if you've got a severe insult if they put something inside the eye that is extremely toxic by mistake we've seen patients who will actually require corneal transplants or desect they'll require a glaucoma valve because they'll have severe glaucoma afterward they'll have the sequelae of chronic inflammation like cystoid macular edema so they can have severe problems with TAS fortunately most cases are either mild to modern they will clear usually on the order of a couple of weeks to a couple of months endophthalmitis depends on how rapidly it's recognized and again on the virulence of the bacteria if it's the most common bug which is a staff epidermis then you know chances of visual recovery if it's caught soon enough and treated properly are pretty good if it's a different type of bug if it's a strep or gram negative or even another gram positive bug then the prognosis is quite guarded and it can be very bad well that's about a 45 minute conversation and we'll get into that either Dr. Crandor or Dr. Armabody do one of you guys want to talk about what you commonly do in your bilateral patients to reduce the risk of endophthalmitis or TAS happening in this science? well I think endophthalmitis unless it's an endogenous endophthalmitis each eye is a separate eye so you know it's one in 2000 and it's one in 2000 would be the risk but TAS is a different story so I always assume that TAS is a high probability so what we do is we do we use no lots that are the same so the BSS lots are different we have the makeup separate intraocular solutions they're all different so the lidocaine the epinephrine come from different lots from the pharmacy each eye is and I do suture the eye by the way because one of the thoughts of endophthalmitis high risk is a poor wound most wounds are self-sealing but I don't take a chance on the bilatils and do them that way and then the biscoelastics that go in the eye I use different biscoelastics and set of eyes we also assume possibility of reactions so we use whenever we can everything's free our gloves are different the two different eyes so I think that we've never had a case of TAS that I know of in any of my bilatils before we get going I'm curious why you took the bilateral kids out of the concept because I think that it's still as big a risk in them as it is because actually the surgery is more aggressive in them those I worry about do the exact same thing on the kids I think that we do that it's considered I'm not sure why the distinctions is it because of anesthesia? anesthesia risk is greater the anesthesia risk is greater than the risk for doing it but nevertheless I do know that there are pediatric Bob's, I don't know if Bob's is there any P's guys there I do know that there are P's guys in the United States that will not do bilateral and I think that so I don't I agree with that but I think that it should be part of the equation great point is there anything else that you routinely do for your bilateral cases that we haven't discussed? no I agree with what Alan said treat every eye as a separate eye in different lots and different drapes and re-prep the eye and everything I will say also that some people that do these what they'll do is they'll take the patient out bring another patient and do another case and then bring the patient back in to me that's what OSHA does to me that doesn't make a lot of sense but does that alter any of the reimbursement considerations? what about from the anesthesia standpoint? anesthesia gets screwed too so does the hospital so that's actually I mean in the discussions in the literature the financial impact is much worse on anesthesia than it is on the surgeon actually I think the hospital takes the biggest hit I might be wrong is Laurel here? anybody from I think numbers wise the hospital takes the biggest hit now one last point we're going to ring up when you're talking about cons before we delve into this is legal issues and in the United States it's different than in Canada and different than other parts of the world but legal issues are something you've got to put in a con whenever you're out in front of the standard accepted practice in a field you worry about potential legal issues and so if indeed you had an outbreak of tasks in your facility and one of the patients was a bilateral patient the lawyers would jump all over that saying that was the standard accepted care and so we have to be very careful and I know Randy and I were working on the American Academy's preferred practice plan for cataracts to be very careful because if you make one statement about the risk involved there and make it sound like that's not an acceptable risk the lawyers would jump on that immediately and I had lawyers when I was an expert witness quote the ophthalmology times and so you have to be careful that's the shiny tabloid thing that we get that's the inquirer that we get every month and so they will quote that and so we have to be very careful when we're doing things like putting out position papers for society or putting out papers for our field that we don't make quotes like that we make it clear that you know under certain circumstances this is an acceptable way of doing things because if not the lawyers will jump all over it and again a rare you know tasks is a very rare thing I mean the incidence is anywhere from point zero three to point zero seven percent but still if you have somehow a bad material used that day and you do get bilateral tasks the lawyers are just going to jump all over that right now the preferred practice pattern you talked about was just in October 2011 or the fall so correct me if I'm wrong is that the first time that the academy preferred practice pattern has mentioned a relative indication for simultaneous bilateral cataract surgery so it was mentioned the previous one but it was generally pretty negative and so this go around it's listed cautiously again I mean Nick's absolutely correct having done a lot of defense work they don't quote all your peer reviewed articles they'll quote every quote that's ever happened in the throw ways of which you know there's hundreds and hundreds and they'll quote something back from you know well what did you what do you think of this doctor Olson well you said that in 1979 I don't remember that I reviewed it and who knows if they voted me accurately so the new one makes it clear that this has changed and it makes it clear that there is controversy but that if people do the kinds of things that you know Alan and Balab talked about that you treated as though it's a totally separate case then certainly that there are indications in people who feel so they don't want to make sure that this wasn't a priori a legal opinion saying you shouldn't be doing this so that that's that's the change that you'll see in this new regulation but it also lists all the caveats and all the concerns so so that's the that's the gut that's the one that you know that often sits there as people consider this the bilateral complication having had a patient who I operated on not at the same time differently go bilaterally blind from expulsive hemorrhages I can tell you it is an awful thing corneal transplants expulse both eyes bilaterally blind so I can tell you that can happen it can happen in other ways and it's an awful thing I just want to point out that I think that the evidence and there's a whole society Nick and I were with Steve Arshanov when we were speaking at a UCLA meeting in which we were literally badgered by him for a period of time and we figured out how we could escape his wrath because he is so on this and he's head of the society and I wrote an editorial for Canadian Journal of Ophthalmology I think all of the different things we've talked about have largely rendered that not much more of a complication because you also have that risk maybe one of four million or so by doing different periods of time you could get a complication if it's a one in 2000 and one in one 2000 other mathematically eventually that's going to catch up with you and happen but the one that we're conserving the most still is the task because even though you can have different lots of the rest, we've certainly had examples where a company has provided a product where everything is bad and I'll never forget the one I remember one of our former fellows called me up had 17 cases he'd done the day before and every case the next day was hand motion division and many of which went on to have severe complications and I will admit that there's nothing you could have done to avoid that in regards to but it's certainly not something that you've done sequentially once it happened once, they go on and it turns out that there was a fly by night company and they just had the PH off on everything and he didn't even know that his ambulatory surgery center had gone for the take a chance ink to grab a new balance salt solution so extremely low risk but that's the one that if it happens it tends to happen to everybody is that epidemic thing and Nick certainly had plenty of examples and is that enough to warrant not considering this because it is a rare overall event to have that happen and I mean that's where it comes down to kind of you've got time on this and Judith, sorry that yeah I think you're right on that first of all you can't do the second eye unless the first side goes perfectly there's absolutely no question about that the second thing is I do change my technique you know in usual cases six, seven minutes we use a low flow technique we're using different agents in each eye so I think your chances of getting bilateral ischemic optic have you ever seen that in the case and oh and by the way we don't we see him that day twice so we don't we watch for pressure spikes there are lots of subtle things that are different and that's a very good point and that's the category of patients that we have to be real careful about is because there's a clear type of patient that's not good or not a good patient for simultaneous bilateral cardiac surgeon it's a patient who for whatever reason you anticipate and these may be anticipated in some situations but if you anticipate that they're at a higher risk for those early post-operative events or even intra-operative complications pseudo eggs, ifis, small pupils and those may be patients that are better to do sequential you know different day cataract surgery you know I sound like Tevion on the roof but on the other hand it's interesting Steve Arshanov who Randy mentioned he's a surgeon from Canada who started this group simultaneous bilateral surgery is very strident about this I mean like in your face strident but they're tracking their data pretty carefully and you know every time I hear him they add another 100,000 cases I mean it's something like 150,000 cases without any endoplamitis or any problem and so the numbers are telling us that the risk of complications is exceedingly low he had a epidemiologist look at some things and to put it in perspective we found that the odds of having bilateral endoplamitis were lower than the odds of getting killed in an automobile accident driving to two separate surgeries so seriously I mean this is the kind of things that they look at and they said okay if you're going to have two separate surgeries someone has to drive you back and forth and you have to go to the surgery and the follow ups and the chance of dying in an automobile accident were actually higher than getting bilateral endoplamitis so you want to put this in a perspective that's not going to mean anything again in the court of law but that's the extent they'll go to defend this so I mean my position has already been well written I mean put together I did that editorial journal of ophthalmology specifically for Steve Arshanov's paper that he had there and I think that doing all the things that people talk that has become unacceptable and it's something that people certainly consider but I'm just going to list a series of things I've seen happen in patients they're not devastating but there's something I would like to have known that I wouldn't have known if I had done sequential surgery so the one thing obviously is that unusual pressure spike and having dealt that with some people just seem really and so I do it a little differently the next time around and my identity will give a myotic the second time for instance so that would have been nice to know another complication that you would see that you'd like to know is that there are some people who are extremely sensitive to cystoid and macular edema comes on early on and I do treat them completely differently in regards to that if they've had that particular response here's another one that I see and this is way more common than anything else we're talking about there are people who you put a lens in who just have overwhelmingly severe pseudo-faking dysphotopsia and they're unhappy for moment one particularly when you're talking premium intraocular lenses well I'd want to know that before you want to go ahead and do the second eye with them and some of the unhappiest people I've seen have been bilateral premium intraocular lenses who are really unhappy with both well I think that that would be an example of something that would be good to know and let's see there was one other oh yeah even though Alan I agree completely we're doing immensely better we still do have refractive surprises and all the evidence out there of the latest studies show that if you take half the difference between your expected and what you actually get using the second eye that you do improve your refractive outcome and don't think that's unimportant I mean I got somebody suing me right now because she's minus three-quarters of a diopter and feels that she should have been planal but I think all those fall into the category I would not do the same day type of patients I wouldn't do somebody that's had previous either lasik or certainly hyper-opic lasik because there still is a little bit of a crapshoot on what you're going to pick up and the pressure spikes I've really gone to whenever I can doing same-day surgery because the surprise to me is how many we miss routinely I see them six hours afterwards the pressures are up and then the next morning they're down so I think one of the things that I'm switching is I'm trying to do more and more same-day surgery at four to six hours and I'm catching a lot of post-op pressure spikes so yeah so I think that in that subgroup you could easily catch those but would you say bilateral premium? I would never do that they're very demanding and they're more likely to have discotopsis well and there you really have to be within a quarter of a day after you're right so that's a different ballgame I mean most of the people that we're doing are somebody we're taking over the main hospital we had one or two they're so large that they had to lift them up on a truck to put them on the anesthesia car to put them asleep I mean that guy is he's going to die if there's a high risk overall this is no problem are there any other? I would like to say one thing that I disagree with I'll get to it in most in third world but they don't do bilateral surgery anymore there were a couple reports I think bilateral is very unusual at least in my experience I don't think I've ever done one in the 50 or so missions that we've done with Jeff and you end up doing the second eye we do the second eye but it's usually a day next day or two days later that's not a situation where you're doing it to save resources no it's just that they're slightly higher risk we think because it's around the third world I just have never seen that done we have some folks here from the third world don't we yes do you never I think that that comment was wrong I'm sorry Dr. Klein do we have the microphone I'm just wondering about the patient choice and transparency, legality consent those sorts of issues those conversations are about triple what our normal stuff is we have to go over everything that we don't know this we don't know that you're looking for some enthusiastic we want this begging Dr. Harry yeah sure the hospital generally will lose money they lose money it actually because of the reimbursement and the costs are essentially the same is that I mean if we did this as a routine and Medica doesn't change we put inventory search on a hospital about this that's medical economics but sadly that is reality Dr. Williams I was wondering if I was invisible there Grant one of the pros that we haven't discussed yet is for some of the patients particularly some of the VA patients the travel to and from appointments is a significant difficulty for them patients coming down from Montana and stuff who don't have very many financial resources I feel like some of these guys you can almost bankrupt them by making them come back three times for one eye and then three times for the other eye and then another thing that hasn't been mentioned is cost to the healthcare system as a whole for example we did bilateral simultaneous cataract surgery on a prisoner this week and the overall cost savings to the healthcare system with not hiring two guards to come to the Moran twice and so on are probably quite substantial and there's some evidence that from a standpoint of reducing the overall healthcare costs of providing cataract surgery although the hospitals and the surgeon may receive less reimbursement the total healthcare system spends less yeah that's a good point your point about the vet was the VA is actually paying for that transportation so patients who for example will come to Salt Lake VA from Montana they fly them down for each visit and that's hundreds of dollars for day one week one so even if we do yeah so it's not them that are bankrupting from this it's all of you so the even on those patients when we do sequential surgery we try to coordinate it where we do the second surgery to coincide with their two week post op appointment or something but that ends up saving them one visit in the long run so yeah simultaneous surgery on those patients would be a benefit for that I'd like to make a couple of points so some of the vets are paid some of them are not depending on their level of service connection but as Nick mentioned the risk of TAS is about one in three thousand and the risk of endophthalmitis is one in three thousand so the combined risk of those is probably one in fifteen hundred and therefore the risk of bilateral TAS or endophthalmitis is if you square those is one in two point two five million it's not a square phenomenon I gotta point out that I'll grant you an endophthalmitis it's not TAS if you've got everything contaminated then your risk is still the one and understand that it's very variable I mean there are times and periods when the risk of TAS has been as high as one percent point seven in one you said so if you had a bad batch you can't square that everybody's at risk for that day everyone's at risk for the day that's the one that you can't square those what if you're using different lots and different companies the whole company I mean like that one company that their pH is off everybody we've not had one we've had several of those it wasn't just a lot I mean the company just point missed it could be your sterilization yeah instrument cleaning sterilization I mean even if you use separate sets of instruments they're still going to be clean and sterilized by the same crew and the same one and so even though you use completely separate instruments and separate trays again the risk of TAS is still there so so endophthalmitis I'll grant you an endophthalmitis it's not quite because you're right some of individual but they're clear to many examples where if you had a point you're going to get the other because every patient got it fair enough does anyone else have any any carry that forward yeah the conjugate risk of bilateral TAS is increased in the second eye if the first eye is bad fair enough however the whole probability as a population still remains three thousand two thousand okay so I guess my point is the risk of bilateral catastrophic vision loss in a patient with bilateral surgery would approach I think if you do the math one in two million something like that the probability of highway fatalities for a highway mile is one point one in a hundred million miles and that means if a patient has to travel more than 50 miles for an extra surgery day and two or three extra post-operative visits that we're increasing the risk of highway fatality over the risk of bilateral catastrophic vision loss and for someone who's coming from Montana and or Wyoming I think travel burden is significant and even just overall last year at JCRS paper that the cost of healthcare travel home care and lost working time was reduced by eleven hundred fifty dollars for patients who had bilateral surgery on the same day so I think these are not insignificant the clearly the precautions that have been mentioned in terms of treating each eye separately are vital but I think it's important to bear in mind that proper patient selection where a patient has travel hardship or is at high risk for general anesthesia and this is exactly what's in the A.A.O. preferred practice pattern general anesthesia where travel is a hardship I think those are significant considerations as far as the refractive outcome issues there have been six articles published on the use of the first eye refractive outcome on the second refractive precision on the second eye four of those have found benefit, two of them did not find benefit the two which were actually clinical trials comparing head-to-head simultaneous versus separated bilateral surgery which also used modern caretometry instruments those were the two that did not find benefit so I think the refractive outcome benefit is still not resolved certainly when we started doing LASIK ten or twelve years ago there were a lot of issues about should we do LASIK on one eye one day and then the second eye the second day and as the instruments got better and as the refractive precision got better and as the complication risk went down the solution where doing bilateral LASIK became accepted so I just wanted to raise a few points and even the even the four studies that showed benefit it was in the range of use of first eye outcome reduced mean absolute error on the second eye from 0.47 doctors to 0.41 doctors and that is significant for the person but the and it reduces the spread certainly it reduces the spread but I just wanted to point out that the literature is not conclusive that there's four in Foyver and two that show no benefit so let me respond to that because I've actually looked at that literature very carefully and the problem with most literature we have on that subject is we take it all comers and looking at all comers and so you have lots of noise in the system because the majority are going to cluster right near your mean and so in order to move your mean by the one to two percent that are over a diopter in some series as much as five percent you know you need huge huge numbers to have the power to really tell a difference so the study that really needs to be done and the ones I'm concerned about they're not the vast majority patients it's those ones that have an error from your outcome of a diopter or more and if you look at that and if you repower the studies that have been done to suggest that rates at two percent those that say there was no difference are underpowered to be able to make that difference because they're looking at all of it what you really need to compare are those ones we all know where you expect everything fine and like holy mackerel this is a diopter and a quarter off how the heck did that happen your biometries fine you repeat it there's lots of reasons and I think as I said in the big course lecture it's the effective lunce position and probably post your corner you're the two reasons why that happens we still don't have a really good way I mean I think the bolster of cornea was that's really Doug Cokes I think the big lecture is another big area we need to look at so I think that that the four studies that showed it the two that didn't I think they were underpowered to look at what they were supposed to look at which is really those outliers so I'll say that now at the same time I don't want to come across is that I feel that this is the wrong thing to do I mean I wrote the editorial and I can tell you what's happening internationally is this is a growing phenomenon Sweden has already made the decision and Sweden is extremely careful and that's one system I know extremely well they have every cataract gets registered in the national registry they look at every complication they know how often a capsule is broken they know endophthalmitis they followed it and they've got outstanding numbers much better than our Medicare data that we have for instance and they're moving towards this and there are many places and I think that right now the Niger's ASCRS they're they're at 15% sequential so I need to point out that I do think that this is definitely a trend that you can make arguments going both ways and so I don't want it to sound like I'm condemning but I do think that there are valid issues and reasons why that you shouldn't feel like it's the wrong that not doing it simultaneously there's plenty of reasons why their advantage is the other way as well I'm not saying that everybody should be doing this either I mean this is very careful it has to be a full team effort you really have to have a your pharmacy has to have the capability of separating all these lots which is sometimes not so easy and that's I think that's also critical I think anybody that is interested there is this international society for bilateral cataract surgery they meet at the European meeting I don't know if you guys are going to that meeting I'm going to talk on tasks I mean it's Monday night during European cataract society every year so they can come and get some info that's why I say that conversation almost doubles the time that we're in there versus the normal because we go through all of the stuff one of the biggest problems is what is informed consent you don't know how many times I have a patient that we're doing the refraction so did you really put a little plastic lens in the eye I mean they've signed the opera board and they ask you that right and you use the laser right yeah I use the laser so it's a real problem it is a real problem and in that we always involve family one of the things we do is because we want someone else to be listening to what we're saying and then we go over the risks that if it happens it's going to happen to both eyes it's low but it's not zero yeah well the best simulation is to have them wear patches on both eyes we don't do that so just real fast, if you want something really fun talk to your cataract patients the day after surgery and say what do you think went on or what happened it's hilarious to think with it oh you scraped something off my cornea I just have a response to Dr. Hartnitz question because refractive surgery is almost always bilateral surgery this comes up a lot and granted bilateral vision loss with refractive surgery is less common but it's still possible I use the analogy of airline travel because I think there are a lot of parallels in a really really safe industry but I say you know you could be the statistic the plane could crash and if it crashes we know what the outcome is and airline disasters patients definitely understand that they definitely understand that and I loved Julia's comment I really think that putting the patient in control is the way to deal with this issue it's not unlike any other surgery that we do in terms of informed consent there are going to be pros and cons there are going to be arguments for and against I think one thing that hasn't been brought up that I think is really important is not everybody wants or needs their second eye done so there's also resource utilization that you know comes into play we take out a lot of 20, 30 cataracts I mean we can call it what we want but we all know we take out a lot of 20, 30 cataracts not everybody needs their second eye done and certainly in the healthcare environment that we're in now that's going to become more and more of an issue and a lot of people are perfectly happy after they get their first eye done how can I give a patient understanding of what it would be like to experience that to be able to give informed consent you don't want to scare them but you know these are things that are really difficult we don't have enough terms in our vocabulary to describe all the things that the visual system does for example one thing you might want to do is come on her Saturday and play with her glasses I've done that it's pretty damn interesting you know the glasses that simulate early glaucoma, late glaucoma macular degeneration and it's pretty interesting the other thing is no matter what we tell patients their macular degeneration is bad but you guys can't see and we're going to do the cataract every single one of them says I know you told me but I was sure I was going to see better reading afterwards they always say that and I get on my knees before I say I'm begging you to tell me right now you know you're not going to read now I always think they're going to read better it's very interesting one thing I wanted to mention was in the process of the conversation in the patient room anytime someone brings up this issue of can I have both eyes done at the same time generally my first comments are discouraging it's going to be a lot harder that first day you're going to have time needed for recovery of your vision and going through the risks and so on and so they really have to want this for whatever reason travel hardship or faster recovery to get back to their job or whatever the context is but the initial conversation starts off as the extra challenges and risks with doing it this approach and then if they really push forward if it's an appropriate indication then I think it's reasonable depending on the patient context to consider it I'm really happy that we've started framing this too in an ethical term so you know allocation of healthcare resources patient autonomy informed consent and we do happen to have an ethical discussion leader here with this I was hoping we'd be able to take over from here and discuss some of the issues that we've been struggling with I think it's actually leader of an ethical discussion and then also I actually appreciate some of you may know I'm actually not leading our division of medical ethics and humanities any longer I've stepped aside from that and my colleague Jeff Bakken is doing that but I continue to really enjoy opportunities like this to learn and I'm sure you notice that this is one where the residents Jeff also played a role in planning this and I think they're very thoughtful and I hope they do get to the sort of the follow-up question or poll that they've talked about one of the things that's rather challenging I think in teaching and learning is that we rarely change our opinions that's actually the case even with science but I think it's much easier to change an opinion about science after one sees a lot of data I'm confident that that changes we rarely change beliefs however and it's intriguing about what does change beliefs so today it's a fascinating opportunity to think that through I wanted to share with you what this looks like from the outside a little bit I think the first thing to say about it is ethical issues are different in every specialty we've talked about that here you work in a specialty where you deal with organs which is absolutely fascinating in terms of the way that changes your feeling about risk and even benefit in some other areas for example there's a very similar response to innovation basically what you're looking at here is a new way of doing things it's not technically so new but it's new sequentially and the proximity of doing one to another people who work on only one organ do not have this issue but they do have the issue of resisting change and I think that's really important a good place to think about that would be in cardiology and so it's actually the case in every field that as technology develops there is some technology for example that may be instantly more appealing to patients than it is to clinicians a good example of that would be anything that reduces scars for example so just think again about people who work on one organ and it's very early in the evolution of a new technique which may be roughly comparable in terms of technical outcome but which has something that appeals to patients for example laparoscopic approaches and just think about what you know about that and the fact that there's always a learning curve so from the medical side moving from open surgery we'll pick another unpaired organ the gallbladder moving from open surgery for the gallbladder to laparoscopic surgery clearly is going to have a trade off in terms of outcomes for a while it's very predictable and some of you spoke about the emotional response of having a very bad outcome a surgeon learning a new technique is going to have some bad outcomes patients were very eager to have laparoscopic surgery and one of the ways of managing that is in fact the ethical technique of dealing with that is sharing the information this is new things that are new have also unexpected consequences as well as the skill increase that comes with time or the decrease skill that is there at the beginning and better later and I think you know from your environment just watching medicine how that happens and you can see actually the trail of these things there were some very severe complications of laparoscopic surgery early because of the techniques not being well understood on the other hand it's very hard to tabulate or calculate what are the benefits of smaller scars versus some of those catastrophes and these things are never easy because in that procedure for example there may be some reduced time that's involved there may be some reduced trauma to other organs and so what you have here today I think is rather interesting in terms of you're trying to add up pros and cons again from an outside perspective one of the problems here is that the pros and cons are not the same on both sides it's just a two way chart but you could be thinking pros and cons for physicians as well as pros and cons for patients and they're not necessarily identical and they never will be so I think one of the problems you know that's a difference in science is that we tend to look only down one road if we're only looking at outcome for example that's all we're looking at we're not really thinking about values, preferences all these other things that might be very important for patients and this is a classic issue of this kind as soon as we talk about litigation and cost we're basically talking about the medical side right and those are serious issues nothing trivial there but that's not an easy thing to balance with say travel convenience because it's not even affecting the same people let alone not of the same magnitude so I think it's reasonable to acknowledge what a difficult challenge this is in terms of kind of coming up with some kind of clear bottom line you know we add up all the numbers and then this one comes out favorable not favorable that's actually an area where kind of ethical analysis might be relevant and you've also actually talked a little bit about some of the problems with that that is wouldn't it be a lovely world if we actually believe that by laying out risks and benefits those for us those for patients to the patients and let them make a decision that that was an informed fully rational decision I think that would be very comforting it's not but you want to remember that it's not for anything else either and we operate with that and what it is is kind of the best we can do in terms of sharing that burden and the better your efforts at informed consent we could even talk a little bit about things that work and things that don't the more likely the consent is actually informed but the patients view of a procedure will never be the physician's view it just it cannot be we can't expect that as a standard so I think even if we're turning to informed consent to balance this we have to understand that will never be the same informed consent that we have I think one of the things that patients are pretty good at is telling you what's important to them and I think that's something that we could sort of pull up a little bit here which is you know we've heard language like they're begging for this procedure this is actually a very useful term because it's a signal that this is very important for occasion but it's worth thinking about why it's so important and one of the reasons for that is that you can then negotiate some of that drain so for example somebody may talk about a planned event that they want to get to and they want to have both eyes right ready for that and so it will all be perfect well interestingly enough just in a discussion about possible risks and benefits that are medical it's possible the event might actually change schedule but as you know faced with the idea that instead of having both eyes ready to go the patient could actually be bilaterally blind at that event not a very likely possibility but patients also vary in terms of their ability to tolerate risk many of us are starting to think this is kind of congenital some of us are more risk averse some of us are not you might think about that in terms of where your classmates win in medicine right the ones that are doing airborne surgery but people are like that as well and so for some people analogizing what the risk might mean would actually cause them to change their mind you know it's interesting the patient recently I had a knee done my left knee total and lots of questions came up so the first question that I heard from many patients is once I had the first leg done I never had the other one done it hurts a damn bad okay and then I heard others say I do it do it bilateral then you then you only go through the pain once so I was talking to my surgeon I said that he said well here's your choices if you take if you do them both on the same day you're going to be out of work eight and a half straight weeks minimum if you let me do them sequentially I can get you back to work in three weeks each time saving two and a half to five weeks of work so I chose one knee because I want to work but that's you know that's that's a decision that I made but it hurts like hell not looking forward to the next one I tell you Jay can I just actually on that I follow this is interesting because I mentioned to a patient who wanted bilateral surgery and I pointed out you know there's a small risk of blindness and I said but you should know because I quoted that that you probably is the person who I owe me you probably have a greater risk of dying in a car accident going bilateral or he blind his response I'd rather die in a car accident be bilateral. I think those are actually both interesting examples and they help us think about things because you know these are physicians but both sharing things that come from a patient perspective and those are not unimaginable things to hear that for some people going back to work earlier might be more important than some pain and for other people there are things worse than bilateral blindness and vice versa so I think that conversation may actually help us a good deal as we're considering a procedure like this because it's just one more way in which patients are different they're different in terms of their intraocular pressures their underlying disease but their values preferences are very different. One of the things that I heard the group talking about again these are outside perspectives and some of them for me are epidemiologic and that is that the idea of related risk and unrelated risk in the two most feared complications one of the fascinating things I think about thinking about a patient where you're doing bilateral or sequential which is a better name is that the risk of ophthalmitis actually doesn't change by that if that's operator dependent for example then you do the first eye at 9 o'clock and the second eye at 11 in each case the risk is there and that would also be true today and three months from now oddly enough because of the epidemic phenomenon of tasks if you do the first eye on a day when the solutions are okay there's actually no risk to the next eye that is isn't that fascinating that it's only one for that day whereas when you do them sequentially each day has the statistical risk of tasks. The other one is about our emotional response to events and again because you take care of two eyes and you're so concerned with blindness it's not just one it's one plus one it's actually the disorder that you fear the most in a sense blind is both eyes if it's only one eye you're not fully blind and so the consequences only associated with the two eyes the task problem is a fascinating one I think what you're all kind of talking about you talk about litigation is actually not so much what the rules are of malpractice or what a judge might instruct the jury to do but rather how a jury might feel faced with a case with this terrible outcome so let's talk about tasks for just a minute in the same way that we talked about you know days to work or pain so it could be the case that on one day 17 people were affected that's just the way that works and we don't control that we don't do only one operation a day we actually live with the idea that on any day there could be that phenomenon in the OR and 17 might be a low number for many ORs so then think about that in the courtroom setting and from the emotional side which let's just make you an economist for a moment and not an ophthalmologist would the economist be more worried about the one patient with two eyes on a day when there were 15 other patients or would he be most worried about a day where you did 20 cases versus 10 because on any day the more cases that you do the more risk there is for an epidemic that would occur to everybody that day so that's just another way to think about that and I think there's no question that for the patient the experience has to be worse to lose vision in two eyes rather than one no comparison I mean a one-eyed patient amazingly has in many ways full function so I mean Julia it isn't exactly the same but we're not talking that a one-eyed patient has half the function so let's say if bilateral vision you gave it a number of a million a one-eyed vision is still probably 900,000, 150,000 and bilateral blindness also then it goes to zero there's a dramatic difference in regards to those two different scenarios I'll do one thing then you go back to it I think the other one that began to come up here and it's always invisible for us when we talk about risk is what the alternative risks are and we actually were talking about driving but during the period of time between one eye and another if that reaches into weeks or months that's of course not the only risk I actually want to think about the other things that happened to people during that time some of which may actually equate with the problem of bilateral blindness I'll just think about that with you a little bit what's the average age of the patient that you do cataracts in so 60, 70 is what I've heard so what you want to think through there is that the life expectancy at 70 is approximately 10 it's actually a little longer than that so I want to think about that so there are 3,650 days left in that person's life expectancy right so the chance of dying if they're all going to die within that time if you want to you could put that as a numerator and a denominator and it's fascinating it's around 1 in 3,000 which is somewhere close to the kind of risk that you've been talking about so it's fascinating to think that in the interval between one eye and another many things could happen an automobile accident a stroke, a sudden death a malignancy a whole host of other things that in a way would end a life or there'd be no vision at all right so again psychologically what we've thought through is that the worst thing because it is us one of the worst things we could imagine is somehow being linked to bilateral blindness in a patient but think about that perspective from a patient's perspective that's one risk in informed consent you'll talk about today to them but quite honestly many of them already know there are many other risks in their life they know that from their family they know when their parents died they know the other things they're all having and so for them perhaps it seems odd to us that the convenience which is the way I think we would frame it the convenience of having this done and taking that risk seems inappropriate but we're not in their life and so we're not exposed to the other risks that they're inevitably exposed to as well so again just a very useful thing to think about in terms of the context of the patient and there's something the panel and you could help me out with a little bit which is the risk of falling which is huge in this population and so it seems like a very relevant one because it speaks to vision so maybe we could just hear a little bit about that is there any argument kind of for or against sequential versus delayed in terms of reducing the risk of falling I think on the day of surgery if someone is having both eyes done they need a lot of support and that's very important that they have family around them to take care of them and so on however the longer it takes for them to cover both eyes vision the more the probability I think of the events that you describe when you have one eye working well and the other eye is not there's an image mismatch there's loss of stereopsis and that interval between the two eyes often do complain that their proprioception or stereopsis is not good in that intervening time further they often get confused by their drop schedules when one eye is done and then the second eye they often get confused what drops do I use in which eye at what frequency and that seems trivial to us but it's actually not trivial to them so those are some other factors to consider thank you for bringing this up you know a good example to say that the patient has got bilateral cataracts who's like a minus five mile they're near-sighted so you do one eye and then during the interval between the two weeks when you do the two eyes one eye is highly near-sighted one eye you can't wear strong glasses in front of one eye nothing in front of the other eye so their depth perception is off they have increased risk of falling so in that setting on one hand on the other hand you would say doing that bilaterally you decrease that risk but then again in that patient population for the retina people here they have a slightly higher risk of retinal detachment so again you're putting them at risk of a retinal detachment in each eye so again you've got to balance it on the teeter totter and see where that's going to play out so I think that's really very helpful for me also to hear that about the falling story and for some patients again that's much more important than others and the context may be terribly important in the home situation where they live what they do all of those things I think are we're talking about Greg I think has planned a couple of other questions for you including the follow up if we wind up having a couple of minutes if you're interested there's actually a lot of work that's been done on informed consent so if for example one of your background concerns is that people can't possibly understand what we're talking about we could have a conversation about what have been shown to improve that so we'll just hold that in abeyance for a minute and Greg you want to pick up with some of your questions I actually just plan to leave this up in the background people are already voting while we're going so like I said I knew people were going to be messing around on their phones anyway so we'll just give them something to do that's constructive but yeah feel free this part is done so we can just vote while we're talking sure thank you we had another very good idea here because I think notice how subtly things change when the context is a family member that is we begin to think about things we haven't asked the question of what you might prefer and I think a relevant question might even be in which surgeon would you ask to do it that is this is an evolving technique if you're going to have bilateral who would you have do bilateral sequential so they're all they're very important points and if I remember the distribution here is a little bit different than what we were seeing before which was you know the the idea that rare might dominate as an indication for this so let's talk a little bit about informed consent for just a minute you all have a lot of experience with it and by the way one of the best experiences are things that we've already heard from the panelists and that is you do inform consent and then you do a follow up question and think about what you're measuring there you're measuring comprehension you're also measuring memory right and they're very different elements and so you would understand that if you you asked content about informed consent six or seven years after a procedure I don't think you'd even be too concerned that people had forgotten some of the details what's rather shocking is how quickly seem people do seem to forget or to misunderstand what have you found is helpful first one is it's a great exercise that anybody can do which is the day after your procedure to just review with the patient what they recalled you saying and what their understanding was let me just mention that you don't need to wait for the day after the procedure and that's actually one of the more important things is that if you're shocked the day after right how would you feel if you got that answer the day before so the point of doing it the day before is that it actually reveals where the knowledge deficits are or the lack of understanding I mean it may seem humorous to us that people have really missed it by a mile but we're actually far better off knowing that the day before than we are the day after so what's the best way to ask people how well they understood what you said well Jay just put it in context there was a study done several years ago that to me just really shocked me in informed consent they came up with questions on the level of a fourth grader and gave it to the patient went over each question with them went over with a family member gave them a copy said read this we're going to quiz you next time you come in so they actually went over with it told them know this we're going to quiz you on it they came back and the response rate was about 20% now this is not just your routine consent this is where they took the time and went over question by question and said they were going to be examined and the response was 20% correct and 20% knew it correctly so with our routine consent it's going to be even less than that so that was a stunning study a couple of examples and again it's always good to go out and get material that either support or refutes our assumption I think many physicians for a long time have made the assumption that people quote don't get it and I don't know what the questions were but I think that's helpful to know the way to say it is what's the worst thing you can do to estimate somebody's comprehension of what you said so not asking at all that must be the worst because I think we'd all agree that doesn't take a big study that not asking you have zero idea of their level of comprehension and since that's going to be distributed somewhere there's somebody who actually understands 100% of what we've said and somewhere there's somebody who understands zero the point of the study is it gives us kind of an average but if you don't ask it could be that it's 100% but it could be zero but you have no information at all so that's a problem at the end of informed consent not inquiring or evaluating now that we all know how poor it is it's actually almost a second mistake on our part what would be another poor way of evaluating comprehension it's one that we do quite often so that's actually you hear this a lot there are two phrases that you hear quite a bit do you understand the other one is do you have any questions and we like that because we like answering questions I mean that's kind of our role as the expert but it's not the psychologist and social scientist find that that's a very poor way for a couple of reasons one is people like you appreciate the time that you've spent especially if you spent a lot of time there's a paradox you spend a lot of time and then you say do you have any questions they're very disinclined to say so because they feel that reflects badly on you it's not a good choice let me get a comment here and then here I just wanted to know that's a very subtle distinction so I almost never ask do you have any questions I think the better question to ask is what questions do you have to come forward and that opens the door anytime you say do you very often the response as you say is no and when you say what questions do you have they're much more likely to ask you stuff just a quick comment again it's a terribly subtle distinction but when you say what questions do you have perhaps the assumption is he thinks I have questions another way of framing that is even though we've spent a lot of time together most patients still have questions where I know I haven't addressed all patients questions so if you flip it around that the question is actually what you expect rather than a judgment on your adequacy probably do make it better yeah well it's another wonderful insight about what it takes to have a question it's often the story that first of all we don't understand when we misunderstand most of us don't recognize that but we need to understand something usually to have more questions about it so we'll wrap up here in sort of a short time the things that helped the most and I think we heard it today are the idea of asking the patient to explain to you what it is they understand those are that helps a great deal and it's very reassuring sometimes it comes out accurately you can feel good about that if it doesn't the point about literacy is very helpful sometimes it's because we use some vocabulary that was just ambiguous they didn't they were guessing they may not know the distinction between cornea and cataract and so they went with what they knew and you're knowing that gives you a second chance to either use another word or to do a drawing so it's very very helpful aside from questions a very nice question that you can ask empathetically is about fear and the reason that's so useful is that it will help you unpack some of the values that are driving patients either chored or away from the procedure and that's one where if you frame it again as it helps me to know what people are most afraid of that's a very inviting way of asking so fears are good is there another comment yes I don't bring it up unless they bring it up the only reason I would bring it up is if there's an issue of general anesthesia and some additional risk so just a background about the conversation and what's in it let's say an administrator once who said what gets measured is what gets done the other thing is about what's incentivized so you might just imagine and there's actually one of the articles that was shared that in the future it might actually be the case that people would not so it's incentivized in Sweden and I would imagine that it is discussed often in Sweden so I think again things to think about here about what we put on the table what are they for really rather interesting and we invite ourselves to spend more time I think if we put that on the table now but you do want to think about that in terms of who is that for is that for the patient or for us we need to wrap up here pretty close so I guess one of the even funnier than that is that they'll come in and they have such an idea it's simple and you do your slip-lap and I've had them say did you just do my cataracts or something that's actually kind of a note we may get to that point in fact the surgeons who use Verset actually have that question all the time did you just do my case thank you all very very much I think one of the things to keep thinking about in terms of informed consent is that there are people who are achieving better outcomes in terms of recall and understanding it's not easy but they shape their presentation based on lots of interviews with people who they've asked this question what do you understand once you have a sense of how people commonly misunderstand it's much easier to deal with that in your explanation so my guess is in a year or two this whole procedure may look very very different I'll just share with you that it's been my pleasure to watch for example how reluctant doctors were for example to do lumpectomies I want to think about that but doctors felt for the longest time that it would be in the patient's best interest to do radical breast surgery they believed that, they continued to believe that but patients actually drove them largely by their perception and a sense of convenience that was a big driver but at the end of the day it's actually worked out well for everybody so thank you very very much and we'll see you again in half a year