I’m going to leave the informed consent “Hot Buttons” series to percolate a bit while I ruminate on one or two other matters. But I won’t be straying far, because today’s article also goes right to the heart of informed consent:

What are laser surgery problems like and who do they happen to?

Most patients’ answers to these questions, and many doctors’, are both predictable and wrong. How do I know? Because only patients to whom it happens know who they are and what the problems are like, and nearly all of those patients will tell you unequivocally that the answers they thought were completely rational before surgery turned out to be wrong. So here’s your chance to identify some common misconceptions.
 

MYTH #1
It always happens to Someone Else.

Without even getting into a discussion of what “it” means, this is widely accepted as axiomatic. Often, the pre-operative “counseling” and informed consent processes merely serve to reinforce it.

Amazing, isn’t it? After all, you don’t exactly need to complete a doctoral dissertation in symbolic logic to understand that this doesn’t make sense. From the perspective of the people to whom “it” didn’t happen, it indeed happened to Someone Else, and from the perspective of the people to whom “it” did happen, well, the fact is, prior to their surgery they held to this myth just as unconsciously and tenaciously as you will probably do.

It’s not that you need to be 100% certain nothing bad will happen to you. You already know that no surgery is flawless. If you want 99% or 100% certainty, you should not be getting elective surgery, full stop. Furthermore, if you want even 85% certainty that you will get good results, you really ought to read the percentages of flawed results obtained in the clinical trials performed on most excimer lasers by highly reputed doctors in ideal circumstances.

No, the problem with this myth is simply that it stops people from taking laser surgery as seriously as it deserves to be taken – as surgery on their eyes – or from considering what they will do if their results are less than they expect them to be.

There was a time, and not many years ago at that, when most people tended to be pretty scared about laser surgery. When the idea of eye surgery made people shudder. When they thought it was possible that “something bad” could happen to them if they were daring and tried it. That time is gone. Now there are lovely bloodless, tissueless animations which shield us from seeing what really happens. Now Cousin Joe and your co-worker and his wife and your next-door neighbour have all had LASIK without problems and therefore LASIK is safe, and if problems do happen, lo, they have never happened to anyone you know (as far as you know) and therefore they cannot happen to you. Or if they did happen to someone you know, well, it’s because – unlike you – they went to a bad surgeon or didn’t do their homework. Right? Well... read on.
 

MYTH #2
Laser surgery problems are like plane crashes: when they happen, they are very, very bad, but they are very, very rare.

Most people assume that if your plane crashes, you will probably bite the big one. That’s a pretty reasonable assumption. There are exceptions. Maybe the landing gear doesn’t retract and they manage to land the plane on its belly, causing only concussions, heart attacks and wet pants. Maybe after the fuel runs out over the Atlantic and both engines shut down, they manage to safely coast to an airport, like that amazing A330 landing in the Azores a few years ago. But for the most part, when you’re sitting inside an enormous metal tube that is either 35,000 feet above the earth or is accelerating or decelerating in near proximity (and at intriguing angles) to the earth, and “something really bad” happens, rapid death is not an irrational prediction.

With laser surgery the exact opposite is true. This is NOT a world of extremes. I think there have been one or two documented cases of actual blindness in all these years, so the eyeball equivalent of death IS possible, but the very things that are more typically termed “rare complications” really cannot reasonably be expected to end in anything half so serious as total blindness. No, there is actually an enormous range of outcomes in laser surgery, with shades of grey (pun intended) everywhere. Within this range is another very large range: that of outcomes which technically count as successes, because the means conventionally employed to measure success remain primitive, for reasons that are not well explained. So when you are thinking about risks, you should not be thinking in extremes. You should be thinking in terms of milder problems which happen more frequently and – importantly – which may not be treatable.

And speaking of frequency...  I didn’t have time to go look up the latest statistics on commercial jet crashes. But I do subscribe to Flight, a weekly aviation magazine, and every year they have an issue that lists the previous year’s serious accidents for all of commercial aviation, including whether there were injuries or casualties, and if so, how many. The list is reliable and exhaustive because it’s pretty difficult to pretend a jet didn’t crash, and all government authorities vigorously investigate and report accidents. (If it was a Boeing jet, the US authorities will probably poke around no matter where it happened.) The accidents that cause injuries or casualties might fill a page at the very most, and of those, typically only one or two happen to airlines you have ever heard of, or occur in countries of which the average American could name the continent without prompting. And believe me, there are more flights happening in a year than there are eyeballs being lasered. My list of injured patients in the US and UK for any of the years 2000 through 2003 is considerably longer than Flight’s typical list of accidents and that’s just the patients that happened to contact me (an obscure patient who took this up as a hobby relatively recently).

But, you will argue, that’s all hearsay and you have no reason to believe me. I could have made it up. Fair enough. Forget about me. You need only go to the FDA website and look up the complications and adverse effect statistics from the clinical trial data submitted for the approval of, say, the VISX, Alcon, Bausch & Lomb and Nidek lasers. The numbers of complications are not negligible, and the adverse effects actually happen to surprisingly large proportions of patients. When you step in an airplane, what is your tolerance for the risk of crashing?  1 in 3?  1 in 4?  1 in 5?  1 in 10?  1 in 20?  Of course not, it’s more like one in a million and preferably less.

So please, can we stop these ridiculous comparisons to risks which truly are statistically rare? Yes, doctors, I’m afraid I really am talking to you...
 

MYTH #3
People who have problems from laser surgery went to bad surgeons or “LASIK mills”.  (Corollary: It won’t happen to me, because I’m going to the best and most expensive surgeon in town.)

To me, this myth is a very sad one, and a very worrying one, because it’s so very natural. To a certain extent, I even relied on it myself. And I simply can’t tell you how many times I’ve heard a patient say, “I just didn’t think something like this could happen to me – I went to the best/most expensive/most famous/most published/best-trained/most experienced surgeon available.” In fact, it happens so often that when I hear from a new patient, I have rather come to expect to hear this. It’s early in the story, and is usually followed by a statement like, “They said I was a perfect candidate”.

I can’t say it enough times:

COST IS NOT A PROXY FOR QUALITY in laser vision correction.

COST IS NOT A SAFE SHORTCUT for doing thorough research before laser vision correction.

I do need to make one important distinction here. There are problems, and there are problems, and it is entirely possible as well as highly advisable to reduce certain risks by means of selecting a certain calibre of surgeon and surgical practice. To explain:

1) There is a class of gross complications (occurring during or after surgery) which are certainly going to happen more often and have more potentially more serious long-term implications for patients if the surgeon is poorly trained and/or inexperienced, or where the business model may preclude attentive and high-quality care. These types of complications may be relatively rare no matter what the context, but they have to happen to somebody, therefore it could be you, and therefore it behooves you to get the best surgeon available to you.

2) There is also a class of problems which affect vision or eye surface comfort, and which do not, in my experience, correlate well with any particular type of surgical practice. Many of the problems in this category occur because of an entire class of patient risk factors which the industry has seen fit to either ignore altogether or deal with cursorily; none of these risk factors have been studied in any depth despite the huge numbers of patients getting surgery. This is a grey area where there don’t seem to be any rules at all, and certainly no accountability.

Perhaps not surprisingly, it is the second class of problems which comprise the vast majority of patients that contact LaserMyEye. I rarely hear from people with major flap complications or postoperative infections. In my view, this happens for a number of reasons: (a) surgeons are getting more experienced; (b) the 2nd class of problems happen considerably more often than the “gross” complications, and (c) they are also less treatable, therefore there are more people wandering around the Internet looking for help or hope.

Bottom line, don’t simply assume you’ll be fine because you think you’re dealing with a Porsche and not a Toyota. There is a lot more to successful eye surgery than the ten minutes it takes to perform it.
 

MYTH #4
People who get problems failed to do their homework.

Patently false as a generalisation. I could cite innumerable examples. Let’s just name one here.

Patient X goes to a reputable, conservative surgeon, Doctor Y. Doctor Y tells him he is an excellent candidate. Patient X is very savvy and has read all about thin corneas being a risk factor for LASIK and he seems to have somewhat borderline corneas. Doctor Y assures him he is well within safety limits and that on Doctor Y’s wonderful high-tech laser, he will have 280 microns of stroma left under the flap after surgery (the broadly accepted minimum being 250). Patient X has a moderate prescription and does not expect to need an enhancement, so he goes ahead. His results appear satisfactory, until several months or a year after surgery when his vision begins to deteriorate. Several expert opinions later, he learns that he does not have 280 microns under the flap, he has 215, because the microkeratome cut the flap far too thick and, possibly, the original pachymetry reading was not entirely accurate. Patient X now has corneal ectasia, a progressive condition where the cornea becomes structurally unstable due to excessive thinning. He will need to wear gas permeable lenses to stabilise his vision and he will probably eventually need a corneal graft or transplant.

Patient X was NOT merely a victim of bad luck. At the time of his surgery, it was known that microkeratomes are imprecise and that a microkeratome that is set to cut a 160 micron flap could be creating anything in a wide range of possible thicknesses, as is well documented in the medical literature. Why didn’t he know this, and what could he have done to prevent this from happening? He did his homework carefully. This information is not widely available and not talked about a lot before surgery. True, there is the Intralase which makes thinner and more reliable flaps, but relatively few doctors have bought into it yet, and Patient X's well-known surgeon seemed to have many good reasons for not yet using the Intralase. So why didn’t the doctor recommend surface ablation, or at least incorporate room for known microkeratome imprecisions? Was it because it would have meant turning away Patient X, and other patients like him? Why couldn’t they simply have told him, so that he at least knew that such a risk existed, since he had no idea despite being so careful? Such questions as these will continue to torment Patient X for the next several years of treatment.

That’s an example of a very serious complication. There may be more information available that could help patients anticipate and prevent less serious complications. But in most cases, there is less, because unlike microkeratome performance standard deviations, many other problems are not documented in the medical literature.

Don’t blame the patient. Please. It is not fair to assume it’s their fault.
 

MYTH #5
People who complain about “vision quality” problems after LASIK are just picky.

This myth is not just believed by prospective patients who come across websites built by unhappy patients; it is apparently a comfortable and widely-held belief amongst laser surgeons. It is so unscientific (not to mention un-doctor-like) that it never fails to arouse my wrath.

I need to digress for a moment in order to define “vision quality” for those of you who either have no idea what I’m talking about, or who think it must be something subjective. Vision quality refers to a host of things that perceptibly affect your vision but without necessarily affecting whether you can read a certain line on the eye chart. For example, if you have triple vision, you may see three eye charts, yet still be able to see the 20/20 line (on all three!). If you see three of everything, you are probably not a happy patient, but by today’s standards, you are technically a successful patient. Other examples are (1) loss of contrast sensitivity, where everything in sight seems to blend together (particularly in dim light), and you find yourself wanting to be surrounded by halogen lamps; and (2) night vision disturbance, where light sources produce all sorts of interesting and sometimes quite dramatic effects. There are objective ways to measure most such effects, however, these objective ways are not used to measure such symptoms after laser eye surgery. It should be noted that any or all such effects may co-exist with a “successful” outcome from laser eye surgery.

Now, it is certainly true that there are amounts of vision quality loss which (assuming the patient has been forewarned) fall into a range where you can justifiably debate about whether the patient is “just being picky” – though if “you” are an eye doctor with refractive error and the patient learns that like most eye doctors you have not had laser surgery, it could be a somewhat uncomfortable conversation. But there is a threshold, beyond which reasonable and normal people suffer significant quality of life impact. There is also, of course, yet another threshold beyond which all people can be described as experiencing a significant disability.

What absolutely makes my blood boil is hearing well-trained ophthalmologists use the patients who objectively have substantial degradation of vision quality but who aren’t complaining about it as a justification for treating all the “normal” people who also have substantial degradation and are complaining as though they are “picky”! This is unethical and utterly contrary to good science and good medicine. Similar logic would state that because there exists a patient who was walking around for ten years in dirty scratched-up glasses with an outdated prescription, and is such a visual slob he never noticed, so an equivalent surgical outcome doesn’t bother him in the least — THAT means I ought to be happy walking around with the equivalent of dirty scratched-up glasses permanently burnt onto my corneas, right? I don’t think so.

Calm, calm. I’ll get off my soapbox now. Just do please humour me by reading a few questions designed to help you, the prospective laser surgery patient, determine BEFORE surgery whether you, too, are “picky” — that is, whether your expectations of surgery are high enough that you ought to learn more about vision quality and how yours will (or might be) affected by laser surgery. Hopefully one or more of these questions will give rise to some useful discussion with your surgeon.

a) Does the idea of, after surgery, not seeing as well even with glasses as you did before, bother you at all? Or does that just sound like a reasonable trade-off for being free from lenses?

b) Do you consciously enjoy your clarity of vision with contact lenses, as compared with your glasses? What do you expect your post-surgery vision to resemble – your contact lens vision or your glasses vision?

c) Would it bother you if you could no longer make out peoples’ faces in, say, a bar or restaurant or other relatively poorly-lit environment? What about if you could not read except in daylight or with bright artificial light?

d) Do you expect to be able to drive at night regularly after surgery? If for some reason you no longer felt comfortable or safe driving at night, precisely what practical problems might it impose?
 

IN A NUTSHELL

We, the people with problems related to laser eye surgery, are NOT different. We are just like you.

We had the same prescription.
We had the same glasses or contacts.
We had the same needs.
We had the same expectations.
We went to the same surgeon.
We did the same amount of research.
We were just as smart.
We paid just as much.

Learn from us. Learn how to prevent the preventable problems. We learned the hard way, but you don’t have to risk going through what we go through, and we don’t want you to.