No, no, I'm not talking about the legal form that you, the patient will be required to read, sign, and (probably) copy selected sentences from in your own handwriting prior to having refractive surgery, hopefully not on the day of surgery, nor after signing the credit card slip, nor after sedation.

Mind you, I'll talk about that form too, just not this week.

No, I mean the real thing: The process by which you, the Consumer, will become informed before you consent. (Hint: In today's environment, the informing part is just as much your job, practically speaking, as the consenting part.)

To help you assess your preparedness for the Informed Consent process, I offer here eight pointers designed to help you not only get the most from laser vision correction, but do it as safely as possible.

Do you place a high enough value on your vision?

Sound like a rhetorical question? After all, if you did not value your vision, you wouldn't be preparing to spend a considerable wad of your own money and undergo the risks of surgery to improve it, would you?

Sorry, I don't buy it. In the age of conspicuous consumerism we habitually spend copious amounts of money with or without a well-articulated reason. In laser eye surgery, those consumers who believe that the more money they pay, the better quality product they will get, are missing an important point. Several, actually.

Suppose you were to decide to get plastic surgery to alter the shape of your somewhat unsightly — at least to you — nose. You search for a really good plastic surgeon (who may or may not be the most expensive around). You find him. You interview him. You decide that he is the bees' knees. And you proceed straightaway to the workup and surgery without knowing anything more about the objective of surgery than that the surgeon is aiming to give you a nose as nice-looking as the average normal nose (which plastic surgeons have some mysterious means of determining). And you trust him to do so and trust that you will be satisfied with the outcome. Right?

We didn't think so. Unless for some strange reason you need to get it done overnight AND your nose frightens the neighbourhood children so badly that any change would be for the better.

In fact, you value your nose, or at any rate the appearance of your face, enough to invest time understanding what it will look like on your face after surgery. You thoroughly appreciate the implications of living the rest of your life with a nose that you in some way dislike. In an elective surgery, it would not make much sense to trade one defect for another, would it? So you are not only cautious but highly conscious of what you want to know before surgery.

You see where I'm going with this. If how others see you is so important, why not how you will see the rest of the world for a long, long time? If you think a nose is complicated, what makes you think eyes and vision are comparatively simple?

Through advertising, LVC so successfully creates an illusion of a safe, cosmetic procedure no more invasive than trimming your fingernails that it's not surprising many people succumb to the hype and fail to spend adequate time researching before surgery. But for those who do take the time, what is very worrisome to us here at LaserMyEye is that they so frequently still do not learn any of the most important things they need to know to maximise their satisfaction with their results and avoid high-risk situations.

What are the right things? Read on.

Do you have a healthy appreciation of the commercial nature of refractive surgery?

Just as some people underestimate the delicate nature of LVC as a medical surgery on sensitive corneal tissue and our most precious sense, vision, so others may rely overmuch on its medical trappings as a psychological security blanket of sorts. This potential vulnerability is perhaps increased in the case of patients referred for LASIK by their regular eye doctor (a common practice in the US under “co-management” arrangements) or who are planning to have LVC in an institutional setting (university or hospital) or with a famous surgeon or with a surgeon who has operated on a celebrity. But most patients never really grasp the broader context of the industry in which all laser centres operate. For many, of course, it doesn't end up mattering very much, but why risk being one of those for whom it does matter, if you can prevent it? Knowledge is power.

Commercial medicine is a confusing business at best. When is my doctor a doctor, and when is he a businessman? When am I a patient, and when am I a consumer? If you have not given thought to these things in the context of LVC, now is a great time to start. Here, I'll help. You are a consumer. Full stop. Period. See, that was easy!

Sound cynical? Not a bit of it. It's simply practical and, from our standpoint, infinitely safer to make that assumption. You risk nothing by approaching LVC as a wary, critical consumer; you risk much by staking your all in ethics and expertise alone when in the context of a young, profitable, high-growth industry. Would you stake your vision on the belief that Tiger Woods' endorsement of a certain national laser centre is fundamentally different from Michael Jordan's endorsement of Nikes? We didn't think so. Michael may like his shoes but the contract didn't do him any harm either.

In fact, marketing methods are rather more aggressive in LASIK than traditional professions of most other sorts, except maybe the increasingly prolific personal injury and mass tort lawyers in the US (funny sort of coincidence, now that I come to think of it) and the people they go to to get their teeth whitened.

I am not going to say that a heavily profit-driven business model in a highly competitive environment is not compatible with the Hippocratic oath. I am simply saying that in LVC, the increased risk to your vision posed by the former can never entirely, and in many cases is hardly at all, be outweighed by the latter.

Make no assumptions about the extent of responsibility your surgeon, to say nothing of your clinic, are taking upon their shoulders to educate you about everything you really need to know about LVC to make the best choice. They cannot give you all the information there is, and it would not be in their interests to do so anyway. You think your surgeon or clinic is an exception? Fine — go right ahead. Just know that having thought so will be no consolation if you ultimately join the ranks of bewildered, disillusioned patients who have contacted LaserMyEye about their unexpectedly poor results and who, before their surgery, thought just like you do. So if you want to be a prudent consumer, read on.

But don't worry. You're not alone. We're here to help you navigate this complex world of LVC and fill in the gaps of information you may well not get elsewhere.

Do you realise you're probably not going to be a repeat customer?

You have one chance to get it right. So you'd better do a good job.

Such is the only prudent way for a consumer to look at elective laser eye surgery. In all cases, you have one chance to get it right without subjecting yourself to unnecessary risk (i.e. additional surgery), and depending on your specifics and the type of treatment you are getting in the first place, as well as the outcome, you may have only one chance altogether.

But, you say, I can always get an enhancement. OK, let's talk about “enhancements”.

If you really have your wits about you during your informed consent process, you will find you frequently come across soothing marketing terms for any of the less than perfect aspects of LVC. The best-known of these terms is the “enhancement”. I am not aware of any other field of medicine in which a surgery that fails the first time around is called an under- or over-correction and further surgery you never bargained for is called an enhancement. Now don't get me wrong — marketing is part of how I earn my living too, so I understand, but in my profession it's all about money and airplanes, and all the companies I have ever marketed to had handy safety nets like credit committees. So I always cringe when I hear this “enhancement” term bandied about like removal of a little bit of bikini area hair they missed the first time around. That's trivialising medical surgery.

So what IS an “enhancement”, really?

Surgery. Much like the first one. With the same risks, typically, and sometimes more, as you have a right and responsibility to yourself to fully understand before signing up.

Let's take LASIK as an example. On the plus side, during a second surgery they are (well, usually, though not always) lifting an existing flap, so you do not have the risks associated with the cutting process, and usually a lot less tissue will be removed, so presumably that translates to less serious defects if something goes wrong with the ablation or healing. On the minus side, with re-lifting a flap there is increased risk of epithelial ingrowth (cells growing under the flap) developing later, and there's always the possibility of wrinkles to the flap when laid down; then, for the unlucky ones who have to have another flap cut there are worse risks such as the second cut intersecting the first and slivers coming out or the whole thing crumpling up. This is not to scare you, of course. All I'm saying is, don't let the terminology deceive you into brushing this off as a routine “touch-up”. That's marketingspeak. Surgery is surgery, so take it seriously, even if it's free, and particularly if the people giving or selling it to you don't appear inclined to take it as seriously as we do.

Another thing you need to realise before signing up is that there is no guarantee you will be eligible for additional treatment even if you need and want it after your original surgery. Your eligibility will to a certain extent be predictable based upon your starting corneal thickness, how large a diameter treatment you get (the larger your pupil gets at night, the wider the treatment needs to be to preserve your night vision quality, with consequent deeper penetration at the centre) and how thick a flap is to be cut (in the case of LASIK). But there are variables as well. Recent medical literature has clearly demonstrated that actual LASIK flap thickness varies greatly and can stray far from the programmed thickness. To thick or too thin a flap, or an uneven flap, may pose serious risks for retreatment. Or there may be unexpected healing complications, or persistent dry eye conditions which render further treatment unwise at best.

Finally, it is most unfortunate that advertising schemes such as “lifetime guarantees” encourage the ridiculous assumption that LASIK just skims the surface of the cornea. No, typically at least one third of the total cornea is penetrated and sometimes considerably more. You do not have infinite tissue to keep whacking away at. There is only so much you can touch while preserving the structural integrity of the cornea as a whole.

All in all, it is not wise to go into surgery banking on the ability to get retreated. You need to think ahead and even think about the fact that you may need a Plan B. This is even more important the higher your prescription is. If you have never thought about this before surgery, you may not realise how powerful the urge, after a less than successful surgery, may feel to jump into an enhancement. Think about the risk/reward balance of enhancements now, while you are not subject to the emotional pull an imperfect outcome often produces.

Do you understand the importance of technology?

There are many technological variables in laser vision correction, including:

1) Choice of procedure (LASIK, LASEK, and PRK) each with unique characteristics, advantages, drawbacks and risks.

2) Choice of excimer laser. There are several different manufacturers and the specifications, characteristics, capabilities and performance of each vary considerably.

3) Standard ablation (laser treatment) vs. wavefront-guided ablation (the latter being additional software which feeds diagnostic data to the laser); both are available from most laser manufacturers although in the US at present there are relatively narrow limitations on how wavefront may be used.

4) In LASIK, the choice of having a flap cut with a microkeratome (automated blade) or with a fematosecond laser (usually called IntraLASIK or all-laser LASIK).

Depending on the specifics of your case, any or all of these might play a minor or major role in your satisfaction with the outcome. For example, patients with large pupils can benefit from a laser capable of a wider zone, and patients with thin corneas are often told they will be better off with LASEK or PRK than LASIK.

In addition to the tools and techniques that are employed in LVC, there are even more factors which can affect the efficacy of the tools. For example, did you know that relative humidity can affect laser performance and that laser ablations may differ from winter to summer? That is how delicate these procedures are. I am not suggesting, of course, that you read a roomful of textbooks and/or take a barometer with you on the day of surgery. I merely want to dispel the popular tendency to trivialise the procedure as a way to simply flap and zap your way to 20/20.

No, in LVC many technological details actually matter. And why do they matter to you?

First and foremost, because there is no single best technology, no single approach that is safest and best for all individuals. What is good for Michael is not good for Mary and vice versa.

Second, because there is no practitioner who is equally experienced with all of the procedures, tools and techniques and therefore who can give you conclusive and unbiased information about their relative advantages and disadvantages for all different types of candidates.

Third, even if a surgeon with this breadth of experience and expertise existed, he would not tell you in detail about all the other options, for many reasons. He can't spend hours upon hours with you and still keep his practice running. He works with a specific laser, or at most two, and presumably because he really does think what he's using is the best, so it would be irrational to expect him suggest another laser may be better. Surgeons are human, too, and have to pay the bills, so in the highly unlikely event they believe the laser centre down the road would be better for you, it's even more unlikely they would send you there.

So there are very practical reasons why you need to be on top of technology, yourself. There will come a point when you need to interview your surgeon about it as well, but this needs to be put in a context you have created for yourself. You cannot expect him to educate you that much.

Do you understand the grey area between success and failure in LVC?

For many people, the greatest risk in LVC will be their own assumptions — common, yet erroneous, assumptions. To LaserMyEye's constant frustration and chagrin, as well as that of many conscientious surgeons I might add, the refractive surgery industry and its advertising apparatus have put great effort into reinforcing the assumptions that are most likely to lead you astray.

Examples:

Assumption: Results come in black and white. That is, either it works and I don't need glasses most of the time, or there is a one-in-a-million catastrophic vision-threatening complication.   (Note: Forms and websites which mention horribly frightening results such as death or blindness reinforce this notion; in the patient's mind, all risks become lumped in the same category, called “rare and extreme cases”.)

Reality: (1) The vast majority of genuinely dissatisfied patients do not have catastrophic complications. (2) There is an awful lot of grey area.

Assumption: The “grey area”, that is, poor results that are anything short of catastrophic, are usually when they undershoot or overshoot the target. At any rate, you just have to go on wearing glasses.

Reality: (1) Under- and over-correction are only two among many potential defects in the “grey area” of LVC results, and are much more easily treatable than most others. (2) The rest of the “grey area” in LVC is, for the most part, not conditions for which you have to wear glasses, but rather new visual “features” that do not improve even when you are wearing glasses.

Assumption: If I can see the 20/20 line without glasses or contacts, I will be happy and so will my doctor.

Reality: (1) Your doctor can be happy even if you are not. (2) The high-contrast eyechart measures but a single aspect of your vision. Other aspects of your vision are affected by surgery too, but are not measured. (3) Seeing 20/20 is perfectly compatible with both small and large amounts of visual trash (ranging from multiple images to night vision disturbances) as well as eye pain and discomfort.

So what constitutes success in LVC? Or patient satisfaction?

First, let's get one thing straight. You and The Industry are going to have different, and possibly conflicting, standards for success.

To you (assuming you are reasonable) success should mean that the stated goals of surgery have been achieved and surgery has not also introduced new vision problems or other eye health problems that you didn't have before, unless your surgeon told you that you would probably get them, and these are mild enough and/or you were dumb enough and he was callous enough to proceed with surgery anyway.

To The Industry (translation: probably, and at least possibly, the surgeon with whom you will have surgery) success means you can see 20/40 or better without glasses after surgery, and real success means you can see 20/20 or better without glasses after surgery. Full stop — period. That is because refractive surgery has always only aimed to achieve one thing (something called uncorrected visual acuity >/= 20/40) even if it achieves a few other things in the process. We'll talk about this more soon.

THEY know what their goal is. Do YOU know what YOURS is? Remember, what you don't know can hurt you.

Do you understand the differences between eligibility and suitability?

I'm not going to talk too much about this one because (a) if you made it this far, you're probably exhausted and (b) there's a lot to talk about on this one. But let me at least outline the broad idea.

“Eligibility” for LASIK, LASEK, PRK et cetera is easy. It is determined by very simple, concrete guidelines which are posted on most clinics websites and, in the US, are determined by the FDA approval parameters for excimer lasers. Broadly speaking, if you are breathing, aren't a kid, aren't pregnant, aren't blind but do need glasses, and don't have certain extremely serious eye diseases, you will be eligible for some form of LVC. And it is absolutely the responsibility of the clinic and surgeon to determine whether you are eligible and if they do surgery on somebody who is not eligible they may find themselves in deep trouble (something that is not really true of suitability at all).

“Suitability” for LVC is another matter altogether. Suitability is relative, and relative levels of suitability will produce correspondingly relatively increased risks for better or worse results or more adverse effects or more serious adverse effects or complications. Suitability is determined by many factors relating to your body, systemic health conditions you may have, medications you regularly take, your eye characteristics (such as pupil size, corneal thickness, how steep or flat your corneas are and even how deep your eye sockets are), any eye diseases or surgeries or even very mild conditions to which you may be prone, and details of your vision at the time of surgery as well as your vision history. Suitability is also relative to the specific treatment plan — the type of LVC and the treatment parameters — and even the laser employed.

Now I'm going to tell you a little secret.

You've all heard of the “good candidate” or “excellent candidate” or “perfect candidate” for LASIK, haven't you? Perhaps you've even had a pre-op evaluation or two (we recommend three, by the way) and somebody has declared you to be a good, excellent or perfect candidate.

Well, the secret is, almost anyone who meets the eligibility factors can be told that s/he is a good, excellent, or perfect candidate for LASIK (or other form of LVC). That says nothing about their suitability. A declaration of perfect candidacy, in fact, could mean anything from perfect eligibility to perfect eligibility plus passing SOME of the tests of suitability. Not all. Never. No pre-op evaluation form ever written covers them all. No optometrist or technician or “counsellor” (salesperson) ever covers them all, and it is not uncommon for some of the items they do include, even some pretty important ones, to not be investigated or discussed with you sufficiently to satisfy you if you knew their true significance. They can't, it's just not practical. But what may not be in their preop workup could ultimately be important to your satisfaction with your results.

Mind you, I'm not saying no one with relative risk factors should have surgery. Not at all — and that would perhaps eliminate a substantial part of the population. To many of you freedom from glasses for some activities or some years is 100% worth some tradeoffs in quality or even comfort and therefore you are willing to undergo increased risks. But ideally, YOU are the one who should be making that choice about the tradeoffs, and you can only make the choice if you know what the tradeoffs are. Perhaps as often as not, patients with minor risk factors will choose to go ahead, and in those circumstances, they will probably be all the more satisfied with a less-than-perfect outcome for having known ahead of time that it would not be perfect. But patients with more serious risk factors, and patients with a greater consciousness of their visual requirements, may feel differently. Forewarned is forearmed.

Why do I sound so adamant about this, you ask? Because the vast majority of patients who contact LaserMyEye about their bad results were told they were good, excellent or perfect candidates and learned all too late what their risk factors were.

What you don't know can hurt you.

Do you know what you want and need from surgery and whether it is achievable?

You'd never believe how many people don't.

It's important to have a very clear idea what is important to you and what you are willing to sacrifice for it. For there will be tradeoffs. If not now, then later, especially when you hit the presbyopia years.

Activities play a key role. How much of what you have to do for a living, or enjoy most in your free time, requires good near or good distance vision? For which activities is it most important to you to be free from glasses, or free from contacts?

Expectations of post-LVC vision in comparison to pre-LVC vision is a key area where communication breaks down. The unspoken assumption of many LVC patients is that after surgery, vision will be the same as it was before surgery with glasses or contacts — except that for glasses wearers, of course, they expect it will be better because they'll finally have peripheral vision. Yet LVC fundamentally alters the shape of the surface of your eye in such a way that a certain amount of change to vision quality is unavoidable. It might be small enough that you don't notice at all (particularly true of people with low prescriptions and small pupils, under an ideal treatment) or it may be much more dramatic, but in any case it will be visible on certain diagnostic tests. You need to know whether you personally, with your eye characteristics and the technique and laser you're proposing to adopt, are likely to be able to achieve small enough amounts of bad changes that they don't bother you, or alternatively get so comfortable with the type of changes that you decide it's worth the tradeoff to you.

Equally high on the list of problem areas in patient education is presbyopia. Many people, mostly under 40 but some even over 40, don't understand it and in what ways LVC is limited by it. They don't realise that in fact you cannot surgically correct your vision in such a way that both eyes can see well both in the distance and for reading. Since most people have LVC so they can get rid of glasses, it is well worth thoroughly understanding what LVC can do for you now and in the future with respect to presbyopia.

Another problem area — thankfully relatively rare, but we know many instances — is the expectation that LVC can improve your vision. If you cannot see 20/20 with glasses or contacts, it is unlikely that you will be able to do so after surgery. If you cannot see 20/40 with glasses or contacts, you shouldn't be having LVC. Note: That is also true for patients who have had LVC and are considering an “enhancement.”

Do you understand the risks?

There are two ways to look at risks:

1) What can go wrong?

2) If it does, how will it affect me in the long term?

Below I will try to briefly outline the main categories of both complications and adverse effects and the main ways in which they may affect you. But first, let's talk about something even more important: How are you going to use this information?

You see, one of the greatest dangers in LVC (and the biggest obstacle to proper informed consent in LVC) is the assumption that risks are random. Most consumers don't understand that many people get preventable adverse effects. Of course, it's easier to look at it that way — you see it as a numbers game, a crapshoot of sorts, you decide your risk tolerance and you go ahead. And that works fine for those who come out fine, but believe me, there is nothing worse than getting a bad outcome and finding out that you subjected yourself to a heightened risk — and an easily preventable risk — without knowing it.

I call those pre-operative complications. We'll talk about them in the weeks to come.

Examples of what could go wrong:

(Please note, this is not an exhaustive list. We will eventually have one posted in the Candidates section of the LaserMyEye website. Also note that the flap complications refer exclusively to LASIK.)

Examples of how you can be affected by things that go wrong:

Well, I hope I've helped you pinpoint some areas for further study. Feeling overwhelmed? Don't be — we're not going to simply send you on your way to do all this homework on your own. Over the next few weeks we'll be exploring some of these points in more details to give you specific practical pointers... but in much briefer segments than this week's, I promise!

Stay tuned!