This is tricky. Never underestimate a patient's ability to mentally assign a huge significance to a tiny risk of complications while ignoring the vastly greater risk of vision loss if they do not get treated. This is especially important to remember in the setting of diabetic retinopathy where—once again—even perfect treatment can't always stop the disease. Patients are very likely to remember your discussion of complications as their vision gets a bit blurrier over time and then they can assume the laser is the problem, even if the blurriness has nothing to do with any laser complication. This puts them on the path to the Dark Side of Noncompliance—something to be avoided if at all possible. The point is that you have to cover the bad things but think carefully about how you do it.

You will be a sucky doctor if you do not make sure patients hear the words "There is a small chance that the laser can make you worse." Even if you become a laser sensei, it is a sad medical fact that bad things can happen, and you never know when both you and the patient will get an unpleasant surprise. You do not want any patient coming back at you claiming that you never said such a thing—no matter how bullet-proof your malpractice carrier says your written informed consent is.

However, you should not leave this (or any other negative concept) hanging at the end of a conversational paragraph. You need to remind them in the following sentence that the risk of treatment is very tiny, but the risk of permanent loss of vision is extremely large without treatment.

Another important warning should be mentioned, especially for Astute Patients (i.e., engineering types): Sometimes, a good observer may forever-after identify the laser spots that you placed in their paramacular vision. This is surprisingly unlikely—most patients are really oblivious of careful, gentle laser for macular edema. However, some patients will notice this, and you get lots of style points for mentioning it before they come to you to complain about it. The key "next-sentence" point to make, though, is that this problem is rare, and even if they do notice something, it is a heck of a lot better to have a few spots on one's peripheral vision than to lose chunks of central vision from untreated disease.

Okay. Once you have gotten the part about the laser making things worse out of the way, it is now even more important to dwell on the biggest problem with the laser: that it may not completely control the disease. Some of this has to do with the general tendency of diabetics to have slowly degraded vision just from being diabetic, as was discussed in the preceding paragraphs. Patients also need to understand that areas of leakage may develop rapidly in any location the diabetes chooses, and even if the treatment works well in one area, the vision may deteriorate if new leaks continue to show up. Patients must be prepared for the possibility of multiple treatments and rapid worsening of vision from progressive disease.

Then you can add that, unfortunately, there are times when the treatment simply does not work at all, and some patients go downhill even with treatment. You can then allude to more aggressive and risky treatments, such as intravitreal steroids, that may help them if the laser can't. Don't let them feel that these more aggressive treatments are Good Things, though. It is easy for patients to think, "Oh well, if the laser doesn't work I'll just have an injection or two and be fine." They need to know that it is much better if they can be controlled with safer, simpler things like a gentle focal laser—in other words, that there is not necessarily a pot of gold at the end of your coherent light rainbow. This is also a good time to emphasize the importance of good systemic control so the patient understands that the laser alone is not going to solve their problem—the patient needs to be an active participant in this process. (Much more on this in The Chapter with a Tantalizing Name.)

As you read this, it may seem like a lot of information to convey when time is limited. However, it really just takes about five minutes to go through this— including the time it takes to be sure patients clearly understand the goals of the treatment. Indeed, making sure the patient understands is perhaps the most important part. The best way to do this is simply to ask patients in a non-judgmental way to repeat the gist of what you have said and then review any areas that aren't clear. Again, the actual treatment will soon become the least of your worries; making sure that patients understand what you are doing is a job that never stops.

Special Problems with Informed Consent in Developing Countries

(and uniquely American institutions such as free clinics, county hospitals, and other examples of how the American healthcare system can bring third-world medicine to your backyard)

The bulk of this chapter refers to dealing with patients who have a fighting chance of taking good care of themselves. It is also hoped this book will be helpful in situations where patients have less of an opportunity to obtain state-of-the-art healthcare—and the extended section title will hopefully remind readers in a certain developed country without universal coverage to keep on reading, because there are special problems that arise when resources are limited, no matter what the gross domestic product happens to be.

Developing regions are cursed with a combination of limited healthcare resources and a limited desire on the part of the diabetic population to access healthcare until their disease is far advanced. The reasons for the latter are numerous and include the cost, the difficulty of obtaining an exam, and the lack of symptoms until things are really bad. One big problem is the perennial dilemma inherent in treating diabetic retinopathy: the perception, on the part of patients, that laser treatment causes blindness.

This dilemma deserves further elaboration. Cataract surgery in developing countries (or any country, for that matter) is met with enthusiasm because the patients experience immediate benefit, and once a cataract is popped out, the problem tends to be over. This sets a level of expectation that is never met by treating diabetic retinopathy in the same setting. Treating diabetic retinopathy usually involves recurring, unpleasant treatments, and there is usually no benefit that the patient can perceive.

This is because diabetics in this situation tend to seek evaluation only when they are forced to by progressive symptoms, at which point their disease is very advanced. Laser treatment is then attempted, and although the treatment usually helps somewhat, the patients still develop severe vision loss. Although one can explain this course of events to patients and their families, there is an inevitable tendency for patients to assume that the laser was the cause of their disease progression rather than to understand that their disease was so hopelessly advanced that the laser could only partially slow the process. The problem is exacerbated by the fact that the affected population tends to be unsophisticated and to have a hard time understanding the nuances discussed in this chapter. The problem is even further exacerbated by the fact that the healthcare workers have limited time and resources to convey such nuances—let alone have time or equipment to perform the treatments.

A vicious circle is then created as patients receive treatment and then go out and tell their friends and family that the laser is "bad." The word spreads, and then more diabetics become afraid to come in for early screening and treatment, and then these diabetics show up with advanced disease that the laser can't stop, and then they think the laser is "bad" because they became worse, and then they tell their friends, and so on and so forth. The problem is compounded by extremely poor systemic control, which makes even timely treatment much less effective.

Overcoming these obstacles by improving the education, monitoring and treatment of diabetics is way outside the scope of this book (although screening with cheap, portable retinal cameras using non-ophthalmic personnel is one way to start). What is well within the scope of this book is how this type of situation can change how the informed consent is presented to the patient. When these patients come crashing into the system with horrible disease, you have to be a bit more blunt and you have to try to offset the whole "laser is bad" thing right from the start. You have to lay out the above facts so the patient understands that your goal is to try to hold on to any vision whatsoever and that they cannot expect to get better or even remain stable. Emphasize that you are going to do everything you can to help them, and it will be a heck of a lot better than doing nothing, but things would have been a lot better if you had seen them well before this point.

You can also beat on them about control, but there may not be much they can do about it in their circumstances. What is really important is that you beat on them to be sure their relatives get checked for diabetes regularly, and if they are found to have diabetes, then they have to get an eye exam once a year. Also, if the patient knows anyone with diabetes, they should tell that person to get in for regular eye exams—no matter what—because if that person doesn't, they may end up in the same mess that the patient is facing.

All this sounds harsh, but you really have to go after the tendency for folks to expect that diabetic lasers will solve their visual problems in this situation and you have to try to break the vicious cycle of having patients being unwilling or afraid to get an exam and then showing up too late. Finally, you have to try to do all this in a setting where your time and resources are likely very limited.

If you are in such a situation—ask for help. There are international organizations that may be able to lend a hand. The American Academy of Ophthalmology maintains a list of such organizations on their web site ( There may also be local religious or service-group organizations that can help you—ask around and contact as many people as you can. You may be very surprised at what a difference you can make for your practice and your patients if you are persistent. You are also welcome to write to the address in the introduction—just try not to get frustrated and give up.

Finally, there will be sections in the upcoming chapters that address how one needs to alter the treatment approach in locations where resources are limited and patients with awful disease are plentiful. It turns out that the focus of the informed consent is not the only thing that may be very different these situations.

References and Suggested Reading

1. Priluck IA, Robertson DM, Buettner H. What patients recall of the preoperative discussion after retinal detachment surgery. Am J Ophthalmol 1979;87:620-3.

Morgan LW, Schwab IR. Informed consent in senile cataract extraction. Arch Ophthalmol 1986;104:42-5.

Herz DA, Looman JE, Lewis SK. Informed consent: is it a myth? Neurosurgery 1992;30:453-8.

VanNewkirk, M. ed. International Ophthalmology. San Francisco: American Academy of Ophthalmology, 2005.

Schwab, L. Eye Care in Developing Nations, 4th Ed. Manson Publishing, 2007.

Actually Doing a Laser for Macular Edema

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