Let's examine the "complication rates" from the FDA clinical trials.
It is well-known that manufacturers of devices (lasers, IOLs, etc.) cherry-pick the so-called top surgeons for clinical trials, and that surgeons cherry-pick patients for these clinical trials, including only patients who are likely to have the best outcomes. This is one reason why clinical trials do not really reflect the outcomes that will be seen in the real world in the hands of average surgeons and borderline patients. Let's "listen in" on an FDA panel meeting:
http://www.fda.gov/ohrms/dockets/ac/03/ ... 3991t1.htm
Quote:
DR. WEISS: I think we have to be careful about this best physicians talking about lack of data. I'm sure these were good docs and good surgeons, but creating this extra god‑like category, I think we should take out of the discussion.
DR. BANDEEN‑ROCHE: That's a point well‑taken. That's a point well‑taken. Nonetheless, I mean, we hardly expect better performance in the field than we do in a clinical trial.
DR. McCULLEY: You don't have data to support that statement, do you? Do you have data to support that statement? You do. Okay.
DR. ROSENTHAL: With all kinds of devices.
DR. McCULLEY: All right.
DR. WEISS: What I would then like to lead to is since there's agreement ‑‑
DR. ROSENTHAL: Wait.
DR. WEISS: Yes.
DR. ROSENTHAL: I want to make sure I said the right thing. Once they go out in the field, they tend to have more problems than they do within the clinical trial.
DR. McCULLEY: But you don't have data to support that the people who do the trials are the best of the best.
DR. ROSENTHAL: No.
DR. McCULLEY: I think that is opinion ‑‑
DR. MACSAI: That's my opinion.
DR. McCULLEY: That is Marian's opinion, and it should not be in our discussions.
DR. WEISS: So we're going to take out the "god" factor out of the discussion.
(Laughter.)
That's just one problem with complication rates.
No one is tracking complications in "the field".
Another problem is that many of these clinical trials reported complications at 3 months and 6 months. But what about late on-set complications, such as ectasia. Complications may not emerge for weeks, months, or even years. There are many case reports in the peer-reviewed literature of late on-set LASIK complications.
And what about the Hawthorne effect? "It states that by merely participating in a test, trial or study the participants (or patients) have a better experience because of the focusing of interest toward them which is gratifying and thus rewarding in its own sake. For this reason the persons involved document better results irregardless of the change provided or the treatment experienced."
And who gets to define a complication? The patients who are suffering? Or the doctors who have a financial stake in the "complication rate"?
This article was published anonymously in Journal of Refractive Surgery, Sept/Oct 2002:
Quote:
Money evaporated like water as huge sums of advertising dollars were spent on radio, cable TV, and newsprint advertising to get the ball rolling. Initial surgery went well, but diffuse lamellar keratitis (DLK) was experienced in 20% of cases. Furthermore, this rate of DLK increased over time to as much as 50% of eyes with this postoperative inflammatory response. Over the next 2 years, a myriad of corrective measures were tried, and I became an unwitting expert on the treatment of DLK. Uninterrupted weekends became a thing of the past, as I would be in the office every Saturday and Sunday monitoring the course of Sands of the Sahara patients.
Because these patients weren't part of a clinical trial, these cases of DLK were never "counted".
What about the two most common complications (based on my definition), dry eyes and night vision disturbances? Should they "count"?
Here's what an AAO report says about the frequency of these complications:
Quote:
Ophthalmology. 2002 Jan;109(1):175-87.
Laser in situ keratomileusis for myopia and astigmatism: safety and efficacy: a report by the American Academy of Ophthalmology.
Sugar A, Rapuano CJ, Culbertson WW, Huang D, Varley GA, Agapitos PJ, de Luise VP, Koch DD.
Ophthalmic Technology Assessment Committee 2000-2001 Refractive Surgery Panel.
Serious adverse complications leading to significant permanent visual loss such as infections and corneal ectasia probably occur rarely in LASIK procedures; however, side effects such as dry eyes, night time starbursts, and reduced contrast sensitivity occur relatively frequently.
If they count, then the complication rate is high, very high.
Let's just look at a couple of FDA clinical trials, and the rate of these complications as reported by the patients:
And that's the biggest problem with so-called complication rates. Complications like dry eyes and impaired night vision are not even counted in the bogus 1-2% complication rate, even though these complications may be life altering and incapacitating.
