Exposing the LASIK Scam
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The Problem with Complication Rates
http://lasikscam.com/viewtopic.php?f=3&t=1679
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Author:  Broken Eyes [ Mon Sep 24, 2007 1:13 am ]
Post subject:  The Problem with Complication Rates

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:

Image


Image

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.

Author:  Eye Pain [ Mon Sep 24, 2007 3:01 am ]
Post subject:  This is madness!

If only the FDA group valued people's most precious organ (eyes) over MONEY ($$$'s), they would have never approved LASIK with the rate of complication listed in the chart. To make matters so much worse, there are factors that BE points out so well above that understates the statistics on the chart.

1) Best MD's/best patients in clinical studies. I'm sure they screened for dry eye at pre-screening and ruled out people with scotopic pupil sizes that were too large.

2) Hawthorne effect

3) Cognitive dissonance

4) Limited time tracking (3 and 6 months only)

We need to drive home the FACT that dry eyes and HOA's are LASIK complications. Referring to complications as "symptoms" will not hold up to any responsible scrutiny. The only ones who feel that they can call these complications "symptoms" are the greedy LASIK MD's who benefit from using this term. However, that dog don't hunt.

Author:  Regrets [ Mon Sep 24, 2007 10:08 pm ]
Post subject:  Re: The Problem with Complication Rates

Broken Eyes wrote:


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.



BE,

This fits really well with the point I was trying to make with my "1-2%" topic post!

Also, with what you said here, how does this stuff work with the statute of limitations? When people are getting ectasia several years down the line, and it's a known FACT that it's caused from LASIK...will there ever be anything done about it? Will LASIK surgeons be held responsible? Nothing can be done after 2 years, or whatever the law in a person?s state?so the LASIK surgeon gets off with a clean break??? They can't take any legal action at that point, can they? I'm terrified that I may end up with ectasia, and my Dr. KNOWINGLY put me at risk of it...KNOWING that I would not be suffering from such an ailment for many years?when she may very well be retired. And IF, she did NOT know that ectasia was a risk (which I can not bring myself to believe) I think she would be guilty of malpractice because she has clearly not been reading up on recent research regarding the procedure that she does on human beings EVERY WEEK.

Author:  Scientist [ Mon Sep 24, 2007 11:49 pm ]
Post subject:  Class action lawsuit will take down surgeons, too

A class action lawsuit against the laser companies VISX (AMO), Alcon and Bausch and Lomb would also take down the surgeons because they'd have no tools of destruction. The suit can take place years after the surgery... when patients realize these companies have damaged them - which is how ever many years it takes for people to develop ectasia out there.

There is so much evidence that these doctors know that ectasia is a problem and covered it up... they will all look like war criminals when all is said and done.

Author:  Scientist [ Mon Sep 24, 2007 11:52 pm ]
Post subject:  Links to the bad LASIK outcome data on FDA site?

Broken Eyes, where is table 8 from? Was that the VISX wavefront clinical trials? Could we have links for those so other reporters can sift through the scary bad data?

Author:  Broken Eyes [ Wed Sep 26, 2007 12:30 pm ]
Post subject: 

Here's the B&L one:

http://www.fda.gov/cdrh/pdf/P990027S006d.pdf

I'll have to go back and find the CustomCornea one. I'm out of time right now.

Author:  Broken Eyes [ Thu Sep 27, 2007 12:33 am ]
Post subject: 

Here's the link for the CustomCornea data:

http://www.fda.gov/cdrh/PDF/p970043s015c.pdf

I didn't use VISX for a good reason. VISX played a dirty trick with their data. Typical VISX crap. I'll show you when I have more time. It's easy to see past their tricks, though. The amazing thing is that FDA let VISX get away with it, as they always have.

Author:  Broken Eyes [ Sat Sep 29, 2007 4:18 pm ]
Post subject: 

Here's the VISX data with some of the dirty tricks erased:


Image


Image

Even after erasing their dirty tricks, we still don't know if the data was cooked, or how well they weeded out patients with large pupils from the clinical trials. In my opinion, anyone working for or with VISX (now AMO) cannot be trusted.

If you're interested in the data before I erased their dirty tricks, click on the links below:

http://www.fda.gov/cdrh/pdf/P930016S016d.pdf

http://www.fda.gov/cdrh/pdf/P930016S016c.pdf

Just an FYI... I used the "low myopia" study to give them an advantage.

If any VISX user says he can correct those "tiny imperfections" in your vision, he's full of it:

Image

Author:  Broken Eyes [ Thu Oct 25, 2007 1:27 am ]
Post subject: 

http://www.pubmedcentral.nih.gov/articl ... id=1810384

J Zhejiang Univ Sci B. 2007 March; 8(3): 177?180.

Comparison of high order aberration after conventional and customized ablation in myopic LASIK in different eyes of the same patient

Chi-xin Du,? Ye Shen,?? and Yang Wang

It is well known that up to 30% of patients experience night vision problems after LASIK such as glare and halo, decreased contrast sensitivity, and poor subjective vision despite excellent objective uncorrected visual acuity (UCVA).

Author:  Broken Eyes [ Wed Nov 21, 2007 2:07 am ]
Post subject: 

Joe R. McFarlane Jr., MD, JD:

Quote:
We are also just now learning of some of the long-term complications of refractive surgery, which are being reflected in new allegations and lawsuits. For example, some patients are developing postrefractive ectasia years after the procedure; this condition not only compromises vision, but also may need to be treated with a corneal transplant.


Source: EyeNet, November 2007
http://www.aao.org/publications/eyenet/ ... ature3.cfm

Author:  Broken Eyes [ Wed Feb 27, 2008 3:27 pm ]
Post subject: 

Cornea. 2007 Apr;26(3):246-54.
Outcomes of LASIK for myopia with FDA-approved lasers.
Bailey MD, Zadnik K.
The Ohio State University College of Optometry, Columbus, OH 43210 , USA. mbailey@optometry.osu.edu

Quote:
To report expected outcomes of laser in situ keratomileusis (LASIK) for myopia and myopic astigmatism from existing US Food and Drug Administration (FDA) data.

Data from Summaries of Safety and Effectiveness for each of the 12 lasers approved by the FDA for LASIK for myopia or myopic astigmatism between 1998 and 2004 were recorded from the FDA Web site.

Conversely, there was no difference across laser types in the proportion of patients who experienced dry eye symptoms or for the proportion of patients with low to moderate myopia who experienced night vision symptoms that were worse or significantly worse than before LASIK.

Night vision and dryness symptoms still occur in a significant proportion of patients.

Author:  Broken Eyes [ Sat Mar 15, 2008 11:40 pm ]
Post subject: 

http://www.fda.gov/cdrh/pdf/P930016s016b.pdf

There were only 86 eyes (43 patients) in the 12-month analysis of this VISX clinical trial.

Author:  Broken Eyes [ Tue Mar 25, 2008 11:15 pm ]
Post subject: 

Another problem with complication rates... In the FDA clinical trials, if they have 100 patients, they calculate everything on 200 eyes. So if one patient has a retinal detachment, it only counts as .5%, not 1%. They cut the complication rate in half if only one eye is affected.

Author:  Broken Eyes [ Fri Apr 18, 2008 2:40 pm ]
Post subject: 

Bailey MD, Zadnik K. Outcomes of LASIK for myopia with FDA-approved lasers. Cornea. 2007 Apr;26(3):246-54.

Quote:
Summaries of the Safety and Effectiveness data for each of the lasers approved by the US Food and Drug Administration (FDA) for use in LASIK are readily available on the Internet.1 Although many of the studies conducted for FDA approval of lasers remain unpublished, data contained within the summaries of safety and efficacy on the FDA?s Web site have served as a source of information on LASIK outcomes that is available publicly for patients and eye care practitioners to evaluate. For this study, we analyzed these datasets to summarize expected outcomes of LASIK eye surgery for all lasers that have received premarket approval by the FDA for LASIK.


Quote:
Although there seem to have been improvements in visual acuity outcomes with changes in technology, there were few trends showing improvements in the proportion of patients whose symptoms were worse or much worse than before LASIK.


Quote:
When the analyses were repeated for patients with only low to moderate myopia, however, there were no statistically significant differences in the proportion of patients who had glare, halos, or night driving problems between scanning lasers and wavefrontguided lasers.


Quote:
No trends for improvement in the proportion of patients experiencing dryness were found for either all patients or low to moderate myopes only. The percentage of patients experiencing this symptom was consistently ~20%. This result was expected. Lamellar flaps were cut during the LASIK procedure for all 4 types of laser, and the changes in technology that were implemented across laser types were not
intended or purported to improve symptoms of dryness.


Quote:
Overall, ~20% of patients experienced night vision or dryness symptoms after LASIK.


Quote:
In these studies, ~15% of patients experienced night vision symptoms that were worse or significantly worse than preoperative night vision symptoms. Approximately 20% of patients experienced dryness symptoms that were worse or significantly worse than preoperative dryness.

Author:  lasikcomplications.com [ Wed Apr 30, 2008 2:10 am ]
Post subject: 

Image

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