BioShape: An Alcon Insider speaks out

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The following has been extracted from emails from Stephan Schründer of BioShape to Dr. Morris Waxler

BioShape were employed by Alcon (one of the major excimer laser manufacturers) to do research to improve laser ablation of the cornea.

My name is Stephan Schründer and I founded BioShape together with Daniel Kluting in 1999. Our goal at BioShape was to establish a technology that would allow the laser system to detect erroneous ablation results during refractive procedures and to optimize the treatment “on the fly”. That would eventually lead to higher quality outcomes and lower retreatment rates. We managed to acquire some venture capital which we used to build a prototype device in 2000/2001. As from 2002 we were funded by Alcon who were interested in learning more about how we could improve their laser. In 2003 we did some clinical trials with our technology attached to Alcon Ladarvision 4000 lasers in Milan and Prague.

For the trials we captured 3d profiles of the corneal surfaces of patients at different times during the procedure. (We never interrupted the actual laser treatment though. That would have been too complicated.) By subtracting those profiles from one another we managed to calculate the effective surface changes. Those changes were then correlated with intended corrections that were fed into the laser and with achieved corrections that were diagnosed using an aberrometer (before and one month after the treatment).

We mainly measured LASIK patients. The most interesting data, as intended, were gathered right before and after the refractive treatment. Unfortunately the surface shape underwent additional changes during that period that were not connected to the laser. The eyes were strongly deformed by the microkeratome suction. During treatment this deformation is reversed due to the intraocular pressure. Hence our measurements were corrupted by this effect. We measured very few PRK patients with much better correlations. But that was not Alcon’s focus at that time.

At the end of 2003 Alcon suggested taking a closer look into treatments that do not involve the microkeratome cut. They wanted to focus on PRK and retreatments. I went to Orlando in 2004 to install a machine in their lab. But the new clinical trials were never done. When we took another look at the original data we came up with the attached proposal of Nov 15th, 2004.

The data of the trials were never published as Alcon considered it meaningless.

On the other hand we still believe that our technology can make a huge difference. After all it is the surface which has most influence on the optical performance of the visual system. And the surface is what our technology characterizes with very high accuracy. So if you intend to improve the way refractive surgery is performed today you might consider our technology to contribute to that goal.

The results of our clinical trials showed that cutting the LASIK flap leads to a permanent aberration of the front surface of the eye. A fold remains at the hinge location for an extended time period. And there are wrinkles as the flap does not fit in the bed any more after the treatment. Also the transition zone of the laser treatment was shown to have a large impact on the visual outcome, especially in dim light with large pupils. These finding were derived directly from corneal shapes that were measured with our technology. We believe that these findings should have been reported to the FDA as adverse effects of the treatment. It should have lead to further investigations and additional clinical trials to make sure that the problems are avoided or at least minimized in the future. With our findings we learned that these vision disturbing side effects are part of the outcome of the LASIK procedure. The effects are more pronounced with higher myopic treatments and thicker flaps. In 2004 we urged Alcon to publish this information and offered to do it ourselves but we were reminded by Alcon to keep all data confidential. We obeyed as we were afraid of being pushed out of business by Alcon. This fear no longer exists so now we can talk to you without any reservations.

Daniel Kluting also of BioShape

We think that LASIK in general is to dangerous to be allowed! This does not depend on our technology. The problem is that the lasik cut brings problems to the structure of the eyes. Because we have the only measuring device that is able to measure the topometry of the eyes with resolution of a few microns, we can look deeper into microeffects than anybody else. One of the major questions in research is, what the cornea is build of. From our researches it seems to be that it consists of tissue layers with a tensive strain to all sides. Think about cutting in something like that! In addition we saw other things, that refractive surgery is not take care of right now.

…from our point of view we would like to see LASIK stopped immediately. Then the laser manufactures need to do some basic research on eyes is probably come up with a completely new way how to do refractive surgery. During the last 7 years the laser industry knew the problems, but did not want to go through the process of basic researches combined with the stop of LASIK. Right now with LASIK the cornea is damaged, the only good thing is that the cornea excuses a lot and the eye is still able to see. Nearly all risks of LASIK are because the procedure is not safe. Its not because of the patient or a misfortune.

We have just a measuring device. Our goal was to measure the ablation during refractive surgery to avoid using nomograms and be more precise. We did clinical trails with one of the large players on the market. But we found out that first all surgerons and the industry need to understand the eye better. We have a couple of ideas how refractive surgery can be in the future, but till now that laser manufacturers avoid to talk with us. Even those we made the clinical trials with, 8 years ago. Its easier to leave the moneymaking machine LASIK turned on than to go through the struggel of development.

Its not that Alcon or VISX had withheld information concerning the dangers of their individual products, they withheld the information that the whole procedure is not safe. Some basis investigations need to be done, to be able to provide a safe procedure. Mabe there is no safe procedure for refractive surgery. But they do not want to do these investigations, they just want to make easy money with LASIK. Probably they do not have the chance to stop LASIK because they will get sued to death.

One point is that we saw that the cornea is not a massive material it seems to consist of thin layers, which have a tensile strain from all sides. If you cut into such layers like with the lasik cut, you get into trouble. Before we build our system nobody was able to measure the topometry of the eye with a few microns in resolution. Our goal was to make the procedure safe by measuring the cornea ablation during refractive surgery, but beside of healing and swelling processes we came up with things that question the whole procedure and would need to stop LASIK immediately. Latest since 2005 all laser manufacturers knew the problems of the procedures.

Everybody knows that the flap never heals. It can be flipped back again after years. The only thing what might hold the flap is the epithelium, if it does not grow under the flap…… right now we can only measure it, but the knowledge in the world about the eye is to small. Some Scientists will need to do researches how an eye is constructed and our measuring device would be their most important tool to do it. Then they will know how to help people like you and how to provide a save refractive procedure – if there is one. But somebody needs to finance them. Hopefully somebody makes sure that Alcon, VISX, Nidek and the others pay these researches.

We are a small company and we have highly educated engineers and physicists. We know a lot about optics. We could never believe with which extreme tolerances eye surgeons work on the eyes. Its like plastic surgeon who works with a Machete. Nobody in industrial application would allow something like that. We know from the physical point of view what is going wrong and would like to start in international discussion with medical scientists. But since we figured out these problems with LASIK, no laser manufacturer talks with us anymore. We are to small to buy a refractive laser and hire a couple of scientists to do the researches. We might find an investor but with all laser manufacturers hand in hand with the FDA at the end we would not be able to market it afterwards.

We are not allowed to give all information in detail. We did the main clinical trials in the beginning of 2002. We did the trials to improve the refractive surgery procedure with a realtime cornea measurement. During the trials we found out that the procedure LASIK itself has major risks. Beside of other problems, the LASIK-Cut weakens the stability of the cornea, it comes to a peripheral bulging of the cornea. It seems to be that the theory is true that the cornea is not a massive part, it probably consists of sheets or tapes. Because of this and the bending of the flap the flap will not fit after the surgery and the whole stability of the upper part of the eye is damaged. The blend zone of the refractive surgery is also an area that is not solved yet and results in bad night vision. The eye excuses a lot of damages. We have a eyedoctor who says “An eye wants to see”. But I am afraid about the long term problems.

The results of trials pointed in the direction to get away from LASIK and completely change the way who to look at refractive surgery. But you know what would happen to the industry, if one of the Lasermanufacturer would say this. All patients in the US would sue them because they waited so long. We are now working in the field of Scleral lenses. The laser manufactures who we need for our product are making sure that they together keep us away from their market.

Normally they should be interested to do some fundamental research in the field of eyes, eye surgery and healing. But we are sure that they would lose a lot. LASIK may be dead, but other surgery procedure might come up. The surgery inside the cornea in a couple of steps without touching the surface might be a solution, but this is a technology that the big players do not have right now. But it is available.

A patient can be lucky when he can see after refractive surgery and nobody knows how long that will stay. We know that refractive surgery companies have been at court and have said that they do not have any information and knowledge that show they there are significant problems with the procedure. That is just not right. But the refractive surgery market is not the only market that behaves like that but it destroys the quality of living.

You can read a published document from BioShape holdings here which demonstrates the complications surrounding laser vision correction

Read Dr. Waxler’s petitionRequest a Public Health Advisory with a voluntary recall of LASIK devices in an effort to stop the epidemic of permanent eye injury caused by lasers and microkeratomes used for LASIK eye surgery.

*A 2007 review of data from FDA clinical trials for LASIK devices, including newer custom wavefront technology, demonstrates that approximately 20% of patients report dry eyes and night vision problems persisting beyond six months after surgery.