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Post Info TOPIC: EPI ON OR OFF?


Phase Two

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Posts: 482
Date: Fri Apr 27 10:36 AM, 2007
RE: EPI ON OR OFF?
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This Dr is trying to blur the issue.

1) He does not have FDA approval, this is why he does it his way and is playing of the back of the orginal crosslinking and its success. He wants to say he is doing it as well, ...he say's its "similar" (what does that mean? it could mean anything!!) but the feeling is not mutual from those who do the Orginal method he is trying to liken it to.

2) The Epi off method is approved in Europe

3) The clinical studies he mentions is for the Epi off method on his site

4) Why doesn't he explain he does it differently on his site?

5) The Epi off method has passed animal studies... his has not.

6) Its an exaggeration (to put it mildly) to say his method is done all over the world. Two Drs... is that world wide?!... can you see what this Dr is like with his over estimation!!,,, He does it his way as its EASY FROM HIM!! (the one or two Drs doing it... is just trying it out... when in Europe there is no need to do it any other way as its approved for the right way!!) This Dr adds other Drs names to his method... WHEN THEY DON'T WANT NOTHING TO DO WITH HIM OR HIS METHOD.

7) He sends out attachmenmts to everyone which tell's patients that they WILL need a transplant and take his treatment to stop a transplant happening

8) They studied both method here in the UK and found that the epi off method did not work

9) There is a method in crosslinking where no haze was found to occur and B2 getting in to the places in the cornea where it should be, its the "middel way" (which may be the way things will go) But in Europe there is no need to debate the two methods as we make sure humans are given a safe treatment by first doing animal studies.

10) Please only do a treatment if its approved, like the Orginal method. As that's why its approved.

Be careful of the marketing, patiotic feelings, just stick to the mulitple facts. I hope in time (and it will take a very long time, as this Dr is holding the cards very close to him) they will expose the truth, by that time will any one know or care what happened to this Dr and method, and the patients who has had this "treatment" with out being told the whole truth... firstly through this Dr's Site... it should be written on there clearly... the athorities should look in to fhis claims and take action... but the ONE women show at the NKCF don't care... they want an easy life and a thick purse... thats it...

Stick to the many stuidies... its certainly is the more the merrier!!

All the best



-- Edited by QuintriX at 22:19, 2007-04-27

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Posts: 45
Date: Fri Apr 27 2:56 PM, 2007
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Simon, you may wish to check some of the other KC message boards and online groups to reach out directly to patients who have had the procedure in Beverly Hills. I can't remember if it's on this board or another, but a young patient was actually having crosslinking redone in Germany because it didn't work the first time. This young man was feeling some apprehension, if I remember correctly, because he was in a lot of pain with the epi off method. The recovery from the procedure as done in Beverly Hills may be less painful, but that is tough to find objective evidence on. Talk to people who have had it done.

To address a broader issue, it is not uncommon here in the states for patients to choose to have medical procedures done before they are FDA approved. We often choose to pay privately for new procedures that are neither approved nor covered by insurance. In diseases where time is of the essence (and KC is certainly one of them) this can be an appropriate choice for an individual to make, and it should be respected.

I was in a similar situation about nine years ago and tried an intervention to avoid major surgery for another disease, before it was fully approved. It is not a choice I ever regretted. It involved doing my own research and reaching out to the few hundred patients who had had the procedure done before me. Fortunately, in the internet ear, this is easy to do.

Simon, are you considering intacs as well as crosslinking? In the US they are done in a single visit, but I am not sure they will do them both at the same time in Europe. I would imagine that having the intacs done first, then the crosslinking, opens the corneas and enhances penetration via the channels that are made for the intacs insertion.



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Joanne in NY


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Posts: 35
Date: Fri Apr 27 9:10 PM, 2007
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Wow!  I can definitly see that backed up studies are a safer bet.   I guess at the end of the day if the US mehtod fails, it will only be in that the c3r may not last as long.  I think I read here that Dr. Kolhaas gives this procedure a 10 prediction guarantee.  If the EPI is on, this may obviously be shorter because the B2 doesn't penetrate as deep.Man I wish this was easier than flying across the world.

You mentioned in your Point number 8 that EPI ON studies have failed in Europe?  Is that somewhere to be read?

Thanks Quintrix,  I will ask Dr. Boxer some of the questions you posted here. 

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Simon


Phase Two

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Date: Fri Apr 27 10:44 PM, 2007
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Jo, There is a thread on the Uk site where the epi on failed... you can not talk to everyone who had the treatment, if there is a choice then the studies have it. And Crosslinking does NOT WORK when the cornea is in such a bad shape that only a transplant will do, it DOES NOT GIVE PEOPLE A NEW CORNEA. A cornea damaged by KC to an extend has no way back. Going around telling people to do a treatment which is not approved is not something that one should be doing. Why isn't it on the Dr's site that it is not approved? The NKCF bans any talk which makes them look not so good... no one sees it as the waist off space who runs it... is just a simpleton.

The pain can be reduced with an extened wear contact lens... As metioned before... if is does not hurt... it did work...

Stick to the facts... just because your son had the epi on... it does not mean everyone has to... don't be biased... and if anyone asks the Dr over there to do the epi off... will he do it... no... because he can't... and he gives all this other bull to cover it up... and make a quick buck at the same time


Simon... your first post has disappeared?! I was told that they tested with a control group, a epi off group, epi on group, a small trauma to epi group, a B2 only group, with which corneas where under test... and penitration only happened with the full orginal method... no one is interested or has the time to write it all up, as the orginal method is approved here (not even the Dr over there doing the epi on has done this... and yet again its Europe doing the scientific work and the right thing... and the hyped marketing is all coming from over there)... .... anyway, why should would anyone want to say that the Epi off did not work or is suspect when it did not work and is suspect... there is no need to...

Collegan turn over does happen in the cornea... and that crosslinking will not last for ever but at least by a decade is the very conservative estimate (the longest follow up has now coming to the end of eight years, so its close onjh in practicle terms) and it even may be much longer... no one knows... as no one has a crystal ball... but the orginal method will hopefully (when done at tyhe right time) get people through to when the body starts crosslinking by it self due to age.

THERE IS ONLY ONE CROSSLINKING



-- Edited by QuintriX at 23:07, 2007-04-27

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Date: Sat Apr 28 12:11 AM, 2007
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Quin, please re-read my last post carefully, I don't think it was as biased as you accused me of. Simon asked for feedback, which I tried to give. Whatever he decides, I hope he has full confidence in his doctors, is treated with excellent care and compassion, and most importantly, gets a wonderful result and improved vision. I have no vested interest here in winning him over to a particular choice.

For the record, I would have supported my son's decision to go to Dresden or to Beverly Hills. The choice was his. He is a young adult and he did the research online, and I explained to him the differences in the US and European procedures and had him read the web information. I was desperately trying to persuade him to go to Dresden during the time in which Boxer Wachler suspended treatment for a few months. When he made up his mind, I did not want to debate it with him or undermine his decision. My role as a parent was to support him, keep him feeling positive, accompany him on the treatment trip, and pay for his medical expenses because he could not pay for them himself.

The only thing I told him to keep out of his evaluation was cost, because we were willing to pay anything to help him see normally again.

There is a chance for success with both methods. Patients have the right to participate in the non approved procedure under informed consent. Everyone will weigh all the different factors differently, and make their own choice. What I see recurring on the message boards is support for most choices, but a lot of negativity directed at patients who choose one particular doctor.


I am really happy that in Europe, you can place such confidence in the approval process you have over there, you are extremely lucky. As an American consumer of medical goods and services, I don't have the same high esteem for our FDA (and many of my doctors don't either by the way, they see it as part of the problem with our medical system). Off-label uses of drugs (drugs prescribed for conditions other than those that have received explicit FDA approval) is common over here. Many surgical techniques have subtle differences from doctor to doctor. Each modification is not re-approved necessarily.

Yes, marketing in medical practices is something we have to deal with in the US. We do our personal research, and we find our way to the doctors who can give us the best shot at success. It's a fact of life over here. Our intellectual property laws and the process for commercializing new technologies and medical procedures is another fact of life over here, it's how innovation gets into the medical marketplace. I have always felt that one reason for the differences in the procedures were partly an attempt to lock up patent rights by creating something that is just different enough to be able to be covered by a unique patent. That's the way our intellectual property system works in the US.

By the way, Boxer Wachler's site does curently point out the difference between his procedure and epi-off, so could you please stop raising that as an objection? Additional studies and presentations were also posted recently.

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Joanne in NY


Phase Two

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Posts: 482
Date: Sat Apr 28 12:57 AM, 2007
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Jo, Thanks for expanding on the issues.

1) Can you tell me where the Dr on his site says that he is doing it diferently?

2) He says. on his site.. and i quote "This is the process that has been shown in laboratory and clinical studies to increase the amount of collagen cross-linking in the cornea and strengthen the cornea. In published European studies, such treatments were proven safe and effective in patients."

3) if you tried to tell you son about the orginal crosslinking... then why don't you tell it here, in that it is better from the facts.

4) The word negativity can be thrown around by anyone, it can be from you, or even from me... its a easy thing to say... when there is no argument that can be put up... how can it be negative to cite studies? facts?

What is he on about (there are other instances as well) HIS METHOD is not the method in the quote shown above. He is mixing it. Anyone can add names and present studies at meetings... why ain't no one else in the US doing it if its so good?

I have only imagine a young person hoping on hope... and then finding that Dr's site and thinking thank god... I was happy that Dr BW was doing his bit for KC... until... I looked closer and the only studies he was putting up was other people ones which where NOT for his method.

May be... I hope so... that in time the US and the places yet to get crosslinking will get it soon before its too late for some... in the mean time... Dr's who are following crosslinking to the letter of the law keep saying... they don't know what he is up to... and that its just all bull

Profit is taken away from the medical health system over there in to private hands... thats the trouble... that does not happen here... everything is put back in... its a young country of just over 200 yearts history... its still learning.

BTW on another note have a look at this link:

It covers the removal of a "bumb" on the cornea... and also intacs (which may be of interest to you)

http://www.eyesite.org/corneahome-keratoconus.html


-- Edited by QuintriX at 00:59, 2007-04-28

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Date: Sat Apr 28 2:14 AM, 2007
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The paragraph on this page

http://www.keratoconusinserts.com/cornea.html

does seem to have been added recently (the one with the bolded text, about two paragraphs below the diagrams of crosslinking).

I also found some recently added research abstracts

http://www.keratoconusinserts.com/research14.html

and this one on single vs. double segment intacs

http://www.keratoconusinserts.com/research15.html

I do think that these were added in the last month or so, as they were not there when I first went to this site, or right before we went out west for my son's treatment. Perhaps this is a response to some of the questions raised here.

I think that when you say "better from the facts" in your last post, I would need to see some published results on the study comparing the exact epi on procedure (with swabbing to loosen the tight junctions)  that Boxer Wachler uses with epi off. Does it compare:

Degree of flattening of corneas?
Subjective measures of post procedural pain and duration of light sensitivity?
Incidence of hazing?
Any difference in post procedure infection rates?

I would think that all of the above, and possibly more factors would have to factor into an evaluation of what "better" means. As I said before, I truly believe both methods work and probably work well. And over time, the procedure may continue to be tweaked and optimized--the originally approved method may be replaced by something yet to be approved.

The sample size is probably too small to really do a direct comparison at this point, so I find it difficult to tell with certainty that one method is better than the other in a statistically significant way. 
  

There have been many tremendous medical advances originating within the US medical system, but I don't feel like I am being unpatriotic if I say it is a flawed system. I am lucky in that I can afford to seek out treatments for myself and my family even if our insurance does not cover them. It is heartbreaking that many people don't have the financial means to make these free choices here.  But, I live simply and keep money in reserve for emergencies like suddenly being told I have a child with a rare disease.

Yes, we are a relatively young country, but our 200 year history was born out of taking risks and seeking the new frontiers. Maybe we are, as a group, more comfortable taking risks, and that is why I don't feel as concerned about the whole FDA approval issue, which is a concern that some feel quite strongly about.

I guess the only other thing I can add is this, to anyone who is looking into the method currently offered in the US, and that is my son's experience thus far.

My son is 22. He was diagnosed with KC in October. His uncorrected vision has never been worse than 20/40. He did not want to wait and see if it would progress and wanted to try to halt the disease's progression as soon as possible while he could still sort of function without glasses or lenses. He does not really like to travel and is especially disinclined to travel to foreign countries, and he does not have  passport. These (seemingly minor to me) considerations were probably significant in his decision to go to California for treatment.

He had two intacs put into one eye, and one intac put into the other eye on April 5, followed immediately by epi-on C3-R in both eyes. When I went into the recovery area to see him, he seemed happy that the ghosted image was already fainter. He had no pain, and was able to watch television, use a computer, and type text messages on my blackberry within forty eight hours. He was actually able to get around outdoors with sunglasses within 24 hours. Since the treatments his vision has never been any worse than before the procedure, with periods of improved vision. As you all know, time will tell if the progression has stopped, and if this combined treatment of Intacs +C3-R has actually improved the corneal curvature.

As far as how we were treated at this clinic, I only have good words to say. We were informed of the nonFDA approval status as soon as we initiated email discussion with them. The emailed records were reviewed promptly and the many emails with questions were patiently answered. The day before the procedure many tests were done, and some were done more than once to make certain of the readings. The doctor patiently answered all questions. My son was treated kindly by all the staff, and I was warmly treated by the reception area staff while I waited. The doctor called in the evening to check on his status, and we were cleared to leave Los Angeles at a followup visit the next morning.

In closing (it's getting late here this evening in NY) I'd like to apologize if anything I've said has upset anyone. I know that everyone on this board is either suffering with this disease, or watching a loved one suffer, or is a medical professional trying to help people with KC--I wholeheartedly wish restored vision to those with KC, strength and courage to those loved ones who feel powerless to help them, and wish to thank all those medical folks who are helping people regain their sight.

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Joanne in NY


Phase Two

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Posts: 482
Date: Sat Apr 28 8:44 AM, 2007
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First of all the posts here are not in sequance?! There is a fault that needs to be reported about the forum.

Anyway, its a step in the right direction (still but too little too late) that there is mention (in a round about way) that there is a difereance in the methods. I looked at that site last night and did not read the bold. Thank you for that, at least now patients will know something more.. it is a great gesture to make by the Dr, I also think he is a good Dr, but his hands are being tied by the FDA.

But still... this paragrapgh still bothers me, as its not clear that the proof and the history can not/should not be compared to the method done over there.

"The collagen crosslinking with riboflavin has its roots in dermatology. Doctors were looking for a way to strengthen sagging skin and realized that triggering collagen cross linking was the way to achieve this. The process was taken one step further by eye physicians in Germany who performed initial studies. They reported results of treatments done as long ago as 1998, so there is a good track record for this procedure. Links to these research publications can be found to the left side of this page. It is important to note in these studies that the proper dosages of the components are a very important part of the treatment. When used properly, there were no negative effects."

Will he do the epi off if a patient wants it?

Anyway... these test which was mentioned before was done not on humans... but on corneas from pigs in a lab... the only test that matters and which was tested was if the cornea stiffened... and yes it was reproduced the fact that the orginal method was the only one to show that this had taken place.

There is no other alternative to the FDA, but yes you are right, in that your health care is in your hands. Also with intacs I guess it is the epi off method in a way which was done for your son (the incision channels in to the cornea helping some what). With the added benefit of the rings. In time the cornea will hopfully change some more. If it changes to a more regular shape, that will be enough for easier correction to be applied to get increased vision. More flattening how ever small is still on the cards as well as it takes time for the cornea to settle.

Any intervention to stop the progression of KC is wise if the patient is young.


Every good wish to you



-- Edited by QuintriX at 11:37, 2007-04-28

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