Exposing the LASIK Scam

One Surgeon at a Time
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 Post subject: There is no cure yet for permanent LASIK-induced dry eye
PostPosted: Mon Dec 05, 2005 12:40 am 

Joined: Mon Nov 14, 2005 4:28 pm
Posts: 643
There is no cure yet for permanent LASIK-induced dry eye

(Thank you Zelly for contributing the link to the article about the potential neuroregenerative properties a drug target called hedgehog).

Ophthalmologists knew about LASIK dry eye and discussed it openly during FDA hearings? in transcripts they thought would never be read by the general public. Here are some excerpts:

From the FDA transcripts:
Dr. I Howard Fine, Past President of the American Society of Cataract and Refractive Surgery:

"As we all know, Lasik transects the cornea nerves, therefore inducing dry eyes in most patients."
http://www.fda.gov/ohrms/dockets/ac/01/ ... 3806t1.doc

Recent studies by the Mayo Clinic indicate that nerve damage after LASIK increases between years 2 and 3, resulting in an average loss of over 40% of the corneal nerve density at 3 years:

Corneal Nerve Damage Continues to Increase years 2-3 after LASIK
http://www.ncbi.nlm.nih.gov/entrez/quer ... query_hl=2
Invest Ophthalmol Vis Sci. 2004 Nov;45(11):3991-6.
Corneal reinnervation after LASIK: prospective 3-year longitudinal study.
Calvillo MP, McLaren JW, Hodge DO, Bourne WM.
Department of Ophthalmology, Mayo Clinic College of Medicine, Rochester, MN 55905, USA.
Between 2 and 3 years they [corneal nerves] decreased again, so that at 3 years the numbers remained <60% of the pre-LASIK numbers (P <0.001). Both subbasal and stromal corneal nerves in LASIK flaps recover slowly and do not return to preoperative densities by 3 years after LASIK. The numbers of subbasal nerves appear to decrease between 2 and 3 years after LASIK

What?s really criminal is that the Ophthalmic devices panel acknowledged that dry eye was a refractive surgery industry-wide problem, but they didn?t force Alcon to include dry eye warnings in their labeling because other approvals had gone through before Alcon?s without this restriction and they didn?t think it would be fair to Alcon. Though somehow they thought it would be fair to patients to withhold information about LASIK-induced dry eye:

http://www.fda.gov/ohrms/dockets/ac/02/ ... 3883t1.doc
p231 lines 4-14
DR. WEISS: I mean, where I'm coming from is we had more than one person talk about the severity of the dryness they have and the point that they wish they knew and only 7.4 percent had significantly worse but 21.5 percent had worse. So you have 32 percent that had worse, and I think I personally would want to know that as a patient without being too burdensome, but I think that's important information. Dryness, glare, halos, night driving difficulty, and fluctuation of vision, all of those had approximately more than 20 percent of people in the worse or significantly worse category which is not trivial.

P236 lines 5-22
This dry eye issue, as far as I know, isn't inherent to this procedure that you're discussing today for this application. So this is a new issue that's industry-wide. I don't think this PMA application should be burdened with having that as, you know, a portion of their labeling while the other ones don't.
DR. WEISS: Dr. Bullimore?
DR. BULLIMORE: This is Dr. Bullimore.
I welcome the opportunity we have to set a precedent, and I would also welcome the rest of the industry being asked to update their patient and physician information to reflect the current climate. So I mean, if you feel that the industry wants to come back to the FDA and update all of the physician and patient booklets, I think the panel would be generally supportive of that issue.
DR. WEISS: I can see them lining up.

With the exception of Dr. Bullimore those doctors are laughing about keeping information on dry eye away from patients. Dry LASIK-induced dry eye patients are not amused.

And where would we be without Stephen Slade?s deposition where he states:

p.75 lines 18-21
Q. When you do -- or when LASIK is done, the flap, does it actually cut or
transect the nerve?
Slade: We do believe it cuts and transects some nerves.

9.76 lines 12-14
Q. Are you familiar with studies that indicate that that nerve doesn't ever fully

Slade: I have seen some studies like that.

Just in case you?d like to open a dialogue with a long term LASIK-induced dry eye sufferer, visit a very nice Oncologist named Eric who has to wear goggles with a script. This is what happens when both your vision and your nerves are ruined by LASIK. Instead of a convenient pair of glasses that give you good crisp vision and your pre-op comfortable eyes with their healthy uncut nerves? you end up with nerve damage and a need for glasses. Fortunately, moisture-seal goggles are now manufactured for active sports and are becoming more stylish. But still? stuck in prescription goggles for life from an elective surgery that is supposed to improve your vision?

There?s a lot not to like about refractive surgery.

 Post subject:
PostPosted: Fri May 18, 2007 3:47 am 

Joined: Sat May 12, 2007 9:18 pm
Posts: 45
Location: Studio City, CA
Any theories as to why the nerves would grow, then diminish again?
Why would they grow at all? What makes them grow? What makes them stop?
House plants need water, food, CO2 and sunlight.
What do nerves need?
Have any neurologists tackled the corneal nerve issue?

 Post subject: What do nerves need?
PostPosted: Sat Jun 30, 2007 6:15 pm 

Joined: Sat Nov 26, 2005 1:06 am
Posts: 621
Nerves don't like to be cut. Nerves also don't like toxins! Corneal refractive surgeons cut and burn nerves. Dead and dying cells in the area release pharamcologically active agents into the immediate environment that feed the inflammatory process. Inflammation is bad for nerves.

Why does the Mayo Clinic study find that nerves increase in density, then decrease? Perhaps there are long-term issues with inflammation in the post-surgical corneal stroma and flap interface that contribute to this phenomenon?

I would guess that having a permanent wound that never heals cut into your cornea is a bad thing for the cornea and its nerves. The flap interface could very well be a toxic microenvironment for cells and nerves. Cells at the flap interface in the post-LASIK cornea have lost their cell-cell contacts and tight junctions that help cells communicate normally, allow the tissue clean itself - and maintain proper fluid balance.

I would be willing to guess that any surgical trauma to the eye has the potential to also damage the endothelial cells of the cornea, which also do not regenerate. Once the endothelial cells are lost past a critical densitiy, worsening vision and corneal decomposition (loss) result.

I wish our corneal nerves, corneal stroma and corneal endothelium were more like house plants. We could simply have a nice lunch, drink some water and go outside in the sunshine to restore them! :?

We can easily forgive a child who is afraid of the dark. The real tragedy of life is when men are afraid of the light. -Plato

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