Lasik Eyes Surgery - Lasik damaged dry eyes is incurable!

Author

Lasik damaged dry eyes is incurable!

Ace

2006-10-20, 2:30 am

There is no cure for permanent LASIK-induced dry eye

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...ipts/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:
---------------------------------------------------------------------------=
=AD-----------------------------------------------------

Corneal Nerve Damage Continues to Increase years 2-3 after LASIK
http://www.ncbi.nlm.nih.gov/entrez/...3D15505047&q...

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.
Excerpts:
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.
---------------------------------------------------------------------------=
=AD---------------------------------------------------

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...ipts/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.
(Laughter.)

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=2E75 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=2E76 lines 12-14
Q. Are you familiar with studies that indicate that that nerve
doesn't ever fully
regrow?

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

at dryeyezone.com 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 that don't give you the

visual quality of your pre-lasik glasses. Fortunately, goggles are
becoming more fashionable. But still... stuck in prescription goggles
for life from an elective surgery that is supposed to improve your
vision?=20

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

Ragnar

2006-10-20, 4:30 pm

There is no such thing as permanent lasik induced dry eye. When are
you going to get that through your head?

On 19 Oct 2006 23:29:30 -0700, "Ace" <acemanvx@yahoo.com> wrote:

>There is no cure for permanent LASIK-induced dry eye
>
>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:
>
>
>
>
>
>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...ipts/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/....=15505047&q...
>
>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.
>Excerpts:
>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...ipts/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.
> (Laughter.)
>
>
>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
> regrow?
>
>
>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
>
>at dryeyezone.com 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 that don't give you the
>
>visual quality of your pre-lasik glasses. Fortunately, goggles are
>becoming more fashionable. 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.