"Dry eye occurs when people don’t have either enough tears, or the correct composition of tears, on the surface of their eyes to lubricate the eyes and keep them comfortable.”. . .“If you have dry eye, your eyes can feel persistently gritty, itchy, burning, and painful.”  http://www.theschepens.org/dry_eye_fact_sheet.htm

Take the dry eye test at http://www.dryeye.org/test.htm.  Let me mention some, not all, of just the dry eye problems that may effect these hundreds of  thousands+ of people.  Notice these end in dysfunction or "itis" meaning "Inflammation or disease of" and "Excessive preoccupation with, indulgence in, reliance on, or possession of the qualities of".

Blepharitis, Mebomian or Lacrimal Gland Dysfunction (mebomianitis), conjuntivitis, and kerato­con­junctivi­tis sicca.  Keratitis (Inflammation of the cornea)- Diffuse Lamelar Keratitis (DLK), Punctate Epithelial Keratitis (PEK) and superficial punctate keratitis (SPK).

It is so difficult to grasp the magnitude of the impact that I asked some others who are suffering greatly after LASIK for their comments on how to explain the degree of suffering and constantness of it better.  For additional research and a patient story on the permanent impact on Quality of Life, see http://www.lasikliberty.com/index.php?option=com_content&task=view&id=37&Itemid=57

There are many reasons why LASIK causes dry eye.  From reading the literature and talking with patients my estimate is that if a blade is reused for LASIK, then all patients' eyes are drier after LASIK than before, 10 to 50% of eyes are so permanently dry that they use preservative free (if they're properly informed) eye drops for the rest of their life, and that 10 to 20% of patients are so severely effected by dry eye that it dramatically changes their life forever.  Even without any eye surgery or LASIK, over 3 million people have dry eyes.  Also, most prescription medicaions cause dry eyes which means millions more people have dry eyes even before they have LASIK. 

Saying that "significant" vision loss is "rare" or very rare is not enough for a patient to comprehend the full impact that dry eyes can have on their lives.  Most people do Not understand that Dry eye effects vision.  A relative of mine went through chemo therapy for cancer with all the associated problems (nausea, sickness, etc.).  She complained about dry eye as having the biggest negative impact on her quality of life.  After the dry eye, she had a lot more understanding about what I was going through- if you haven't experienced it, you have no idea just how severe it is.

Over 8 million people have had LASIK so a few hundred thousand people with severe problems are considered "rare" or even "very rare".  My conclusion is that the words very and rare mean something different to me than it does to the Government and medical Doctors- I consider rare to be 1 in 10,000 which is what I was told the total sum of the risk was for LASIK.  8 million people divided by 10,000 means that only 800 people in the US would now have problems after LASIK.  That would be rare, when the blades are reused no one knows for sure how many have permanent problems.  You can look up information on google and see the extensive research and problems for yourself. 

Oddly, some people go from doctor to doctor for years asking for help with eye pain or photophobia without receiving a diagnosis of dry eye, much less being offered any treatment options. If this is true for you, request that you be tested for each of the above conditions (http://www.dryeyepain.com/#DryEye).  Dry eye pain is discussed a lot on the internet too. 

There are many reasons why LASIK causes dry eye.  Saying that "significant" vision loss is "rare" or very rare is not enough for a patient to comprehend the full impact that dry eyes can have on their lives.  Most people do Not understand that Dry eye effects vision.  A relative of mine went through chemo therapy for cancer with all the associated problems (nausea, sickness, etc.).  She complained about dry eye as having the biggest negative impact on her quality of life.  After the dry eye, she had a lot more understanding about what I was going through- if you haven't experienced it, you have no idea just how severe it is.

Most people do Not understand that Dry eye effects vision.  A relative of mine went through chemo therapy for cancer with all the associated problems (nausea, sickness, etc.).  She complained about dry eye as having the biggest negative impact on her quality of life.  After the dry eye, she had a lot more understanding about what I was going through- if you haven't experienced it, you have no idea just how severe it is.

"It's very rare for LASIK to cause permanent, significant vision loss"
Quote is from the websites of many LASIK surgeons.

After LASIK, the cornea may be permanently damaged by using eye drops with preservatives (e.g., visine can no longer be used safely).  Extensive use of Expensive non-preservative eye drops and prescription medications (e.g., restasis and antibiotics) may be required for LIFE (as has been prescribed for me by numerous Doctors).

LASIK has a known COMMON adverse event of causing vision quality problems (including night vision problems and problems during the day) and dry eye that very SERIOUSLY (and irreparably in most cases) impairs ones quality of life forever.  In the Nidek clinical trials, for instance, there were unreasonably high rates of night vision problems (69%) but the FDA approved LASIK WITH reused blades as safe anyway.

“side effects such as dry eyes, night time starbursts, and reduced contrast sensitivity occur relatively frequently."   Ophthalmology. 2002 Jan;109(1):175-87.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/transcripts/3806t1.doc

The FDA knows that patients are Not likely to read the FDA's website before surgery (note that in many cases, the drop therapy and plugs do Not fix the problems).

Some patients may develop severe dry eye syndrome. As a result of surgery, your eye may not be able to produce enough tears to keep the eye moist and comfortable. Dry eye not only causes discomfort, but can reduce visual quality due to intermittent blurring and other visual symptoms. This condition may be permanent. Intensive drop therapy and use of plugs or other procedures may be required.
http://www.fda.gov/cdrh/LASIK/risks.htm

I think that a reused blade does Not make a very sharp, smooth, even cut through the corneal nerves severed by LASIK.  During my artemis exam, the cut in my flaps was described as being in a wave where it went up and then down and back up again (~30um to ~100um and back to ~30um) in both eyes.  I believe that a dull blade would also tend to make fine irregularities (e.g., blade "chatter") and make the edges of the flap less smooth (I've actually read this in the literature).  I believe this makes it more difficult for the nerves to grow back as well as they would otherwise.  I was surprised that despite my severe dry eye and gland dysfunction that the confocal exam (see flap damage page) showed typical nerve regrowth post-LASIK.  There are articles showing that the nerve regrowth after several years (up to 10) reaches as much as 80% of that before LASIK, but the shape of the nerves is never the same as before.  Some people have enough tear film while they are young that they do Not notice the loss.  Everyone's eyes get more dry as they get older so I wonder what will happen when they get in their 60s and 70s?  Eye drops are big business now, but for people with severe dry eye after LASIK they are Not sufficient to fix the problem.

There are 2 sets of corneal nerves which provide the important feedback to the glands to tell them the eye is dry and to generate more tears to rewet it.  If the LASIK flap hinge is at the top, then both sets of these nerves are cut.  If the flap hinge is at the side (usually nasally), then only one set of these nerves is cut.  For some reason, top hinged flaps are much more commonly done (maybe because the Hansatome Keratomes do top hinged flaps and more were sold better than others?)- Doctors who reuse blades do Not tell patients to my knowedge about this problem or give them a choice before surgery.

For many people, LASIK also results in dysfunction of the glands themselves that produce the tears and instead of making a nice oily tear film.  Thus, the tears produce painful crusty residue inside and on the edge of the eyelids as well as in the eyes.  This crust stays inside the eyelids (large clumps are referred to as chelazion- there's fancy names for all this stuff) and forms painful blockages of the glands.  On the eyelids, it sticks so strongly like glue that it is Not even possible to remove with the commercial lid scrubs which Doctors say to use for blepharitis (a word for crusty junk on the eyelids and eyelid infections).  This crust is VERY painful and even more painful to try to remove from the eyelids with eyelid scrubs.

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/query.fcgi?cmd=Retri...=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.
 
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.
 

Dry eye is a refractive surgery industry-wide problem, but there are No dry eye warnings in the labeling.

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.)

http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3883t1.doc

From another patient.

The picture you show on the bottom of the permanent dry-eye page is good insofar as can read “Art” on the Art book; wonder if addition of a captain stating that LASIK ‘doctors’ would consider this (& include in their ‘studies’) a SUCCESSFUL result – a ~20/20 (or 30 or 40) result because can make out letters even though, if not singling out one particular letter and looking more generally at the scene, turns the world into a horrible mess. In other words, something that shows how 20/20 or similar can in fact be horrendous (yet would still be considered a success by one’s ‘doctor’) – which is difficult to explain to most people but captured well in that picture if is pointed out.

MyLeftEye