I think many of the problems from reusing microkeratome blades go unreported.  LASIK is reported to cause many problems so there is no debate that they occur.  Some Doctors state they have Never had many of these flap problems in ANY patient.  Are these the Doctors who use new microkeratome blades?  The FDA and the CDC will Never find out because they claim to have no jurisdiction.  So what if a few million people have these problems unnecessarily? 

The question is how often do these problems occur and how much more likely are they to occur with a reused microkeratome blade (with or without sterilization) versus a new microkeratome blade?  No one knows the answer to these questions.  There is no way to ethically do a controlled clinical trial because the blades should Never be reused (this is my opinion- there may actually be some published clinical trials with reused blades).

IF Doctors who do "second opinions" after LASIK (this is a big business due to all the people with problems) are used to seeing good results from LASIK, then why aren't the Damages from reusing microkeratome blades obvious to them?  As odd as it sounds, many patients have told me their Doctors acted as if they did Not believe what they were telling them about their eyes and vision.  My own statements about my vision and eye pain, etc. do Not appear in many of my medical records, and some Doctors have one diagnosis but Not others (in some cases I initially found out Only by getting copies of my medical records because some of the Doctors did Not tell me they had put these diagnoses in my records).  One Doctor who was on the FDA's Ophthalmic devices panel said the objective evidence (without reviewing my artemis or confocal exams) was Not consistent with what I said about my vision.  I was shocked when he said "I know many patients who would be happy with your vision".  I'm sure that blind people would be happy with my vision, but how does that help with my terrible vision and eye problems that bother me all the time?

Because the cornea is clear, transparent tissue some Damage to the cornea may Not be readily apparent even after a thorough exam by an eye Doctor.  More sensitive equipment and diagnostic tests are Not available in most eye Doctors' offices and are only available to a select few Doctors.  Even if self-paying without insurance, these tests can only be ordered after with a medical diagnosis (which some Doctors are reluctant to provide without prior objective evidence).  Doctors are required to file Medical Device Reports with the FDA and are Not expected to record everything.  Furthermore, many infectious diseases have no symptoms for years (including Aids/HIV and mad cow disease, CJD can only be detected after death). 

Here is a list of a few, not all, of the eye problems I have had that were Not detected by one Doctor or diagnostic device or the other. The details regarding why these were Not always detected by the Doctors are discussed below.  All of these problems could be caused by Not following the Microkeratome Operators manual insructions and/or reusing the microkeratome blades.

1.  A 1.3 x 3mm scar and "clumps" of something under the flap (one measuring ~40um, 5 x 8) as measured by a confocal microscope exam.

2.  Thin, irregular, uneven flaps and epithelium as observed only by an Artemis Ultrasound exam (see below).  "The Bowman’s membrane interface is irregular in character, with occasional breaks, indicative of microfolds or striae." (Two Doctors who did FDA clinical trials said there was "NO striae" just before I had the artemis exam).  Multiple Microkeratome cuts as observed only by the Artemis and removal of the epithelial layer during a follow-up surgery. 

"When I mechanically remove the epithelium, there were 2 semicircular demarcation lines, one indicating the outer limit of a LASIK flap, and the other about 2 mm inside the outer line and extending for about 3 mm superiority.  This most likely represents a second, incomplete LASIK flap."

3.  Mebomian Gland Dysfunction and Keratitis- Diffuse Lamelar Keratitis (DLK), Punctate Epithelial Keratitis (PEK) and superficial punctate keratitis (SPK) resulting from LASIK-induced dry eye syndrome.

4.  Severe loss of vision quality including 4 diopters of spherical aberrations (Not sure which test showed this because the Doctor cancelled my appointments, but could be the Interwave which is Only used by a few Doctors in the entire country- who work in just one location). 

It is Not possible to simulate the total effect of LASIK on vision quality loss.  The effect is like looking through cracked glass, haze, fuzz, etc.  No rational person would agree to take a 69% risk of having this degree of vision quality loss.  I am told that I am 20/20 in one eye and 20/15 in the other, but my vision loss has ruined my life.

 

Eye Doctors cannot see what their patients see.  Aside from higher order aberrations (which is only part of what causes visual aberrations after LASIK), the Doctors just do Not know how badly patients are injured- see www.visionsimulations.com and http://www.surgicaleyes.org/Starbursting.htm for some ideas. 

Most eye Doctors use a slit lamp and various eye drops (usually florescein) for diagnostic purposes.  "The slit lamp is a microscope with a light attached that allows the doctor to examine your eye under high magnification.  The instrument’s name is derived from its adjustable light beam.  By changing the width of the beam, the doctor can gather important detail about each eye structure.http://www.stlukeseye.com/eyeq/SlitLamp.asp

One main reason why these problems go undetected is that only 1 to 3mm of the central cornea is tested during standard eye exams.  Although light comes into the eye from all over the cornea and pupils may be as large as 6 or even 8mm at night, only a small portion of the cornea is needed to read the letters on the eye charts in the Doctor's office.  The Visual quality from the rest of the cornea is Not typically tested at all (see information on owls and pupil size below for info. on some ways the rest of the cornea is used for vision).  LASIK Doctors also have topographers available, but none of these problems were Noted from my corneal topographies to my knowledge.  The topographers look at the surface topography of the outer layer of the cornea, the epithelial cells, without directly examining the flap itself or the rest of the cornea. 

"For uncorrected myopes of 3.0 D or less, visual acuity was nearly as good with a 1-mm pupil as for corrected myopes. ". . ."Effective pupil size was varied by inducing mydriasis and then placing artificial pupils of between 1.0 and 8.0 mm diameter before the eye. ". . ."For the corrected myopes considered as a group, maximum visual acuity occurred for 2--3 mm diameter pupils, but larger pupils reduced acuity only marginally. "
Large eyes, with a wider pupil, larger lens and increased retinal surface can collect more ambient light.

I have hundreds of pages of medical records from numerous Doctors and could write several books on this subject, but I'll be brief.

Using slit lamp exams, Doctors referred to my corneal scar (which is fully 1/2 the width of a normal 6mm pupil) as "not that bad" or "a little fibrosis".  The flap cut in the cornea is Not visible under the slit lamp and the edges of the flap may only be visible if there is scarring (several Doctors referred to my flap as "good" and "well healed" under slit lamp exam).  As the cornea is clear and and the scar is not in my central cornea, the slit lamp exam has no way to determine the effect of the flap irregularities and the scar on my vision. 

Even the Artemis ultrasound exam (which can detect corneal scars- see below) did Not report the scar in my cornea.  Perhaps either the scar was Not detected because the Doctor who examined me with the slit lamp prior to the Artemis needed to mention to the examiner the location of the scar first (this same Doctor who also did FDA clinical trials for LASIK said "my topogrphies looked good" and "I don't see any problems in your eyes") or they did Not even consider it worth looking at because so many patients (over 90% after "successful" LASIK in study #2 and #3 below) have scars at the edge of the flaps and other flap problems (study #1) after LASIK.

Study #1. "Flap complications (such as displaced flaps or folds in the flaps that necessitate repositioning, diffuse lamellar keratitis, and epithelial ingrowth) are common in lamellar corneal surgeries [6]

"A Finnish study found that particles of various sizes and reflectivity were clinically visible in 38.7% of eyes examined via slit lamp biomicroscopy, but apparent in 100% of eyes using confocal microscopy[7]."

http://en.wikipedia.org/wiki/LASIK 

Study #2.  "Permanent pathologic changes were present in all post-LASIK corneas. These changes were most prevalent in the lamellar interface wound."

http://www.corneajrnl.com/pt/re/cornea/abstract.00003226-200501000-00014.htm;jsessionid=GwqFVyvgG2Mh7TQMFRDSddT1QtpgTF8JYQ2vTl91ZYpTvnL1FVVv!50530596!-949856144!8091!-1 

Study #3. 
"superficial punctate keratitis (SPK) resulting from LASIK-induced dry eye syndrome.". . ."
Diffuse lamellar keratitis (DLK) is a non-infectious complication of LASIK, which results in accumulation of inflammatory cells in the interface between the LASIK flap and corneal stroma. This gives the appearance of diffuse, fine infiltration of the interface. The incidence of this condition is estimated to be one in 50 for mild cases and one in 5,000 for the most severe cases."
http://www.optometry.co.uk/files/4e647978719a958607ddece8edd87d1f_chawla20040423.pdf
July 9, 2004Re: Patterson, Michael #33189, 33190Michael Patterson was scanned OU using the Artemis high-frequency ultrasound system on 7/7/04 for evaluation of post-LASIK corneas.The right cornea had a central thickness of 485 microns with an epithelial thickness of about 60 microns. A shallow flap was faintly visible at a depth of 110-120 microns, (slightly deeper peripherally) which indicates a stromal component of the flap of about 50 microns, although occasionally thinning to as little as 30 microns. The residual stroma has a minimum thickness of 370 microns. There is also a very faint interface seen at a depth of 150-160 microns, suggestive of a second, deeper flap interface.The left cornea had a central thickness of 465 microns and epithelial thickness of approximately 60 microns. A flap interface is seen irregularly at a depth of about 105 microns, leaving approximately 50 microns of tissue in the stromal component of the flap, with some areas as thin as 35 microns. The residual stroma has a minimum thickness of 340 microns. The Bowman’s membrane interface is irregular in character, with occasional breaks, indicative of microfolds or striae.In both eyes, the pattern of epithelial hyperplasia was irregular, making it difficult to ascertain the width of the ablation zone.

Sincerely,

Ronald Silverman, PhD

Ronald H. Silverman, Ph.D.
Professor of Computer Science in Ophthalmology
Research Director, Bioacoustic Research Facility
Department of Ophthalmology
Weill Medical College of Cornell University
1300 York Ave. Room A855
New York, NY 10021

"The resolution of the Artemis, when set to scan cornea, is sufficient to distinguish individual corneal layers such as the epithelium, stromal component of the flap, residual stromal bed, and others in three-dimenstions thanks to multi-meridional scanning.  The Artemis VHF digital ultrasound technology is able to consistently detect internal corneal lamellar interfaces (sucah as the keratectomy track [the track made by the microkeratome blade]) because of the permanent "mechanical" interface present even years after surery, and despite total optical transparency.  Analog UBM is not able to image the interface consistently because analog processing does not produce a high enough signal-to-noise ration between interface echo complex and the surrounding tissue."

"We have also examined the shape of Bowman's layer, the measurement of anterior corneal scars for planning therapeutic keratectomy, the quantitative analysis of corneal scarring (haze) after PRK, and the measurement of the depth of radial keratotomy incisions.  In 1999, we were the first to publish on the analysis of epithelial and stomal changes after lamellar corneal surgery [e.g., LASIK], demonstrating significant epithelial changes after uncomplicated LASIK and the masking of stromal surface irregularities that were producing optical complications."

Reinstein & Silverman, Chapter 19, p.208.  Artemis VHF Digital Ultrasound Technology.  Corneal topography in the Wavefront Era, A Guide for Clinical Application Edited by Ming Wang, MD, PhD.  SLACK Incorporated.

"Another benefit of 7x50 binoculars is that “the image leaving the eyepiece is about 7 millimeters,” . . .“It is the same diameter as a human eye pupil in low light.” "
"Another night vision aid is that the owl's pupil can dilate to an extreme opening to allow more light to hit the rods. No animal can see in absolute darkness but they can see in the faint light of the night even when there are clouds blocking moon and starlight. "
The Doctors admit they cannot predict who will be unhappy with their vision and who won't- and for those who they can predict are more likely to be unhappy with their vision, they INTENTIONALLY do Not tell them they're at higher risk than others (those who have pupil sizes larger than the effective optical zone they know can be reliably produced with the techniques they use).  The LASIK Doctors have no way of knowing what they’re patients’ vision is like.  ALL the tests they have at their disposal (including wavefront, topography, etc.) only show a portion of the problems LASIK cuases to reduce vision quality (some of the higher order aberrations, but not all and not other vision quality problems).

MyLeftEye