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U
PDATED
9/30/09
T
EN
C
OMMON
S
ENSE
R 
EASONS
W
HY
Y
OU
S
HOULD
NOT H
AVE
L
ASIK 
by Ariel Berschadsky
After years of dealing with the hassleof spectacles and contact lenses, you’vedecided to reward yourself by havingLasik. You’ve read the glowing reportsin the media about the wonders of this“state of the art” procedure and your ophthalmologist has just pronounced you“a perfect candidate.”It is at this time, more than at anyother time in your life, that you must pause, stand back from the excitement of the moment, and reflect deeply on whatyou are about to do. Lasik will permanently alter the optics and physiology of your eyes. Most likelythings will go well. But there is asignificant chance, much greater thanmany ophthalmologists realize or will publicly admit, that your eyes will beirreversibly damaged. The results could be devastating.When considering elective surgeryone must ask if the benefits trulyoutweigh the risks involved. You’veheard a lot about the benefits, no doubtfrom the surgeon who stands to gainfinancially by operating on your eyes.But you owe it to yourself to take a fewminutes to read the rest of this documentin order to become better informed aboutLasik’s risks. Once you understandthese risks, you may conclude that the prudent course of action is to avoid theLasik fad until the procedure has fullymatured, withstood the test of time, and been proven safe. After all, we’retalking about your eyes.
1. The True Degree of Risk is Unclearand is Being Downplayed.
Before surgery, patients are typicallytold that the risk of complications fromLasik is 1%, and even lower in the handsof an experienced surgeon (such as theone trying to sell you the procedure).For starters, you must realize that therisk being referred to is for 
each
eye, sothe combined risk that permanentdamage will occur to at least one eye is, by these figures, actually 2%. Doesn’tsound so good anymore? Read on…During the process of obtaining Foodand Drug Administration (FDA)Preliminary Market Approval (PMA) for its LADARVision Excimer Laser System, Alcon Corporation admitted that22.8% of Lasik patients complained of light sensitivity post-operatively, 7.1%now suffered from headaches, 31.9%had glare symptoms, and 32% nowexperienced night driving difficulties.
1
The FDA nevertheless approved theLADARVision laser for commercialuse,
2
 despite the fact that 12.7% of LADARVision patients stated that theyexperienced “worse” or “significantlyworse” quality of vision, as reported inthe PMA.
3
Another study states thatcomplications from Lasik surgery occur in approximately 4% of eyes operatedon.
4
These complications often producevision-distorting irregular astigmatism.Unlike regular astigmatism, which iscorrectable with glasses, irregular 
1
 
See
Premarket Approval Application#P970043/S5, available through DocketsManagement Branch (HFA-305), FDA, p.19.
2
Approved May 9, 2000.
See
Docket #OOM-1592, p.1.
3
 
See
Premarket Approval Application, p. 23.
4
 
See
Sugar A.
et. al 
.,
 LASIK for Myopia and  Astigmatism: Safety and Efficacy
, O
PHTH
.,Vol. 109, pp.175-87, 2002.
 
U
PDATED
9/30/09
astigmatism cannot be corrected withglasses. Rigid Gas Permeable (RGP)contact lenses offer some hope to thosesuffering from Lasik-Induced Irregular Astigmatism (LIIA) because they provide a smooth surface that maskscorneal irregularities by permitting pooling of tears beneath the lens.However, due to the flattening of thecornea following Lasik, it is nearlyimpossible to find RGP lenses that willstay centered over the pupil and will notrub against the interface between treatedand untreated areas of the cornea. Theresult is that RGP lenses are extremelyuncomfortable for the post-refractiveand therefore do not offer a viablesolution to irregular astigmatism. Newlaser techniques involving eye trackingcan treat irregular astigmatism, but theyare yielding mixed results and maynever be precise enough to correct LIIA.Many ophthalmologists are unawareof Lasik’s true risks because they tend toavoid patients with post-Lasik complications, given that it is less profitable to treat such a patient than tooperate on a fresh candidate. Thesedoctors therefore never gain an accurateawareness of the extent of damage that is being done by Lasik.
2. Lasik Technology is in its Infancy.
The refractive surgical communitydepends financially on the averageindividual’s tendency to get swept up byfads. This natural human tendency provides refractive surgeons and medicaldevice manufacturers with largenumbers of patients on whom to refinetheir surgical techniques and devices.At present, for example, there is noconsensus on what kind of excimer laser  provides optimal results. Nidek’s single beam laser follows a very differentapproach to ablating corneal tissue fromthat of Visx’s broad beam laser, yet bothare touted as being “state of the art.”Many surgeons cut the Lasik flapfrom side to side (a nasal hinge) becausethey feel that this method transcectsfewer nerves.
5
 Other surgeons prefer the“up-down” flap.The field of refractive surgery is stillso young that many ophthalmologistsdevelop and market their own surgicalinstruments to perform various procedures, such as cutting, lifting, or irrigating flaps. Perhaps some of their enthusiasm for Lasik stems from thegoal of “creating rapid profits by promulgating sales of surgicalequipment and adopting new surgicaltechniques,” as one eminent refractivesurgeon has speculated.
6
 Marketers recognize a type of consumer known as the “early adopter,”someone who enjoys buying productswith the latest technology. Refractivesurgeons are also keenly aware of this,and most medical texts about Lasik contain one or more chapters on how to boost profits by targeting suchconsumers. The discussion of marketingstrategies in medical texts speaksvolumes about the commercializednature of this field of “medicine.”
5
 
See Nicole Nader, Smaller Flap, Nasal Hinge Reduce Lasik-Induced Dry Eye Symptoms
,O
CULAR 
S
URG
. N
EWS
, 2/15/04 (“The nerve trunksin the cornea enter nasally and temporally,” Dr.Donnenfeld said. “A superior hinge transects both areas of the cornea where innervationoccurs, severing both arms of the neuroplexus.”A nasal hinge transects only one of these nervetrunks, the temporal arm.)
6
See
George O. Waring III, MD, FRCOphth,
 ACautionary Tale of Innovation in RefractiveSurgery
, A
RCH
O
PHTH
., Vol. 117(8), Aug. 1999.Dr. Waring has stated that he would not bewilling to take even a 1 in 500,000 risk on hisown eyes through elective refractive surgery.
See
Jeffrey Weiss,
 Demand High for RK EyeSurgery
 –
Critics Say Glasses, Contacts Work  Best, Doctors Just Trying to Enrich Themselves
,S
EATTLE
T
IMES
, Jul. 12, 1993, at A4.
 
U
PDATED
9/30/09
There is no harm in being an earlyadopter when one is dealing with a videogame or laptop computer. But does thisapproach make sense with anirreversible surgical procedure on one’seyes? Dr. George Waring, Editor-in-Chief of the
 Journal of RefractiveSurgery
, answers this question best whenhe writes that “…we proceed with activeteaching of hundreds or thousands of ophthalmologists to use a technique thatwe are simultaneously figuring out howto do
 –
including the identification of complications and statistical outcomes.Is it not safer for patients and morerational for the profession to proceed ina graduated manner, refining thetechniques and improving the results onsmaller numbers of patients (or in thelaboratory), and saving our masseducation for the time when we haveworked the bugs out of the techniqueand have acquired reasonablyquantitative descriptions of safety andefficacy?”
7
Do you want your eyes to be theones to help these doctors learn how to perform Lasik more safely andsuccessfully?
3. Lasik Induces Optical Aberrationsthat are Poorly Understood byOphthalmologists.
Refractive surgery tries to eliminatespherical and cylindrical defocus, themost important optical aberrations.However, this approach ignores the factthat the eye has significant higher-order aberrations. According to Dr. RaymondApplegate of the Department of Ophthalmology of the University of Texas Health Science Center, thesenaturally occurring higher-order 
7
George O. Waring, III, MD, FACS,FRCOphth,
 Editorial 
, J. R 
EFRACT
. S
URG
.,Vol. 12(3), Mar./Apr. 1996.
 
aberrations, combined with largeincreases in the eye’s higher-order aberrations induced by refractivesurgery, can decrease visual performance despite the elimination of spherocylindrical errors. Surgically-induced higher-order aberrations havereceived less attention than thecorrection of defocus errors despite their importance to optimal visual performance.
8
Moreover, the normal cornea isrelatively trouble-free whereas the post-refractive cornea frequently has a moreaberrated optical performance. It isoften unstable and its optical performance deteriorates at night or in patients with larger-than-average pupils.Contact lenses and spectacles do not permanently alter the physiologic opticsof the eye. Refractive surgery does.According to Dr. Leo Maguire of theMayo Clinic, “When one altersirreversibly the most trouble-freecomponent of the human visual system,one runs the risk of compounding thevisual aberration caused by componentsof the visual system thatcharacteristically show dysfunction withage (the lens and macula).”
9
 Dr.Maguire worries about how manyrefractive patients who can compensatefor their aberrated cornea will be able todo so when the lens and macula developage-related changes. How much sooner will they require cataract surgery or visual aids for macular degeneration?
10
Another reason why the eye’s opticsare degraded by Lasik is that excimer lasers were designed by engineers who
8
 
See
Raymond A. Applegate, OD, PhD &Howard Howland, PhD,
 Refractive Surgery,Optical Aberrations, and Visual Performance,
J. R 
EFRACT
. S
URG
., Vol. 13, May/Jun. 1997.
9
 
See
Leo J. Maguire, Mayo Clinic,
 Keratorefractive Surgery, Success, and the Public Health
, A
M
. J. O
PHTH
., Vol. 117(3),Mar. 1994.
10
 
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