| Brent Hanson - LASIKFRAUD.com 2005-11-18, 10:58 am |
| Bilateral Simultaneous LASIK?
Not on my patients!
by Jame J. Salz, MD
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I have personally never performed bilateral simultaneous RK, AK, PRK,
LASIK, clear lens extraction, or cataract surgery because I am
convinced it is not in the patient's best medical interest to do so.
Of all these procedures, I would agree that the strongest case for
bilateral simultaneous surgery can be made for LASIK. Why then do I
advise my patients not to have any refractive surgery procedure on both
eyes at the same time? It really comes down to a personal philosophy to
always place the patient's best medical interest before issues of
patient and surgeon convenience, financial considerations for patients,
surgeons and laser centers, and building refractive surgery volume.
I will concede that if the surgery and post operative course are
without complications and side effects, bilateral simultaneous LASIK
and even PRK and RK are very convenient for the patient since both eyes
heal together, time away from work is minimized, and the necessity of
temporarily wearing a contact lens in one eye is eliminated. The
surgeon and the laser center also benefit financially since it takes
just a few additional minutes to perform the surgery on the second eye
once everything is set but the fees are usually doubled (at times with
a modest discount for the second eye) and the follow-up visits are
effectively cut in half. Because the vast majority of patients will do
quite well, this is a very effective practice builder since all these
satisfied (WOW) patients will go out and sing the praises of the
surgeon and the center.
So why not do it? Let's look at that little word if at the beginning
of the previous paragraph. What if the surgery, the postoperative
course and side effects present problems. I can separate my arguments
against simultaneous surgery into three potential disadvantages for the
patient and one potential major disadvantage for the surgeon. Potential
disadvantages for the patient are: the risk of serious complications
leading to significant visual loss; the possibility of an unpredictable
outcome; and potential dissatisfaction with the side effects of the
surgery. For me to recommend simultaneous surgery, I have to be certain
there will not be a vision threatening complication, that the outcome
will be predictable, and if the outcome is predictable that the patient
will be satisfied with the quality of their vision in the real world.
Since I can never be certain of any of these three conditions, I cannot
in good conscience recommend this to my patients. If our primary
responsibility as physicians is to always do what is in the patient's
best medical interest, it's hard to justify elective, simultaneous
surgery. The disadvantage to the surgeon involves the potential
magnitude of a potential malpractice claim in the event of significant
bilateral loss of vision. Let's first explore the potential
disadvantages to the patient.
Risk of serious bilateral loss of vision
The risk of infection following LASIK appears to be very low, despite
the fact that it is not truly a completely sterile technique like
cataract surgery because it is not performed in a hospital operating
room with more stringent standards of sterile technique and the entire
microkeratome cannot be completely sterilized because of the motor and
cord. Although the risk of infection appears to be quite low, the
presence of an infection under the LASIK flap presents unique
challenges in management and would be quite likely to lead to
significant scarring and loss of vision. Should an infection occur in
one eye, it will quite likely occur in the other eye since the same
microkeratome and blade are used in both eyes. Even if this risk is
only 1 in 5,000, given the potential for the infection to occur in both
eyes and the potential for serious scarring at the interface, even if
the infection is adequately controlled, I don't think the risk is
justified. What's the hurry?
Although not as potentially serious as an infection, Bobby Maddox and
others have reported numerous cases of bilateral interface haze
appearing within the first two or three postoperative days. At the
recent ISRS meeting is San Francisco, Dr. Lawrence Spivak from Denver,
Colorado described interface haze in 22 eyes following LASIK. Although
one or two were unilateral cases, most had bilateral simultaneous
surgery. On the first postoperative day, the haze was mild to moderate,
gradually increasing over the next several days, with clearing over the
next few weeks following treatment with topical corticosteroids. The
decrease in best corrected visual acuity varied from 20/25 to 20/200
during the acute phase with recovery to 20/20 in all but one eye which
was overcorrected to +2.00 D with 20/30 visual acuity. Interestingly,
this case was a re-operation where the original flap was lifted without
the use of the microkeratome. Since the etiology and exact incidence of
this unusual but perplexing complication is unknown, it would seem only
prudent not to put both eyes at risk. What's the hurry?
Just this past year I have examined 3 patients for second
opinions that had bilateral complications following LASIK. One was an
ophthalmologist, one a dentist and one a businessman. All three missed
several weeks of work because of their bilateral complications,
primarily
related to the inflammation under the flap, called diffuse lamellar
keratititis. Had only one eye been operated on, they would have been
able to
function with their contact lens in the unoperated eye while the eye
with the
complication gradually improved with treatment.
In addition to the risk of bilateral simultaneous infection and
bilateral interface haze, an even more serious concern is the
possibility of vision threatening retinal complications. Certainly the
possibility of vitreous hemorrhage , central retinal artery occlusion,
retinal hemorrhage and retinal detachment all exist, and some of these
complications have now been documented. At the International Society of
Refractive Surgery Symposium, October 25, 1997 in San Francisco, Dr.
Jose Luna from Argentina reported non-refractive complications after
700 bilateral simultaneous LASIK cases. One patient (approximately -12
D pre-op) who underwent bilateral simultaneous LASIK was found to have
bilateral sub-macular hemorrhages and best corrected visual acuity of
20/400 on the first post-operative day. Six months later best spectacle
corrected visual acuity was 20/60 in each eye. Dr. Luna also reported a
post-operative retinal detachment in one eye and another case with
bilateral iatrogenic keratoconus following the inadvertent use of a 360
micron thickness plate.
At the annual meeting of the Argentine Society of Ophthalmology last
summer, Dr. Ricardo Dodds reported bilateral simultaneous retinal
detachments on the first post-operative day following bilateral LASIK
and another case with extension of lacquer cracks into the macula. Try
to tell these unfortunate patients with the retinal complications, some
facing permanent loss of vision in both eyes, that these complications
are rare. For them, the incidence is 100%. These problems could have
been avoided with even a delay of one day between eyes.
In a recent article in Ophthalmology Times the headline stated
"Same-time LASIK safe, study says." This was based on a study at Emory
comparing the results of a prospective randomized study on 709
patients, 378 had bilateral simultaneous LASIK and 331 had sequential
LASIK two weeks apart. Fortunately, there was no significant difference
in intraoperative complications or in the number of patients who lost
two or more lines of best spectacle corrected visual acuity. In
discussing the study, Dr. George Waring stated: "The risk for
intraoperative complications is the same, because if we are operating
on a patient where we intend to do bilateral surgery and have a
complication in the first eye, we don't do the second eye, so that
safety is built in."
In fact, not having an intraoperative complication in the first eye is
certainly no guarantee that the patient will not end up with a
bilateral post-operative complication. None of the procedures leading
to serious retinal complications in the patients from Argentina and
none of the patients with bilateral interface haze had complications at
the time of surgery. I think it is misleading to state that the Emory
study showed that "same time LASIK is safe, "because the numbers are
too small. Simply doubling the number of cases as was reported in the
study in Argentina, resulted in serious bilateral complications.
If I performed 378 bilateral simultaneous cataract operations without a
serious complication and compared them to a series of 378 unilateral
cataract operations, I could state that my study showed that bilateral
simultaneous cataract surgery is safe. Does that really mean we should
all start doing it? At least cataract surgery is being performed on
eyes with true pathology and already decreased vision. The majority of
these LASIK eyes have 20/20 best corrected vision. Why risk permanent
bilateral visual loss no matter how low the risk. Refractive surgery,
being performed on essentially normal eyes, should surely be held to a
higher standard. What's the hurry?
Predictability of outcome
Although there is certainly less influence in the healing process by
surface mediators in LASIK compared to PRK, the possibility of an
unexpected result still exists. The algorithms are still being modified
for the various lasers and even now the role of factors such as patient
age, amount of myopia and room humidity in predicting the final
refractive outcome in LASIK are still being debated among the experts.
Individual variations in the cornea's response to the excimer laser
still occur, and by delaying the surgery at least five to seven days
between eyes permits the surgeon to modify the surgical plan in the
second eye based on the results in the first eye. This can at least
theoretically lead to a better outcome in the second eye and possibly
eliminate the need for a re-operation in the second eye.
Although many LASIK surgeons discuss the ease of lifting the flap and
doing more surgery, this is not as benign as it sounds, and many of the
speakers at the recent ISRS symposium discussed the increased risk of
complications such as epithelial ingrowth following secondary flap
manipulations. If sequential surgery can possibly improve the outcome
in the second eye because the amount of correction can be adjusted
after seeing the result in the first eye, then the incidence of
re-operations in the second eye can be reduced, thus reducing the risk
of complications. What's the hurry?
Patient satisfaction with the procedure
There is certainly more to the final result of any refractive surgery
procedure than the uncorrected visual acuity and best spectacle
corrected visual acuity. Both of these objective measurements can be
excellent in a patient who is nonetheless quite unhappy with some
aspect of their postoperative vision. We have all had patients who have
had a refractive surgery procedure with an excellent outcome in terms
of visual acuity but are unhappy about some aspect of their vision in
the real world. It can be halos or glare at night, difficulty with
night vision due to some loss of contrast sensitivity, or vision that
is simply "not as good as it is with my contact lens in the other eye."
Of course I have heard bilateral LASIK advocates seriously state that
this is one reason to do the two eyes together, so that the patient
can't compare the LASIK eye with the contact lens eye!
This perceived difference in the quality of their vision can be a major
concern for some patients, and it is certainly in their best interest
to let them fully appreciate the quality of their new vision in the
real world before they commit to having the surgery in the second eye.
This is particularly true in patients with relatively low refractive
errors who have the option of either wearing glasses or contact lenses
in the untreated eye. With all the advances in contact lens technology,
even the higher myopes can usually be fit with a contact lens in the
second eye while they evaluate the quality of their vision in the
treated eye. If they are not completely satisfied, they have the option
of continuing in the contact lens until new developments such as larger
ablation zones, flying spot lasers with customized potentially smoother
ablations or phakic intraocular lenses become available. Once again,
what's the hurry?
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