I am devoting this month's column to the FDA panel meeting held on Friday, April 25, 2008. The session focused on the efficacy of LASIK and the incidence of complications with this procedure.
IMPETUS FOR THE MEETING
I believe that several factors led to the panel meeting and will briefly identify some of them.
First, several high-profile LASIK lawsuits have resulted in multimillion-dollar verdicts against the surgeon.
Second, LASIK's generally excellent results have seduced some surgeons into choosing a refractive procedure for a patient based on an anticipated "wow" factor rather than logical medical consideration.
Third, many patients now believe that new technology is more important than the ophthalmologist to the surgical outcome.
Fourth, some LASIK patients (approximately 7 to 10 in my experience) are using antidepressants.
Finally, the cause of corneal ectasia is unknown, and, currently, there is no scientifically proven, foolproof way of predicting which patients will develop keratoconus and corneal pellucid marginal degeneration after LASIK.
THE CURRENT SITUATION
In the hands of an experienced surgeon, LASIK on a truly healthy cornea has a success rate of approximately 98. Some, but not all, corneas with undiagnosed forme fruste keratoconus will develop corneal ectasia after LASIK. I have found that maybe 2 to 3 of the refractive surgical population has preoperative forme fruste corneal ectasia. As a result, a small percentage of LASIK patients will inevitably experience postoperative ectasia and irregular astigmatism due to an inherent, undetectable corneal condition.
Intraoperative problems occur in a small proportion of LASIK cases. Depending on the severity of the complication, surgical outcomes may be excellent or less than optimal for these eyes.
Given these facts, I would guess that a small percentage of LASIK patients are dissatisfied with their results. Their unhappiness may be minor, as serious as extreme irregular astigmatism and blurry vision, or anything in between. Most patients' visual acuity improves so much with LASIK that they happily tolerate a less-than-perfect result.
All forms of surgery can lead to complications. I believe the main problem with LASIK is exaggerated definitions of its success and excessively high expectations on the part of some candidates for the procedure. As a result, I think that certain patients are unable to cope with a good but not perfect outcome. I am referring to cases in which, for example, a 32-year-old -5.00 D myope enjoys a UCVA of 20/15 OU for 2 years after LASIK but regresses to 20/30 UCVA thereafter and sues his surgeon.
THE BEST COURSE OF ACTION
I recommend that surgeons personally discuss the LASIK procedure with every patient and provide each candidate with an informed consent that clearly establishes what he can expect to achieve with surgery. Ophthalmologists should emphasize that they, not the technology, are the most important factor in LASIK surgery. They should stress that complications and less-than-desirable results are relatively rare but do occur.
It is the lot of the refractive surgeon to have the occasional unreasonable patient. My advice is to grin and bear it. I strongly recommend, however, not performing LASIK on an individual who seems to have a need for perfection. Happily, most patients will appreciate the vast improvement the procedure brings to their vision and lifestyle.
Lee T. Nordan, MD, is a technology consultant for Vision Membrane Technologies, Inc., in San Diego. Dr. Nordan may be reached at (858) 487-9600; laserltn@aol.com.
