FDA LASIK panel review will benefit all

June 1, 2008

Guidelines physicians should use to minimize the number of patients who are "unhappy" and the rate of complications, according to Ernest W. Kornmehl, MD include sending each patient unbiased information about LASIK prior to the visits, discussing with each patient and his or her family the likely refractive result, and the fact that patient selection is just as important as the surgery itself.

Arecent literature review of 19 studies involving 2,199 patients worldwide presented at the April 25 FDA Ophthalmic Devices Panel meeting by Kerry D. Solomon, MD, documented that 5% of LASIK patients are dissatisfied (See Ophthalmology Times, May 15, 2008 issue, Page 1). That statistic is of great concern, but it is not surprising. Although a 95% success rate for most medical procedures is considered outstanding, it should be much higher for LASIK.

The overwhelming majority of ophthalmologists and their patients understand that LASIK is a serious surgical procedure and treat it as such. Unfortunately, a small minority treat it as business transaction or a commodity, often leading to a poor result.

The American Academy of Ophthalmology, the American Society of Cataract and Refractive Surgery, the FDA, and the National Institutes of Health's National Eye Institute soon will begin a study to evaluate the causes of patient dissatisfaction and how they can be prevented. In my experience, if physicians use the following guidelines, the number of patients who are "unhappy" will not be statistically significant, and the rate of complications will be minimized.

• The surgeon should examine the patient before the day of surgery to develop a doctor-patient relationship; diagnose pre-existing dry eye, meibomitis, and any other ocular pathology; and ensure that the patient has realistic goals and expectations. All patients will have a neurotrophic cornea for 3 to 6 months following surgery.1 This condition is best tolerated if pre-existing dry eye, meibomitis, and exposure are diagnosed and treated before surgery.

• Patient selection is just as important as the surgery itself.2 Do a surface procedure if the topography or pachymetry is "borderline." Absolutely no reason exists to put patients with borderline conditions at increased risk for an elective procedure. Wavefront-based PRK recently was demonstrated to have as good or better visual results than LASIK.3

• The surgeon should have a thorough discussion with each patient and his or her family to review the likely refractive result, the potential need for reading glasses or glasses for driving at night, increased level of dryness in the eye for 3 to 6 months, the likelihood of a second operation, or the need to do a surface- or lens-based procedure. Most patients are willing to tolerate temporary discomfort from an abnormal ocular surface if it is managed and discussed before surgery. Physicians should be tracking their results so they can use their own data to provide each patient with an accurate assessment of the likelihood of the necessity of a second procedure. Patients must be made to understand that even under the best circumstances, a second procedure may be necessary to obtain the desired refractive result.

• If a surface- or lens-based procedure is recommended, the patient should be given unbiased written information about the procedure and another appointment should be scheduled to discuss it. This course of action allows the patient the time to gain an understanding of a new procedure that he or she did not anticipate would be considered the best option.

• The patient never should sign the consent form the day of the initial appointment. The patient should take the form home, read it, and sign it after any further questions have been answered.

The physician and patient each must do their parts to ensure that the patient obtains the result he or she expected. As with any surgical procedure, complications can occur even under the best circumstances. If the above guidelines are followed, however, the patient and physician both will be confidant that everything possible was done to minimize the risk of a complication and can work as a team to manage any complications that may occur.

Ernest W. Kornmehl, MD, FACS is medical director of Kornmehl Laser Eye Associates, is on the faculties of the medical schools at Harvard and Tufts universities, Boston, and is an associate medical editor of Ophthalmology Times.

References

1. Wilson, SE. Laser in situ keratomileusis-induced (presumed) neurotrophic epitheliopathy. Ophthalmology. 2001;108:1082-1087.

2. Kornmehl EW, Young JA. Preoperative evaluation for refractive surgery. In: Yanoff M, Duker JS, eds. Ophthalmology. 2nd ed. St. Louis, MO: Mosby; 2004:133-136.

3. Randleman JB, Loft ES, Banning CS, Lynn MJ, Stulting RD. Outcomes of wavefront-optimized surface ablation. Ophthalmology. 2007;114:983-988.