LASIK patient advocates have expressed strong concern of bias on the part of military LASIK surgeons, particularly Navy LASIK surgeons, who have close ties with organized ophthalmology. For example, Steve Schallhorn, MD, Capt, US Navy (Retired) is a paid medical malpractice defense expert witness and an industry consultant, has made public statements and published literature denying connection between a poor LASIK outcome and diminished quality of life, has financial interests in companies that manufacture LASIK devices, and is currently medical director of one of the largest corporate providers of LASIK in the world. Furthermore, LASIK patient advocates have questioned a defense contract awarded around the time of Schallhorn’s retirement from the Navy. In December 2006, IntraLase announced that the Dept. of Defense had awarded the company a $45 million, 5-year contract to supply its flap-cutting lasers to the U.S. Army, Navy, Air Force, Marine Corps and federal civilian agencies. Shortly thereafter, it was reported that Schallhorn was a consultant for and had financial interests in Advanced Medical Optics, the company that acquired IntraLase. Further evidence of bias can be found in an article in the December, 2009 edition of JAMA, which reported that Schallhorn is “confident that once the quality-of-life issues are studied, LASIK will be shown to be even more safe and effective”.
Dry eye is the most common complication of LASIK. Corneal nerves that are responsible for tear production are severed when the flap is cut. Medical studies have shown that these nerves never return to normal densities and patterns. Symptoms of dry eye include pain, burning, foreign body sensation, scratchiness, soreness and eyelid sticking to the eyeball. The FDA website warns that LASIK-induced dry eye may be permanent. Approximately 20% of patients in FDA clinical trials experienced “worse” or “significantly worse” dry eyes at six months after LASIK.(1)
In the United States, the Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety of drugs and medical devices. But can you really trust the FDA? The agency has a long history of approving drugs and devices that were later found to cause serious injury and even death. Many FDA-approved products have been withdrawn from the market or recalled by the agency.
Prior to the introduction of LASIK, cataract surgery was the bread and butter of the ophthalmologist’s practice. In the United States in the 1990s, Medicare made a series of cuts to cataract surgery reimbursements. In response, eye surgeons, scrambling for a new income stream, turned to the more lucrative practice of LASIK.
LASIK surgeons can be split into two categories: More worringly, those who refuse to get LASIK will not wear glasses in their own clinics, as they know they cannot sell LASIK if they themselves show they haven’t had it.
Behind the cornea is the colored part of the eye called the iris. The iris muscle controls the size of the pupil, regulating the amount of light entering the eye. In dim light the pupil opens to gather more light. The dark-adapted pupil diameter varies widely among individuals. In 2004, researchers found the pupil size of patients seeking refractive surgery ranged from 4.3 to 8.9 millimeters with an average of 6.5 millimeters.