Double vision?

The U.S. Food and Drug Administration (FDA) has convened its advisory board on ophthalmic devices and scheduled a hearing to review the popular surgical procedure for improving one’s eyesight, known as LASIK (for Laser Assisted In Situ Keratomileusis).

There have been complaints of double vision, dry eyes, night blindness, and halos after LASIK surgery coming from most patients which have persisted beyond the supposed recovery period for vision to stabilize.

For the period 1998 and 2006, there have been 140 reports filed with the FDA complaining about complete dissatisfaction with the procedure.

Aside from FDA experts, the panel will include representatives from the National Eye Institute, the American Society of Cataract and Refractive Surgery, and the American Academy of Ophthalmology. Basically, their mission is to assess the quality of life for patients who have undergone LASIK.

Nearly 700,000 people have LASIK procedures each year in the country. Since 1995 when it was first approved by the FDA, over 12 million Americans and 28.3 million people worldwide have undergone LASIK.

LASIK doctors insist that complications are rare after surgery. But there is a growing number of complaints and the unhappy tales are getting more attention from the public.

The FDA clarifies that the issue is not about the safety and effectiveness of the procedure. Rather, it is about trying to find out how to make a safe and successful procedure even more successful.

Most of the complaints center on complications after LASIK.

Common complaints involve dry eyes, irregular astigmatism (LASIK was meant to correct astigmatism), and some ghosting of vision. According to the FDA, vision should stabilize three to six months after surgery. During this period of stabilization, people also experience halos, difficulty with night vision including driving at night, and painful glare from bright lights.

Some patients are now saying there was no full informed consent for the procedure. For instance, they were not informed about loss of contrast sensitivity, which enables the eye to clearly see an object in relation to its background. For some of them, it has been years since surgery but their eyes still sting, have double vision, and see halos or blurred lights.

LASIK practitioners point out that previous studies have indicated 95 percent satisfaction rate. But analysts say most past studies measured the degree of vision correction and incidence of infection but did not address issues like night vision and contract sensitivity which have everyday effects on quality of life.

LASIK surgeries are expected to drop dramatically in 2008, not because of the FDA review but due to the sour economy.