Lasik Surgery: FDA keeping a watchful eye…

October 19th, 2009. By AbiK

Lasik surgery’s been around for a while now (since the late 80’s, with the first Lasik laser being approved for use in 1998). And reports indicate some 6,000,000+ have had Lasik. I only know of one person who’s had it done and she raves about it. So much so that I even looked into it myself, but my ophthalmologist rejected me. It was worse than being dumped. So, while I cursed him at the time, the fact that the FDA is now beginning its study of Lasik long-term effects and post-procedure “quality of life” has me feeling a little better.

But it’s also got me thinking…what’s going on? Why now? The FDA doesn’t just casually decide to start snooping around in someone’s backyard…right?

Any time the FDA starts snooping around something (and this time it’s in tandem with their sending out warning letters to 17 Lasik facilities that were not properly reporting problems with Lasik procedures) I raise an eyebrow. Yes, I’m a bit jaded in the line of work I’m in. But you have to wonder why a procedure that’s seemingly been one of the most successful new surgical treatments we’ve seen in recent history for a fairly common problem—lousy eyesight—is now under the watchful eye of the FDA.

While the FDA focuses a portion of its Lasik study on long-term results and/or implications from the procedure, here’s the run-down of potential right-after-surgery Lasik complications, compliments of the FDA site:

• Some patients lose vision. Some patients lose lines of vision on the vision chart that cannot be corrected with glasses, contact lenses, or surgery as a result of treatment.
• Some patients develop debilitating visual symptoms. Some patients develop glare, halos, and/or double vision that can seriously affect nighttime vision. Even with good vision on the vision chart, some patients do not see as well in situations of low contrast, such as at night or in fog, after treatment as compared to before treatment.
• You may be under treated or over treated. Only a certain percent of patients achieve 20/20 vision without glasses or contacts. You may require additional treatment, but additional treatment may not be possible. You may still need glasses or contact lenses after surgery. This may be true even if you only required a very weak prescription before surgery. If you used reading glasses before surgery, you may still need reading glasses after surgery.
• Some patients may develop severe dry eye syndrome. As a result of surgery, your eye may not be able to produce enough tears to keep the eye moist and comfortable. Dry eye not only causes discomfort, but can reduce visual quality due to intermittent blurring and other visual symptoms. This condition may be permanent. Intensive drop therapy and use of plugs or other procedures may be required.
• Results are generally not as good in patients with very large refractive errors of any type. You should discuss your expectations with your doctor and realize that you may still require glasses or contacts after the surgery.
• For some farsighted patients, results may diminish with age. If you are farsighted, the level of improved vision you experience after surgery may decrease with age. This can occur if your manifest refraction (a vision exam with lenses before dilating drops) is very different from your cycloplegic refraction (a vision exam with lenses after dilating drops).
• Long-term data are not available. LASIK is a relatively new technology. The first laser was approved for LASIK eye surgery in 1998. Therefore, the long-term safety and effectiveness of LASIK surgery is not known.

Personally, I’m no longer considering getting Lasik—believe me, I could probably find a doctor or clinic to perform the procedure if I really wanted to (always other fish in the sea, right?)—but I’m not. Not with that list of possible complications. But clearly quite of few of you out there have had Lasik regardless of the above. So here’s my question: if you’ve had LASIK surgery, how was your experience and are you glad you did it? And does the FDA have anything to be concerned about?

Tags: FDA, Lasik

This was posted on Monday, October 19th, 2009 at 7:19 pm and is filed under Drugs/Medical, Emerging Issues . Feel free to respond, or trackback. Read our comments policy.