LASIK and the FDA

Last week, you may have heard LASIK news such as the following:

"The FDA’s Ophthalmic Devices Panel heard last Friday from both satisfied and dissatisfied LASIK patients, as well as representatives from the American Academy of Ophthalmology and the International Society of Refractive Surgery (ISRS) of the American Academy of Ophthalmology who spoke about the extensive track record of safety and effectiveness for LASIK.

Following a long day of testimony and presentations, the panel made several recommendations for consideration by the FDA, including:

• Adding photographic illustrations of certain side effects to the FDA Web site
• Better explanation of certain outcomes, such as myopic patients who have LASIK eventually needing reading glasses post surgery
• More understandable information about the potential risks of LASIK (such as dry eye, halos, glare, starbursts, etc.) and about conditions that might make a patient a poor candidate for LASIK (such as a family history of keratoconus and a history of depression)
• Additional information or guidance in the labeling about postoperative intraocular pressure, and additional guidance for implant measurement for post LASIK cataract surgery"

Yeah, you say, but what does that mean?

It means that LASIK is as safe as it has always been. But LASIK, no matter how simple and quick the results are, is still a surgery. With any surgery, there are risks and chances of complications. Unfortunately there are doctors who perhaps do not emphasize these risks well enough to their patients and there are patients who, even though informed, do not pay enough attention to these risks. As a result, patients are undergoing LASIK surgery without being fully informed.

The panel of advisors for the FDA that met last week has put together a list of suggestions hoping to better educate patients before they undergo surgery. As an office that provides LASIK, we are proud to say that we already adhere to these recommendations. As a patient seeking LASIK, our advice to you is to learn all you can before you undergo the vision correction procedure. Learn your options and be honest about your eye history. If you suffer from dry eye, perhaps you should consider PRK instead. If you have a family history of kerataconus, ask your doctor if LASIK is really right for you.

LASIK surgery is an extremely beneficial procedure. Millions of people around the world have undergone the procedure and are happy with their results. Whether or not you would be happy with LASIK depends a lot on your expectations. Research, ask questions, and think carefully before getting your eyes zapped. Your comfort with your doctor and the information you receive will greatly determine your comfort post-procedure.