March 17, 2010
Fda to Look Into Lasik Complaints
By Staff in Categories: LASIK
Interesting article
LASIK is not a good option for everyone, and that has been known for many years. When the FDA first approved LASIK, in the mid 1990s, many ophthalmologists rushed to offer it to all and sundry. You could even say that some vision clinics operated like LASIK assembly lines, whisking people in one door and out the other without adequately screening them.
Some kept their expenses down by buying cheap equipment, not changing the microkeratome blade for each patient, not sterilizing instruments often enough, and keeping a small staff. The eye surgeon did not meet with patients before or after the actual surgery, but delegated that to assistants. With low expenses, such clinics were able to offer low prices to attract a lot of patients.
The result was that many people had LASIK who should not have had it. They were poor candidates.
How LASIK is Done
Briefly, it reshapes the eye’s cornea, the clear part in front. The cornea, being curved and transparent, bends light as it enters the eye. In a 20/20 eye, it bends it at just the right angle to give clear vision. If you are near- or far-sighted, it bends it at the wrong angle. If you are astigmatic, it bends light in multiple ways, giving blurry vision.
To reshape the cornea, a small, thin flap is first cut with a tool called a microkeratome. The flap is folded back out of the way, and the treatment laser (Excimer laser) vaporizes tiny pieces of corneal tissue beneath the flap area, according to a pre-determined plan. This gives the cornea a new curvature: flatter for nearsighted people and steeper for farsighted people.
The corneal flap is then replaced carefully and heals up by itself. Now that the cornea has a modified curvature, incoming light will be bent correctly and will focus clearly on the retina at the back of the eye. You will have clear vision at all distances.
LASIK Developments
More information has been gathered since the early days. More follow-up studies have been done, and modified forms of LASIK have been developed which are safe for people who cannot have standard LASIK.
• Wavefront-guided LASIK delivers a more precise treatment, preventing many of the side effects that often resulted from standard LASIK, such as halos and starbursts around light sources, ghosting (kind of double vision), and poor night vision.
• Intralase uses no microkeratome blade to create the corneal flap, but instead uses a second laser. This makes a thinner flap and enables those with thinner corneas to still have vision correction
• LASEK and epi-LASIK also do not use a blade to cut the corneal flap. They use alternative methods to make thinner flaps, making vision correction possible for more people.
Public FDA Hearing today
Today, April 25, 2008, the FDA is beginning a second look at LASIK. The plan is to work with eye surgeons and do a major study on many hundreds of people who have complained about their LASIK results. What exactly are their complaints? Were they poor LASIK candidates to start with? Depending on their findings, they may issue a new warning about LASIK.
About 7.6 million people have had a LASIK procedure in the U.S., and the percentage of people who achieve 20/20 vision or better is in the high nineties. LASIK is truly something of a miracle for anyone who has lived their lives with poor vision and suddenly has clear vision. It is almost always a huge success. But the first line of defense against any complications afterwards is to choose a good LASIK surgeon.
The FDA’s website has a page on all the LASIK devices and systems they have approved. There are links to more detail on each one, and to warning letters issued by the FDA, press releases and patient information. If you are considering LASIK for yourself, this would be a good place to start your self-education about it.
Be sure and choose an experienced and highly-trained LASIK surgeon, who will give you a thorough eye examination, check your medical history and general health, and listen to your goals and concerns. Make sure that this same surgeon will personally do your follow-up checks. If you feel any reservations or discomfort about working with a particular eye surgeon, move on and schedule a consultation with another surgeon. An educated patient is always the best kind, so do your homework, choose a good surgeon, and you will likely be jazzed and delighted at the results.
Contact the Laser Eye Center of Silicon Valley for more information about LASIK and your other options.