DEL.ICIO.USAgency conducts study to identify who has bad outcomes and why
Associated Press
Published on: 04/25/08
WASHINGTON (AP) — Patients harmed by Lasik eye surgery alternated between fury and despair Friday as they told federal health officials of suffering years of eye pain, blurred or double vision — even of people driven to suicide.
"Too many Americans have been harmed by this procedure and it's about time this message was heard," said David Shell of Washington, D.C., who had Lasik in 1998 and says he has "not experienced a moment of crisp, good quality vision since."
|
Colin Dorrian was a college student when he was told he wasn't a good Lasik candidate, but went ahead anyway — and his father, Gerald, described six years of eye pain and blurred vision before reading his son's suicide note to a Food and Drug Administration panel: "I can't and won't continue facing this horror."
Matt Kotsovolos actually worked for the Duke Eye Center when he had a more sophisticated Lasik procedure in 2006, and said doctors classified him as a success because he now has 20-20 vision — something Kotsovolos charged is a deceptive industry practice.
"For the last two years I have suffered debilitating and unremitting eye pain," Kotsovolos said. "Patients do not want to continue to exist as helpless victims with no voice."
A decade after Lasik hit the market, the FDA is taking a new look at whether warnings about its risks are appropriate — and pairing with eye surgeons for major study to better understand who has bad outcomes and why.
Most Lasik recipients do walk away with crisper vision, and the American Society for Cataract and Refractive Surgery reviewed studies showing about 95 percent of patients say they're satisfied with their outcome.
But not everyone's a good candidate, and an unlucky fraction do suffer life-changing side effects: poor vision even with glasses, painful dry eyes, glare or inability to see or drive at night.
How big are the risks? The FDA agrees that about 5 percent of patients are dissatisfied with Lasik. How many struggle daily with side effects? How many are less harmed but unhappy that they couldn't completely ditch their glasses? The range of effects on patients' quality of life is a big unknown — and the reason the FDA help a public hearing Friday as part of its new move.
"Clearly there is a group who are not satisfied and do not get the kind of results they expect," said Dr. Daniel Schultz, the FDA medical device chief. The study should "help us predict who those patients might be before they have the procedure."
About 7.6 million Americans have undergone some form of laser vision correction, including the $2,000-per-eye Lasik. The Lasik procedure is quick and, if no problems occur, painless: Doctors cut a flap in the cornea — the clear covering of the eye— aim a laser underneath it and zap to reshape the cornea for sharper sight.
Doctors advise against Lasik for one in four people who seek the surgery, said Dr. Kerry Solomon of the Medical University of South Carolina, who led a review of Lasik's safety for the ASCRS. Their pupils may be too large or corneas too thin or they may have some other condition that can increase the risk of a poor outcome.
Solomon estimates that fewer than 1 percent of patients have severe complications that leave poor vision.
Other side effects, however, are harder to pin down. Dry eye, for instance, can range from an annoyance to so severe that people suffer intense pain and need surgery to retain what little moisture their eyes form. That's the kind of question the FDA's new study is being designed to answer.
Dry eye is common even among people who never have eye surgery, and increases as people age. Solomon says that 31 percent of Lasik patients have some degree of it before the surgery and that about 5 percent worsen afterward.
But dry-eye specialist Dr. Craig Fowler of the University of North Carolina says other research suggests 48 percent of patients experience some degree of dry eye at least temporarily after Lasik. Cutting the corneal flap severs nerves responsible for stimulating tear production, and how well those nerves heal in turn determines how much dry eye lingers long-term, he said.
Vote for this story!
More on ajc.com
- FDA takes closer look at Lasik complaints (04/24/2008)
- Feds put focus on Lasik eye surgery (04/26/2008)
- Seeing in a new light (09/29/2008)
- Government probes heart disease study (09/26/2008)
- Apple to make iTunes more accessible for the blind (09/26/2008)
- FDA reviews experimental use of anemia drugs (09/26/2008)
- Panel hears of possible cellphone risk (09/26/2008)
- Government probes chelation-heart disease study (09/25/2008)
- Report: FDA lax in oversight of produce industry (09/25/2008)
- Inhaler lung drugs tied to heart problems, deaths (09/23/2008)
Inside AJC.COM
'Housewives' sneak peek
Season Two starts July 30, and we got a copy of the first episode. Here's some juicy tidbits.
Can you see the change?
What's altered in the two photos? See how you score when you play the Find 5 challenge!
Private Quarters Splurge
The Appletons kept the historic feel of the Kirkwood neighborhood with their newly constructed home.
Southern recipes
A little food coloring. A little buttercream frosting. And a whole lot of history with red velvet cake.
She lost 60 pounds!
"My confidence is through the roof ... I can do anything," says Sonya Moste of Fayetteville.
Search
Do Good Locally » Find nonprofit causes near you
Services » Find the right people for the job
We want to know what you think
Customer Care »
Vacation stops, manage subscriptions and more
AJC Services
News Sections
Other Editions
Guides
Visitor Agreement | Privacy Statement
© 2009 The Atlanta Journal-Constitution
Comments
By Kim
Nov 17, 2008 2:53 PM | Link to this
If you have dry eyes (before or after surgery) please see a Rheumatologist to be tested for an auto-immune disease called "Sjogren's Syndrome." It can attack the tear ducts (dry mouth is another possible symptom.) I had LASIK not knowing I had Sjogren's and it has caused the dryness to become even worse.
By Rosie
Jul 3, 2008 9:23 AM | Link to this
Hello everyone.
I had Lasik about 3 years ago with Dr. Eugene Smith at Lasik Plus. I see someone that had it done with him 7 years ago above and she seems satisfied as well. I have no problems so far. Its the best investment of my life so far. Im so glad I did it. They make you feel very comfortable thru out the whole process. Eugine Smith is from GA.
By Matthew Beaty
May 13, 2008 1:25 PM | Link to this
Hi, I am sorry to hear about all the cases of Lasik gone wrong. There is a good site at www.lasikuniversity.com that will teach people about lasik. www.lasik.fm
By M
Apr 30, 2008 3:42 PM | Link to this
Not 20/20
I also have a very difficult prescription, and have had doctors screw up my prescription. I found a really great eye doctor/surgeon about 5 years ago and he has always made sure my prescription is right. Dr. Newman, Center for Sight, in Conyers GA. He may be able to help get your prescription right. sorry if that sounded like a bad commercial, lol.
By Rhianna
Apr 30, 2008 3:27 PM | Link to this
I had Lasik about 7 years ago ę Dr. Eugene Smith at Lasik Plus did my surgery. I have had no problems at all. I think it was the best decision I have ever made. I would pay 3 times the price ę that is how much I have loved the procedure. As with any surgery there are always risks. There isnęt anything in this world that is flawless. I think it is funny to hear the 5 percent complaining. They knew the risks that were associated. I hope this doesnęt give Lasik a bad name!
By songbird
Apr 29, 2008 4:49 PM | Link to this
I had LASIK in 2002 by Dr. Andrew Feinberg. He's at Crawford Long and TLC on Peachtree Dunwoody Rd. I never had a problem with my vision until I had eyelid plastic surgery 18 months ago. Since then I have had dry eye in one eye which has caused my vision to blur in that eye. The other eye is still perfect.
I think the key is the doctor and his/her experience and training on this procedure. I would never use the $499 per eye centers. I bet that is where most of the problems come from.
By Benevolous
Apr 29, 2008 2:04 PM | Link to this
I had mine done at the Woodham's Eye Clinic. From day 1 I have had 20/12.5 during the daytime, which exceeded my expectations. However, I see halo's at night, which is frustrating; I had 1 touch-up which improved my night vision to where it is tolerable and am not going to risk any further treatment. I love not having to mess with contacts or glasses anymore, but the night vision issue before the touch-up scared me and made me question my decision. Dr. Woodhams has been great.
By woodie
Apr 29, 2008 10:30 AM | Link to this
I had this done three years ago and threw away my glasses I'd been wearing for 30 years. But the procedure is not flawless. Dry eyes, uneven correction, and loss of close up vision were problems I had. I hated glasses though so it's all the same to me. I'm older though and had really bad vision so I'm probably one of the worst cases. Dry eyes is the worst problem. It never got better like it does for many.
By rn
Apr 29, 2008 7:09 AM | Link to this
A LASIK procedure is surgery. There are risks associated with any surgical procedure and LASIK is no different in that regard. What is an issue is that for many, LASIK is more cosmetic than corrective. When you read about people who stated that they were told that they were NOT a candidate for LASIK,then shopped around until they found someone to do the procedure and now have problems, they share the blame. Many will not take NO for an answer or they think that "it will never happen to me." LASIK is a great procedure for those who are in need of a lot of correction to be able to see, but that doesn't negate the risks that are a part of the procedure that even those needed the procedure may experience.
By Damien
Apr 28, 2008 11:45 AM | Link to this
I had my LASIK at Woolfson Eye Institute and I had a great experience. Not only did I research Dr. Woolfson but my own eye doctor had his surgery with Dr. Woolfson so I was totally amped.
It wasn't cheap but I'm not looking for the bargain basement folks when it comes to my eyes!
[1 2 3 4] next
Commenting is open from 8 a.m. to 5 p.m. M-F, except on Tuesday when it's open until 9 p.m.
Post a comment
*HTML not allowed in comments. Your e-mail address is required.
Request a comment be removed