FDA to Study Negative Effects of Lasik Eye Surgery

WASHINGTON -- The Food and Drug Administration announced plans Thursday to study the scope of problems connected with laser eye-correcting surgery, which include blurred vision and dry eyes.

The FDA says it will work with the National Eye Institute and the Department of Defense to determine the percentage of patients who experience negative side effects following surgery.

The first phase of the project is already under way, with plans for an online questionnaire to help patients gauge their quality of life following surgery, according to an FDA statement.

The project will also include a clinical trial tracking patients who undergo the procedure, which is expected to conclude by 2012.

"This study will enhance our understanding of the risks of Lasik and could lead to a reduction in patients who experience adverse effects," said Dr. Jeffrey Shuren, the acting head of FDA's medical device division.

An estimated 6 million Americans have undergone Lasik surgery, which permanently reshapes the cornea, a clear layer covering the eye. There are no guarantees of 20/20 vision and the long-term safety of the procedure is still unknown.

Ophthalmology societies report that about 95 percent of patients are satisfied with their new vision.

Source: , Associated Press/AP Online
mystic49's picture
I am 60 years old and had Lasik Surgery at LasikPlus at St. Louis, Mo. I had the procedure done Oct.09. I have not had any adverse affect what so ever. I have 20-20 vision and could not believe how well I can see. (Dust on fan blades, dust in intake vent ). I have had to wear glasses or contracts since I was in 6th grade. I was near sighted and far sighted. I do have to wear reading glasses sometimes, but only 1.25, for small print. I could not believe how easy and painless this procedure was. LasikPlus gives you a free examination and puts all variables together to find out if your a candidate or not. My daughter had Lasik surgery 2 years ago and has not had any problems. I do sometime use drops when I first wake up in the morning, I was informed that it will take up to 4 to 6 months for my eyes to fully heal. I love being able to get up in the morning and not have to look for my glasses. Thank you. Marilyn Jumper
Ads by Google