US laser eye-correcting firm to be investigated
Published 17/10/2009 | 00:00
The US government is to investigate problems connected with laser eye-correcting surgery, which include blurred vision and dry eyes.
The Food and Drug Administration (FDA) says it will work with the National Eye Institute and the Department of Defence to determine the percentage of patients who experience negative side-effects following Lasik 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 the FDA.
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 six 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% of patients are satisfied with their new vision. But a small number of patients have reported permanent damage to their eyes following the surgery, including double vision, dry eye and halos around objects at night.
The FDA agreed to look into the problems in 2008 after years of complaints.