U.S. FDA To Probe Links Between Laser Eye Surgery, Complications

February 25, 2008 10:33 a.m. EST

Raleigh, NC (AHN) - Because of a large number of complaints it has received from patients who have undergone laser eye surgery, the U.S. Food and Drug Administration is planning to have a national study on the relationship between LASIK complications and life quality.

Patients who agree to undergo the laser therapy sign release forms that inform them of potential health risks that may arise following the vision-correction procedure. But depression, which may lead to suicide, is not on the list.

For those who underwent the procedure, but failed to get clearer vision, frustration and sorrow may follow. Others instead suffer from non-stop eye pain or their sense of vision is permanently damaged. For eye patients in that situation, they may experience serious emotional problems.

A medical student from Philadelphia even went to the extreme of committing suicide after suffering from permanent visual distortion for the past six years. A suicide note Colin Dorrian left attributed his life taking attempt to the botched medical procedure.

But laser eye surgeons insisted cases like Dorrian's do not have their root causes in the procedure itself. Rather, the patient usually has a problem on depression or psychological trouble prior to the surgery. Dr. Steven Schallhorn, ex-chief of the Navy Refractive Surgery, said, "There's no cause and effect."

Optometrist Christine Sindt said people with eye problems normally already have depression. For LASIK victims, remorse is added to their negative feelings because, "It's not just that they lose vision... They paid somebody (who) took their vision away."

LASIK or laser assisted in-situ keratomileusis is considered a safe and successful medical procedure. Over 1.3 million Americans undergo the laser surgery yearly with generally successful results. The 9,000-member American Society of Cataract and Refractive Surgery estimated that only 2 to 3 percent of LASIK surgeries develop complications.

Known complications include halos, double vision, loss of contrast sensitivity, glare, dry eyes, over or undercorrection, visual acuity fluctuation, light sensitivity and variations of flap damage.

The FDA started to look into the link between LASIK complications and quality-of-life issues in 2006. For the new study, the FDA will convene a task force made up of representatives from the National Eye Institute and the National Institute of Health.