20/20 Vision in the Blink of An Eye

FDA takes a closer look at Lasik.

April 24, 2008— -- The prospect of perfect vision in the blink of an eye has attracted thousands of patients to Dr. Roy Rubinfeld's office for Lasik surgery. The vast majority of them, Rubinfeld said, walk away happy.

"There is no foolproof medication, no foolproof procedure," said Rubinfeld, who himself had Lasik surgery in 1995. "But the safety profile of this procedure, in my medical experience over a long period of time, has been unparalleled."

To be sure, Lasik is one of the world's most popular elective surgeries. About 28.3 million people worldwide have decided to undergo the surgery since the mid-'90s to improve their sight. Lasik doctors said complications from the eye surgery are rare, and a study published in January's American Journal of Ophthalmology showed that the benefits of Lasik can last a decade.

But not everyone sings the praises of Lasik.

Lauranell Burch is one patient who is not happy with the results.

While working at Duke University, Burch received a mailing to employees that touted the benefits of the university's laser eye surgery. A senior medical researcher, Burch did her homework before undergoing the Lasik procedure, which stands for laser-assisted in situ keratomileusis, in March 2004. She read the clinical trials with interest and combed the Internet for details. Still, she said, she didn't get the whole story.

"No one has received full-informed consent for Lasik," Burch said. "If anyone knew what this procedure really does to their eyes, they wouldn't have it."

On Friday, the Food and Drug Administration will hear from patients to learn more about their experiences. After receiving reports of double vision, night blindness, dry eye and halos, the FDA is now preparing a nationwide study with the National Eye Institute, the American Society of Cataract and Refractive Surgery and the American Academy of Opthalmology to measure how the 700,000 patients who undergo Lasik each year in the United States fare after the surgery.

Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said today that the clinical study will help get a large, reliable data set that documents quality of life for Lasik patients. Though the FDA has data from when the laser devices went to market, there is no post-market data on how the people who used them have fared.

The FDA received 140 comments about Lasik dissatisfaction between 1998 and 2006.

"This is not about safety and effectiveness of Lasik surgery at all," said Dr. Kerry Solomon, professor of opthalmology at the Medical University of South Carolina. "This is about trying to take a very safe and very successful procedure and trying to learn as much as we can about trying to make it more successful."

But in Roger Davis' experiences, many people are unhappy because of complications from the surgery. Davis, a researcher with a Ph.D. in clinical psychology, said he often hears from patients who are battling depression and thoughts of suicide after surgery. Davis had Lasik surgery in 1998 and now experiences dry eyes, irregular astigmatism and some ghosting in his right eye.

"Anytime that you have a catastrophic physical injury, you're going to have a period of physical distress," Davis said. "I don't think catastrophic Lasik surgery is any different."

"If you look at the research submitted to the FDA, I'd say the quality of life data wasn't that good," Davis said.

The FDA said it could take as many as three to six months for vision to stabilize after surgery. During that time, the agency noted that people may experience glare and halos, and have a difficult time driving at night. The FDA also outlines the risks associated with Lasik on its Web site.

For good candidates, those with thick enough corneas and healthy eyes, Rubinfeld said the complications are rare. He said he rejects about 10 percent of patients for Lasik on a given day.

Still, patients like Burch said clinical trials failed to inform her that Lasik patients were losing contrast sensitivity, which enables people to distinguish an object from its background.

"I feel like someone threw sand in my eyes every day," said Burch, who now works for a branch of the National Institutes of Health. "My eyes sting and burn."

Shawna Tunnell, a 42-year-old attorney, who had worn glasses since age 4, said her experience proved otherwise. Tunnell recently had Lasik after her colleagues raved about the procedure.

Tunnell said she had "a little discomfort in the eyes" but has otherwise been happy with the results.

"It's amazing to see you without thick glasses or contacts," she said.

In the past 10 years, Rubinfeld and other doctors said Lasik technology has improved. Now surgeons are also more experienced than ever before with the procedure.

"When we look at outcomes of Lasik -- 20/20 rates -- our outcomes of Lasik today are better than they have ever been," South Carolina's Solomon said. "The technology has advanced to the point that there has never been a better time to undergo Lasik eye surgery. Our outcomes are better and these procedures are safer."

ABC News' Radha Chitale contributed to this report.