FDA Warnings Aside, More Eligible for LASIK

Eye surgery is possible for more patients but FDA warns doctors to explain risks

/ Author:  / Reviewed by: Joseph V. Madia, MD

In December, the FDA sent letters to some LASIK providers for failing to provide details about the risks of surgery. Overall, however, the procedure is considered safe and more patients than ever can be treated.

At the end of last year, the US Food and Drug Administration (FDA) warned five eye care providers to stop misleading advertising and promotion of lasers used in LASIK corrective eye surgery.

LASIK surgeons like Richard A. Norden, MD, at Norden Laser Eye Associates in Ridgewood, New Jersey, agree with the FDA that patients need to know about the risks and benefits of LASIK before agreeing to surgery.

Dr. Norden also stresses that advances in technology have made the eye surgery safer and available to more patients who would otherwise need contacts or eyeglasses.

"Know possible risks and side effects before getting LASIK surgery."

Steve Silverman, compliance director at FDA’s Center for Devices and Radiological Health, said, “Advertising by many eye care professionals who perform laser vision correction surgery provides patients with the risk information that they need to make informed decisions.”

He advised providers who do not offer adequate risk information that the FDA is serious about consumer protection.

Knowing the Risks

The most common risks of LASIK vision correction surgery with refractive lasers include:

  • dry eye syndrome, which can be severe
  • the possible need for glasses or contact lenses after surgery
  • visual symptoms including halos, glare, starbursts and double vision, which can be debilitating
  • loss of vision

The FDA reminded consumers that eye surgery such as LASIK is irreversible, that not all patients will achieve optimal results, and that some patients may need additional procedures. The Federal Trade Commission says that in rare cases, errors during surgery (like the malfunctioning of the laser device) or complications after surgery (for example, inflammation) may cause irreversible damage to the eye, including permanent blindness.

Knowing the risks, possible consequences, and alternatives is essential before undergoing surgery, according to Dr. Norden. When a patient gives permission to have an operation, after gaining full knowledge of the procedure, it is called informed consent.

“Informed consent is a process; it’s a conversation,” said Dr. Norden. “I see every patient, and I go through potential serious risks. Informed consent is not just looking at one piece of literature or an ad.”

Dr. Norden emphasized that LASIK procedures have a strong track record for safety. According to the Eye Surgery Education Council, LASIK vision correction has the highest patient satisfaction rate of any elective surgery: 95.4 percent, according to a 10-year survey of scientific studies from around the world. The majority of patients enjoy 20/20 vision or better after laser vision correction. About 700,000 LASIK procedures are performed annually.

LASIK Basics

LASIK, or laser-assisted in situ keratomileusis, is a surgical procedure using an excimer laser to permanently change the shape of the cornea. The cornea is the clear covering of the front of the eye and it contributes most of the eye’s focusing power.

Surgeons use a mechanical microkeratome (a blade device) or a laser keratome (a laser device) to alter the cornea. The procedure is relatively quick with patients being in the laser room for a total of about 10 minutes. Minus prep time and putting info into the laser, the amount of time actually spent on each eye can be about a minute and a half.

LASIK is a relatively new technology. The first laser was approved for LASIK eye surgery in 1998, according to the FDA. Therefore, the long-term safety and effectiveness of LASIK surgery is not known.

A 2009 Consumer Reports Health Ratings Center survey of 793 US adults who had the surgery over the previous eight years found that costs per eye vary widely. The typical national price (per eye) for laser vision surgery was $1,657. About 7 percent of the consumers said they paid less than $499 per eye; 12 percent paid between $2,500 and $3,999 per eye; and 4 percent shelled out $4,000 or more per eye.

Major Misconceptions

Dr. Norden said that the biggest misconception is that LASIK is only for distance vision. The fact is it can be performed for reading vision as well.

“Most people think the surgery is strictly to replace contact lenses or a distance pair of glasses,” he said. “We have been doing this LASIK monovision procedure for over 18 years.”

With monovision, one eye is adjusted for distance (if needed) and the other eye is adjusted for near vision.

“Monovision is basically a blended vision and it’s extremely effective,” said Dr. Norden. “The only way you notice it is if you cover one eye and go back and forth. The brain filters the blurry portions out from the other eye and it fuses into one sharp image between the two.”

Many patients also have a fear that they will move their eyes or head and ruin the surgery. “Technology has evolved to a point where the patient can’t mess this up,” said Dr. Norden.

The patient’s head is held in place by a firm rubber pillow. The eye is held open by a metal eyelid holder. The laser has a 3-D tracker that locks to patient’s cornea. If the patient’s eye makes little movements during lasering, the laser beam moves with the cornea.

“If the patient should happen to look at a clock on the wall—the moment the eyeball comes off the capture position, the laser shuts off,” said Dr. Norden. “It doesn’t start back up until they come back to the original capture position.”

More Qualify Than Ever

Advances in eye surgery have made it possible for more people than ever to get this surgery. Dr. Norden estimates that 98 percent of patients who wear contacts or glasses are eligible for LASIK.

Traditionally, people with the degenerative eye disorder keratoconus could not have the operation. In the last few years, however, treatment of keratoconus has changed to strengthen the collagen, which helps the eye maintain its structure.

“Now a lot of people get the keratoconus fixed and have LASIK afterwards,” said Dr. Norden.

He also believes that those with thin corneas may be suitable for LASIK surgery. In a study presented last year at the American Society of Cataract Refractive Surgery meeting in Chicago, Dr. Norden followed the progress of 159 eyes with thin corneas that had been treated with LASIK. He found that none had any adverse effects after about 10 years.

“The overall message is to understand that most patients will see better after LASIK than they did with their contact lenses or glasses,” said Dr. Norden. “It’s an incredibly safe procedure and it’s safer than contact lens wear (which can cause infection). It’s pain free and recovery is rapid. Patients typically go off to work the next day.”

Review Date: 
January 20, 2013