The FDA estimates that about 700,000 people in the U.S. undergo LASIK surgery each year. Nearly 5% of those patients are said to experience some sort of post-operative condition, such as eye pain, blurred or double vision and difficulty driving at night.
In fact, just last week, a federal panel was prompted to seek clearer warnings for LASIK surgery because of a deluge of patient complaints regarding unwanted side affects from a surgery that gives promise to forever shedding glasses and contacts.
Now a market that allows for companies to offer products that counter the potential negative effects of LASIK surgery is rapidly growing.
"It's not always a story of 'Someone did me wrong' when it comes to some of these LASIK errors," Kellie Kaseburg, VP of global marketing at SynergEyes (Carlsbad, California), told Medical Device Daily. "Just like any surgery anything can go wrong. These patients are in a difficult position because the size of the cornea has changed and they can't wear contact lens or glasses."
SynergEyes is offering one such solution in the form of its SynergEyes (PS) post-surgical hybrid contact lens. The lens was approved by the FDA in October 2005 and combines the best attributes of soft contact lenses and rigid gas permeable center lenses, but with none of the lenses' weaknesses.
"We actually bond the two types of lenses together for the hybrid," she said. "This is nothing new — there have been attempts for almost 30 years to do this. But we actually hold the patents that allow this bonding to occur."
The hybrid lens received CE-mark status in early 2006.
"I think the market for these lenses is there now and has always been there," Kaseburg told MDD. "People have been having these surgeries for years and sometimes complications arise. I think SynergEyes has a product that can help [address] some of the problems."
To understand how SynergEyes works, one must first consider what happens during LASIK. The procedure involves a laser that pretty much alters the shape of the cornea, rendering most contact lens and glasses ineffective.
"Soft contact lenses fit the form of the cornea, and using a soft lens on someone who has undergone LASIK is like putting a glove on the cornea ... it just doesn't lead to the correction of the stigmatism," she said. "In rigid gas permeable lenses, the lens would slide off and fall in the altered parts of the cornea. What makes the hybrid so effective is that we're able to design a lens to the specific shape of the [altered] cornea. It's a really amazing product. We design the lens to fit the cornea of the eye."
Typically soft lenses are comfortable, but they can't fully correct a person's stigmatism. Rigid gas permeable center lens offer greater correction but are more discomforting because of its ability to float loosely on the cornea.
This floating allows for debris to easily get underneath the lens, as well as a person to just "blink" it out of the eye entirely at times.
The hybrid is comfortable like a soft contact – by having the soft outside skirt of the soft lens. The center is tinted blue with the appearance of a rigid gas permeable center lens.
To date more than 2,000 eyecare practioners have fitted patients with the hybrid lens.
"There isn't a day that goes by here when we don't have a patient that says 'You gave me my life back,'" she said. "We had a deposition attorney that wasn't a good candidate for LASIK – he wasn't told that, so he went through with the procedure and was unable to see clearly. He couldn't see faces clearly in the courtroom and it was severely affecting his career. And a deposition attorney needs to be able to read the looks on people's faces in a courtroom. With our lens he was able to return to the courtroom and continue with his career. There are stories of success like this that come in all the time."
SynergEyes, a private company, was founded in 2001 and is mostly funded through venture capital firms. The company declined comment on its market capitalization and offers three other lenses with FDA approval that include SynergEyes A, a lens for naturally occurring ametropia, targeting patients with astigmatism, current gas permeable lens wearers and patients demanding optimized vision; the SynergEyes KC for keratoconus and the SynergEyes Multifocal lens for presbyopia.