Corneal Implants Might Make Reading Glasses Obsolete
For Lori Bandt, who works as a medical technician and an EMT in a suburb of Madison, Wis., the print on vials of medication has become so difficult to read that if she forgets her reading glasses she has to resort to having a younger EMT worker read the directions. The 45-year-old says: "I'm just stuck."
And she's hardly alone: 1 in 5 Americans needs reading glasses or bifocals because of presbyopia. With age, the formerly pliable lens of the eye starts to harden. That makes it harder for muscles to squeeze the lens to focus on nearby objects.
But eye doctors are trying to come up with options for people like Bandt. Her doctor, Dr. John Vukich, is one of them. The corneal inlay, called KAMRA, is a flexible doughnut-shaped ring that is surgically inserted into the eye and creates a sort of artificial pupil. He is working as a consultant to the company marketing the implant.
The surgical procedure uses a laser to make a small incision in the very front of the cornea, where the ring is placed. The results with a corneal inlay are "immediate," says Vukich, restoring near vision right away. And there isn't much down time for patients. He says the procedure is far less complicated and invasive than LASIK.
The KAMRA corneal inlay has been used in Europe since 2011, and is also being used in South America and Asia.
But members of an FDA advisory panel have raised concerns about the safety of the device. At the committee's meeting in June, the company presented data from a 36-month trial that found that 83 percent of the 478 patients enrolled achieved visual acuity of at least 20/40 or better.
However, that did not include 44 patients who dropped out of the study and had the corneal inlays removed. Most of those patients, 86.4 percent, said the device didn't improve their vision like they expected.
Had the patients been included, the device's efficacy rate would have dropped to 75.8 percent. Officials also noted that even after removal of the inlay, some patients still had hazy vision or fluid buildup in the cornea.
The FDA advisory panel determined that the device was effective, voting 7 to 1 in favor. But when it came to safety, it voted 4 to 5 against the inlay. The FDA hasn't decided whether it will approve KAMRA, but it often follows the advice of its advisory committees.
The fact that some patients had vision problems after the inlays were removed is a problem, says Dr. Anne Sumers, an ophthalmologist and spokesperson for the American Academy of Ophthalmology. "This is the windshield of the eye, and the windshield of the eye needs to be crystal clear like your car windshield," she says. "If there's haze or fluid in it, it's not crystal clear."
Even so, the technology has great potential, says Sumers, and might prove a reasonable option for aging boomers in the near future.
STEVE INSKEEP, HOST:
Researchers are working on technology that could make reading glasses obsolete. NPR's Patti Neighmond reports.
PATTI NEIGHMOND, BYLINE: Like many people in their mid-40s, Lori Bandt has trouble reading the small print. Bandt works as a medical tech and EMT in the suburb of Madison, Wisconsin.
LORI BANDT: We have little vials of medication, and the print on the vials is very small. So if I don't have my readers on, it's - I have to have one of the younger EMTs read it for me.
NEIGHMOND: It's just inevitable, says Bandt's doctor, ophthalmologist and eye surgeon Dr. John Vukich. If you're over the age of 40, he says, you'll be needing reading glasses sometime soon if you don't already have them.
JOHN VUKICH: It's sort of like getting gray hair or wrinkles. Eventually we all get them.
NEIGHMOND: Most children and young adults don't have up-close vision problems because the lens of their eye is pliable and automatically adjusts when they shift their gaze from, say, watching something in the distance to their computer screen.
VUKICH: As we mature, the lens becomes harder and, as a gradual process, loses that ability to change its shape.
NEIGHMOND: So the classic remedy is magnification, either bifocals or reading glasses. But Vukich is working on a new device that could take the place of reading glasses. It's a tiny, thin, flexible doughnut-shaped ring that's surgically inserted into the eye.
VUKICH: It essentially gives us an artificial pupil, if you will - a static size of 1.6 millimeters. So we can see up-close. We can see at distance, just like those photographs where things in the near foreground are in focus and distance are at focus as well.
NEIGHMOND: The device readjusts the way light travels into the eye through this tinier opening. Vukich says the idea builds on a centuries-old principle.
VUKICH: The fact that a small aperture or a small opening will clear an out-of-focus image has been known since 500 B.C. And it was described by Leonardo da Vinci in the year 1500 in his codex. This is something that we've known about for very long time.
NEIGHMOND: Vukich is a consultant with a company that's developing this artificial pupil. The Food and Drug Administration is now reviewing it and two similar devices, evaluating them for safety and effectiveness. Dr. Anne Sumers is an ophthalmologist and spokesperson for the American Academy of Ophthalmology.
ANNE SUMERS: They want to make sure that any device that we use doesn't harm the patient and it does what it says it's going to do and it works for the patients that it's intended for.
NEIGHMOND: And in fact, FDA officials have raised some concerns about safety. A recent study by the company found the device to be very effective, but a small number of patients experienced worrisome side effects - haziness, blurred vision and difficulty seeing in certain light. About 8 percent dropped out of the study and had the device removed. Even after removal, some patients still had hazy vision or fluid buildup in the cornea.
SUMERS: And that is the windshield of the eye, and the windshield of the eye needs to be crystal-clear, like your car windshield. And so if there's haze or fluid in it, it's not crystal clear.
NEIGHMOND: Researcher Vukich says the hazy vision ultimately went away for these patients. The FDA won't comment on devices under evaluation. Vukich is hoping the device will be approved within the year, but even if it's not, ophthalmologist Anne Sumers says it's an exciting time for aging baby boomers. The technology is nearly ready, and therefore, so is the prospect of someday choosing a tiny eye implant over bifocals or reading glasses. Patti Neighmond, NPR News. Transcript provided by NPR, Copyright NPR.