Have good distance vision, but struggle to see what’s right in front of you?
A tiny new device implanted in the eye, which received approval from the Food and Drug Administration in April, could potentially offer millions of Americans a first-of-its kind surgical fix for presbyopia, the farsightedness that commonly occurs in middle or old age.
The miniscule, round KAMRA inlay, developed by California-based AcuFocus Inc., is inserted through a laser procedure that creates a pocket in the cornea. It’s placed in one eye — not both — to restore near vision, used for reading a book or looking at information on a smart phone.
Considered a cosmetic procedure like LASIK, which corrects deficits in distance vision, it’s not covered by insurance, and cost is expected to hamper many from undergoing the procedure.
Parameters recommended for using the FDA-approved device — such as in patients ages 45 to 60 who do not need glasses or contacts for distance vision, and who haven’t had procedures such as LASIK or cataract surgery — further narrow the field of potential candidates.
Still, with presbyopia affecting a billion people worldwide, and the device having been implanted internationally for about five years, many, like Dr. Phillip Hoopes, Jr., medical director of Hoopes Vision in Salt Lake City, see great promise in the new technology.
Hoopes was the first ophthalmologist to implant the KAMRA inlay commercially in the U.S., when he performed the laser procedure May 19. He also participated in research by the device maker to receive FDA approval, and — excited about the technology’s prospects from early on — he purchased shares in the company.
“At Hoopes Vision, we’ve had the opportunity to perform this procedure probably on 40 patients to date,” he says. He’s done about 20 of the procedures, and his father, ophthalmologist Dr. Phillips Hoopes, Sr., the practice’s owner and CEO, along with the practice’s third ophthalmologist, Dr. Michael Bradley, have completed the remainder.
“The reason that we’re excited about this technology, the reason that we’re early adopters [of] this technology, is this is a truly novel procedure in the world of eye surgery, something we haven’t seen ever,” says Hoopes Jr.
“[The device allows] people to keep their distance vision and improve the depth of focus out of the eye that has KAMRA,” he continues.
In the very early going, the cost of having the device implanted ranges from about $3,500 to $6,000 nationwide, Hoopes says. AcuFocus CEO Jim Mazzo similarly estimates the average cost of the procedure to implant the KAMRA inlay at about $4,000 to $6,000 for now, though he doesn’t expect pricing to deviate much from that in the years to come.
Hoopes charges $3,800, noting that pricing varies mainly by the market in which a patient has the procedure done.
Through December, AcuFocus plans to partner with 100 ophthalmology practices, training eye doctors with experience in refractive and cataract surgery as part of a deliberately slow rollout of the technology by the company to exercise caution and ideally, to improve overall outcomes. “You really have to, when you have first-of-its-kind [technology], walk before you run,” Mazzo says.
“Then next year we’re planning to add another 200 on top of that — it might be a little more based on how the first 100 go — and then scale up from there,” he says.
The company is specifically targeting markets that skew toward their target age group, to hone in on larger concentrations of patients suffering presbyopia; these include markets in and around Los Angeles, Miami, Chicago and Boston. It’s listing practices providing the procedure at kamra.com.
After reviewing research conducted by the device’s maker, the FDA found that 83.5 percent of more than 400 patients studied achieved near vision of 20/40 or better, without glasses or other visual correction, 12 months after having the KAMRA inlay implanted. That’s the level needed to read magazines and newspapers, according to the agency.
However, the FDA also noted the KAMRA inlay may cause or worsen dry eye. “Other risks include vision and eye symptoms (such as problems with glare, halos, night vision, blurry vision, dryness, color disturbances, distortion, double vision, ghosting and pain/burning); decreased contrast sensitivity; [and] decrease in the ability of your visual system to distinguish between an object and its background, which is most noticeable in low-light situations, like when driving a car down a dimly lit road at night,” the agency said in an email response.
“In some cases, after receiving the KAMRA inlay, patients may still require glasses or contact lenses for some activities, such as reading small print or reading in dim lighting,” according to the FDA.
In addition, it’s unknown how safe or effective the device is in eyes already altered by LASIK and other refractive procedures, the agency says — a reason it did not recommend the KAMRA inlay for these patients.
Still, given that millions have undergone LASIK, cataract surgery and other procedures, eye surgeons are expected to look closely at this off-label use for the KAMRA inlay in the future.
“For our initial series, we have followed the FDA recommendation and the FDA guidelines to implant it in people between the ages of 45 and 60, people who have never had eye surgery,” Hoopes says. “But as we gain experience, this will be a lens that can used in multiple situations. So, yes, we do plan to use it in people who have had prior LASIK surgery, and even patients who have had prior cataract surgery, as long as the eye is healthy.”
He adds that there’s an entire generation of patients, himself included, who have had LASIK and enjoyed freedom from glasses, but are now facing problems with near vision. “This is a generation of patients that was already willing to undergo eye surgery once to improve their vision, and I think they’re certainly going to be excited to undergo the surgery, knowing that it could improve near vision so that they don’t have to rely on reading glasses,” Hoopes says.
He acknowledges the potential for additional risks — including dry eye — and the unknowns for this group, however. Hoopes says additional precautions would need to be taken when evaluating these patients, including those who have previously had cataract surgery. “You want to make sure that they don’t have any additional health issues to their eyes, such glaucoma, such as macular degeneration,” he says
But, he adds, there’s international precedent for implanting a KAMRA inlay after a previous eye surgery, and he plans to look at that option in the future. “As long as they have a healthy eye, and as long as they have had good distance vision following their cataract surgery, they should be able to consider the KAMRA inlay,” Hoopes says.
Nicholas Tarantino, the chief clinical and regulatory officer who heads up research and development for AcuFocus, emphasizes that the company is not promoting the procedure for off-label uses. “It is AcuFocus’s policy to only promote the KAMRA inlay in accordance with our FDA-approved labeling within the United States,” he says.
Dr. Mark Blecher, co-director of Cataract and Primary Eye Care at Wills Eye Hospital in Philadelphia, says the practice is evaluating whether it will offer the KAMRA inlay to patients in the future.
Blecher sees advantages, including the fact that the procedure only needs to be done in one eye and that it uses the same type of laser, a femtosecond laser, used for LASIK. “So there’s not going to be a huge learning curve for that,” he says.
He adds that in addition to near vision, helpful for reading written words on a page, research shows the device improves intermediate vision, used for looking a cell phones, computers and tablets. “So it’s nice that this particular device doesn’t just give you a specific reading distance, it gives you a wide range of distances,” he says.
However, he says there are patients whose vision can’t easily be returned to close to 20/20 using the device, which is another limitation. “Patients with irregular corneas or severe dry eye — those are patients would not be well-served by having this,” he says.
For patients who experience vision issues after a procedure to implant a KAMRA inlay, the FDA notes that the device can be removed, though the agency adds that in some cases, decreased vision could become permanent.
Blecher reiterates that FDA parameters further limit those considered optimal candidates. However, like Hoopes, he expects surgeons to look at patients who have had LASIK for KAMRA inlay procedures down the road.
“There’s nothing about the inlay that really should not work well for those patients,” he says. “It’s just the FDA did not evaluate the inlay in those groups.”
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Newly Approved Corneal Implant Corrects Near Vision Loss originally appeared on usnews.com
