The agency says in a news release that the KAMRA implant is meant for people ages 45 to 60 who haven’t had cataract surgery, can’t focus clearly on near objects or small print and need reading glasses, but don’t need glasses or contacts for clear distance vision.
"Presbyopia is a natural part of aging and can make reading and performing close-up work difficult," says William H. Maisel, MD, MPH, deputy center director for science in the FDA's Center for Devices and Radiological Health. The KAMRA offers some people a new option for correcting their near vision, he says.
People usually begin to get presbyopia around age 40.
The new device is a ring-shaped, opaque implant that improves vision in the affected eye, but doesn’t affect the ability of both eyes to work together for distance vision, according to the FDA statement. The KAMRA inlay is implanted with the help of a laser, which forms a pocket in the cornea into which the device is then placed.
Initial Concern About Safety
The approval follows a meeting of the FDA's Ophthalmic Devices Advisory Committee in June 2014. At that meeting, the committee largely agreed the device works. But it was tied on whether the vision implant is safe, requiring a tie-breaking vote. It ended up voting 4 to 3 that the device's benefits outweigh its risks. One member didn't vote.
At the July 2014 meeting, the committee discussed results from three clinical studies. The main study showed that 83.5% of 478 participants gained uncorrected near vision of at least 20/40 within a year. That’s the vision level needed to read the text in most magazines and newspapers.
The FDA says the implant is not meant for people with:
- Severe dry eye
- An ongoing eye infection or inflammation
- A recent or repeating herpes eye infection or complications resulting from a previous infection
- Uncontrolled glaucoma
- Uncontrolled diabetes
- Active autoimmune or connective tissue disease
Also, the device's labeling warns that its safety and effectiveness in people who’ve gotten prior LASIK or other refractive procedures isn’t known.
The inlay may cause or worsen dry eye and other vision-related problems, including glare, halos, night vision problems, and blurry vision. It also can cause complications of the cornea. The focusing power of the eye may change, causing blurry vision and the need for glasses.
In Europe, where the device is already available, more than 20,000 inlays have been implanted. Of those, 362 have been removed because of customer complaints.