FDA OKs First Near Vision Fix That Needs No Cataract Surgery

Troy Brown, RN

Disclosures

April 21, 2015

The US Food and Drug Administration (FDA) has approved the first short-distance vision implant for certain patients with presbyopia who have had no cataract surgery, according to a news release from the FDA.

The implant (KAMRA Inlay, AcuFocus, Inc) is "intended for use in patients 45 to 60 years old who, in addition to not having had cataract surgery, are unable to focus clearly on near objects or small print and need reading glasses with +1.00 to +2.50 diopters of power — but do not need glasses or contacts for clear distance vision," the FDA statement explains.

"Presbyopia is a natural part of aging and can make reading and performing close-up work difficult," William H. Maisel, MD, MPH, deputy center director for science in the FDA's Center for Devices and Radiological Health, said in the statement. "The Kamra inlay provides a new option for correcting near vision in certain patients."

Patients usually begin to develop presbyopia at around age 40 years. The new device is a ring-shaped, opaque implant that improves vision in the affected eye but does not 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.

The implant improves short-distance vision by blocking unfocused, peripheral light rays and allows central light rays to pass through a small, 1.6-mm opening, or aperture, in the center of the device.

Initial Concern About Safety, Risk–Benefit Profile

The approval follows a meeting of the FDA's Ophthalmic Devices Advisory Committee on June 9, 2014. At that meeting, the committee largely agreed that the device is effective; was tied on whether the device is safe, requiring a tie-breaking vote; and voted 4 to 3 with one abstention on whether the device's benefits outweigh its risks.

At the July 2014 meeting, the committee discussed results from three clinical studies. The primary study showed that 83.5% of the 478 evaluable participants acquired uncorrected near visual acuity of at least 20/40 at 12 months. This is the vision level required to read the text in most magazines and newspapers.

The implant is not meant for those who have undergone cataract surgery or those with severe dry eye, an ongoing eye infection or inflammation, corneal abnormalities associated with thinning or irregular shape of their eye surface, insufficient corneal thickness to tolerate the procedure, a recent or repeating herpes eye infection or complications resulting from a previous infection, uncontrolled glaucoma, uncontrolled diabetes, or active autoimmune or connective tissue disease, the FDA explains.

In addition, the device's labeling warns that its safety and effectiveness in those with prior LASIK or other refractive procedures is not known.

The inlay may cause or exacerbate dry eye and other vision-related problems, including glare, halos, night vision problems, and blurry vision. It also can cause complications of the cornea including swelling, clouding, thinning and potential perforation, and difficulties evaluating and managing eye problems. Some patients experiencing vision problems after the surgery may experience improved vision after removal of the device. Decreased vision may become permanent in some patients. Focusing power of the eye may also change, causing blurry vision and the need for glasses.

The company has postmarket data from more than 30 countries, including in Europe, where the device is already available. More than 20,000 inlays have been implanted, and of those, 362 have been removed because of customer complaints.

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