FDA Approves Corneal Implant for Presbyopia

The FDA today approved a corneal implant designed to improve near vision in certain patients with presbyopia.

The FDA today approved a corneal implant designed to improve near vision in certain patients with presbyopia.

The Kamra inlay, which is the first implantable device for correcting near vision in patients who have not undergone cataract surgery, is an opaque device placed in the cornea of 1 eye, an FDA press release stated.

The inlay is intended for patients aged 45 to 60 years who have trouble seeing close objects or small print and need reading glasses with +1.00 to +2.50 diopters of power, but who do not need assistance with distance vision.

A study of the Kamra inlay demonstrated that 83.5% of 478 patients had 20/40 vision or better at the 1-year mark. The FDA noted that this level of vision is what most patients would need to read text in magazines or newspapers.

The device works by preventing unfocused light rays from entering the eye, so that the patient is better able to see close objects. It blocks peripheral light so that central rays are concentrated through a small opening in the center of the device, which allows the individual to focus better.

Patients interested in obtaining the Kamra inlay would have a pocket created in 1 of their corneas, in which the eye surgeon would place the device.

Patients could potentially experience dry eye, glare, night vision problems, and blurry vision, and the device could cause corneal complications. Those who experience vision problems after surgery may benefit from the removal of the device, while others could have permanent decreased vision.

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