The Food and Drug Administration (FDA) has approved the KAMRA inlay (AcuFocus Inc.), an opaque, ring-shaped device for corneal implantation in one eye to improve near vision in certain patients with prebyopia. The device is indicated for adults 45–60 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 evaluated the safety and efficacy of the KAMRA inlay by reviewing results of three clinical studies. The results of the main study showed that 83.5% of the evaluable 478 participants achieved uncorrected near visual acuity of 20/40 or better at 12 months.
The device works by blocking unfocused light rays from entering the eye in order to improve near vision. It blocks peripheral light rays while allowing central light rays to pass through a small opening in the center of the device, making near objects and small print less blurry. Insertion of the implant into one eye allows the patient to have improved near vision in that eye without affecting the distance vision of the two eyes working together.
For more information visit FDA.gov.