FDA approves corneal inlay for presbyopia

The Kamra corneal inlay from AcuFocus is the first FDA-approved implantable device for presbyopia correction in emmetropic patients who have not had cataract surgery.

The Kamra inlay functions similarly to the F-Stop controls on a camera, creating a small-aperture effect that provides an extended depth of focus. Made of polyvinylidene fluoride and nanoparticles of carbon, it's an opaque, ring-shaped device implanted only in the patient’s nondominant eye. A femtosecond laser is used to create a corneal pocket at a depth of 200 µm, in which the inlay is inserted. The device, which can be explanted, has minimal effect on distance image quality but improves intermediate and near vision.

The FDA approval was based on results from a 5-year clinical study of 508 patients who experienced an average improvement in uncorrected near visual acuity of 20/40 or better during a 12-month follow-up. Compared to other presbyopia procedures, mean preoperative uncorrected distance visual acuity in the inlay-implanted eye was maintained during follow-up, according to the company. 

Approved in 50 countries throughout the world, an estimated 20,000 corneal inlays have already been implanted. 

The labeling warns that the device’s safety and effectiveness in patients who have had LASIK or other refractive procedures is unknown. The inlay may cause or worsen dry eye and various vision-related problems, such as glare, halos, night vision problems and blurry vision. It also can cause corneal complications such as swelling, clouding, thinning and potential perforation, and challenges evaluating and managing eye problems.