Views 295
Citations 0
News From the Food and Drug Administration
June 2, 2015

New Corneal Implant Approved to Correct Age-Related Vision Problem

Author Affiliations

Copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2015;313(21):2115. doi:10.1001/jama.2015.5643

The first implantable device to correct presbyopia recently received FDA approval.

The KAMRA inlay, implanted in the cornea of 1 eye, is intended for use in people aged 45 to 60 years who need reading glasses with +1.00 to +2.50 diopters of power but do not need glasses or contacts for clear distance vision, according to an FDA statement.

Contraindications include having had cataract surgery, severe dry eye, an active eye infection or inflammation, corneal abnormalities, insufficient corneal thickness to withstand the procedure, a recent or recurring herpes eye infection, uncontrolled glaucoma, uncontrolled diabetes, or active autoimmune or connective tissue disease. The labeling warns that its safety and effectiveness in people who have had LASIK or other refractive procedures isn’t known.

First Page Preview View Large
First page PDF preview
First page PDF preview