title: Overview of contact lens postmarket surveillance in the United States:  system and recent study results.
abstract: This is an overview of the US contact lens (CL) postmarket surveillance systems and surveillance study results that include silicone hydrogel CLs. As 30-night continuous wear silicone hydrogel and rigid gas-permeable (RGP) CLs were approved for use in the United States in 2001, the Food and Drug Administration (FDA) mandated large postmarket surveillance studies to assess the risk of microbial keratitis with those products when worn with the 30-night wearing schedule. Since the time of the approvals, RGP 30-night wear has been used sparingly and a shift from 30-night wear has occurred for silicone hydrogel lenses. Several silicone hydrogel lenses have been approved and most of these lenses are being prescribed for daily or flexible wear and not for 30-night wear. With daily wear and less overnight use, silicone hydrogel lenses are regularly exposed to lens care products, lens cases, and improper handling, all of which may introduce sources of microbial contamination that could trigger lens-related complications. This summary of CL postmarket surveillance system and methods gives results of FDA-mandated surveillance and of recent US studies that observed "real-world" populations for safety results outside the bounds of highly controlled prospective clinical trials.
authors.affiliation: Clinical Trial Consultant, Atlanta, GA 30307, USA. Chalmers2097@gmail.com
authors.forename: Robin L
authors.initials: RL
authors.lastname: Chalmers
authors.forename: William
authors.initials: W
authors.lastname: Gleason
mesh_terms: D003261:Contact Lenses / Q000009:adverse effects / Q000592:standards; D006801:Humans; D020100:Hydrogels; D011159:Population Surveillance / Q000379:methods; D011358:Product Surveillance, Postmarketing / Q000379:methods; D012828:Silicones; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D020100:Hydrogels; D012828:Silicones