Topical Review: Contact Lens Eye Health and Safety Considerations in Government Policy Development.

SIGNIFICANCE: As new federal or state policies are introduced in the United States to shape the evolving contact lens market, it has never been more important to amplify the importance of patient health and safety during contact lens wear and promote the value of the eye care professional-patient relationship.Within the United States, contact lenses are regulated by the Food and Drug Administration as class II or III medical devices that require additional regulatory and professional oversight to keep consumers safe. The contact lens market and broader eye health landscape are rapidly changing. Recently, the U.S. Federal Trade Commission finalized its 10-year review of the Contact Lens Rule, implementing new policies that will shape the contact lens market in the United States for years to come. The purpose of this clinical perspective was to compile and review key data regarding contact lens-related adverse events, including their economic impact on the health care system, to inform government policy development. Although contact lenses provide many benefits to the wearer, a variety of complications can occur ranging from asymptomatic events or mild discomfort to severe sight-threatening adverse events such as microbial keratitis. Patients who do not routinely visit their eye care professional or do not receive the lenses prescribed to them are at a greater risk of contact lens-related adverse events. Nearly 1 million people in the United States experience ocular infections or inflammation annually, resulting in significant health care costs. The economic burden of contact lens-related microbial keratitis in the United States has been estimated to be approximately $175 million annually. The importance of eye care professional oversight of contact lens wear cannot be emphasized enough to key stakeholders, including lawmakers, government regulators, contact lens manufacturers and distributors, and the broader eye health community.