WASHINGTON – The American Academy of Ophthalmology today praised the findings of a newly released study that provides further evidence of the dangers of improperly dispensed decorative plano contact lenses. The study, “Over-the-Counter Decorative Contact Lenses: Cosmetic or Medical Devices? A Case Series,” published in Eye & Contact Lens: Science and Clinical Practice, effectively illustrates the need for immediate passage of pending Academy-backed legislation that would require the Food Drug Administration (FDA) to regulate the lenses as medical devices.  

The study presents 12 new case studies involving severe eye injuries caused by misuse of plano decorative contact lenses. All the patients obtained the lenses from vendors without a prescription, proper fitting or proper instructions on the care and use of the lenses. The study also includes findings from a survey of 159 patients, 23 percent of whom used decorative contact lenses. Of the plano lens wearers, 51 percent responded that they obtained the lenses from vendors without a prescription. Dr. Steinemann previously authored an October 2003 case report of six patients treated for complications related to these lenses, which showed similar results. Both studies included patients suffering blinding infections requiring hospital admission, including at least one patient in each who required a corneal transplant.

“Clearly, people seeking decorative lenses are all too often getting them from sources that do not provide the usual regulatory safeguards such as dispensing them with a prescription fit or adequate direction on proper lens care,” said Thomas L. Steinemann, MD, the study’s principal investigator, a member of the American Academy of Ophthalmology and associate professor of ophthalmology at Case Western Reserve University. “The latest study bears out what we already know, whether worn to correct vision or for decorative purposes, the distribution of all contact lenses needs to be regulated as a matter of public health to reduce the risk of serious eye injuries.”

The Academy initiated efforts last year to regulate cosmetic plano contact lenses because of reports of teenagers who developed serious eye problems after using nonprescription cosmetic lenses purchased from flea markets, beauty parlors, gas stations and other unauthorized vendors.

Legislation was again introduced in both the Senate and the House this year that would amend the “Federal Food, Drug, and Cosmetic Act” to provide that all contact lenses shall be deemed to be medical devices. The bill, sponsored by Sens. Mike DeWine, R-Ohio, and Edward Kennedy, D-Mass., passed the Senate on July 29.  A companion bill (H.R. 371), sponsored by Reps. John Boozman, R-Ark., and Henry Waxman, D-Calif, is awaiting House consideration.

“This study is further proof that something must be done to improve the safety of over-the-counter, non-prescription contact lenses,” said Sen. DeWine. “All too often decorative, non-corrective contact lenses when not used correctly, have grave consequences. These are senseless injuries and that is exactly why I sponsored a bill to begin federal regulation of decorative contacts. I hope my colleagues in the House will see the importance of this legislation and will join the Senate in an attempt to prevent needless eye complications.”

“We are pleased to recognize the tireless work of Dr. Steinemann on this important issue. He has seen first hand the harm that can be caused by unregulated lenses and knows how critical the plano lens legislation is,” said Catherine Cohen, Academy vice president for governmental affairs. “His latest study should provide the House with ample reason to move quickly to pass the bill and send it to the President for his signature.”