In 2001, Tim Steinemann, MD, and his residents treated a 14-year-old girl with a contact-lens related Pseudomonas corneal ulcer. The contact lenses were decorative and were purchased over-the-counter (OTC). Dr. Steinemann and his residents went about telling their story. The AAO worked aggressively with other organizations to oppose new FDA rules that allowed OTC sale of contacts. After vigorous lobbying by all the groups involved, the bill was signed into law in November 2005 and enacted in January 2006.
Just think how many open globes you've seen from fireworks explosions and BB-gun pellets, corneo-scleral lacerations with traumatic cataract due to a nail gun at a construction site, severe hyphemas from paintball injuries, orbital fractures in unrestrained drunk drivers-the list of senseless injuries goes on and on. Our hearts sink when we see these (often young) patients, and we can become angry and frustrated at the extent of the injury. However, we find a way to stay focused, trying to salvage the patient's vision.
In 2001, Tim Steinemann, MD, associate professor at Case Western Reserve University School of Medicine, Cleveland, and his residents treated a 14-year-old girl with a contact-lens related Pseudomonas corneal ulcer. After fortified antibiotics and a 4-day inpatient admission, the infection was controlled, leaving the patient with a severe scar (later requiring a corneal transplant). One resident was curious and elicited an interesting history-the contact lenses were decorative and were purchased over the counter, at a video store. No contact lens fitting; no instructions on hygiene. The residents pushed further: could the patient's mother return to the video store, purchase another pair, and save the receipt?
Dr. Gail Royal, an ophthalmologist in Myrtle Beach, SC, was having a similar experience. In the course of 1 to 2 weeks, she came across 12 cases of corneal abrasions as well as ulcers in children who had purchased plano contact lenses on the local boardwalk. She reported these cases to the AAO-Washington, DC, office, which began looking into the issue.
Politicians in alternate reality?
At about the same time (in what must have been an alternate reality), political appointees at the FDA were considering deregulation of decorative contact lenses. In August 2001, a lawyer named Daniel Troy was appointed to the FDA by the Bush Administration. Troy seemed to dislike government oversight of industry. In fact, he believed that the U.S. Constitution did not give Congress the power to regulate manufacturers, an interpretation that would virtually abolish the FDA.