by Sheila O’Hearn
Health Canada, the Centre for Contact Lens Research, the Canadian College of Optometrists, and many other health-care organizations and practitioners can claim a small but recent victory in their efforts to include non-corrective with corrective contact lenses as medical devices, through Bill C-313, an Act to amend the Food and Drugs Act.
Over-the-counter on online dispensing of cosmetic contact lenses, including circle lenses, have led to a variety of eye diseases among its wearers. Because the product only alters the appearance of the eye, it was not considered a medical device in Canada and, therefore, not subject to the same level of regulatory safety management and quality control. The long-anticipated passing of the Bill will end this discrepancy, and the time is drawing closer. Passing its third successful reading at the Federal House of Commons, the Bill’s first reading in the Senate took place at the end of May, with an expected second Senate reading scheduled for mid-June.
“However, I am not sure it can clear all the required hurdles before the Senate recesses for the summer at the end of June,” warns Dana Cooper, Director of Government Relations with the Canadian Association of Optometrists. “If not, we expect it to complete its journey when the Senate and House reconvene in September. Once it does receive royal ascent, (the Bill) does not come into effect until Health Canada has drawn up the accompanying regulations.”
Trendy, especially among teens and club-venue goers, the notorious circle lenses are coloured contacts designed to make the eyes look bigger by covering the iris and even part of the eye-whites. Asia is known as one of the largest exporters of the lenses, widely available online. The price is an affordable $20 to 30 dollars a pair, and fiercely competitive sales make the product even more attractive for unsuspecting teens to buy.
In an article by Health Canada, Associate Professor Dr. Bariah Mohd Ali says that eye practitioners are seeing more cases of teenagers with keratis related to the accessory. “Wrongly fit contact lenses can easily cause corneal oedema and infections that lead to blindness.” Combine this with questionable soft lens materials that are porous and can admit bacteria, the unsanitary means of dispensing the lenses, lack of instructions on how to clean and care for them—and that wacky, wild fashion statement suddenly becomes a “prescription” for eye diseases and even blindness.
Regulated eye-care professionals have pursued this matter for over 12 years. In 2008, MP Patricia Davidson of Sarnia-Lambton introduced private-member legislation to classify cosmetic contact lenses with corrective contact lenses as class II medical devices. Party support was unanimous, but a called election put an end to its progress. Bill C-313 was introduced into the House of Commons for first reading on October 31, 2011.
Bigger Eyes, Less Sight
Although Lady Gaga has received the bad rap for popularizing circle lenses among her millions of fans, the trend began much earlier in underground subcultures as statements of identity and individuality. Predating Gaga by at least a decade, young Asians embraced the lenses to emulate the wide-eyed appearance of Japanese anime characters.
Unfortunately, self-expression and today’s mainstream fashion trends in Canada that include circle lenses have cost in the form of compromised eyesight. Allergic reactions, lacrimation, tingling, dry eyes and, worst-case scenario, blindness have been added to the list of diseases cited by several leading ophthalmologists.
In a CBC interview (www.ctv.ca/ CTV News/TopStories/2010), Dr. Desmond Fonn, founder of the Centre for Contact Lens Research at the School of Optometry, University of Waterloo, strongly cautioned that cosmetic contact lenses, such as circle lenses, increase the wearer’s risk two to three times of developing serious corneal infections that are impervious to therapeutic drug treatments, and could lead eventually to a corneal transplant.
The Bill is Only a Start
Any unregulated device put in the eye can cause an infection, but, surprisingly, Canada remains one of the only countries, that does not classify novelty lenses as medical devices. The designation, through Bill C-313, means that wearers would require a prescription. “Unfortunately, the public protection that Bill C-313 provides does not go the distance eye-care professionals want to see, regarding non-corrective contact lenses,” Cooper says. “What (the Bill) will accomplish is some control over product distribution.” She adds that, once effective, the new regulation will require all non-corrective contact lenses sold in Canada to be licensed through Health Canada as medical devices. Additionally, distributors of non-corrective contact lenses would require a medical-device-establishment license from Health Canada. The regulations relating to the prescribing and dispensing of all contact lenses would be provincially determined.
Notably, and this is good news for stylish teens and wary parents, cosmetic lenses, including circle lenses, can be worn and safely, simply by going to an eye practitioner and getting fitted out properly and instructed on proper maintenance. Until the Bill in Canada is passed, medical authorities continue to work hard to get the message out to the public.
“Risks can be minimized if your optometrist dispenses your contact lenses based on your contact lens prescription,” a public message from the College of Optometrists of Ontario states. “Improperly fitting contact lenses may cause blurred vision, eye strain, eye pain, headaches or redness and swelling of the eye that can range from mild to severe. The most serious complications include infection and corneal ulcer, which can develop quickly and can lead to irreversible vision loss if not treated appropriately.”
Meanwhile, the Canadian Association of Optometrists and other organizations are generating public awareness. “We proactively communicate with organizations to inform them about the risks associated with the products and ask they discontinue over-the-counter sales of the products,” Cooper says. “Most have been receptive to our requests. The products end up in their stores as a result of distributors who present an opportunity for a unique product to sell. The problem is (little) understanding or awareness of the vision health risks associated with cosmetic contact lenses and the necessity for proper fit and handling.”
Cooper is less optimistic about online sellers of circle lenses and other non-medical contact lenses. “I am not sure any information would dissuade sales or encourage more responsibility for online sellers with websites primarily dedicated to these products.” Nevertheless, some websites might take note from the popular Oriental Grocers that append, “For customer safety all of our contact lens orders require prescriptions before the contacts can be shipped out.” •