16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995 #00480

Submission Number:
Sathyasri Narasimhan
Initiative Name:
16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995
As an eye care professional it is my responsibility to ensure that my patients are healthy and happy with their optical correction. Spectacles and contact lenses play a major role in ensuring that patients are able to achieve their full visual potential and are leading a satisfactory lifestyle. The role of spectacles as an essential medical device can well be understood from the following: With regard to vision care, it is well documented that uncorrected refractive error is the most common causes of treatable blindness worldwide. In 2010, it was estimated that 123 million people had significant vision impairment due to uncorrected refractive errors affecting vision. The global economic cost in lost productivity due to avoidable vision impairment alone was estimated to be $269 billion. Visual impairment due to uncorrected refractive error is a major global public health problem. It restricts educational and employment opportunities of otherwise healthy people thereby imposing constraints on social and economic effects on individuals and communities. The duration of the effect is also significant -- due to the earlier age of onset refractive error can account for twice as many blind-person-years compared to cataract. Proper diagnosis and treatment can significantly reduce the number of years the patient will experience vision impairment. Although refractive error is the most common cause of visual impairment globally, it is also the easiest to 'cure'. Spectacles are an extremely cost-effective treatment, providing immediate correction and instant relief from visual impairment. It has been well documented that refractive errors are prone to change throughout life. Significant changes that adversely affect vision can often go unnoticed unless the patient has regular eye exams. Regular comprehensive eye exams has proven to be an effective way to identify people in need of eye care or those at high risk. It also provides excellent access to the population for screening of more serious eye diseases like diabetic retinopathy. For example, Diabetes is the seventh leading cause of death globally. Diabetic retinopathy is the most common cause of vision loss among people with diabetes and is the leading cause of blindness among working-age adults. Although diabetic retinopathy often goes unnoticed until vision loss occurs, early detection, timely treatment, and appropriate follow-up care can protect against vision loss. A contact lens is a foreign object that is placed into the eye. An ill-fitting contact lens can create a toxic environment for the eye. Overwearing contact lenses can lead to lactic acid build-up within the cornea, resulting in swelling. When swelling occurs, the cells in the cornea may spread apart. Bacteria and viruses can more easily enter these potential spaces in the cornea, leading to vision-threatening infection and scarring. Overwearing contact lenses can also lead to oxygen deprivation; new blood vessels will begin to grow into the cornea to compensate for the lack of oxygen. Approximately 6% of CL wearers per year will develop some complication associated with their CL use. A recent study has found that CL complications account for 9.1% of the referrals into urgent care units. The following is an example of some the predisposing factors that can cause problems with CL wear: poor lens care and/or prolonged lens wear including overnight wear, dry eye, blepharitis, atopic or allergic conjunctivitis, giant papillary conjunctivitis, smoking, immunosuppression, ocular trauma or surgery, increasing age and systemic disease. It is extremely vital that patients are routinely checked out every year to make sure that their contact lenses are not causing problems, and that the prescription is accurate for their current needs. Yearly contact lens check is essential to protect vision by maintaining the optimal health of the eyes.