CONTACT LENSES TODAY

February 1, 2004

Contact Lenses Today® is edited by Dr. Joseph T. Barr and the staff of Contact Lens Spectrum. This week CLToday® reaches nearly 10,000 readers in 74 countries.

Fairness to Contact Lens Consumer Act Takes Effect Soon
According to the American Optometric Association (AOA), the new federal Fairness to Contact Lens Consumers Act (FCLCA) is similar to the mandatory prescription release rules for eyeglasses. The AOA has developed sample patient materials and a sample contact lens prescription release form, but note that some state laws specify the information that you should include in a prescription, so verify the requirements of your state. Also, once the final FTC rule is implemented, the AOA says it will publish a comprehensive compliance and practice management program. AOA members can download relevant forms and get further practice information in a member-only Web site area at http://www.aoanet.org/eweb/DynamicPage.aspx?site=AOAstage&WebCode=HTFCLCA. The AOA also recommends that optometrists forward or fax any incidents or examples of sellers failing to verify a contact lens prescription in accordance with the new law to Jeff Mays at the AOA (jgmays@aoa.org or fax 703-739-9497), as such reports will serve as critical information to bring to the Federal Trade Commission's attention as the rulemaking process continues.

Luxottica and Cole National to Merge
Eyewear company Luxottica has agreed to buy Cole National Corp. for $401 million in cash. This news answers the question of what mystery company had offered a $19.65-per-share bid for the company several months ago. The deal will reportedly merge the two U.S. optical retail chains. According to Luxottica, the Cole acquisition will only have a marginal impact on its 2004 net earnings.

Rat Studies Show that Eye Drops Block Diabetic Cataracts
High doses of verapamil (Calan, Isoptin; an antihypertensive, antianginal and antiarrhythmic) administered orally or by subcutaneous injection were previously shown to prevent diabetic cataracts in rats, but these forms of administration led to unacceptable side effects. Therefore, researchers tested the effects of verapamil eye drops t.i.d. on the progression of diabetic lens opacities in rats. In the January issue of the British Journal of Ophthalmology, the researchers reported that severe opacities in the central region of lenses developed in 17% of untreated rats compared with only 4% of verapamil-treated rats. Not only did the verapamil prevent severe cataract, but it also reduced the density of cataracts that did form. The researchers admit that further investigations are necessary in understanding the exact mechanism of action for the eye drops.

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Alcon Files NDA for Glaucoma Drug
The FDA has accepted Alcon's filing of a new drug application (NDA) for a new eye medication (Travoprost 0.004% + Timolol 0.5% Fixed Combination [TTFC]) to treat glaucoma. The company presented preliminary data from Phase III clinical trials showing that TTFC reduced IOP by up to 12mmHg. According to Alcon, the results of the Phase III trials confirmed that TTFC was safe and well tolerated in the patients who participated in the trials.

Euclid Receives Approvable Letter from FDA
After first beginning a study on overnight orthokeratology a couple of years ago, Euclid Systems Corporation has received an approvable letter from the FDA approving the company's PMA application for its Euclid Systems Orthokeratology Contact Lens for Overnight Wear. Euclid and the FDA are communicating final changes regarding labeling, but the company expects final approval in the near future.

1-800 Contacts Hits Milestone
1-800 Contacts, Inc. recently announced that it has shipped its ten millionth order. "Filling our ten millionth order this year is just the beginning for us as numerous exciting changes are taking place in the contact lens industry," said Jonathan Coon, 1-800 president and CEO.

Abstract: Wearing GP Scleral Lenses Overnight Induces Swelling
To better understand the hypoxic effect of extended GP scleral contact lens wear, investigators measured the corneal swelling after overnight wear of a GP scleral contact lens in four normal subjects who wore a GP scleral lens overnight in one eye on four occasions. The researchers performed optical pachymetry and used specular microscopy to estimate endothelial cell density. They found that overnight wear of scleral contact lenses induced a variable amount of corneal swelling among subjects from 5% to 18%, which correlated strongly with endothelial cell density. The investigators concluded that overnight wear of GP scleral lenses, when compared to daytime wear, caused an increased degree of corneal swelling, which shouldn't rule out overnight therapeutic scleral contact lens wear if the disease process is deemed more damaging than the hypoxic effect of a GP scleral lens worn overnight. They did note that when used for refractive correction, GP scleral lenses shouldn't be left in overnight.
Smith GT, Mireskandari K, Pullum KW. Corneal Swelling with Overnight Wear of Scleral Contact Lenses. Cornea 2004 Jan;23(1):29-34.

Editor's Commentary: Get Ready for CL Rx Release
Here are some tips for preparing to release contact lens prescriptions:

Use the patient's DOB as well as his name.
Put your office hours on the prescription along with your phone and fax numbers, name and address.
Include the exam, Rx issue, expiration and don't fill after the date on the form.
Besides the complete lens Rx, put the quantity, wearing schedule, care schedule and a place for no substitutions. Have a place for your signature and license number.
A disclaimer such as, "Wear of these medical devices requires ongoing care. If you experience blurred vision, discomfort or eye redness, remove your lens and call our office immediately or contact a nearby eyecare professional."

Remember, for optimal care, when you're asked to fill a prescription by another supplier, it may be a good time to call the patient regarding the need for an examination.

Fitting Tip: When It's Time to Replace Lenses
At the time of a GP continuous wear patient's annual examination, carefully inspect the condition of the lenses, especially with your radiuscope. You can use the real image to assess any buildup of mucus or protein that may have occurred during the year of continuous wear. Buildup, scratches, cracks or chips, lens warpage or any other findings at the annual exam that you can't cure with a simple polishing indicates that a replacement contact lens may be necessary.
--Robert D. Buffington, O.D.
Sacramento, Calif.

Mark Your Calendars for GOS
(July 22-25, 2004 Toronto, Canada)
At this year's Global Orthokeratology Symposium (GOS), a full-day, stand-alone session, "Fundamentals of Contact Lens Corneal Reshaping" has been added and requires an additional registration fee. In addition, simultaneous language translation services will be available in German, French, Mandarin Chinese and Japanese for all general sessions for our international attendees. http://www.gos2004.com

Report adverse contact lens reactions here:
http://www.accessdata.fda.gov/scripts/medwatch/ or call (800) FDA-1088.

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