CONTACT LENSES TODAY

May 4, 2003

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.

Focus Night & Day Lenses Approved for Therapeutic Use
CIBA Vision recently announced that the FDA has approved its Focus Night & Day contact lenses for therapeutic use. Now, according to the company, U.S. eyecare practitioners can use the lens as a bandage in protecting the cornea and in relieving corneal pain in the treatment of acute or chronic ocular pathologies and after eye surgery. Focus Night & Day lenses are also approved to be worn for up to 30 continuous nights.

Paragon Gets FDA Approval for Presbyopic CRT Study
The FDA has granted approval of Paragon Vision Science's Investigational Device Exemption (IDE) application for clinical study of Corneal Refractive Therapy (CRT) for presbyopia. According to the company, the study will use the principles of the Paragon CRT design and prescribing system to manage presbyopia. The study will start early next month and eventually will include more than 200 patients at 15 U.S. locations.

Future Legislation May Clarify Decorative CL Status
As you may remember, last summer, Congressman Henry Waxman (D-CA) brought to light the issue of cosmetic contact lenses being bought without a valid prescription or proper fitting. Since the FDA recently issued its document entitled "Guidance for FDA Staff on Sampling or Detention Without Physical Examination of Decorative Contact Lenses," Mr. Waxman may be reviewing the notice and possibly considering legislation to clarify the status of these lenses.

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Second GOS to be Held
The second annual Global Orthokeratology Symposium (GOS) in Toronto this August will offer continuing education courses on topics such as clinical outcomes of overnight treatment, topographical changes in corneal reshaping, contact lens myopia management update and managing and marketing the overnight orthokeratology practice. Register online at http://www.boucher1.com/secure/hccggos.asp or call (800) 549-3656 for more information.

AOA to Help Out with CLES
The American Optometric Association (AOA) has agreed to help the Contact Lens Institute (CLI) in producing the second annual Contact Lens & Eyecare Symposium (CLES) for January 2004 at the Disney Coronado Springs Resort in Orlando. The AOA and the CLI will work together with the Contact Lens Society of America and the Contact Lens Association of Ophthalmologists to produce this contact lens-focused educational symposium. For more information on this meeting, visit http://www.cles.info.

CLMA Reports an Increase in Membership
The Contact Lens Manufacturers Association (CLMA) recently reported an impressive growth in membership of more than 20% from 2002. The mission of the CLMA is to increase awareness and utilization of custom manufactured contact lenses. The majority of custom contact lens manufacturers in the United States belong to the CLMA.

Abstract: Drug Uptake and Release in Hydrogels
Using spectrophotometry to evaluate the concentration of ciprofloxacin in saline solution, researchers examined the in vitro uptake and release of the drug from silicone-based hydrogel and conventional pHEMA-based hydrogel contact lenses. They found that the two hydrogel lenses showed similar drug uptake but different levels of drug release. However, they concluded that the differences in ciprofloxacin uptake and release between silicone-based hydrogels and pHEMA-based hydrogels may not be clinically significant because the amount of drug released from all lenses would be above the MIC (90) of ciprofloxacin for common ocular pathogens.
Karlgard, CC; Jones, LW; Moresoli, C. Ciprofloxacin Interaction with Silicone-Based and Conventional Hydrogel Contact Lenses. Eye & Contact Lens 2003 Apr;29(2):83-89.

Editor's Commentary: Plano Decorative Soft Contact Lenses Still Raising Concerns
The FDA seems to be maintaining a consistent view that lenses on the US market that are FDA approved as medical devices available in Rx powers, or are available for cosmetic purposes with plano power -- solely to change the appearance of the eye -- involve risks to the wearer that cannot be sufficiently controlled without the fitting and supervision of an eyecare professional. Manufacturers who try to import lenses and market contact lenses as a cosmetic without the involvement of an eyecare practitioner face seizure and penalties. The same applies to other manufacturers who attempt to market plano contact lenses as cosmetics to be sold OTC. Thus, Mr. Waxman may introduce legislation to ensure that all contact lenses remain medical devices and do not become OTC cosmetics.

Fitting Tip: Checking Pupils
Have you ever had trouble seeing pupil reactions on patients who have dark iris color? It's hard to tell where the pupil ends and the iris begins. Try using one of the old Burton ultraviolet black lamps (usually used to check rigid contact lens fluorescein patterns). By holding the lamp in a dimly lit room in front of the patient's pupils, you'll notice the pupil fluorescing, making it easy to distinguish from the iris margin. Note: The patient must be phakic because it's the crystalline lens that fluoresces. Now just use your penlight or transilluminator in front of the Burton lamp and you'll see how easy it now is to check pupil reactions.
-- Phillip E. Apfel, O.D., Cincinnati, Ohio

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