CONTACT LENSES TODAY

November 7, 2004

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

FDA Warns of Possible Dangers from Decorative CL Wear
With the Halloween season in mind, the FDA issued consumer warnings about the risks of using decorative contact lenses distributed without appropriate involvement by an eyecare professional. The FDA claims it has received reports of corneal ulcers associated with the wearing of decorative contact lenses. Other risks include conjunctivitis, corneal edema, allergic reaction and corneal abrasion caused by poor lens fit. This kind of unsupervised lens wear can also lead to reduction in visual acuity, contrast sensitivity and other visual functions. "Consumers should understand that decorative contact lenses, like contact lenses intended for correcting vision, present serious risks to eye health if they are distributed without the appropriate involvement of a qualified eyecare professional," warned Dr. Lester M. Crawford, acting FDA commissioner. This warning applies not only to the Halloween season, but to all times of the year. Go to the links below to report any complications you've encountered.

CLMA Presents Awards
The Contact Lens Manufacturers Association (CLMA) presented the following awards at its 43rd Annual Meeting and International Exposition last month:
·Creative Design and Process Award Nick Siviglia, PhD, of Lancaster Contact Lens, Inc. for Innovation in Lens Design and Manufacturing Process to the Enhancement of the Contact Lens Industry
·Trailblazers Award Mr. Joe Sicari of Paragon Vision Sciences for Outstanding Achievement in Product Development to the Enhancement of the Contact Lens Industry.
·Industry Enhancement Award Joseph T. Barr, OD, MS, of Ohio State University College of Optometry for Unselfish Dedication to the CLMA and the Contact Lens Industry.
·Honorary Recognition Award Kyoichi Tanaka, chairman of Menicon Company Ltd. of Japan in Appreciation for a Lifetime of Dedication and Service to the Contact Lens Industry.
·Leonardo da Vinci Award David T. Rusch of Firestone Optics, Inc. for Vision in Establishing and Focus of the CLMA and Unflagging Dedication to the Achievement of its Goals.
·GP Lens Practitioner of the Year Cornel LeBlanc, OD, of LeBlanc Eye Center in Alexandria, Louisiana for Outstanding Professional Expertise in Fitting GP Contact Lenses to the Benefit of the Contact Lens Industry and Corneal Health.

Canadian Government to Toughen Requirements for Corneal Reshaping CLs
Only one company (Paragon Vision Sciences) has applied and has been licensed to sell orthokeratology lenses in Canada, but according to a recent Canadian Press NewsWire article, at least five other brands appear to be available. Also recently, Canadian government officials have decided to ask to see safety and efficacy information if contact lenses are to be used for overnight vision correction with orthokeratology. Therefore, Health Canada is investigating whether the importers or manufacturers of the other five lens brands are marketing them to correct vision overnight. If Health Canada finds the companies in violation of the regulations, it can force the company to comply, order an immediate halt to sales and issue a recall.

ACUVUE^® ADVANCE^™ launches Nationwide "Comfort Challenge" driving patients into practices.
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Inspire to Fund Glaucoma Product
Inspire Pharmaceuticals, Inc. has entered into an agreement to license exclusively several patents from the Wisconsin Alumni Research Foundation (WARF) for use in developing and commercializing new therapeutics for treating glaucoma. Under the agreement, Inspire will undertake the development of products that are covered by the licensed patents. As a result, Inspire will fund all further research, development, testing, regulatory filings and potential marketing activities related to any product developed from this license. Inspire will pay WARF potential milestone payments during the development process.

CIBA Announces New Packaging; Survey Points to Interest in Overnight Lens Wear
In a March 2004 CIBA Vision consumer study of 196 soft contact lens wearers, 84% of wearers said that they nap in their lenses and more than one-third said that they do so frequently or all of the time. When consumers in the same study were asked which wearing schedule they would prefer if their eyecare professional assured them it was safe, 73% indicated that they prefer a wearing schedule that includes overnight wear at least occasionally.

Study Using Stem Cells Raises Hope for Retinal Tissue
Scientists at the University of Toronto conducted a study (the details of which they published in a recent issue of Proceedings of the National Academy of Sciences) in which they implanted human retinal stem cells into the eyes of chicks and mice. The cells then developed into light-sensing photoreceptor cells and retinal pigment epithelial (RPE) cells. According to one of the researchers involved in the study, the next step is to transplant retinal stem cells from healthy mice into mice that have diseased eyes to see if the stem cells develop into photoreceptor and RPE cells. The research may some day help scientists develop treatments for degenerative eye diseases such as macular degeneration and retinitis pigmentosa.

Abstract: Recovery Rates After Ortho-k
After investigating refractive and corneal topographic recovery after the use of reverse-geometry contact lenses for overnight orthokeratology, researchers found that low myopes achieved full effect of overnight orthokeratology within one week of initiating use of reverse-geometry lenses. The also concluded that recovery after short-term use of reverse-geometry lenses is rapid for corneal thickness and corneal curvature and that refractive correction and binocular uncorrected visual acuity recovered fully after two weeks. The researchers reported that monocular uncorrected visual acuity was the slowest to recover and hadn't achieved full recovery after two weeks. They reached these conclusions after fitting 15 subjects with reverse-geometry contact lenses, which they wore for one month. Ten subjects completed the investigation, during which researchers measured uncorrected visual acuity, refractive correction (sphere and spherical equivalent), corneal curvature and corneal thickness.
Soni PS, Nguyen TT, Bonanno JA. Overnight Orthokeratology: Refractive and Corneal Recovery After Discontinuation of Reverse-Geometry Lenses. Eye & Contact Lens 2004 Oct;30(4):254-262

Editor's Commentary: Good Move by FDA on Decorative Lenses
This is a major move by FDA and I am so pleased that so many people, especially Tim Steinemann, M.D., in Cleveland, reported their adverse events associated with the important public health issue: illegal misuse of cosmetic contact lenses. I know this makes manufacturers uneasy, but this has got to be controlled. No, it will not hurt the entire contact lens field, but it will harm people, most of whom are young. I believe we all need to educate all of our young patients (no matter what correction they wear) that buying lenses to enhance their eyes without professional supervision or trading lenses with their friends is dangerous.

Fitting Tip: Fitting an Irregular Cornea
When fitting an eye with an irregular cornea (e.g., a corneal transplant) and topography mapping is available, I'll frequently ignore the central 3mm to 4mm and look at the region just beyond. I base my next initial lens selection on the curvature reading of approximately 5mm to 6mm in diameter around the central cornea. I'll use this as information for determining and placing the first lens on the eye. A rigid lens will vault over the central region and frequently, you can ignore this area and look at the region beyond and obtain a better fit.
--Bruce Anderson, OD
Tampa, Florida

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

Access a reporting form for complications you've seen that were a result of contact lenses dispensed without a valid prescription at the Association of Regulatory Boards of Optometry's (ARBO's) Web site: http://www.arbo.org/arbo.asp?dt=R&doc=Complications. Complete and send the form online or print it out and fax it to (866) 886-6164.

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