The U.S. Food and Drug Administration (FDA) is taking steps to improve contact lens safety by reminding consumers of the importance of following proper cleaning and storing procedures. The FDA is also telling consumers that those who do not follow instructions for contact lens care and use increase their risk of serious eye infections that can lead to blindness.
     To support proper cleaning and storage, the FDA has developed a new video on contact lens safety, which can be found on the FDA's website at http://www.accessdata.fda.gov/videos/cdrh/contactlens.wmv, along with an in-depth Consumer Update article found at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm164197.htm. The video and the article stress the importance of emptying the solution out of the contact lens case after each use and using the rub-and-rinse method for added effectiveness. Other important lens care tips include: do not top off or reuse lens cleaning solution; use a contact lens solution to clean, rinse, and then air dry contact lens cases after each use; and do not expose contact lenses or lens storage cases to any type of water or other non-sterile solutions.
     In its June 2008 meeting, the advisory panel for ophthalmic devices made specific recommendations for contact lens product labeling and directions for use, including adding a discard date on their products, in addition to the usual expiration date. In early 2009 the FDA convened a workshop called "Microbiological Testing of Contact Lens Care Products," in collaboration with several eye care professional groups, to develop consensus on test methods for evaluating contact lens solutions (click here for details). Based on discussions from this workshop and from the 2008 advisory panel meeting, the FDA is developing manufacturer guidance on potential labeling improvements for these products.
     In addition, on May 19, 2009, the FDA's Center for Devices and Radiological Health issued a letter to manufacturers of contact lens multipurpose solution products that include an option for cleaning without a step for rubbing the lenses. This letter informed these manufacturers of the panel's conclusion that there is improvement in lens care when using a rub-and-rinse regimen as compared to a rinse-alone regimen, which omits the rubbing step. The direction to rub and rinse lenses, based on the advice of an eye care professional, has always been part of the labeling for multipurpose contact lens care products.

Paragon Vision Sciences (Paragon) announced the immediate availability of Paragon CRT Dual Axis, a breakthrough design enhancement and product extension for their therapeutic lens for overnight corneal reshaping, Paragon CRT. Paragon CRT Dual Axis allows for modulation of the lens periphery in two meridians when corneal elevation or curvature differences limit the success of a fit. According to the company, the Dual Axis option will provide CRT certified practitioners the ability to accommodate up to 30% more corneal reshaping patients.
     Paragon CRT Dual Axis lens features auto-orientation, with no prism or slab off, while maintaining its flexure resistance and its overall thin lens design. The enhanced design also improves centration while maintaining an optimum treatment zone and providing a lens perimeter that remains round and planar, per Paragon. The company also states that the product's ability to permit independent manipulation of a second RZD and LZA, that doesn't alter the dimension found optimum in a first meridian, expands CRT's technological superiority.
     "Dual Axis will enable hundreds of thousands of new patients who are seeking an alternative to daytime contacts and glasses to have the same benefits of current CRT lens wearers; unaided visual acuity during waking hours. Children love the daytime visual freedom that CRT provides and a growing number of daytime contact lens wearers are realizing that the simplest, and perhaps most effective solution to their discomfort, is not to wear contacts during the day," said Joe Sicari, Paragon's President and CEO.
     For more information on Paragon CRT Dual Axis, go to http://www.paragoncrt.com/dualaxis/documents/CRTDA_ZNL100095E.pdf. 

Patients wearing contact lenses for astigmatism feel the lens sometimes rotates on the eye, resulting in blurry vision. The Accelerated Stabilization Design (ASD) of ACUVUE® OASYS™ Brand Contact Lenses for ASTIGMATISM provides greater stability by harnessing the pressure of the blink. ASD has four zones of stability to help maintain the position of the lens, resulting in more consistent visual acuity during repetitive eye movements and throughout everyday activities. So with ACUVUE® OASYS™ Brand for ASTIGMATISM, you provide your astigmatic patients with stable, crisp vision throughout their day.
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SynergEyes, Inc. announced that it has been issued two new patents from the U.S. Patent and Trademark Office. The first new patent has an extensive claim set of 27 claims and provides protection for aspheric geometries within the landing area, which includes the just-launched ClearKone and other subsequent design evolutions. In addition, the patent claims the use of a diagnostic set to fit high Dk hybrid contact lenses and the use of fluorescein to evaluate the fit of a high Dk hybrid contact lens. The second patent controls modulating skirt curves per base curve.
     Both new patents complement prior patents awarded SynergEyes for its high Dk hybrid contact lens designs, and bring SynergEyes' intellectual property patent portfolio to a total of eleven patents. For information on SynergEyes contact lens designs, visit www.SynergEyes.com.

Allergan, Inc. announced that the United States Food and Drug Administration (FDA) has approved Ozurdex (dexamethasone intravitreal implant) 0.7 mg as the first drug therapy indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Retinal vein occlusion (RVO), including BRVO and CRVO, is the second most common retinal vascular disease after diabetic retinopathy and is a significant cause of vision loss.
     According to the company, Ozurdex is a first-of-its kind therapy administered via intravitreal injection delivering dexamethasone, a highly potent corticosteroid, via Allergan's proprietary Novadur solid polymer delivery system. Via the Novadur delivery system, Ozurdex, a biodegradable implant which enables the extended release and effect of dexamethasone, is placed in the vitreous cavity in the back of the eye treating the macular edema associated with RVO, thereby improving a patient's visual acuity.

Tissue degradation in corneal thinning disorders, such as keratoconus (KC), involves the expression of inflammatory mediators. The purpose of this study was to determine the levels of proinflammatory cytokines and matrix metalloproteinase 9 (MMP-9) in tears from both eyes of unilateral keratoconus (KC) patients.
     Thirty patients diagnosed as having asymmetrical KC (30 KC eyes, and 30 subclinical KC eyes) and 20 normal control subjects (one eye) were studied in a prospective, cross-sectional study. Keratoconus screening programs were performed on these participants. Ten microliters of tears was collected from each eye. The concentrations of cytokines (interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-alpha)) and MMP-9 were measured by ELISA.
     Mean values for IL-6 levels were similar in KC and subclinical KC samples (5.5 (4.9 to 6.9) vs. 5.7 (4.5 to 6.2) pg/ml, p = 0.131), but significantly higher in relation to the control group (2.2 (1.0 to 4.1) pg/ml, p<0.0001). Significant differences were found in TNF-alpha levels between KC and subclinical KC eyes (5.4 (4.1 to 6.8) vs. 4.8 (4.2 to 6.0) pg/ml, p = 0.032) and control group (1.8 (1.5 to 2.3) pg/ml, p<0.0001). Increased values of MMP-9 were found in KC (59.4 (50.6 to 66.1) ng/ml) vs. subclinical KC eye (7.0 (4.8 to 8.6) ng/ml) (p<0.0001). MMP-9 levels in the control group (6.1 (3.9 to 8.3) ng/ml) and subclinical KC were similar (p = 0.203).
     The researchers concluded that IL-6 and TNF-alpha are overexpressed in the tears of subclinical and KC eyes. Increased MMP-9 levels were found only in the KC eye. These results indicate that the pathogenesis of KC may involve chronic inflammatory events.
Lema I, Sobrino T, Duran JA, Brea D, Diez-Feijoo E. Subclinical keratoconus and inflammatory molecules from tears. Br J Ophthalmol 2009;93:820-4.

Granted research is important, but often it substantiates what clinicians have found "in the trenches." The research does not always drive the clinical decision making, but rather, can often reinforce it and gives retroactive scientific approval for what has been gained in practice. A case in point is the use of prostaglandins in treating glaucoma. Initially they were used as secondary treatment when beta blockers were the primary mode of therapy. Clearly, the prostaglandins are now primary and the beta blockers are perhaps not even secondary. Vioxx is another example, as are many other medications that have been "researched" thoroughly and have attained FDA approval. 
S. Moshe Roth, OD
Old Bridge, NJ

The American Optometric Association (AOA) is holding its annual meeting this week from June 24 through June 28, 2009 in Washington, DC. There are obviously many worthwhile events and activities that you might consider attending at this meeting. This includes some very important discussion on the current AOA proposal on board certification at the meeting's Congress. If you have not already, I urge you to share your views with your state leadership about board certification as soon as possible.
Jason J. Nichols, OD, MPH, PhD, FAAO

This month at www.siliconehydrogels.org: the relationship between wettability and comfort; corneal ecstasia vs. corneal warpage; best lenses for aging eyes; and the effect of contact lens materials on physiology.