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Sunday, April 8, 2012  
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Editor's Commentary - Jason J. Nichols, OD, MPH, PhD, FAAO

The professional practice of providing eye care varies dramatically around the world, and there are sometimes many similarities and differences amongst the "three O's"—ophthalmology, opticianry, and optometry. This is often confusing to not only patients, but also those of us involved in practice. While our mission is not necessarily that of printing "political" content, it is interesting to see how the global differences in modes of practice across the three O's impacts the practice of contact lenses. Our recent "Views from Abroad" guest contributions are hopefully shedding some light on the practice of contact lenses across the globe.

Menicon's "Magic" Contact Lens Takes ADFEST Gold

Menicon Co., Ltd.'s Magic, the world's thinnest daily disposable contact lens, won a Gold Award in the Design Lotus category at the Asia Pacific Advertising Festival (ADFEST). In addition to the Gold Award for best logo, package design and overall communication plan, Magic also won three Silver Awards, making it the most awarded product in the Design Lotus category.

ADFEST, which marked its 15th anniversary this year, is the largest and one of the most prestigious international advertising award programs in Asia.

Magic's novel flat pack, created through the company's proprietary technology, contains a uniquely prepared contact lens and measures a thickness of just 1mm. As the world's flattest and most compact lens pack, Magic offers convenience for storage and carrying. The flat-pack's unique design is also highly hygienic.

Magic was launched on a pilot basis at the company's Magic Store Tokyo concept shop in Japan on November 7, 2011 and will be sold nationwide in Japan beginning this June.

CooperVision to Relaunch Avaira Toric Contact Lenses

CooperVision, Inc. announced that the U.S. Food and Drug Administration has granted a Special 510(k) clearance for CooperVision's Avaira Toric two-week silicone hydrogel contact lenses for astigmatism. Avaira Toric highlights CooperVision's commitment to provide eyecare practitioners with a choice within the two-week modality segment for their patients.

CooperVision will relaunch Avaira Toric with shipments available for select distribution beginning early May 2012.

Practice Partnership Webinars Now Online, COPE Credit Available

ABB CONCISE announced that the Practice Partnership Webinar series presented by Patrick Caroline, FAAO, of Pacific University and supported by Paragon Vision Sciences, has continued COPE approval. This ABB CONCISE exclusive webinar series focuses on topics that support successful treatment options and outcomes with gas permeable lens fitting.

Highlights from the webinar series include: contact lens fitting using corneal topography, myopia control with corneal reshaping, scleral lens design and fitting, management of irregular cornea, and special lens designs for keratoconus patients.

The webinars are free to all who are interested in viewing. Those looking for the CE credits will need to pay a nominal fee of $35 and pass a 10-question online exam, administered by Primary Eyecare Network (PEN).

The recorded webinars can be accessed on the ECP tools page after login on www.abbconcise.com. To obtain the CE exam after viewing the webinar, practices can send an email to education@primaryeye.net or call PEN at 800-444-9230.

Alden Optical Extends NovaKone Webinars

Alden Optical, Inc. announced that it will extend its series of NovaKone webinars through May 2012 to address the ongoing interest in this new soft lens for keratoconus. These comprehensive webinars cover lens design, patient selection and fitting philosophy; ensuring that participating practitioners are successful with this novel new lens. To register for a NovaKone Introductory Webinar or for more information on the lens, practitioners should visit the NovaKone page on Alden Optical's website at www.aldenoptical.com/novakone or contact Alden Optical directly at 800-253-3669.

Axenfeld's Anomaly
By Gregory W. DeNaeyer, OD, FAAO

This is a picture of posterior embryotoxon of a patient who has Axenfeld's anomaly. Posterior embryotoxon is a prominent Schwalbe's line that may be a partial or complete bilateral ring and is usually visible on gross external examination. It is an indication of either Axenfeld's anomaly/syndrome or Rieger's anomaly/syndrome, both of which are anterior chamber syndromes that put patients at risk for glaucoma.

For more on this patient and this diagnosis, see http://www.clspectrum.com/articleviewer.aspx?articleID=103694.

Reference: Catania, LJ. Primary Care of the Anterior Segment 2nd Ed. Appleton & Lange 1995. p. 242-243

We welcome photo submissions from our readers! It is easy to submit a photo for consideration for publishing in Contact Lenses Today. Simply visit http://www.cltoday.com/upload/upload.aspx to upload your image. Please include an explanation of the photo and your full name, degree or title and city/state/country.

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Update on Silicone Hydrogel Lens Groupings
Guest Columnist: Ralph Stone, PhD

The original lens grouping proposal was developed by me as a response to an initiative from FDA. The original proposal was vetted in the industry (CLI and CLMA) and with Academics (both individually and at the IOCLE meeting). It was then presented to FDA which included the grouping system in their guidances for lenses and lens care. Later ISO considered this proposal and eventually included it in the definitions standard (ISO18369-1).

When silicone hydrogel lenses came on the scene 12 years ago, our initial approach was to put them into the same groups as our traditional soft contact lens materials. This approach has persisted in the literature. As we evaluated the materials, we found silicone hydrogels are quite different from the earlier materials in their interactions with the tear film and care systems. These materials are "biphasic," having portions that are hydrophilic and other portions that are hydrophobic.

The first approach has been to put silicone hydrogels into a separate class of lens materials, which has been designated as group V in the ISO standards. As we have moved past 12 different lens materials in the silicone hydrogel class, we have come to understand that we need to recognize differences between these materials. Efforts are ongoing to define the differences so we can group the materials for testing to assure safe and effective use by patients.

Using research carried on by academia and industry, efforts are under way to understand the differences in silicone hydrogels just as nearly 30 years ago with conventional hydrogels when we established the traditional four classes of soft contact lens materials. Today the U.S. standards organization (ANSI) and the international standards organization (ISO) are diligently working toward the appropriate testing framework for silicone hydrogels.
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Loretta B. Szczotka-Flynn, OD, PhD, MS, FAAO

A Unique Indication for Scleral Lenses

Its rare that the use of a therapeutic gas permeable contact lens actually reverses clinical pathology. Two recent articles provide case reports on the use of scleral lenses in limbal stem cell deficiency (LSCD) (Rathi 2012, Schornack 2011), and one of these (Schornack 2011) demonstrates the reversal of the condition even after the cessation of lens wear.

One of these reports discusses a patient with a one-year history of clinically diagnosed LSCD that was worsening despite aggressive topical and systemic medical therapy (Schornack, 2011). The condition resolved rapidly with initiation of scleral lens wear. The integrity of the ocular surface was maintained for 18 months even after the cessation of lens wear. The initial intent of the author was to relieve pain and improve optical quality by masking the compromised ocular surface from environmental stress – a traditional thought process in scleral lens fitting. However, the patient's ocular surface response suggested that the clinical picture of stem cell deficiency was more of a temporarily dysfunctional stem cell population. The scleral lens was postulated to aide in the treatment of clinical LSCD by protecting the epithelium from the lids' shear forces and providing continuous hydration of the cornea through the post-lens fluid reservoir. Additionally, the protection of the limbus might also have played a role in improving stem cell function.

While we traditionally think that therapeutic gas permeable lenses treat conditions of the ocular surface only while they are being worn, this case challenges this thought process, and opens up novel, non-surgical treatment possibilities for a variety of patients.

Schornack MM. Limbal stem cell disease: management with scleral lenses. Clin Exp Optom. 2011 Nov;94(6):592-4.
Rathi VM, Sudharman Mandathara P, Vaddavalli PK, Dumpati S, Chakrabarti T, Sangwan VS. Fluid-Filled Scleral Contact Lenses in Vernal Keratoconjunctivitis. Eye Contact Lens. 2012 Feb 23. [Epub ahead of print]

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Ronald K. Watanabe, OD, FAAO

More Multifocals for Astigmats

In my last column, I wrote about soft toric multifocal contact lenses for presbyopes with astigmatism. I also mentioned that GP multifocals can work for astigmats. All non-toric GP multifocals create a lacrimal lens that automatically corrects corneal astigmatism. However, there are two situations where this type of design may not work.

First, this type of lens may not center or stabilize well on a cornea with 2 D or more of corneal astigmatism, which would compromise visual performance. In this case, a back surface toric or bitoric GP multifocal can be designed. The multifocal optics are retained, and with a better lens-to-cornea relationship, lens position and therefore vision are better controlled. Second, internal astigmatism more than 0.75 DC requires a front surface toric design. If so, prism ballast is also required to prevent lens rotation, but this may cause the lens to position inferiorly. This works well for segmented designs that are already prism ballasted, but aspheric designs may not work well due to the inferior lens position. Ask your GP lab if they have these toric multifocal GP options, and you will be able to fit virtually any astigmat with a multifocal contact lens.

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A Phase 2 Randomized, Double-Masked, Placebo-Controlled Study of a Novel Integrin Antagonist for the Treatment of Dry Eye

The goal of this study was to investigate the efficacy and safety of an investigational integrin antagonist (SAR 1118) ophthalmic solution compared to placebo (vehicle) in subjects with dry eye disease.

This was a multicenter, prospective, double-masked, placebo-controlled trial. A total of 230 dry eye subjects selected with use of a controlled adverse environment were randomized 1:1:1:1 to receive SAR 1118 (0.1%, 1.0%, 5.0%) or placebo eye drops twice daily for 84 days. Principal eligibility criteria included exacerbation in corneal staining and ocular symptoms with controlled adverse environment exposure, no active lid margin disease, and Schirmer test (mm/5 min) >1 and <10. Ocular signs and symptoms (Ocular Surface Disease Index, OSDI) were assessed at day 14, 42, and 84. No supplemental artificial tears were allowed. Primary outcome measure was inferior corneal staining score at day 84.

A dose response for the corneal staining score (P = .0566) was observed for SAR 1118 at day 84 compared to placebo. Mean change from baseline to day 84 showed significant improvements (P < .05) in corneal staining score, total OSDI, and visual-related function OSDI scores for SAR 1118 compared to placebo; improvements in tear production and symptoms were observed as early as day 14 (P < .05). Adverse events were mild and transient in nature with no serious ocular adverse events. SAR 1118 5.0% showed increased instillation site adverse events relative to placebo but were limited to the initial dose.

The researchers concluded that SAR 1118 demonstrated improvements in signs and symptoms of dry eye compared to placebo and appears safe when administered over 84 days.

Semba CP, Torkildsen GL, Lonsdale JD, et al. A Phase 2 Randomized, Double-Masked, Placebo-Controlled Study of a Novel Integrin Antagonist (SAR 1118) for the Treatment of Dry Eye. Am J Ophthalmol. 2012 Feb 11.

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