I have heard through the years that some manufacturers feel that once a device is approved by a regulatory agency (e.g., the FDA), they are not obligated to monitor safety associated with the device when in the field unless there is such a contingency associated with the approval. If true, this troubles me for a variety of reasons, particularly in that the FDA can be slow to respond to issues when they might arise in the field. It would be great to hear manufacturer's perspectives on this in the future, particularly if this information is off-base. As always, please feel free to contact me with your thoughts, perspectives and opinions at jnichols@optometry.uh.edu.

Ashley McEvoy has been appointed to the position of Company Group Chairman of Johnson & Johnson Vision Care Inc., effective January 1, 2012. She succeeds Michael Sneed, who will become Vice President, Global Corporate Affairs, Johnson & Johnson (J&J).

McEvoy currently is Worldwide President for Ethicon Products. Prior to joining Ethicon, Ashley served as President of McNeil Consumer Healthcare. She joined J&J in 1996 as an assistant brand manager for Tylenol and Nicotrol. McEvoy became Vice President of Marketing for McNeil's consumer over‑the‑counter (OTC) business in 2003, and was promoted to General Manager of the OTC business in 2005 and President of McNeil Consumer Healthcare in 2006.

Prior to J&J, McEvoy achieved marketing successes in Europe and the United States, managing branding and advertising for household‑name consumer products such as Jif Peanut Butter, Clairol and product lines for Unilever and Procter & Gamble.

Menicon Co., Ltd. announced an agreement with W.I. System, Inc. that will turn one of Japan's leading contact lens retail chains into a wholly owned subsidiary of Menicon. Terms of the acquisition were not disclosed.

Tokyo area-based W.I. System, with annual gross sales of USD 130 million, ranks fourth in contact lens retail sales in Japan. It operates 68 Tokyo-area retail stores and one franchise store that do business under the name Ace Contact or Ekicon. The stores offer primarily contact lenses, and also sell eyeglasses, hearing aids and nutritional supplements for pets.

The company announcement stated that the acquisition will significantly bolster Menicon's retail presence in greater Tokyo and will expand opportunities for Menicon to reach users who do not currently use Menicon products. W.I. System stores will continue to provide a broad array of lenses and lens-related products from Menicon and other manufacturers to meet the diverse needs of Japan's contact lens wearers.

Menicon believes that by striving to satisfy its newly expanded customer base as a result of the acquisition, the experience ultimately will strengthen the company's and the industry's capabilities for developing and marketing lenses and lens care products that meet diverse needs in the broader global market.

Alden Optical, Inc. announced a series of NovaKone webinars to address the interest in this new soft lens for keratoconus. These webinars, less than 45 minutes in length, will provide interested practitioners with the tools necessary to successfully fit NovaKone. On average, the webinars will be held every week.

According to the company, NovaKone is a novel new soft lens option for the correction of vision in patients with keratoconus and other irregular corneas. At the core of NovaKone is a lens design that offers the comfort and ease of fit associated with soft lenses. The lens employs a sophisticated posterior design to neutralize irregular astigmatism and optimize physical fit. Front surface toricity is then applied to correct for residual regular astigmatism, while Alden Optical's proprietary Dual Elliptical Stabilization ensures excellent rotational stability.

For a schedule and to register for a NovaKone Introductory Webinar, practitioners should visit http://aldenoptical.com/novakone or contact Alden Optical at 800-253-3669.

There is still time to register for the 2012 Global Specialty Lens Symposium at the Paris Hotel & Casino in Las Vegas. With an expert international faculty and a CE-accredited agenda, the 2012 GSLS will feature insightful presentations by experts in the field and hands-on demonstrations of cutting-edge products, as well as scientific papers and posters. COPE, JCAHPO and NCLE accreditation. Look for more detailed information in Contact Lens Spectrum and online at www.GSLSymposium.com.
--ADVERTISING

Vision Source has named Walter D. West, OD, FAAO, as Vice President of Practice Development.

West is a consultant, lecturer, author and editor who most recently served as Program Director for The Vision Care Institute LLC, a Johnson & Johnson company. For the past three years, West has been a featured speaker for the Vision Source Experience practice management series, delivering more than seventy presentations to over 11,000 Vision Source doctors and staff members.

In his new role with Vision Source, West will spearhead Vision Source practice management education for member doctors and staff. That will include content development and management of the Vision Source Experience program as well as providing content for the network's online educational programs.

A graduate of the Southern College of Optometry, West founded Primary Eyecare Group in Brentwood, Tennessee in 1975. He sold his practice in 2003 to focus on education and consulting, founding Walt West Management and Consulting. He is the author of When Your Success Is On The Line and Pulse Points of the Million Dollar Practice, and has served as Chief Editor for Optometric Management.

Ocusoft, Inc. announced an agreement with Scope Ophthalmics of London, UK to exclusively distribute and market its Ocusoft Lid Scrub to the ophthalmic market in the United Kingdom and Ireland.

Founded in 2009, Scope Ophthalmics is a leading distributor of innovative ophthalmic products in the UK. With offices located in London and Dublin, as well as established relationships in the ophthalmic community, the company already has a significant presence in both markets.

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The patient whose eye is pictured suffers from severe aqueous tear layer deficiency and meibomian gland dysfunction. Upon presentation, her case history strongly suggested dry eye disease. This initial diagnosis was confirmed with Schirmer (without anesthesia) testing, meibomian gland expression/transillumination, and vital staining of the cornea and conjunctiva with lissamine green.

For more on this patient, including assessment and management, see http://www.clspectrum.com/article.aspx?article=104440.

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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MATERIALS & DESIGNS
Ronald K. Watanabe, OD, FAAO

Daily Disposables Should Be Worn DAILY

I have been a proponent of daily disposable contact lenses (DDCLs) for a long time, primarily because I feel that they reduce problems that patients encounter when using the same lens multiple times. A recent article (Boost, 2011) investigated the effects of reusing DDCLs. They had 20 subjects wear various brands of DDCLs for one day, then store them overnight in the original blister pack with the original packaging solution. The lenses were then cultured. They found that 67% of the lenses and almost half of the packaging solution samples had significant growth of bacteria, most commonly Staphylococcus species, but also a few gram-negative species like Pseudomonas and Klebsiella.

This may help explain why some previous studies have found that the risk of complications with DDCLs is not lower than other modalities (Dart, 2008, Stapleton, 2008). It is important for practitioners to make sure that their patients are actually replacing their lenses daily, and if not, to remedy it in some way. Almost all of my DDCL wearers tell me that they replace their lenses daily, and they tend not to have any problems. For those who say they reuse them or wear them overnight, I re-educate them on proper use of their lenses or refit them into a more appropriate option.

Boost M, Poon K, Cho P. Contamination Risk of Reusing Daily Disposable Contact Lenses. Optom Vis Sci 2011; 88(12): 1409-1413.
Dart JKG, Radford CF, Minassian D, et al. Risk factors for microbial keratitis with contemporary contact lenses. Ophthalmol 2008; 115(10): 1647-1654.
Stapleton F, Keay L, Edwards K, et al. The incidence of contact lens-related microbial keratitis in Australia. Ophthalmol 2008; 115(10): 1655-1662.

A Reminder About Fungal Keratitis

As the old saying goes, "out of sight, out of mind." However, we should not get complacent in considering the possible involvement of fungal species in atypical contact lens infections. A recent publication (Edelstein 2011) reported on a case of resistant contact lens associated Fusarium keratitis progressing to endophthalmitis and eventual enucleation. A 52-year-old soft contact lens wearer in the U.S. had a corneal abrasion and developed a corneal infiltrate. Examination of corneal scrapings revealed filamentous hyphae with septation and conidia. Despite aggressive antifungal therapy with topical natamycin, amphotericin B, and systemic fluconazole, the keratitis progressed, and repeat penetrating keratoplasties, intravitreal amphotericin B injections, and pars plana vitrectomies were performed. The culprit was a multidrug-resistant Fusarium solani species complex, which is extremely rare.

Other recent Fusarium keratitis case reports can be found on PubMed. A 2010 report from Croatia presented a Trichophyton spp. fungal ulcer in a 22 year old contact lens wearer (Mravicic 2010), and a 2011 report from Korea (Byun 2011) reported on a fungal infection which developed after (and was masked by) application of fibrin glue in an infectious corneal ulcer.

Clinicians should remain alert for potential fungal infections in contact lens wearers; although they are rare, they can result in devastating consequences.

Byun YS, Kim MS. Superimposed fungal ulcer after fibrin glue sealant in infectious corneal ulcer. Korean J Ophthalmol. 2011 Dec;25(6):447-50. Epub 2011 Nov 22.
Mravicić I, Dekaris I, Gabrić N, Romac I, Glavota V, Sviben M. Trichophyton Spp. fungal keratitis in 22 years old female contact lenses wearer. Coll Antropol. 2010 Apr;34 Suppl 2:271-4.
Edelstein SL, Akduman L, Durham BH, Fothergill AW, Hsu HY. Resistant Fusarium Keratitis Progressing to Endophthalmitis. Eye Contact Lens. 2011 Oct 8. [Epub ahead of print]

These researchers wanted to evaluate ocular surface changes in long-term silicone hydrogel contact lens wearers.

Thirty patients were included in this study. Twenty patients (40 eyes) using contact lenses constituted group 1 and 10 (20 eyes) volunteers constituted group 2. The duration of average contact lens usage was 7.74+/-3.3 years. Ocular surface was evaluated by surface staining, tear film break-uptime (TBUT), Schirmer I test, and conjunctival impression cytology with color-coded mapping technique and by the Ocular Surface Disease Index (OSDI).

The mean break-up time was lower and staining scores were higher in group 1 (p<0.001) but Schirmer values were not significantly different from group 2 (p>0.05). The mean OSDI score was 34.59+/-11.93 to 19.28+/-6.7 in group 1 and 2. Increased metaplastic predominant changes of grade II and III were observed in the interpalpebral and perilimbal areas in group 1. Significant correlations were observed in TBUT, cornea staining, and grade II to grade III metaplasia ratios between duration of the lens usage and contact lens wear time in a day.

The authors concluded that silicone hydrogel lenses produce significant changes on tear film and impression cytology of the ocular surface in long-term use.

Sengor T, Aydin Kurna S, Ozbay N, Ertek S, Aki S, Altun A. Contact lens-related dry eye and ocular surface changes with mapping technique in long-term soft silicone hydrogel contact lens wearers. Eur J Ophthalmol. 2011 Nov 11:0. [Epub ahead of print]

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