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Sunday, January 19, 2014  
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Do you believe that using an artificial tear in a contact lens wearer (an "off-label" use compared with using a rewetting drop) puts the lens wearer at risk for increased complications?



Editor's Commentary
How often have you stopped to think about component pricing of contact lenses as they make their way from the manufacturer to the patient? For instance, if you took the sale of a single contact lens (let's say it is $1 for this lens) and broke it down, what percentage of that $1 would go to the manufacturer? The distributor? Eyecare practitioner? I would be interested to hear your thoughts on this. Please email me at jnichols@optometry.uh.edu .

Google Tests Diabetes-Tracking Smart Contact Lens Prototype

Google introduced its smart contact lens project to the public in its official blog, http://googleblog.blogspot.com. According to the blog, Google is testing a smart contact lens that's built to measure glucose levels in tears using a tiny wireless chip and miniaturized glucose sensor that are embedded between two layers of soft contact lens material. The company is testing prototypes that can generate a reading once per second. Google is also investigating the potential for this to serve as an early warning for the wearer by exploring integrating tiny LED lights that could light up to indicate that glucose levels have crossed above or below certain thresholds.

The company states it is in discussions with the FDA, but there is still a lot more work to do to turn this technology into a system that people can use. Google plans to look for partners who are experts in bringing products like this to market; partners who will use their technology for a smart contact lens and develop apps that would make the measurements available to the wearer and their doctor.

Sauflon Plans to Introduce clariti 1 day in United States

Sauflon announced that it is entering the U.S. contact lens market with its award-winning clariti 1 day silicone hydrogel daily disposable contact lenses. As the world's first and only family of sphere, toric and multifocal silicone hydrogel daily disposable contact lenses, clariti 1 day is able to satisfy a broad range of practitioner and patient needs. According to the company, Sauflon's breakthrough AquaGen technology produces high quality silicone hydrogel lenses that provide exceptional comfort and affordable convenience for the wearer.

Sauflon will be the only company offering a complete family of affordable silicone hydrogel daily disposable contact lenses in the U.S. market. clariti 1 day is the top selling line of silicone hydrogel daily disposable contacts in the United Kingdom.

Sauflon's patented manufacturing process makes it possible to provide high-quality silicone hydrogel daily disposable contact lenses and is designed around modular production cells for maximum efficiency and high scalability as the daily disposable market continues to expand. This proprietary technology enables Sauflon to produce and sell state-of-the-art silicone hydrogel daily disposable lenses at the same cost as hydrogel lenses.

Leading Sauflon's U.S. expansion will be a veteran management team with over 130 years of contact lens industry experience: Jim Welch, CEO; Brad Jones, President U.S. Sales & Marketing; Rick Franz, OD, FAAO, EVP U.S. Technical & Professional Affairs; Dave Allen, EVP U.S. Sales; and Adam Kronstat, EVP U.S. Operations.

The company currently plans the U.S. rollout of clariti 1 day in early March 2014. To learn more about Sauflon and to register for updates, please visit www.sauflonusa.com, email info@sauflon.com or call 1-800-682-3240.

It Is Not Too Late to Register! Don't Miss the 2014 Global Specialty Lens Symposium.
Register today to attend the Global Specialty Lens Symposium to be held January 23 - 26, 2014 at the Rio All Suites Hotel and Casino in Las Vegas, Nevada. Brought to you by Contact Lens Spectrum, this 3 1/2 day comprehensive meeting focuses on the latest techniques and technologies for the successful management of ocular conditions using today's specialty contact lenses. It includes insightful presentations by international experts in the field, hands-on demonstrations of cutting-edge products and valuable continuing education credits.

Visit www.GSLSymposium.com for more information and registration. Onsite registration will also be available.

Art Optical Introduces New Multifocal Management Program

To streamline and simplify the fitting and ordering of multifocal lenses for eyecare practitioners, Art Optical has introduced their "FlexFit Multifocal Management Program." When working with a professional fitting consultant, the FlexFit program allows ECPs unlimited fit adjustments and design changes in a 6-month fitting period, with full cancellation/money back privileges. For added convenience and to save the practice handling time and return shipping expense, refit lens returns are no longer required and instant credit processing has been implemented.

The portfolio of proprietary lens designs offered in the FlexFit program include the Renovation series, which is the nation's leading GP multifocal; as well as Art Optical's mPower! and CLASIKcn GP designs; and their Intelliwave Multifocal & Multifocal Toric custom soft lenses.

According to Art Optical, the goal of the FlexFit program is to reduce the risk involved with multifocal fitting so ECPs can feel confident introducing the multifocal option to a broader range of their presbyopic patients. The flexibility of the lens design platform and the simplification of policies are geared toward improving fitting success, saving chair time, reducing return handling and making multifocal patient management easier and more efficient.

For information, contact Art Optical at 800-253-9364.

EyeCarePro Announces the Return of Seeing is Believing Virtual Conference

This past year marked the beginning of something new for EyeCarePro and the greater optometric industry: virtual conferencing. Last January brought Seeing is Believing (SiB), optometry's virtual eye care conference dedicated to educating ECPs and their staff about the power of online tools, techniques and technology. Following that success, CEing is Believing, optometry's virtual COPE approved continuing education conference, was held in July, featuring 24 online CE courses from some of the industry's top speakers.

Get ready for an even better virtual conferencing experience when SiB 2014 returns to computers and tablets everywhere January 29-30. The two-day conference will run live from 12PM to 9PM EST and on demand for 90 days following. This year, SiB will feature 30 presentations with topics focused on matters of interest for each of your optometric staff members, including ten clinical CE COPE approved courses, ten courses focused on practice management, five more for staff, and five for opticians. There will also be a grand exhibition hall featuring exhibitor booths where vendors will be available with live support for assistance throughout the conference. Additionally, SiB's specialty booths will provide visitors with topical content on a wealth of educational subjects such as dry eye, patient communication tools, employment, glaucoma, practice management software, and more. These 'unmanned' booths ensure that you can read and download content, browse information from various vendors and even watch an educational video - all at your own pace and convenience.

EyeCarePro offers three different conference passes: a Solo Pass for $139, a Practice Pass that allows you to register everyone from a single office location for a flat fee of $279, or a Society Pass that allows unlimited registration for multiple office locations for $995. For information and registration, visit www.sib2014.com.

Hallatt Joins Alden Optical

Industry veteran Bernie Hallatt has joined Alden Optical to lead QA and Regulatory functions. In his 34 years in the contact lens industry, Hallatt successfully led QA, Regulatory and Manufacturing teams, and most recently was Director of Manufacturing Operations at CooperVision. He assumes full responsibility for Alden Optical's Quality System and Regulatory Affairs department.

Alden Optical (www.aldenoptical.com) was established in 1969 by Charles "Pat" Creighton, OD. The company is known for manufacturing premium specialty and custom made-to-order soft and gas permeable contact lenses while offering unparalleled customer service.

OPRI Launches New Manufacturing Plant for Rejuvenated Business

Optical Polymer Research, Inc., aka OPRI, announced the completion of the company's rejuvenation plan and the launch of their new manufacturing plant in Mesa, Arizona. OPRI's mission is to develop and deliver high-quality and innovative contact lens polymers to custom finishing laboratories, eyecare providers and their patients. According to the company announcement, OPRI will offer enhanced, FDA-approved technology in their polymers that is unavailable from any of their competitors. This will allow global custom lens manufacturers new material choices to enhance the laboratories' capabilities and success. In addition, OPRI can and will provide turnkey systems in the areas of plasma surface cleaning treatment, lens laser marking, specialized GP lens design and even hydrogel lens manufacturing and sterilization experience. Secondarily, OPRI will be engaged in developing optical polymers that have a variety of uses beyond that of contact lenses.

Hank Stute and Krist Jani lead OPRI's management team. Stute has over 30 years of entrepreneurial, innovative product and manufacturing achievements in medical devices, and consumer products. He has a wealth of knowledge about this industry within the United States and internationally. Jani, as well, is a veteran of 30 years of marketing, sales, domestic and international business development experience within the ophthalmic marketplace. For full biographical information on either principle, along with information on the company, please visit www.OPRI.net.

Intacs Now Exclusively Available Through Oasis Medical

Oasis Medical Inc., U.S. manufacturer and distributor of high quality disposable surgical instruments and ocular lubricating and cleansing solutions, jointly with Spain-based AJL Ophthalmic, S.A., manufacturer of ophthalmic implants, announced an exclusive relationship for the sales and distribution of Intacs corneal implants for the treatment of keratoconus and FDA approved for the treatment of myopia

AJL Ophthalmic announced the acquisition of Addition Technologies in January 2013. Addition Technologies will continue the manufacturing and remain the FDA approved Humanitarian Device Exemption (HDE) holder of the Intacs device.

Intacs is a unique corneal implant option that restores the natural shape of the cornea improving the patient's vision and potentially avoiding corneal transplants, according to the company. The minimally invasive procedure has a recovery period of days rather than months when compared to a corneal transplant procedure.

Last week  Dr. Nichols asked for your thoughts on why the United States market has typically lagged behind many other markets in terms of the uptake of daily disposables and what makes the U.S. market different in this regard. Here are a couple of comments we received.

I believe we lag behind the world in daily disposable lenses because people are comfortable with our access to clean water. We believe our homes are ok in a "hygienic" way. We are comfortable re-using contact lenses. I also think cost, especially with the lingering recession, affects patients' decisions towards daily disposables.

Craig Match, OD
Halifax, PA

My patients, many now being young technology people, are very candid about why they resist daily disposables (when they do):
1) Ecology and related issues: they feel too much plastic is being used and wasted, and they take up too much space
2) Economy: yearly costs are too high
3) QA: too many lenses are defective
4) Comfort: they are just not as comfortable as their extended use lenses.

Stewart Gooderman, OD
San Francisco, CA

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Research Review
S. Barry Eiden, OD, FAAO

I'm allergic to my contact lenses - Can it be real?

A literature review was recently published to investigate the evidence or lack thereof pertaining to the antigenic properties of silicone which is utilized in the production of silicone hydrogel contact lenses. The question posed was if such an antigenic response could be at the heart of reported increases in contact lens associated inflammatory events such as corneal infiltrates.

Following their review of the literature the authors stated that immune cells cannot interact with silicone directly but can interact with antigens on these lenses. These antigens could be due to tear film deposits, microbial contamination, or components of care systems used with these lenses. The conclusion of their review was that the inflammatory events found with silicone hydrogel contact lenses cannot be due to an allergic reaction to silicone itself.

It is not uncommon to hear statements by both patients and their eyecare practitioners that they experienced an allergic reaction to their contact lenses. While this paper indicates that allergy to the contact lens material is not what is occurring, associated factors such as deposits on contact lenses, solutions used with contact lenses and others are in fact responsible for the immunological inflammatory responses. Undoubtedly certain contact lens materials can promote specific lens deposits and may have specific interactions with certain care solution components. Understanding these relationships will allow the contact lens practitioner to better address these complications and minimize their chances for occurrence.

Hall BJ, Jones LW, Dixon B. Silicone allergies and the eye: fact or fiction? Eye Contact Lens. 2014 Jan; 40 (1): 51-7

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Materials & Designs
David Kading, OD, FAAO

Multifocal Lens Optics: ERROR ERROR (part 1)

Multifocal lenses are certainly a major blessing, however at times they can really take a lot of chair time. There are times when a patient just does not get the vision that they desire and when performing VAs we do not get the sight that we expected from the lens. Every company has updated their fitting guide within the last couple years, and by simply following them, we can make a dramatic improvement, but not always. A couple years back, our colleagues at Pacific University lead by Dr. Matt Lampa decided to perform topography over multifocal contact lenses. What they discovered is that the line of sight does not always pass through the center of the cornea. This difference is called angle lambda. By noting which patients are failing with their lenses due to this misalignment, we can dramatically reduce our headaches. Tune in next time to discover quick ways to observe this misalignment and which lenses to turn to.

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Clinical Performance of a New Hybrid Contact Lens for Keratoconus
The objective of this study was to compare the clinical performance of the Clearkone hybrid contact lens for the treatment of keratoconus against the habitual contact lens of the patients.

A total of 33 eyes from 18 patients were fitted with the Clearkone. High- and low-contrast visual acuity (HCVA and LCVA), central corneal thickness (CCT), and contrast sensitivity acuity (CSF) were recorded with habitual lenses (prestudy visit) and after 1 week, 15 days, and 1 month of wear of prescribed Clearkone. Subjective vision and comfort were rated using visual analogue scales (VAS).

Three patients discontinued the study, one because of diffuse corneal staining after 1 day of use and the other two because of extreme discomfort. The rest of the patients completed the 1-month study. High contrast visual acuity and LCVA (logMAR) improved significantly from 0.16 ± 0.12 and 0.44 ± 0.22, respectively, with the patients habitual contact lenses to -0.006 ± 0.058 and 0.23 ± 0.13 after 1 day wearing Clearkone, remaining significant during all follow-up visits (P<0.001; repeated measures analysis of variance [RM-ANOVA]). There were no statistically significant differences in the mean CCT. The improvement of CSF was statistically significant with hybrid contact lenses prescribed compared with the patients habitual contact lenses (P<0.001; RM-ANOVA test). Improvement in VAS score, with prescribed Clearkone, was statistically significant for comfort (P=0.043; RM-ANOVA test), but not for the subjective vision (P=0.759; RM-ANOVA test).

The authors concluded that Clearkone provides an improvement in visual acuity, contrast sensitivity, and subjective comfort in patients with keratoconus when compared with other contact lens options. However, clinicians must get specific training to fit the lens and be aware of potential adverse events.

Carracedo G, Gonzlez-Mijome JM, Lopes-Ferreira D, Carballo J, Batres L. Clinical Performance of a New Hybrid Contact Lens for Keratoconus. Eye Contact Lens. 2014 Jan;40(1):2-6.

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Important Links:
To report adverse contact lens reactions visit: http://www.accessdata.fda.gov/scripts/medwatch/ or call (800) FDA-1088.
To report possible grievances related to the Fairness to Contact Lens Consumers Act or associated Contact Lens Rule visit: https://www.ftccomplaintassistant.gov/.

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