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Sunday, January 2, 2011  
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Materials & Designs
Ronald K. Watanabe, OD, FAAO

With the New Year comes a new product with new materials and a new design, which is a welcome addition in the area of hybrid lenses given the limited number of lens offerings in this category. The Duette is the latest hybrid offering by SynergEyes. The rigid center is made of a new high Dk (130), high modulus GP material that blocks UV. The soft skirt is a new silicone hydrogel material with a Dk of 84 and low modulus to promote durability and protein resistance. The surface is plasma treated to create a low wetting angle.

The design of Duette is different from the SynergEyes A lens. The GP center is still 8.4 mm in diameter, but the optic zone diameter was decreased to 7.0 mm and the peripheral curve, now called the "junction lift area", was increased to 0.75 mm in width. The radius of curvature of the junction lift area is flatter than the base curve and the soft skirt, allowing the GP-skirt junction to be lifted off the cornea and improving tear exchange and movement. The base curve is selected about 1 D steeper than flat-K, which is a little flatter than the A design, resulting in an alignment fit in the central GP portion. The Duette is available in single vision and multifocal designs.

Research Review
Loretta B. Szczotka-Flynn, OD, PhD, MS, FAAO
At the recent American Academy of Optometry Annual Meeting, the Section on Cornea, Contact Lenses and Refractive Technologies held a symposium on corneal collagen crosslinking as a treatment for keratoconus and corneal ectasia. A less well known potential application of crosslinking is the treatment of recalcitrant microbial keratitis. Makdoumi and colleagues from Sweden (Cornea 2010) published a case series of seven eyes with severe infectious keratitis and corneal melting that were treated with collagen crosslinking. In six cases the patients experienced improvement in symptoms within 24 hours and two patients reported no symptoms whatsoever by 24 hours. Corneal melting was arrested and complete epithelialization was achieved in all cases. In two eyes with hypopyon, it regressed completely within two days after the procedure.

This case series and other reports suggest that collagen crosslinking could be an effective tool in battling difficult cases of infectious keratitis. Its important to note this procedure is still experimental in the United States and the current active trials in the US are being performed for the treatment of corneal ectasia and keratoconus. Further investigation of this procedure in the US and abroad are needed to uncover the safety and efficacy of this procedure for other conditions such as resistant microbial keratitis.

Makdoumi K, Mortensen J, Crafoord S. Infectious keratitis treated with corneal crosslinking. Cornea. 2010 Dec;29(12):1353-8.
NEWS

SynergEyes Expands Parameters for Duette for Astigmatism

SynergEyes, Inc. has expanded the parameters of its new silicone hydrogel hybrid contact lens for astigmatism, Duette. Duette is currently available in limited release in the U.S., at select practices. A nationwide launch began January 1, 2011.

Duette is now available in sphere powers from +4.00D to -12.00D. This expansion in parameters is the first of additional parameter expansions planned for 2011. Because the hybrid platform is rotationally symmetric, Duette is approved to correct up to 6 diopters of corneal astigmatism without having to worry about axis shift, as reported by the company.

The Duette lens features a new SynergEyes-developed GP material, MaxVu and a proprietary Flex2O silicone hydrogel skirt. The high modulus MaxVu GP has a Dk of 130 and incorporates a class II UV blocker, while the low modulus silicone hydrogel skirt has a Dk of 84 and is 32% water. A patent-pending surface treatment, HealthyEyes, increases wettability and resists protein deposits to maximize comfort, according to the company.

For more information, contact SynergEyes at 877-733-2012.

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B+L Extends Crystalens Patient Rebate Program

Bausch + Lomb (B+L) announced that it will extend its "See Better and Save" patient rebate program for patients who have the Crystalens accommodating intraocular lens (IOL) implanted before March 31, 2011. Patients will be eligible for a rebate of up to $250 per eye.

The "See Better and Save" program was introduced by the company last fall. The rebate is available regardless of the patient's choice of physician, hospital or surgical center.

Crystalens is the only FDA-approved accommodating intraocular lens. For more information about the Crystalens, please visit www.crystalens.com.

RegeneRx's RGN-259 Phase 2 Trial Begins

RegeneRx Biopharmaceuticals, Inc. announced that the first patient has been screened and is being enrolled in a Phase 2 clinical trial testing the company's drug candidate RGN-259 in patients with dry eye associated with graft vs. host disease. The double-blind, placebo-controlled, investigator-sponsored trial is expected to enroll a total of 20 patients over the next several months, with data reported later in 2011. RGN-259 is a sterile, preservative-free topical eye drop formulation of the novel therapeutic peptide Thymosin beta 4, or Tβ4.

The clinical trial is being conducted under a physician-sponsored IND in Detroit, Michigan. Steven Dunn, MD, the principal investigator in this study, is an ophthalmologist and corneal specialist who previously treated a group of patients with recalcitrant neurotrophic keratitis with RGN-259. In a group of six such patients, Dr. Dunn reported substantial healing within the treatment period or follow-up. His results have been published in the Archives of Ophthalmology.

Treatment of chronic nonhealing neurotrophic corneal epithelial defects with thymosin beta 4. Dunn SP, Heidemann DG, Chow CY, Crockford D, Turjman N, Angel J, Allan CB, Sosne G. Arch Ophthalmol. 2010 May;128(5):636-8.

Global Specialty Lens Symposium, January 27-30, 2011, Paris Hotel & Casino in Las Vegas

There is still time register for the Global Specialty Lens Symposium! With an expert international faculty and a CE-accredited agenda, the 2011 GSLS will include insightful presentations by experts in the field, hands-on demonstrations of cutting-edge products as well as scientific papers and posters. Look for more detailed information in Contact Lens Spectrum and online at www.GSLSymposium.com.
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B+L Appoints Heinick as Corporate Vice President, Global Human Resources and Transformation

Bausch + Lomb (B+L) has named Rick Heinick as Corporate Vice President, Global Human Resources and Transformation.

Mr. Heinick most recently served as a senior partner with Schaffer Consulting, where he advised executives on organizational transformation and people issues. A member of Schaffer's leadership team, Mr. Heinick was an advisor to a number of multinational companies in the health care sector during his 15-year tenure with the firm, including B+L. Other clients included Johnson & Johnson, C.R. Bard, and Schering-Plough.

Prior to Schaffer Consulting, Mr. Heinick was the founder and president of PPS, Inc., a software company focusing on increasing people's performance. He began his career with Mercer Management Consulting.



This month at www.siliconehydrogels.org: Children and contact lenses, myopia progression, use of silicone hydrogels for patients with epidermolysis bullosa, and our synopsis of silicone hydrogels at the 2009 ARVO meeting.
Editor's Commentary
Jason J. Nichols, OD, MPH, PhD, FAAO

In our last CL Today Quick Poll, we asked about your impressions regarding the impact of daily disposable lenses on complications in general. The vast majority of you felt that daily disposables were associated with a reduction in overall complications. In the next series of Quick Polls, we'd like to get your opinion on the impact of daily disposables on specific complications associated with lens wear.

Thank you for providing this very important feedback.

CLToday Quick Poll

If you are having problems voting, your email settings may be blocking you. Click here to vote through your browser.
Reader Commentary
We hand out an "instruction" sheet to every new contact lens wearer (new to contacts or new to our office) and tell them to be sure to read it over carefully. When they show up for their follow up appointment and we've reviewed the fit, they are required to answer ten "true or false" questions related to the instruction sheet. If they don't get all of them right, we make sure they are told to re-read the instructions and what the proper care of the lenses should entail. It really drives the point home.

Jeffrey Anshel, OD, FAAO
President, Ocular Nutrition Society
Abstract
Soft CL Biosensor for In Situ Monitoring of Tear Glucose as Non-Invasive Blood Sugar Assessment

A contact lens (CL) biosensor for in situ monitoring of tear glucose was fabricated and tested. Biocompatible 2-methacryloyloxyethyl phosphorylcholine (MPC) polymer and polydimethyl siloxane (PDMS) were employed as the biosensor material. The biosensor consists of a flexible Pt working electrode and an Ag/AgCl reference/counter electrode, which were formed by micro-electro-mechanical systems (MEMS) technique. The electrode at the sensing region was modified with glucose oxidase (GOD).

The CL biosensor showed a good relationship between the output current and glucose concentration in a range of 0.03-5.0mM, with a correlation coefficient of 0.999. The calibration range covered the reported tear glucose concentrations in normal and diabetic patients.

Also, the CL biosensor was applied to a rabbit for the purpose of tear glucose monitoring. The basal tear glucose was estimated to 0.11mM. In addition, the change of tear glucose induced by the change of blood sugar level was assessed by the oral glucose tolerance test.

The researchers reported that, as a result, tear glucose level increased with a delay of 10 minutes from blood sugar level. The result showed that the CL biosensor is expected to provide further detailed information about the relationship between dynamics of blood glucose and tear glucose.

Chu MX, Miyajima K, Takahashi D, Arakawa T, Sano K, Sawada SI, et al. Soft contact lens biosensor for in situ monitoring of tear glucose as non-invasive blood sugar assessment. Talanta. 2011 Jan 15;83(3):960-5.


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