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Sunday, June 23, 2013  
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Editor's Commentary - Jason J. Nichols, OD, MPH, PhD, FAAO

There are numerous technologies that are becoming available or emerging relative to the clinical management of dry eye disease. Some are promising, while others are still a way off. Please look at our Annual Dry Eye Issue of Contact Lens Spectrum, which publishes each July and will be available soon. It is packed full of information on these aforementioned new technologies, in addition to potentially promising treatments for dry eye disease.

Menicon Progent Large Diameter Contact Lens Case Receives FDA Clearance

Menicon America Inc., announced its subsidiary company, Lagado Corporation (Englewood, CO), received FDA clearance for the Menicon Progent Large Diameter Contact Lens Case - a non-vented barrel-style case designed for deep cleaning large diameter GP lenses (11 mm to 23 mm) in Menicon Progent.

The case is molded polycarbonate (PC) and the non-vented screw cap and lens basket are molded acrylonitrile-butadiene-styrene (ABS). The two compartments of the lens basket are marked ("L" or "R") for ease in lens identification. The procedure for the Menicon Progent treatment is the same as for smaller diameter lenses, except that instead of inserting lenses into the holder, the lenses will be place in the appropriate basket compartment within the case.

The Progent large diameter lens case will be available for purchase on the Menicon WebStore in early July. The company welcomes eyecare practitioners to call 800-636-4266 or visit the Menicon WebStore at https://store.meniconamerica.com/ecp for further information.

Visionary Optics Introduces 16mm Europa Scleral Lens

Visionary Optics LLC announces the release of a 16mm version of the Europa Scleral lens to complement the 18mm Europa Scleral lens introduced earlier this year. The new lens is available in both a 7-lens and 14-lens diagnostic fitting set.

With the 18mm, and now 16mm, version of the Europa Scleral lens, Visionary Optics has refined its Jupiter Scleral technology and capitalized on the design tenets of a true scleral lens with the goal of improving fit and comfort, according to the company. A modified scleral zone and enlarged optic zone are designed to optimize scleral landing and improve corneal vault. The new design also incorporates a reverse curve to fit a wider range of corneas, simplifying the fitting process. Visionary Optics will continue to offer the lowest cost scleral lens diagnostic set in the industry in order to give its new and existing customers a great opportunity to experience fitting their scleral design on irregular cornea patients.

For more details and further information, please visit http://www.visionary-optics.com/europa-scleral or call 877-533-1509.

Oasis Medical and Shape Ophthalmics Announce Joint Venture

Oasis Medical Inc., manufacturer and distributor of high quality reusable and disposable surgical instruments, punctal occlusion devices, and ocular lubricating and cleansing solutions, and Shape Ophthalmics, LLC, announced a joint venture to introduce a proprietary shape memory plug technology triggered by natural body heat. This unique punctal plug for the treatment of dry eye will be manufactured exclusively by Oasis Medical Inc. for worldwide distribution.

Shape Ophthalmics LLC is a company founded by Malik Kahook, MD, Naresh Mandava, MD and Robin Shandas, PhD, faculty members from the University of Colorado's Ophthalmology and Bioengineering departments. Among its research endeavors, Shape Ophthalmics is currently exploring several innovations in medical devices for use in ophthalmic practice.

Oasis expects to begin distribution of the plug in 2014. For more information on Oasis Medical Inc. visit www.oasismedical.com.

Nicox to Promote Test for Early Detection of Sjögren's Syndrome to Eyecare Practitioners

Nicox S.A. announced that it has entered into an exclusive agreement with Immco Diagnostics Inc., a worldwide leader in autoimmune diagnostic products and services, to promote a proprietary laboratory test targeted at early detection and diagnosis of Sjögren's Syndrome to eyecare professionals in North America (U.S., Canada, Puerto Rico, Mexico). Dry eye is one of the early primary symptoms of the disease and the collaboration will give eyecare practitioners and their patients' increased access to this new and unique test.

Nicox will be responsible for all marketing activities, while Immco will carry out the test in its CLIA-approved laboratory in Buffalo, NY, and be responsible for regulatory activities and reimbursement. Nicox also has a nine month option to negotiate an agreement to promote the test in the rest of the world. During this period, Immco and Nicox are planning to study and evaluate the feasibility and implementation steps for the test in other markets, including Europe.

In the U.S. alone, it is estimated that more than 20 million patients aged 40 years and older have dry eye disease.1 Studies indicate that 10% of these may have early stage, yet to be diagnosed, Sjögren's Syndrome.2 At present, many of these patients who develop the advanced disease will not be diagnosed until much later by another medical specialty.

The new laboratory test is a highly sensitive and specific diagnostic test combining three novel proprietary biomarkers (SP-1, CA-6, PSP) and the traditional markers (ANA, Ro, La, RF). According to the company, this breakthrough test can aid in diagnosing Sjögren's Syndrome at an earlier stage compared to traditional methods. The test was approved by the appropriate U.S. regulatory authorities in 2013, and is already available to doctors across North America.

1. 2010 Datamonitor report
2. Liew MS, Zhang M, Kim E, Akpek EK. Prevalence and predictors of Sjögren's syndrome in a prospective cohort of patients with aqueous-deficient dry eye. Br J Ophthalmol. 2012 Dec;96(12):1498-503.

Your Interesting Case Photo Here

Have you seen an interesting case lately? Would you like to share it with your colleagues? An image from that case could appear in this column next week!

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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Katherine M. Mastrota, MS, OD, FAAO

Is Hypercholesterolemia a Risk Factor for Dry Eye?

A June 2013 Korean population-based study1 enrolled 5,627 adults who participated in the Korea National Health and Nutrition Examination Survey. Clinically diagnosed DED and its symptoms were surveyed, and biochemical blood analysis data were collected. Dyslipidemia was defined as any of the following: hypercholesterolemia (total cholesterol >200mg/dL), hypertriglyceridemia (triglyceride >150mg/dL), low levels of high-density lipoprotein (<40mg/dL), or high levels of low-density lipoprotein (>100mg/dL). After adjusting for demographics (age and body mass index), lifestyle (smoking, drinking, exercise, and residential district), and medical factors (diabetes, hypertension, previous ophthalmic surgery, menopause, and rheumatologic disease), elevated serum cholesterol level was found to be associated with increased likelihood of DED in women.

The authors suggest that increased cholesterol in the meibomian lipid would increase its melting point to 46°C versus the normal meibomian lipid melting point of 30-34°C and, thus, lead to increased viscosity and plugging of the meibomian orifice. Although the authors point out that in the Beaver Dam Eye study, Moss et al. found that the incidence of DED was not significantly associated with serum total cholesterol, HDL, or cardiovascular diseases after controlling age and gender in population-based cohort,2 they suggest that the results of this study highlight the significance of eye examinations and lipid profile monitoring in dyslipidemia patients due to the possible correlation with DED. Further studies are needed to confirm the exact mechanism and correlation between DED and dyslipidemia.

1. Chun YH, Kim HR, Han K, Park YG, Song HJ, Na KS. Total cholesterol and lipoprotein composition are associated with dry eye disease in Korean women. Lipids Health Dis. 2013 Jun 5;12(1):84
2. Moss SE, Klein R, Klein BE. Prevalence of and risk factors for dry eye syndrome. Arch Ophthalmol. 2000 Sep;118(9):1264-8.

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Susan J. Gromacki, OD, MS, FAAO

GP Lens Nonwetting

Occasionally, a new gas permeable (GP) contact lens will exhibit areas of nonwetting on its front surface. This can occur with both plasma- and non-plasma-treated lenses. According to some manufacturers, this can be more prevalent with scleral GP lenses. One theory is that since the lens blank for sclerals is larger than for small corneal lenses, the diamond lathe makes contact with the lens blank for a greater amount of time, thus creating additional heat and resulting in nonwetting.

While the manufacturing community works on finding a permanent solution, there are some simple solutions for us clinically. First, request a new lens from your laboratory. Nonwetting is fortunately a rare enough occurrence that a new lens will likely be just fine. However, if your patients are like mine and want/need the lens immediately, there is something you can do. First, clean the lens with an alcohol-based daily cleaner (see list from CL Today April 7, 20131 or Sof/Pro2 (Lobob)); a daily cleaner such as Optimum (Lobob); or an extra-strength cleaner such as Boston Laboratory Cleaner (Bausch + Lomb). Then rinse the lens with tap water and massage it with a soft multipurpose solution containing a viscous wetting agent.* Lastly, apply the appropriate fluid for lens application (conditioner for corneal lenses or non-preserved saline for scleral lenses) and insert the lens. Note that although the in-office surface modifications will solve the problem, they may also negate the effect of a plasma treatment.

*consult your laboratory for its specific recommendations
1. http://www.cltoday.com/issues/CLToday_040713.htm

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Selection of an Initial CL Power for Infantile Cataract Surgery without Primary IOL Implantation

The purpose of this article is to provide guidelines for the selection of an initial contact lens (CL) power based on the preoperative characteristics of the patient in eyes undergoing infantile cataract surgery without primary intraocular lens (IOL) implantation. Included in this cohort study were eyes on which cataract surgery was performed without primary IOL implantation before 1 year of age, a SilSoft CL (Bausch + Lomb, Rochester, NY) was placed immediately after surgery, and postoperative refraction data were available within 1 month after surgery.

The target CL power was calculated by using the postoperative refraction at the corneal plane for each eye. A regression formula was derived using the targeted CL power and the axial length (AL). The CL power also was estimated using various formulas. An A-constant was derived to estimate CL power using IOL power calculation formula. Main outcome measures included contact lens power.

Fifty eyes of 50 patients were analyzed. Age at the time of cataract surgery was 2.4+/-1.7 months. Refraction at the corneal plane was 29.6+/-4.4 diopters (D). Regression analysis revealed that CL power = 84.4 - 3.2 x AL (R2 = 0.82; P<0.001). Contact lens power can be estimated using an A-constant of 112.176 in the IOL power calculation formula. If a CL power of 32 D had been used, 22 (44%) of 50 eyes would have needed a replacement of CL.

The authors devised guidelines on selecting the initial CL power based on preoperative AL. The IOL power calculator also can help to estimate CL power. Refraction at the conclusion of surgery in infants may be difficult, and preoperative biometry can be used to estimate CL power.

Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Trivedi RH, Wilson ME. Selection of an Initial Contact Lens Power for Infantile Cataract Surgery without Primary Intraocular Lens Implantation. Ophthalmology. 2013 May 21. [Epub ahead of print]

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