As you read this editorial, the 11th Annual Global Specialty Lens Symposium, presented by Contact Lens Spectrum, is in its concluding moments of the program. This year continued its success covering a full range of topics that relate to specialty lenses, in addition to every other aspect of contact lens wear. We also noted record-breaking attendance, with more than 700 regular attendees registering for the meeting. Look forward to an upcoming, full length feature article summarizing the meeting in Contact Lens Spectrum in the months to come.
Jason J. Nichols, OD, MPH, PhD
FDA Joint Meeting to Discuss Peroxide-Based Contact Lens Products
The U.S. Food and Drug Administration (FDA) announced a forthcoming public advisory committee meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee. The meeting will be open to the public. The meeting will be held on March 17, 2017 at the Hilton Washington, DC North/Gaithersburg in Gaithersburg, MD.
The committee will discuss and make recommendations regarding the potential risks of misuse of peroxide-based contact lens products. Specific issues to be discussed include adequate labeling and packaging of these over-the-counter products. The FDA intends to make background material available to the public no later than two business days before the meeting here.
Bausch + Lomb (B+L) has resolved its patent infringement lawsuit versus Vitamin Health, Inc., filed in September 2013 in the U.S. District Court for the Western District of New York. Among other claims, the lawsuit accused Vitamin Health of infringing B+L’s U.S. patent 6,660,297 covering PreserVision AREDS and AREDS 2 Formula eye vitamins through Vitamin Health’s manufacture and sale of certain of its Viteyes eye vitamins.
On July 25, 2016, the court issued a decision and order awarding summary judgment to B+L on its motion that certain of Vitamin Health’s AREDS-based formula and AREDS2-based formula eye vitamins infringed the aforementioned patent. After proceeding to trial, the parties reached a settlement resolving other claims.
As part of the settlement, the court issued a consent decree on Dec. 20, 2016, reflecting that Vitamin Health has admitted the patent is valid and enforceable and that certain other of Vitamin Health’s AREDS and AREDS 2 Formula eye vitamins infringe the patent. Per the terms of the settlement, Vitamin Health has agreed to pay an undisclosed sum to B+L.
X-Cel Specialty Contacts Expands Atlantis Scleral Line
X-Cel Specialty Contacts has expanded its Atlantis Scleral product line with two new options. The Atlantis Scleral Multifocal is a bi-aspheric multifocal design that allows a controllable center-distance zone resulting in superior distance, near, and intermediate vision, according to X-Cel. The Atlantis Scleral 3D-Vault with Limbal Control Technology allows the limbal sag apex to be adjusted in/out or up/down, to customize and optimize peripheral clearance. Both can be fit utilizing the standard Atlantis fit set.
In addition, through a sublicense with Contamac, X-Cel is one of the first U.S laboratories to offer the Hydra-PEG coating technology on the Atlantis Scleral family of lenses and other GP lens designs manufactured in Optimum, Optimum Extra, and Optimum Comfort materials.
Mark Eaton Named CFO at Envision
Envision announced that it has named Mark Eaton as CFO. Reporting directly to CEO/President Michael J. Monteferrante, he will lead and support Envision’s accounting and IT operations and help accelerate the organization’s strategic path movement through acquisitions and the launch of new business initiatives.
Eaton joins Envision from a role as president of Great Lakes Polymer Technologies (GLPT). Prior to that position, he spent three years as CFO and COO of Fabpro Oriented Polymers, LLC. Earlier in his career, he was founder and president of Southwood Associates, LLC, a Minneapolis-based firm offering CFO and COO advisory services to private equity groups, corporations, and nonprofit organizations, and senior manager of mergers and acquisitions at Ernst & Young LLP in Chicago.
Paragon Vision Sciences Opens Education and Training Center
Paragon Vision Sciences launched the Paragon Education and Training Academy, a state-of-the-art learning and training center, located at the company’s new headquarters in Gilbert, AZ.
The high-tech facility includes a fully equipped media suite, capable of offering live-streaming content worldwide. The Academy will host a series of live monthly webinars from leading industry experts to help practitioners keep up to date on techniques and developments in myopia management, specialty contact lenses, and other subjects. Additionally, Paragon Vision Sciences will work with its strategic laboratory partners and experts from around the world to produce high-quality original digital video content in any language.
IACTA Pharmaceuticals Buys North American Rights to Nanomerics’ NM133
IACTA Pharmaceuticals, Inc., a privately held pharmaceutical company, has acquired the North American rights to develop and commercialize NM133, an investigational medicine designed to help treat dry eye, from its developer, Nanomerics, Ltd. Nanomerics is a privately held, UK-based, research-stage company with a proprietary Molecular Envelope Technology (MET) licensed from University College London that allows a hydrophobic drug such as cyclosporine to be encapsulated and delivered to the tissues of the eye. NM133 is a nano-enabled form of cyclosporine A that is being investigated for the treatment of dry eye.
BostonSight Introduces Scleral Lens Fitting System
BostonSight introduced a new system called BostonSight Scleral, for more easily fitting patients with scleral lenses that virtually eliminates any costly and time-consuming modifications, according to the nonprofit.
BostonSight Scleral offers the first fitting system with right- and left-eye anatomical designs. Available in 18.0mm, 18.5mm, and 19.0mm diameter designs, it uses a single starting point regardless of a patient’s condition. BostonSight Scleral is also the first scleral lens to provide front-surface eccentricity options, including, a quadrant-specific toric peripheral haptic system.
In addition to BostonSight Scleral, practices will be able to use BostonSight’s three-part program called Beyond the Fit for ongoing lens ordering and patient support. The program includes: FitConnect, a Web-based fitting and order management system; FitAssist, a lens voucher program, which allows BostonSight Scleral practitioners to provide their patients with financial assistance; and MyFitReport, a patient-generated health data (PGHD) program that provides practitioners with patient-specific feedback.
The BostonSight Scleral fitting system has no startup costs, and requires no extensive training or special equipment. Qualified practices receive complimentary diagnostic lens sets and online training webinars. To sign up a practice, register at www.BostonSightSCLERAL.org or call 888-SCLERAL.
Optometry Cares-The AOA Foundation Announces 2017 Scholarship Recipients
Optometry Cares-The AOA Foundation, the charitable organization of the American Optometric Association (AOA), announced the winners of the following scholarships for 2017:
InfantSEE Scholarship Grant: Jason Foote, Southern College of Optometry, was honored with first place ($7,500) and Alyssa Drew, Michigan College of Optometry–Ferris State University is runner-up and was awarded second place ($3,000).
Bernard Maitenaz Scholarship: Third-year student Paula Kutzner, Pacific University College of Optometry, is the recipient of the $10,000 scholarship.
Dr. Pat & Patrick Cummings Scholarship: Nathan Morrow, a fourth-year student from Indiana University College of Optometry was honored with the $5,000 scholarship.
Dr. Larry J. Alexander Scholarship for Education: Valerie Thatcher Tran, a third-year student at the University of California-Berkeley College of Optometry, is the recipient of the $2,500 scholarship. Additionally, the family of Dr. Larry Alexander bestowed a one-time “Inspiration Award” to Phuong Liem of New England College of Optometry in the amount of $1,000.
Dr. Seymour Galina Grant: Third-year student Seth Goolsbee, University of Houston College of Optometry, is the recipient of the $2,500 grant.
Bausch + Lomb’s Specialty Vision Products (B+L SVP) launched ScleralFil sterile buffered solution with no preservatives, which is indicated for application and rinsing of scleral lenses. This product will be available to order from the new SVP Web Store as well as through select Authorized Boston Manufacturers.
ScleraFil contains no preservative or mercury-containing ingredients that can be sensitive to some contact lens wearers, and is buffered to maintain pH. The solution is indicated for use to apply scleral lenses and can also be used to rinse soft (hydrophilic) and GP contact lenses to remove debris and traces of daily cleaner, prior to lens application.
S. Barry Eiden, OD
It’s Getting More Virtual…Computer-Based Contact Lens Fitting in Keratoconus
Computer-assisted contact lens fitting continues to develop for the management of both regular refractive errors and for irregular corneas. Topography data, as well as standard refractive and keratometric data, have been incorporated into virtual fitting nomograms that can determine a best “first lens” to either select from a diagnostic lens set or to order directly from the fabricating laboratory.
A recent article was published that attempted to calculate and validate a new web-based algorithm for selecting the back optic zone radius (BOZR) of spherical GP lenses in keratoconus eyes. A retrospective calculation (n=35; multiple regression analysis) and a posterior prospective validation (new sample of 50 keratoconus eyes) of an algorithm to select the BOZR of spherical KAKC design GP lenses (Conoptica) in keratoconus were conducted. BOZR calculated with the new algorithm, manufacturer guidelines, and APEX software were compared with the BOZR that was finally prescribed. The number of diagnostic lenses, ordered lenses and visits to achieve optimal fitting were recorded and compared those obtained for a control group [50 healthy eyes fitted with spherical GP (BIAS design; Conoptica). The algorithm highly correlated with the final BOZR fitted (r2 = 0.825, p < 0.001). BOZR of the first diagnostic lens using the algorithm demonstrated lower difference with the final BOZR prescribed (-0.01mm ± 0.12mm, p = 0.65; 58% difference ≤ 0.05mm) than with the manufacturer guidelines (+0.12mm ± 0.22mm, p < 0.001) and APEX software (-0.14mm ± 0.16mm, p = 0.001). The authors concluded that this new algorithm (free access at www.calculens.com) improves spherical KAKC GP fitting in keratoconus and can reduce the practitioner and patient chair time to achieve a final acceptable fit in keratoconus.
Virtual contact lens fitting has the potential advantage of increased efficiency and accuracy versus diagnostic lens fitting. There are many software programs now available for such virtual contact lens fitting. Many corneal topography instrument companies have such software incorporated into their instruments and often direct linkage with fabrication laboratories are possible. New diagnostic technologies are also being developed that can not only measure corneal shape, but can extend out peripherally and enable measurement of cornea-scleral profiles. These systems can allow for customization of scleral contact lenses, which can be fit virtually as well. We can expect further developments of these technologies that can help us provide optimal outcomes for our patients.
1. Ortiz-Toquero S, Rodriguez G, de Juan V, Martin R. New web-based algorithm to improve rigid gas permeable contact lens fitting in keratoconus. Cont Lens Anterior Eye. 2017 Jan 2. [Epub ahead of print]
OCULAR SURFACE UPDATE
Katherine M. Mastrota, MS, OD
Lashing out Against Oils
I spend lots of time looking and thinking about the eye’s anterior segment. However, examining the posterior segment, of course, is part of a patient’s comprehensive clinical evaluation. For this task, I often use a widefield, non-contact vitreo-fundus lens. The lens I use needs to be held quite close to the eye for the best retinal view.
Here’s the thing: At the end of every day, or sometimes even during the day, I need to clean away oily debris from the surface on my fundus lens. This oil is transferred from the patient’s eyelashes. I have been wondering about the origin of this “lash-oil” and welcome your ideas. I believe the eyelash oil is derived from multiple sources.
We do know that a healthy eyelash follicle has a sebaceous gland that services the eyelash. I would imagine this is the primary oil that coats my fundus lens. However, there is the question of sebum from the skin, and yes, oils from the meibomian glands. There is a natural “boundary” (the Marx line) in the lid margin that segregates these oils; but, in lid disease, this is altered. Do we have lipid mixing on the lashes as these oils merge and/or migrate onto the eyelash surface?
Then we have all the products that patient’s apply to the skin and the eyelashes, such as moisturizers, cosmetics, shaving products, and dermatology medications. All these products have an opportunity to leave traces on the lashes, contributing to my “oily lens” problem.
These oils are deposited to my non-contact lens by the eyelashes brushing across the surface of the lens when the patient blinks. How does this same transfer of mixed oil impact the ocular surface? We are singular in thinking about the lipid contribution to the tear film. Is there more than meibum?
Meibomian Gland Dysfunction and Contact Lens Discomfort
Meibomian glands are located in the eyelids and secrete meibum, which gives rise to the lipid layer of the tear film. Changes to these glands can lead to the development of meibomian gland dysfunction (MGD), which is associated with various ocular symptoms such as fatigue, dryness, burning sensation, and heavy sensation. Thus, the diagnosis of MGD relies on evaluation of ocular symptoms, meibum condition, and lid margin abnormalities. The recent development of noninvasive meibography and tear interferometry has provided important insight into meibomian gland structure and function, respectively. Wearers of contact lenses complain of ocular symptoms that are thought to be attributable to a variety of causes, such as a diminished aqueous or mucin layer of the tear film, changes in tear protein concentration, and altered meibomian gland structure or function.
Many studies have examined the relationship between contact lens wear and meibomian gland changes. Such studies have found that lens wear is associated with adverse changes in meibomian gland morphology and in the condition of the lid margin and meibum, suggesting that contact lenses negatively affect meibomian glands. MGD—like changes in meibomian glands induced by contact lens wear, may therefore be responsible for at least some of the ocular symptoms in lens wearers.
1. Arita R, Fukuoka S, Morishige N. Meibomian Gland Dysfunction and Contact Lens Discomfort. Eye Contact Lens. 2017 Jan;43:17-22.