Scleral contact lenses can have a significant impact on our patients’ lives in terms of vision, comfort, and associated quality of life. That said, scleral lenses can also be associated with various complications. This is where you come in—please take a few moments to respond to our December Quick Poll below to help us understand the frequency of scleral lens complications. We look forward to sharing the results with you next week!
Jason J. Nichols, OD, MPH, PhD
Menicon America Launches Miru 1month Menicon in United States
Menicon America now offers in the United States Miru 1month Menicon, a monthly replacement silicone hydrogel lens in spherical, toric, and multifocal designs. Reformulated for the U.S. market, Miru 1month Menicon obtained U.S. Food and Drug Administration approval in February 2018.
Miru 1month features unique geometry to control and minimize lens thickness across the whole lens surface and the entire power range, according to Menicon. Moreover, the Miru 1month toric has a prism-free optic zone and an asymmetric Thin Zones profile to help maximize oxygen transmissibility over the cornea. Menicon says that the Thin Zones design also optimizes centration and minimizes rotation.
The Miru 1month family utilizes proprietary MeniSilk and Nanogloss technologies to achieve high wettability and excellent anti-fouling properties against surface contaminants while maintaining satisfactory oxygen permeability, according to the company. A unique edge profile is designed to provide uniform comfort regardless of lens power.
Miru 1month Menicon is manufactured in asmofilcon A, which has a water content of 40% and a reported Dk/t at –3.00D of 161. Sphere lens parameters include 8.3mm and 8.6mm base curves, 14.0mm diameter, and powers of +6.00D to –6.00D (0.25D steps) and from –6.50D to –13.00D (0.50D steps), no plano. Toric lens parameters include 8.6mm base curve, 14.0mm diameter, sphere powers of plano to –6.00D (0.25D steps) and –6.50D to –10.00D (0.50D steps), and cylinders of –0.75D, –1.25D, and –1.75D in axes of 10º to 180º (10º steps). Multifocal lens parameters include 8.6mm base curve, 14.2mm diameter, sphere powers of +6.00D to –6.00D (0.25D steps) and –6.50D to –13.00D (0.50D steps), and a Low add power. All three designs have a center thickness of 0.08mm at –3.00D.
Alcon Introduces New Medical Affairs Website in North America
Alcon launched a new website, AlconScience.com, for U.S.- and Canada-based eyecare professionals and academic institutions. The new medical affairs website consolidates information about Alcon’s scientific, academic, and related activities into one portal. Visitors can download clinically focused publications, submit grant applications for Investigator-Initiated Trials (IITs), apply for independent medical education support, and apply for educational equipment donations, among other activities.
Visioneering Technologies Inc. Appoints Brian Lane as CFO
Visioneering Technologies Inc. (VTI) has named Brian D. Lane, CPA, as its CFO. Mr. Lane’s responsibilities will include investor relations, strategic planning, and financial reporting as well as legal oversight and regulatory compliance.
Mr. Lane’s career spans more than 30 years. Most recently, he served as CFO with OnePath, a private equity-owned services firm that designs, deploys, and supports technology. Previously, he was controller of PRGX, a global recovery audit and business analytics firm, and he held senior financial positions at several other companies in the financial services, franchise, and manufacturing industries.
FDA Clears Daily Disposable SiHy Contact Lens Coated with Modified Formula of Tangible Hydra-PEG
Tangible Science, LLC announced that the U.S. Food and Drug Administration (FDA) has cleared the first daily disposable silicone hydrogel (SiHy) contact lens coated with a modified formula of Tangible Hydra-PEG. Tangible Hydra-PEG is a coating applied to custom contact lenses to improve lens wettability and deposit resistance, and the new lens utilizes a variation designed to enhance the surface of daily wear lenses.
The newly approved contact lens will initially be available in a single vision, aberration-control design. Future products utilizing the modified Tangible coating will include daily disposable toric and center-distance aspheric designs.
In Memoriam: Brian Banks
Brian Banks, founder and president of Natural Ophthalmics, passed away peacefully on Dec. 2, 2018 after a brief but serious illness. He is survived by two children and a diverse group of family and friends whose lives Brian touched and who miss him greatly.
Mr. Banks started his career in industrial lighting sales, which brought him into contact with many businesses. One of those businesses was the U.S. sales office of a major Swiss homeopathic producer. During that time, he was also a volunteer firefighter. After a house-fire training session in which his eyes became red and inflamed, he reached out to the homeopathic company to see whether he could try its eye drops. Not only did the eye drops help his situation, but because of his enthusiasm, the company offered him a job as a U.S. sales representative.
He started Natural Ophthalmics shortly after leaving that company in 2000, with the mission of providing a high-quality line of eye drops and eye-health supplements to eyecare professionals that could be sold in-office directly to patients.
Natural Ophthalmics continues to thrive and will continue to grow under the dedicated management team created by Mr. Banks over the years. These individuals reflect the values he embodied: kindness, compassion, care for people, and the desire to help alleviate suffering. Natural Ophthalmics was his dream, and now it is his legacy. He will truly be missed.
In Memoriam: Thomas F. Steiner
Long-time contact lens and marketing executive Thomas F. Steiner, 73, passed away on Dec. 6 after a long illness. Steiner spent 35 years as a visionary marketing executive in the optical industry with Wesley Jessen and Ciba Vision and later started a business as a marketing consultant. Among his many accomplishments was his involvement in the launch of cosmetic color contact lenses and in the creation of several unique strategic programs for educating optometrists about the business aspects of practice. He was a mentor to many in the industry.
While at Wesley-Jessen in the 1980s and 1990s, Steiner headed the marketing team for the DuraSoft Colors contact lens brand. When Wesley-Jessen was acquired by Ciba Vision, Steiner joined Ciba but then left to consult in the optical field. He partnered with Jobson Optical Group on many projects.
He is survived by his wife of 51 years, Linda; a son and daughter-in-law Ted and Monica; three grandchildren; and four siblings.
Opternative Changes Name to Visibly
Opternative announced that it has changed its name to Visibly. According to the company, the new company name fully embraces the solutions that it offers to the eyecare industry and appropriately represents the broad scope of whom it can serve.
Vision Source Welcomes Michael Marcroft as New Vice President of Marketing
Michael Marcroft joined the Vision Source senior leadership team on Dec. 10, 2018. He will replace Randy Sones, currently vice president of marketing, who is retiring after a 27-year working history with Vision Source. As the vice president of marketing, Marcroft is responsible for the organization’s overall marketing strategies, initiatives, and communications.
Prior to joining Vision Source, he spent the past 18 years in healthcare marketing. Previous positions include global marketing responsibilities with Boston Scientific Corp., Medtronic, Inc., and Acelity, Inc. He most recently served as vice president, International Sales & Marketing for HyperMed Imaging, a pioneering medical imaging company based in Memphis.
Roger Lopez to Succeed Jim Murphy as Region President of Alcon Japan
Alcon appointed Roger Lopez as region president Alcon Japan, effective Jan. 1. Lopez succeeds Jim Murphy, who is retiring from the company after a nearly 25-year career with Alcon. Lopez is an experienced executive who has worked across multiple geographies, including Europe, Middle East & Africa (EMEA), Asia, and the United States. He will report to Ian Bell, president international, and join the Alcon executive leadership team (ELT).
Lopez, who began his career at Novartis in 1994 when he joined Ciba Vision Spain, has served for the past two years as area vice president of emerging markets with EMEA.. Prior to his current role, he held senior leadership positions within Asia, including vice president Asia Cluster Head and vice president South Asia and Pacific. Previously, Mr. Lopez was general manager of Alcon for the United Kingdom and Ireland.
Which of the following scleral lens ocular complications occurs most frequently in your practice?
This image shows a bubble under a scleral contact lens that is causing epithelial defects on a post-radial keratotomy fit. This patient reported that vision was not affected. However, the patient noticed discomfort after three weeks of lens wear.
We thank Dr. Wong for this image and welcome photo submissions from our other 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 a detailed explanation of the photo and your full name, degree or title, and city/state/country.
S. Barry Eiden, OD
Is There a Difference in How We Approach Astigmatism with Spectacles Versus Contact Lenses?
The development of technological advances in the management of astigmatism with soft contact lenses has been astounding. I have been in practice long enough to recall the time when patients were told that soft contact lenses would not be the best choice to address their astigmatism. Today, with the advent of amazingly stable soft toric lens designs, even high degrees of astigmatism at all axes can be addressed. The question remains: How have the advancements in soft toric lens technologies impacted prescribing habits by eyecare practitioners (ECPs)?
A recent study was published that compared prescribing trends between spectacles and toric contact lenses.1 The authors investigated and compared spectacle and contact lens (CL) prescription trends, with an emphasis on astigmatic refractive error prescribing differences for patients who purchase spectacles or CLs in South Korea. A retrospective study of patient records of a major optical chain in South Korea was conducted. De-identified data of age, gender, and power of prescribed spectacles and/or CLs were extracted from the practice database. Inclusion criteria was being within the first 10,000 purchasers of spectacles or CLs or both.
The first 10,000 purchases comprised spectacles (59%) and CLs (41%). Spherical power distribution of prescribed lenses was similar between the groups; however, cylinder power and axis were significantly different (P < 0.0001). CL astigmatic powers were more likely to be 1.00DC or greater, whereas the majority of spectacle lenses had astigmatic power of 0.75DC or less. In total, 90% of toric CLs were prescribed at × 180 and 9% for other meridians, unlike spectacles for which 50% were prescribed at × 180, 14% at × 90, and 40% at oblique meridians. The authors concluded that there still is an unmet portion of the population that has astigmatism and should be considered for contact lens wear.
Although this study took place in Korea and was based on data from a large optical chain, we can make some significant statements from its results that should be appropriate to generalize to most eyecare practices. Significantly more individuals who have astigmatism of both low powers (those well-known 0.75D astigmats) and against-the-rule and oblique axes should be considered for contact lenses.
In my view, we should no longer consider soft toric contact lenses to be "specialty CLs." The development of modern soft toric lenses has given ECPs an armamentarium of highly effective lenses that can address most forms of regular astigmatism. When you consider prescribing contact lenses for your next astigmatic patient, ask yourself the following: "Would I prescribe the cylinder in spectacles for this patient?" If the answer is "yes," consider prescribing the cylinder in the contact lens as well.
1. Chu BS, Boon MY, Noh DH. Comparing spectacle and toric contact lens prescribing trends for astigmatism. Clin Optom (Auckl). 2018 Nov 8;10:119-127.
OCULAR SURFACE UPDATE
Katherine M. Mastrota, MS, OD
The Next Frontier
My favorite group of meibomian gland dysfunction/dry eye disease/ocular surface disease colleagues will tell you that I believe that the conjunctiva is the next frontier of ocular surface disease.
Well, just published is the presumed first case of a palpebral conjunctival inflammatory nodule associated with Demodex species.1Demodex mite infestation of the palpebral conjunctiva as focal inflammatory nodule has not been previously reported, according to the authors.
In this case report, a 46-year-old man presented to an outpatient eye service with a complaint of lower palpebral conjunctival masses in one eye accompanied by ocular pain, tenderness, foreign body sensation, tearing, and conjunctival redness four weeks before consultation. Slit lamp examination showed focal inflammatory nodules at the inferior palpebral conjunctiva accompanied by conjunctival hyperemia and purulent secretion. Interestingly, cylindrical dandruff was not observed on the eyelashes. Excisional biopsy of this lesion was performed. Pathological evaluation revealed that these inflammatory granulomas were associated with Demodex species in the palpebral conjunctiva. Additionally, gram stains did not demonstrate fungal or bacterial infections.
The authors state that this appears to be is the first case report of ocular demodicosis initially presenting as focal inflammatory nodule at the palpebral conjunctiva. In addition, they note that Demodex sp. needs to be taken into consideration in the differential diagnosis of inflammatory granulomatous nodules in the palpebral conjunctiva.
Remember to critically examine the palpebral conjunctiva (upper and lower). You never know what you may find.
1. Li Y, Kim GE, Yoon KC, Choi W. First report of palpebral conjunctival inflammatory nodule associated with Demodex species. Indian J. Ophthalmol. 2018 Sep;66:1365-1367.
A Review of International Medical Device Regulations: Contact Lenses and Lens Care Solutions
Medical devices are under strict regulatory oversight worldwide, and such regulations prioritize patient safety and efficacy over anything else. Contact lenses fall under the medical device category—a result of direct contact with the eye. Equally regulated are the contact lens care solution products, which include cleaning and maintenance solutions and lubricating and rewetting drops.
In the United States, it is the U.S. Food & Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) that has been overseeing the regulations of medical devices since 1976. In the European Union, the EU Commission is responsible for regulating devices in Member States.
The categorization of contact lenses into medical devices is based on their inherent risk to wearers. Contact lenses are subject to crucial regulatory oversight from concept to clinical evaluation, clinical investigations through to the finished lens product, and finally, strict conditions associated with their marketing approval, including post-marketing surveillance. The physiochemical and manufacturing testing, such as biocompatibility testing alongside pre-clinical stability, sterility, and microbiological testing, are just some of the essential testing that lenses must undergo. Only through understanding the inherent risks and potential complications that can arise from contact lens wear can we truly appreciate the need to adhere to strict regulations.
The challenge, however, lies in the need for more standardized regulations and flexible approaches, ensuring that innovative device technologies reach patients in a timely manner without compromising public health and safety.
This review highlights some key requirements as well as differences and similarities between the FDA and EU administrations in the approval of contact lenses.
Zaki M, Pardo J, Carracedo G. A review of international medical device regulations: Contact lenses and lens care solutions. Cont Lens Anterior Eye. 2018 Nov 13. [Epub ahead of print]