Each January, we publish our Annual Report in Contact Lens Spectrum that summarizes the contact lens market as best as we can for the prior year. We also publish the “Contact Lens Event of the Year”—something from the prior year that we think stands out in the field of contact lenses. It’s traditional for us to solicit nominations for this event from our readership. If you have a nomination—a person, event, idea, technology, theme, etc., that you think is substantial in the contact lens field and that stood out in 2019—please let us know by emailing me directly at email@example.com.
Jason J. Nichols, OD, MPH, PhD
AOA Pushes for FDA Recall of 1-800 Contacts’ Online Vision Test
The American Optometric Association (AOA) is asking the U.S. Food and Drug Administration (FDA) for a product recall of 1-800 Contacts’ online vision test, in light of what the AOA considers recent comparable action against Visibly’s “strikingly similar” online eye test.
On Aug. 8, the FDA posted a recall notice for Visibly’s device because of a “lack of 510(k) clearance.” For more than three years prior to the recall, the AOA had pushed the issue with the FDA due to concerns that the test marketed by Visibly potentially posed serious health risks to the public and did not comply with federal law.
Similar to Visibly, 1-800 Contacts appears to have neither applied for premarket clearance for its ExpressExam online eye test nor met the standard of being substantially equivalent as a legally marketed visual acuity test, according to the AOA. In light of this, the AOA recommends that the FDA should not permit the continued marketing of the 1-800 Contacts device until the FDA’s Center for Devices and Radiological Health (CDRH) has reviewed the safety and efficacy issues raised by the device.
This is not the first time that the AOA has complained to a federal agency about 1-800 Contacts’ marketing and safety. For example, this past spring, 1-800 Contacts changed how it marketed its online eye test after the AOA complained about the name of the device to the Federal Trade Commission, specifically its use of the term “exam” in the name of the device.
J&J Issues Voluntary Recall for Certain Contact Lenses in the United Kingdom
Users of certain Johnson & Johnson (J&J) Acuvue daily disposable contact lenses are being urged by the Medicines and Healthcare products Regulatory Agency (MHRA) to check their lenses due to a voluntary product recall of specific lots initiated by the company in the United Kingdom. The recall affects a low level of the stock of certain lots of 1-Day Acuvue Moist for Astigmatism lenses. If not already contacted, customers should return these lenses to their supplier.
The affected lots may have particles on the contact lens or in the contact lens blister solution. If the particles are not noticed before application, this could cause eye redness or discomfort or corneal abrasion. There have been no reports of serious adverse events to date.
J&J has notified affected eyecare practitioners, recalled the affected lots, and has instructed those practitioners to contact patients who may have received the affected product. Contact lens users who are concerned should speak to their eyecare practitioner. A full list of affected lots can be found on the MHRA website at https://mhra-gov.filecamp.com/s/o8lmdsTtNpvHRxHq/d.
Visioneering Enters European Sales and Distribution Agreement with Menicon
Visioneering Technologies, Inc. has entered into a definitive agreement with Menicon Co., Ltd. through NKL Contactlenzen, B.V., a wholly-owned subsidiary of Menicon Co. LTD. Under the agreement, VTI will supply its NaturalVue Multifocal 1 Day Contact Lenses in Menicon-branded packaging for sale and distribution in Europe. The lenses will be packaged as Menicon Bloom Day Contact Lenses for Myopia Progression Control.
According to the company, the agreement heralds the next step in Visioneering’s accelerating global expansion; NaturalVue MF daily disposable contact lenses have received marketing clearances for treating pediatric myopia control in the European Union, Australia, and New Zealand.
In related news, Visioneering announced its first sale in Asia after recently securing a Certificate of Listing in Hong Kong that includes pediatric myopia progression control. Fulfillment of Visioneering’s products in Hong Kong is being handled by VTI’s distribution partners in Australia/New Zealand, Corneal Lens Corporation NZ and its affiliate Corneal Lens Centre Australia.
Johnson & Johnson Vision (J&J Vision) launched Acuvue RevitaLens Multi-Purpose Disinfecting Solution (MPDS). According to the company, Acuvue RevitaLens MPDS provides peroxide quality disinfection, but with the simplicity, comfort, and convenience of an advanced multipurpose solution. Acuvue RevitaLens MPDS is now available at major retailers nationwide.
Eyeris’ Contact Lens Receives FDA Market Clearance
Eyeris, a Nashville, TN start-up, just closed its second round of funding and secured U.S. Food and Drug Administration market clearance for its new daily disposable contact lens, which will be available in January 2020. The Eyeris lens will be available through a wide network of independent optometrists. The lens is a daily disposable lens manufactured in hioxifilcon A. It has a base curve of 8.5mm and a diameter of 14.3mm.
CooperVision to Expand Clariti 1 Day Toric Parameters
CooperVision announced plans to expand the parameters of its Clariti 1 Day Toric by adding additional axes, some of which will be available in December 2019 and the rest in spring 2020. Clariti 1 Day Toric contact lenses provide astigmatic patients with the advantages of silicone hydrogel and the convenience of the one-day modality, according to the company. All Clariti 1 Day options feature high water content. Additionally, the company says that the WetLoc technology ensures that the entire lens surface is continuously moist and mimics the moisture dispersion of naturally healthy eyes.
Do you believe that scleral lens wear is associated with an increase in intraocular pressure?
Getting the landing right can be one of the most challenging aspects of scleral lens fitting. Studies have shown that the sclera is often highly asymmetrical. Many practitioners utilize toric haptics for optimal fits. Here we can see a nice alignment with no impingement or compression.
We thank Dr. Arnold 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
The Importance of Speaking the Same Language
With the ever-increasing utilization of scleral contact lenses to address a multitude of ophthalmic challenges, it became evident that a standardization of language and terminology was in order. A recent paper was published that aimed to provide an official definition of terms related to scleral lens fitting and manufacturing that would make more uniform the use of appropriate terms when describing, writing, or lecturing about scleral lenses.1
A committee of 12 advanced scleral lens clinicians met and developed a list of terms related to scleral lens fitting and manufacturing. They conducted a literature review using the PubMed database with the keywords “scleral lenses” and “terminology.” Other related publications such as textbooks were also considered valid references. Validation of the terms selected and their suggested definitions were made by consultation with other experts in the field over a two-year time period. A final version was adopted by the Scleral Lens Education Society late in 2018.
The authors included three main sections in the paper: Section I provides the definition of a scleral lens, Section II addresses the general terminology habitually applied to the contact lens field but in the context of scleral lens usage, and Section III suggests a description of terms specifically used when fitting or manufacturing scleral lenses. The authors then finalized their document with recommendations to manufacturers about the essential elements to provide to eyecare practitioners to help them understand specifics about lens designs and to customize the fitting process. The authors concluded that a common language is key to advancing the science and clinical practice of scleral lens fitting. The current terminology suggested in this paper will help standardize this field, helping eyecare practitioners, educators, speakers, and manufacturers to speak with the same language.
A commonly accepted series of terms applied to any area of science is surely critical for appropriate intraprofessional interactions. This is especially needed in the field of scleral contact lenses. More and more scleral lens designs are being developed by multiple lens manufacturers. Each manufacturer seems to utilize many proprietary terms that describe the geometry of that specific lens design. This makes understanding and comparison quite difficult. This paper is an excellent first step in establishing some degree of standardization regarding scleral lens terminology. Hopefully the scleral lens industry will join in with this attempt at having us all speak the same language.
1. Michaud L, Lipson M, Kramer E, Walker M. The official guide to scleral lens terminology. Cont Lens Anterior Eye. 2019 Sep 24. [Epub ahead of print]
OCULAR SURFACE UPDATE
Katherine Mastrota, MS, OD
Put on a Happy Face
A recent meta-analysis that included data from 22 studies including 2.9 million patients found that anxiety and depression are more prevalent in patients who have dry eye disease (DED) than in controls.1 Often, however, there is a great discrepancy between signs and symptoms of DED; the symptoms are often associated more with non-ocular disorders such as depression and post-traumatic stress disorder (PTSD) than with tear film issues.
Therefore, DED could be considered more of a psychiatric than an ophthalmic complaint. In fact, DED and depression feed on one another in a synergistic manner. And, the severity of DED is associated with symptoms of anxiety and depression. Treatment of DED could help reduce depression symptoms, and conversely, effective management of depression could help alleviate symptoms of DED.
Complicating this is the evidence that Selective Serotonin Reuptake Inhibitors (SSRIs) can exacerbate DED. SSRI antidepressants are a type of antidepressant that work by increasing levels of serotonin within the brain. Their effect on DED makes the management of these comorbidities more difficult.
In conclusion, it is clear that DED and depression are closely linked and influence one another in ways that drastically affect patients’ lives. It has been suggested that collaboration between psychiatrists and eyecare providers could be beneficial in the management of patients who have DED. In our next Contact Lenses Today installment: Should eyecare practitioners issue a depression questionnaire to their ocular surface disease patients?
1. Weatherby TJM, Raman VRV, Agius M. Depression and dry eye disease: a need for an interdisciplinary approach? Psychiatr Danub. 2019 Sep;31:619-621.
Higher Order Aberrations, Refractive Error Development and Myopia Control: A Review
Evidence from animal and human studies suggests that ocular growth is influenced by visual experience. Reduced retinal image quality and imposed optical defocus result in predictable changes in axial eye growth. Higher-order aberrations are optical imperfections of the eye that alter retinal image quality despite optimal correction of spherical defocus and astigmatism. Because higher-order aberrations reduce retinal image quality and produce variations in optical vergence across the entrance pupil of the eye, they may provide optical signals that contribute to the regulation and modulation of eye growth and refractive error development. The magnitude and type of higher-order aberrations vary with age and refractive error as well as during near work and accommodation. Furthermore, distinctive changes in higher-order aberrations occur with various myopia control treatments, including atropine, near addition spectacle lenses, orthokeratology, and soft multifocal and dual-focus contact lenses. Several plausible mechanisms have been proposed by which higher-order aberrations may influence axial eye growth, the development of refractive error, and the treatment effect of myopia control interventions. Future studies of higher-order aberrations, particularly during childhood, accommodation, and treatment with myopia control interventions, are required to further our understanding of their potential role in refractive error development and eye growth.
Hughes RP, Vincent SJ, Read SA, Collins MJ. Higher order aberrations, refractive error development and myopia control: a review. Clin Exp Optom. 2019 Sep 6. [Epub ahead of print]