Recently, the U.S. Federal Trade Commission (FTC) announced a public meeting as part of its regulatory review of the Contact Lens Rule (effective Aug. 2, 2004) associated with the Fairness to Contact Lens Consumers Act (passed by the U.S. Congress in 2003). The public workshop is being held Mar. 7, 2018 in Washington, DC (www.ftc.gov/news-events/events-calendar/2018/03/contact-lens-rule-evolving-contact-lens-marketplace) to “explore issues regarding competition in the contact lens marketplace, consumer access to contact lenses, prescription release and portability, and related subjects.”
While competition is a vital part of a healthy free market economy, there are challenges that relate to regulated products such as pharmaceuticals or medical devices. For instance, pharmaceutical companies argue that because they invest billions of dollars to get new drugs to market, their investments should be protected (and they generally are protected for a period of time through the patent process). The industry further argues that loss of this protection also potentially stifles further investment in innovative development of new products. On the contrary, proponents of healthcare reform argue that many elements of our healthcare system prevent certain aspects of a competitive free market environment for pharmaceuticals or medical devices, distorting the semblance of a free market in this particular space.
The FTC’s public workshop relating to contact lenses has the potential to impact the contact lens industry in substantial ways in the years to come. One overarching issue that I think we all agree on is the importance of maintaining patient safety—that is something of which I hope we never lose sight!
Jason J. Nichols, OD, MPH, PhD
EyePromise Announces Senior Leadership Changes
EyePromise and its parent company ZeaVision Holdings, LLC announced a series of organizational changes.
Effective immediately, ZeaVision Chairman and CEO Dennis Gierhart, PhD, will serve as EyePromise’s interim-president while the company performs an executive search to identify a successor to Chris Barber. Bob Kearns has been promoted to senior vice president of sales, responsible for both doctor and direct-to-consumer sales. Brad Hogenmiller has been promoted to vice president, technology & marketing. And, Patrick Curran has been promoted to senior director of sales, where he will work closely with the EyePromise Scientific Advisory Board and key customer-purchasing and practice-management groups.
J&J Vision Appoints Michael Mayers, OD, Director, US Advocacy, Vision Care
Johnson & Johnson Vision (J&J Vision) has appointed Michael Mayers, OD, as director, US Advocacy, Vision Care. In his new role, Dr. Mayers will shape strategy and lead eye health advocacy efforts to promote patient health and safety in collaboration with legislators, regulators, associations, and practitioners. He will also partner with Carol Alexander, OD, director of professional communication, to continue driving J&J Vision’s advocacy efforts with the eye health professional community.
Dr. Mayers joined J&J Vision in 2011 and has since held roles in R&D clinical development, global medical affairs, and global marketing. Prior to joining the company, he practiced in several eye heath settings, including in his own optometric practice, and consulted as a key opinion leader with several eye health companies.
B+L and Prevent Blindness Encourage People to Fight for Their Sight
Bausch + Lomb (B+L) launched a public service announcement and docu-series designed to raise awareness of age-related macular degeneration (AMD). The series includes stories of people living with AMD, while encouraging others to understand the risk factors for AMD and how to help reduce the risk of progression of the disease.
Throughout the month of February, B+L will be encouraging people to show their support of those living with AMD on social media. From Feb. 1 through 28, 2018, every “share” or “like” of a B+L Facebook post promoting AMD Awareness Month will result in a $1 donation (up to $50,000) to Prevent Blindness. The public can also help raise awareness by adding the #WhyEyeFight custom frame to their Facebook profile picture or by sharing social posts with the hashtag, #WhyEyeFight.
Euclid Introduces New Orthokeratology Lens
Euclid Systems Corporation introduced Emerald163 Ortho-K contact lens, featuring tisilfocon A, a hyper-Dk (163) lens material. Emerald163, which is made to order for each patient’s eyes, provides patients with all the benefits of Emerald plus the tisilfocon A lens material.
The U.S. Food and Drug Administration-cleared Emerald163 is available in the United States through Euclid’s authorized distributors: ABB Optical Group, Blanchard Contact Lens, Essilor Contact Lens Specialists, and X-Cel Specialty Contacts.
Lens.com Partners with Opternative on Online Vision Prescription Renewals for Contact Lenses
Opternative Inc. announced that it has partnered with Lens.com Inc. to provide access to online prescription renewal technology on the company’s online eyewear site Lens.com. Lens.com customers will be able to renew their expired contact lens prescription on the company’s website.
AccuLens Announces Building Expansion
AccuLens is expanding its manufacturing operations an additional 1,000 square feet. The expansion includes an environmentally controlled machining and finishing area that increases lathe accuracy, according to the company. The expansion allows the company to increase its quality control suite as well as add additional process verification equipment. Additionally, the incorporated expansion will allow a larger volume of polyethylene glycol-treated lenses to be processed within the lab, with a second plasma processing unit in place.
In the "CooperVision Issues 'Digital Device Usage and Your Eyes’ Report” news story in the Jan. 4 issue of Contact Lenses Today, the number of contact lens wearers willing to pay a premium for an option that reduces symptoms of digital eye fatigue was misreported. The correct number is nearly three in four contact lens wearers.
Stephanie L. Woo, OD, Havasu City, AZ
An 82-year-old patient with 10 years of neovascular glaucoma presented to our office for a routine visit and had no noticeable changes. Upon slit lamp exam, a blood clot was seen in the left eye near the inferior portion of the cornea. The glaucoma specialist to whom we referred the patient confirmed a blood clot due to the neovascular glaucoma.
We thank Dr. Woo 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
A New Flow Chart for Categorization of Contact Lens-Induced Dryness
Anyone who cares for contact lens patients easily realizes that the most common complaint of our lens wearers is that of “dryness” with their contact lenses. These complaints are so common that most patients consider dryness with contact lenses to be part and parcel of lens wear. This is so true that surveys have shown that many patients won’t even report contact lens-induced dryness during their eye exam history unless specifically asked about it. Again, they consider it just “normal” when wearing contact lenses.
A recent study was published that shared information about a new flow chart that allows for categorization of contact lens-induced dryness.1 The authors introduced a novel flow chart-based screening tool for the categorization of contact lens-induced dryness (CLIDE) and its impact on daily visual activities: the Berkeley Dry Eye Flow Chart (DEFC).
In the study, 130 experienced soft contact lens wearers discontinued lens wear for 24 hours, passed a baseline screening and eye health examination, completed the Ocular Surface Disease Index (OSDI), and then were dispensed fresh pairs of their habitual lenses. After six hours of wear, subjects completed a battery of symptom questionnaires and underwent non-invasive tear breakup time (NITBUT) measurement, grading of distortion in reflected topographer mires, grading of lens surface wettability, and a fluorescein examination of the ocular surface. Subjects returned after at least 48 hours and repeated all assessments after six hours of wear with a second fresh pair of habitual lenses.
The results of the analysis indicate that the repeatability of the DEFC between visits was within 1%, and limits of agreement and coefficient of repeatability were comparable to those of the other CLIDE assessments. A higher DEFC score was significantly related to shorter pre-lens NITBUT, higher OSDI score, and higher Visual Analog Scale (VAS) ratings of average and end-of-day severity and frequency of dryness (all p < 0.001). The authors concluded that the DEFC provides a means of quickly categorizing CLIDE patients based on severity and frequency of symptoms and on the degree to which symptoms impact daily life.
The question that I ask when thinking about this topic is: Are we talking about contact lens-induced dryness (CLID) or contact lens-associated dryness (CLAD)? In my opinion, CLID infers that the contact lenses cause the dryness, whereas CLAD suggests that contact lenses exacerbate dryness and that there may be an underlying ocular surface disease (OSD) state. As such, at our practice, all potential contact lens candidates undergo an ocular surface assessment including detailed examination of the lids, lashes, conjunctiva, cornea, and, of course, tear film prior to any contact lens fitting. If we diagnose OSD and/or dry eye, we will institute appropriate therapy prior to finalizing contact lens management. The use of screening tools such as the SPEED and OSDI subjective tests as well as a system such as the DEFC mentioned above can be very helpful in screening for dry eye and OSD in our contact lens practices.
1. Graham AD, Lundgrin EL, Lin MC. The Berkeley Dry Eye Flow Chart: A fast, functional screening instrument for contact lens-induced dryness. PLoS One. 2018 Jan 24;13:e0190852.
OCULAR SURFACE UPDATE
Katherine M. Mastrota, MS, OD
Eyelid tattooing (e.g., permanent eyeliner) is not unusual to observe in clinical practice. It has been demonstrated that eyelid tattooing can shorten tear breakup time (TBUT), increase fluorescein staining, and induce meibomian gland loss, leading to tear film instability.1
However, an interesting case was reported of a tattoo granuloma of the eyelid mimicking carcinoma.2 In this case, a 68-year-old woman presented with an upper eyelid lesion that was worrisome for carcinoma. The mass was well-circumscribed, pink, and firm, with distortion of the eyelid margin, central ulceration, and loss of the lashes. The patient denied previous surgery or trauma in this area, but she had a history of blepharopigmentation (tattoo eyeliner) of all four eyelids approximately seven years prior. Incisional biopsy revealed inflammatory changes consistent with a localized reaction to the tattoo pigment granules. Local triamcinolone acetonide injection was attempted with improvement of the overall appearance, but with persistent deformity including irregularity of the margin and loss of lashes. The persistent abnormal appearance was concerning for an underlying carcinoma missed on the initial incisional biopsy and prompted a full-thickness wedge resection and reconstruction of the abnormal area. The results of biopsy of the excised tissue confirmed absence of malignant neoplasm and showed changes consistent with tattoo granuloma.
Given these findings, tattoo granuloma of the eyelid should be considered in the differential diagnosis of eyelid lesions worrisome for carcinoma in patients who have a history of blepharopigmentation.
1. Lee YB, Kim JJ, Hyon JY, Wee WR, Shin YJ. Eyelid Tattooing Induces Meibomian Gland Loss and Tear Film Instability. Cornea. 2015 Jul;34:750-755.
2. Bee CR, Steele EA, White KP, Wilson DJ. Tattoo granuloma of the eyelid mimicking carcinoma. Ophthal Plast Reconstr Surg. 2014 Jan-Feb;30:e15-17.
Bibliometric Study of Scientific Research on Scleral Lenses
The purpose of this study was to analyze the state of scientific publications in the field of scleral lenses by applying a bibliometric method.
The database used in this bibliometric study was SCOPUS, an abstract and citation database of peer-reviewed literature, including scientific journals, books, and conference proceedings. Using remote download techniques, articles published between 1962 (year of first registrations) and 2015 were selected by entering the main descriptors: “scleral contact lenses” and “scleral lenses,” limiting the field for the article, keywords, and abstract, linked with the “or” tab.
The authors recovered 361 contributions (articles, reviews, letters to the editor, etc.) for the 1962 to 2016 time period. The distribution for five-year periods shows a significant increase between 2012 to 2016, with a growth of 222.22% in comparison with the previous period. The countries with the highest production were the United States with 135 contributions, United Kingdom with 46 contributions, and India with 19 contributions. The most productive institutions were Harvard Medical School, Boston Foundation for Sight, and Moorfields Eye Hospital National Health Service Foundation Trust. The authors with the highest productivity were Kenneth W. Pullum, Perry Rosenthal, and Deborah S. Jacobs, with an h-index between 12 and 19 documents. The number of documents published on scleral lenses showed a significant increase in the last five years, and currently, they represent only 1.44% of all publications on contact lenses.
The report concluded that bibliometric studies have become essential tools for evaluating scientific activity, allowing an overview of the growth, size, and distribution of scientific literature associated with a particular discipline.
Povedano-Montero FJ, Álvarez-Peregrina C, Hidalgo Santa Cruz F, Villa-Collar C, Sánchez Valverde J. Bibliometric Study of Scientific Research on Scleral Lenses. Eye Contact Lens. 2018 Jan 25. [Epub ahead of print]