Thank you for the feedback we received about last week’s editorial relating to the use of hydrogen peroxide-based contact lens care solutions. There is no doubt that there is passion in our field about this important topic, as well as on the general topic of safe contact lens practices. We have seen a lot of press this past week on a Center for Disease Control’s (CDC) “Contact Lens Health Week” August 24-28, 2015 (http://www.cdc.gov/contactlenses/contact-lens-health-week.html). These efforts should be applauded, and it reminds us to remain vigilant in our continued interactions with our patients regarding safe practices in wearing contact lenses.
Jason J. Nichols, OD, MPH, PhD
Voluntary U.S. Recall of Specific Lots of Refresh Lacri-Lube, Refresh P.M., FML and Blephamide
Allergan plc announced that it is conducting a voluntary recall down to consumer level of specific lots of its Refresh Lacri-Lube 3.5g and 7g for dry eye, Refresh P.M. 3.5g for dry eye, FML (fluorometholone ophthalmic ointment) 0.1% (sterile ophthalmic ointment topical anti-inflammatory agent for ophthalmic use, 3.5g), and Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid, 3.5g.
According to the company announcement, Allergan chose to initiate this recall based on a small number of customer complaints which reported a small black particle at the time of use. This black particle, which is part of the cap, can be created by the action from unscrewing the cap of the aluminum tube, and potentially introduced into the product. Reported adverse events include Foreign Body in Eye (12), Eye Irritation (2), Ocular Discomfort (2), Product Contamination (2), Superficial Injury of Eye (2), Eye Pain (1), Eye Swelling (1) and Vision Blurred (1).
Specific lots are being voluntarily recalled in the interest of patient safety.
Allergan has informed the U.S. Food and Drug Administration of this voluntary recall. The recall only applies to specific lots of these products and this recall does not affect any other Refresh or Allergan product. Allergan is contacting retailers and wholesalers who have been shipped affected product lots to initiate the recall and is informing them of the steps needed to return affected product.
CooperVision Hires Andrews as Director of Professional Affairs, North America
CooperVision, Inc. has named Michele Andrews, OD as Director of Professional Affairs for North America. In this newly created position, Dr. Andrews will work closely with eyecare professionals in the U.S. and Canada, further deepening CooperVision’s support of eye care professionals’ needs in the contact lens market. Her other responsibilities include providing technical support for new and existing products, and representing CooperVision at key industry and professional meetings throughout North America, where she will act as a spokesperson to the professional communities.
Prior to joining CooperVision, Andrews most recently served as Executive Vice President of Professional Services at For Eyes Optical Company, where she developed and implemented the organization’s strategy for its affiliated Doctors of Optometry. Prior to that, she was the Senior Director of Provider Relations and Clinical Services at EyeMed Vision Care. Earlier in her career, Andrews spent more than 10 years with LensCrafters, supporting hundreds of optometric practitioners in various locations through the United States. She also has significant clinical patient care experience in multi-unit ophthalmology, LASIK, and private practice settings.
Register Now for GSLS 2016
Registration is open at www.GSLSymposium.com for the 10th Global Specialty Lens Symposium to be held January 21 – 24, 2016 at Caesars Palace Las Vegas, Nevada. Plan now to attend this meeting for insightful presentations by international experts in the field, hands-on demonstrations of cutting-edge products and valuable continuing education credits.
The 2015 event was attended by almost 600 registrants from 36 countries, 42 states, Puerto Rico and Guam. It continues to be the largest conference of its kind in the U.S.
Join your peers in 2016 for the 10th anniversary in Las Vegas! Visit www.GSLSymposium.com for more information.
New Commercial Director at Procornea
Alex Lamse joined Procornea in Eerbeek, Netherlands as their new global commercial director. He will be responsible for all sales and marketing activities of Procornea and will also promote their further development of new products and services. Alex has over 20 years of experience in various marketing and sales positions both within and outside the eyecare business. He is a familiar face to many eyecare professionals around the world.
Procornea was founded in 1975 and is an independent Dutch manufacturer and supplier of GP and soft contact lenses all around the world. Procornea offers a complete range of spherical, toric, multifocal lenses and lenses, as well as the eye care solutions. Procornea supplies only to qualified optometrists, ophthalmologists and eyecare professionals.
Blanchard Partners with Multilens in Scandinavia
Blanchard Contact Lenses announced that Multilens (also known as Nordiska Lins), a laboratory located in Göteborg, Sweden, has signed an agreement as a manufacturer and distributor of Blanchard’s msd Mini Scleral Design lens. The msd lens is known for its distinctive posterior lens surface incorporating reverse geometry with specially designed optical and posterior curves.
The msd lens was first introduced throughout Sweden and Finland via a series of lectures/workshops in April of 2015, and was well received as an excellent scleral lens choice that is simple to fit with minimal variables to determine. This series will be followed by another tour through Norway and Denmark in October 2015.
Multilens is the largest contact lens lab in Scandinavia, selling and manufacturing special soft and GP contact lenses under the brand Nordiska Lins. In addition to contact lenses, Multilens is renowned for its low vision devices and special ophthalmic lenses with distribution throughout Europe.
NovaBay Pharmaceuticals’ intelli-Case Featured in Newscast
The intelli-Case, the innovative new FDA-cleared product from NovaBay Pharmaceuticals, Inc., was featured in news segments on the San Francisco Bay Area’s ABC affiliate KGO-TV.
In the segments, which aired on August 21, ABC news anchor Eric Thomas explained that improperly cleaned and disinfected contact lenses can expose the eye to bacteria and fungi, and cause serious infections. He goes on to discuss the use of hydrogen peroxide for cleaning and disinfection of contact lenses and why its use has fallen out of favor with many consumers. The segment then describes the use of the new intelli-Case device which ensures that lenses are fully disinfected and safe to put in the eye.
NovaBay plans to begin test marketing the intelli-Case in the San Francisco Bay Area later this year with a staged product rollout in 2016.
In last week’s Contact Lenses Today, http://www.cltoday.com/new/issue_082315.asp, we asked for what type of contact lens patients do you use hydrogen peroxide based care systems. Here are some of the comments we received.
I like to make patients aware of peroxide solutions as an "option", especially my monthly disposable patients. I advise them that peroxide will clean their lenses better and make them feel fresh. I tell them some patients use it every day exclusively, and others will use it once a week and will use multipurpose solutions the rest of the week.
I advise them that if their monthly lenses feel like they are not clean in the middle of the month to try the peroxide solution. Mark Margolies, OD Levittown, PA
In addition to using hydrogen peroxide for patients who have problems with chemically based care systems, I use it for many scleral and most hybrid patients. Mike Harmon, OD Clovis, CA
Better vision, greater all day comfort (starting with cleaner lenses each day) and reduced complications (infections and solution incompatibility): what's not to like? I recommend for all non-single use lenses, especially those being worn more than two weeks. Bob Woodruff, OD Northfield, OH
OCULAR SURFACE UPDATE Katherine M. Mastrota, MS, OD, FAAO
Vitamin D Deficiency
A few years after my daughter was born, my thyroid kicked into high gear and I developed hyperthyroidism. Naturally, since then, my primary care physician annually orders a blood thyroid panel. I was certainly surprised to see in my most recent serology results that I was vitamin D deficient! Question: are we as a “dark-room exam” profession at risk for vitamin D deficiency?
News: There is an association between vitamin D deficiency and dry eye! In the August 2015 issue of International Journal of Rheumatic Disease, researchers assessed Schirmer’s test, TBUT, OSDI, Stanford Health Assessment Questionnaire, fatigue severity scale and visual analogue scale-pain in 50 premenopausal women with vitamin D deficiency (serum vitamin D levels <20ng/mL) and 48 controls. The results of the above study parameters demonstrated dry eye and impaired tear function in patients with vitamin D deficiency and suggested that vitamin D may have a protective role in the development of dry eye, probably by enhancing tear film parameters and reducing ocular surface inflammation.1
Certainly the discussion of vitamin D deficiency should be prompted in our patients with dry eye and of course, we can add vitamin D deficiency to our list of dry eye risk factors.
1. Yildirim P, Garip Y, Karci AA, Guler T. Dry eye in vitamin D deficiency: more than an incidental association. Int J Rheum Dis. 2015 Aug 13. [Epub ahead of print]
Prediction of Surgical Outcomes for Intrastromal Ring Segments in Keratoconus
A significant challenge in disease management decisions is created by the variability of surgical outcomes. This is especially true in keratoconus where significant variability of outcomes following implantation of intrastromal corneal ring segments is experienced. Development of predictive models can be highly valuable in clinical decision making. The purpose of a recently conducted study was the simulation of the implantation of intrastromal corneal-ring segments for patients with keratoconus.1 The aim of the study was the prediction of the corneal curvature recovery after this intervention. Seven patients with keratoconus diagnosed and treated by implantation of intrastromal corneal-ring segments were enrolled in the study. The 3D geometry of the cornea of each patient was obtained from individual topographies and a hyperelastic model was assumed to characterize its mechanical behavior. To simulate the intervention, the intrastromal corneal-ring segments were modeled and placed at the same location at which they were placed in the surgery. The finite element method was then used to obtain a simulation of the deformation of the cornea after the ring segment insertion. Finally, the predicted curvature was compared with the real curvature after the intervention. The results showed a flattening of the cornea which was in consonance with the actual improvement of the corneal curvature. The authors concluded that for the first time a patient-specific model of the cornea has been used to predict the outcomes of surgery following intrastromal corneal-ring segments implantation.
The ability to “a-priori” simulate the outcomes of a surgical procedure can have great value to assist in the decision making process of whether or not to go forward or to explore alternative management options. In the case of intrastromal ring segments, outcomes can be either quite beneficial or at other times somewhat disappointing for patients with keratoconus. Utilization of simulation models as described in this study may be a first step towards achieving the ability to accurately predict surgical outcomes.
1. Lago MA1, Rupérez MJ, Monserrat C, Martínez-Martínez F, Martínez-Sanchis S, Larra E, Díez-Ajenjo MA, Peris-Martínez C. Patient-specific simulation of the intrastromal ring segment implantation in corneas with keratoconus. J Mech Behav Biomed Mater. 2015 Jul 30;51:260-268. [Epub ahead of print)
Effect of Three Interventions on Contact Lens Comfort in Symptomatic Wearers: A Randomized Clinical Trial
The purpose of this study was to investigate whether carrying out various interventions part way through the day influences comfort in symptomatic daily disposable (DD) contact lens wearers.
A subject-masked, randomized, controlled clinical trial was conducted in thirty symptomatic soft lens wearers who wore their habitual DD contact lenses bilaterally for 12 hours on two separate days. Five hours after lens application, one of the following three interventions or a control was performed on each eye: replacing the existing lens with a new lens; removing and reapplying the same lens; performing a 'scleral swish'; and no action (control). Comfort scores were recorded using SMS text messages every hour following lens application using a 0 (causes pain) to 100 (excellent comfort) scale. Comfort scores before lens application, at 6 minutes post-application, and at 6 minutes post-intervention were also recorded.
There was a significant reduction in comfort from pre-lens application to 6 minutes post-application for all groups (all p<0.05). Comfort gradually decreased from 6 minutes to 5 hours after lens application for each group (p<0.0001) with no significant difference between groups over the 5-hour period (p = 0.09). There was no significant difference in comfort 6 minutes post-intervention for any group (all p>0.05). After the intervention, comfort continued to decline (p<0.0001) with slightly lower mean scores for the control group compared to the new lens group (p = 0.003). Change in comfort relative to pre-intervention (5 hours) was similar for all groups (p = 0.81). There was no difference in comfort at 12 hours between groups (p = 0.83).
The researchers concluded that this work has confirmed that comfort shows a continual and significant decline over a 12-hour wearing period in symptomatic DD contact lens wearers. None of the interventions investigated had any significant impact on end-of-day comfort. These data suggest discomfort in lens wearers is more heavily influenced by changes to the ocular environment rather than to the lens itself.
Navascues-Cornago M, Morgan PB, Maldonado-Codina C. Effect of Three Interventions on Contact Lens Comfort in Symptomatic Wearers: A Randomized Clinical Trial. PLoS One. 2015 Aug 12;10(8):e0135323. doi: 10.1371/journal.pone.0135323. eCollection 2015.