Although not well studied, it is thought that midday fogging occurs in a fair number of scleral contact lens wearers. This phenomenon is unquestionably a nuisance to patients. While not associated with any clinical sequelae (to my knowledge), attempts should be made–with lens materials, designs, or care regimens–to help reduce or, better yet, prevent continued fogging. Further research is needed to determine the source and mechanism of this scleral lens complication so that optimized prevention strategies can be implemented.
Jason J. Nichols, OD, MPH, PhD
FDA Grants Third Extension of UDI Compliance Date to Soft Contact Lens Labelers
The U.S. Food and Drug Administration (FDA) granted a third extension for soft contact lens labelers that have yet to comply with the requirements of the Unique Device Identification (UDI) system because of the agency’s resource limitations.
The rule, which was originally published in Sept. 2013, created a UDI system and outlined label, data submission, and date formatting requirements for all medical devices commercially distributed throughout the United States. The rule was to be phased in over seven years, and the compliance date for all class III medical devices was Sept. 24, 2014; the compliance date for class II medical devices was Sept. 24, 2016.
The FDA has previously granted two extensions to the soft contact lens industry – the first in August 2014, a one-year extension for class III soft contact lens devices; and the second, dated Oct. 6, 2015, granted an additional two-year extension for class III soft contact lens devices and a one-year extension of the Sept. 24, 2016 compliance date for class II soft contact lens devices.
Recently, the FDA says it will grant another extension of the requirements to provide a UDI on the device label and packages, format dates on the device label, and submit data to the Global Unique Device Identification Database (GUDID) until one year after the FDA: develops and fully integrates the technical solution into the GUDID production system; provides any necessary updated technical specifications to affected labelers; and notifies industry that the extension will expire via emails to industry, communication via trade associations, and via the UDI website. Those products granted this third extension include:
• soft (hydrophilic) contact lenses (extended wear), product code LPM, classification regulation 21 CFR 886.5925(b)(2)
Novartis to In-License ECF843 for Ophthalmic Indications
Novartis has exercised an option to in-license ECF843 for ophthalmic indications worldwide (outside Europe). The closing of the deal is subject to customary closing conditions including regulatory approvals. The financial and other terms of this transaction are not disclosed.
ECF843 is a recombinant human lubricin (rh-Lubricin) protein developed by Lubris LLC. According to the company, lubricin protein deficiency is observed in dry eye patients. Lubricin is an endogenous glycoprotein expressed in areas of high shear stress and friction, including the tear film where it binds to and protects tissues of the ocular surface. Additionally, ECF843 is hypothesized to restore the tear film function, reduce friction, and relieve the signs and symptoms of dry eye, according to the company.
Paragon Vision Sciences has entered into a series of educational partnership programs with several leading research institutions and organizations devoted to advancing eyecare practitioner education about myopia. Partnerships include:
The Myopia Control Clinic at University of California, Berkley (UCB): Paragon and the Myopia Control Clinic at University of California, Berkley (UCB) will work together to develop educational programs to provide current and future eyecare practitioners around the world with the most up-to-date research and treatment options for myopia. Under the leadership of assistant professor of clinical optometry at UCB will work and clinic founder Maria Liu, OD, PhD, the first of these educational programs will commence on April 12 when The Myopia Control Clinic hosts an international delegation of practitioners from China.
The Vision Research Institute (VRI) at the Michigan College of Optometry: Paragon and the VRI at the Michigan College of Optometry will work together to develop educational tools focused on employing technology to simplify the effective and efficient diagnosis and fitting of corneal reshaping/orthokeratology and specialty contact lenses in general eyecare practices.
Scleral Lens Education Society (SLS): Paragon and the SLS will collaborate on the development of non-product-related educational programs at The Paragon Education and Training Academy located at the company’s headquarters in Gilbert, AZ.
International Academy of Orthokeratology: Paragon will collaborate with the International Academy of Orthokeratology on an educational series devoted to myopia management. Additionally, Paragon is covering registration fees for optometry students attending Vision by Design 2017.
EyePrintPro Expands U.S. and Canadian Provider Network
EyePrint Prosthetics LLC has announced that eyecare providers in 36 sites across the United States and Canada are now certified to fit the EyePrintPro. EyePrintPro is a prosthetic scleral cover shell that is designed through taking an impression of a patient’s cornea and then using a numerically controlled machining system to produce a lens that matches the impression.
EyePrintPro is indicated for keratoconus, irregular astigmatism, ocular surface disease, trauma, extreme eye deformity, pellucid marginal degeneration, chemical burns, post-surgical corneas, pinguecula, pterygium, or simply those who desire better vision and comfort.
A full list of the providers who are now certified to fit EyePrintPro is available at www.eyeprintpro.com/patient. EyePrintPro requires comprehensive training in the EyePrint Process. If you are interested in becoming an EyePrintPro provider or would like more information about practitioners in your area who fit EyePrintPro, visit www.eyeprintpro.com/contact-us.
National Eyecare Facilities Conference Announced
Cleinman Performance Partners announced the First Annual National Eyecare Facilities Conference. “Building the WOW” will be a two-day conference designed to help eyecare practitioners develop a facility that separates their brand from the competition. It will educate optometric practice owners on how to successfully plan and execute a facilities project and will provide a roadmap for OD/owners who are embarking on a remodel or new build, according to Cleinman.
The conference will take place Oct. 13 to 15, 2017 at the Crowne Plaza O’Hare in Chicago. Attendees can experience workshops by experts from both within and outside of the eyecare industry as well as an “Ask the Experts” interactive Q&A session. Cleinman says the conference will cover everything from planning to site selection to design to financing to retail merchandising. Attendees will also receive a “How To” manual that will provide both planning tools and expert insight into this investment decision.
This mid-40s male came into our office with a chief complaint of “getting something in my eye.” He described it as feeling like a rock. Over-the-counter drops provided no relief. There also was no past history of eye disease. On initial slit lamp examination, I saw this excellent example of an corneal dendrite. Because it was “a perfect textbook presentation," I took the photograph with a smartphone camera at one of the slit lamp oculars.
We thank Sergina M. Flaherty 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
That Old Argument Again? Which Is Safer CLs or LASIK?
Ever since refractive surgery became a player in the world of vision correction, the argument over which modality has greater risk–contact lenses or refractive surgery–has been going on. A recently published article evaluated the risk for microbial keratitis in patients wearing contact lenses and those undergoing laser-assisted in situ keratomileusis (LASIK).1 An extensive literature search was performed in the PubMed database between December 2014 and July 2015. This was followed by a meta-analysis using a mixed-effects modeling approach.
The results of the meta-analysis found that after one year of daily soft contact lens wear, there were fewer microbial keratitis cases than after LASIK, or approximately two cases fewer per 10,000 (P = 0.0609). If LASIK were assumed to have essentially a one-time risk for microbial keratitis, five years of extrapolation would yield 11 more cases per 10,000 with daily soft contact lens wear than with LASIK, or approximately three times as many cases (P < 0.0001). The extended wear use of soft contact lenses led to 12 more cases compared to LASIK at one year, or approximately three times as many cases (P < 0.0001), and 81 more cases at five years (P < 0.0001).
When incorporating an estimated 10% retreatment rate for LASIK, these results changed very little. The authors concluded that microbial keratitis is a relatively rare complication associated with contact lens use and LASIK postoperatively. The risk for microbial keratitis was similar between patients using contact lenses for one year compared to LASIK. Over time, the risk for microbial keratitis was higher for contact lens use than for LASIK, specifically with extended wear lenses.
So let’s pull back and think about this. The bottom line is that both forms of vision correction are amazingly effective when applied to the appropriate patients. The relative risks are quite low, again with proper patient selection, care, and after care.
Defining complications is another issue. When we say “microbial keratitis,” what is our definition? Would a contact lens peripheral ulcer (CLPU) that has typically no risk for induced vision loss be combined in the assessment data with a sight-threatening central ulcer? It is important to consider these and other variables when counseling our patients with regard to their vision correction options. All in all, we have many marvelous options today for vision correction that are far more effective and safer than ever before. Let’s share the evidence-based data and information with our patients and help them make the best decision for their individual circumstance.
1. Masters J, Kocak M, Waite A. Risk for microbial keratitis: Comparative metaanalysis of contact lens wearers and post-laser in situ keratomileusis patients. J Cataract Refract Surg. 2017 Jan; 43:67-73.
OCULAR SURFACE UPDATE
Katherine M. Mastrota, MS, OD
The Good and the Bad of Mascara
My 19-year-old daughter, Audrey, and I recently had a makeup conversation. Audrey posed the following question to me: “If you were only allowed to use one makeup product, which one would it be?” I did not have to think much at all–mascara.
Yes. Every morning, I apply a coat of mascara to my eyelashes, and perhaps a second coat. Sometimes the second coat is a different brand (i.e., mascara wardrobing for those in the know). Mascara brands are touted as having different effects on the lashes (e.g., curling, spiking, lengthening, or thickening), so I figure why not have it all and double up on the desired lash-enhancing effects.
At the end of the day, the mascara is removed. I am always amazed at how difficult it is to remove all of the mascara. Some products are better than others at removing the made-to-stick, black, tarry enhancer. However, regardless of which remover I use, there is always mascara residue at the base of my lashes and on the eyelid skin near the lashes. After a few wipes of a cotton pad with cleaner, a cotton-tipped applicator dipped in remover is always required to get in between the individual lashes and lash line to be truly rid of product. It takes a bit of work.
What is my point? Well, I guess that good lid hygiene is not so easy, and effective lid hygiene is neither quick nor inexpensive.
Investigate the wonderful eyelid hygiene products that are commercially available. Tailor your recommendations to the patient’s needs and habits. Try each product yourself, and share your experiences with your patients.
Sub-Basal Corneal Nerve Plexus Analysis Using a New Software Technology
The purpose of this research was to study sub-basal corneal nerve plexus (SCNP) parameters by in vivo corneal confocal microscopy using a new software technology and to examine the effect of demographics and diabetes mellitus (DM) on corneal nerve morphology.
A ConfoScan 4 (Nidek Technologies Srl) was used in this cross-sectional study to image the SCNP in 84 right eyes at the Miami Veterans Affairs eye clinic. Images were analyzed using a new semiautomated nerve analysis software program (The Corneal Nerve Analysis tool), which evaluated nine parameters including nerve fibers length (NFL) and nerve fibers length density (NFLD). The main outcome measure was the examination of SCNP morphology by demographics, comorbidities, and HbA1c level.
The authors found that interoperator and intraoperator reproducibility were good for the nine parameters studied (Intraclass Correlations [ICCs] 0.73-0.97). Image variability between two images within the same scan was good for all parameters (ICC 0.66-0.80). Older individuals had lower SCNP parameters, with NFL and NFLD negatively correlating with age (r = -0.471, and -0.461, respectively, P < 0.01 for all). Patients who have diabetes had lower mean NFLD 10987.6 μm/mm (±3,284.6) and NFL 1,289.5 μm/frame (±387.2) compared with patients who don’t have diabetes (mean NFLD 15077.1 μm/mm [±4,261.3] and NFL 1750.0 μm/frame [±540.7]) (P<0.05 for all). HbA1c levels in patients who have diabetes were inversely correlated with NFL and NFLD (r = -0.568, and -0.569, respectively, P < 0.05 for all).
The researchers concluded that the Corneal Nerve Analysis tool is a reproducible diagnostic software technique for the analysis of the SCNP with confocal microscopy. Older age, DM, and higher level of HbA1c were associated with a significant reduction in SCNP parameters.
Batawi H, Shalabi N, Joag M, Koru-Sengul T, Rodriguez J, Green PT, Campigotto M, Karp CL, Galor A. Sub-basal Corneal Nerve Plexus Analysis Using a New Software Technology. Eye Contact Lens. 2017 March 24. [Epub ahead of print]