We are all well aware of traumatic eye injuries, which can have a variety of different causes and devastating effects. Historically, it has often been shown that sports relating to the use of balls (e.g., basketball, baseball, softball) are associated with a greater frequency of injuries (probably given that these sports are also played more frequently). However, a recent report1 showed a staggering increase of about 170% in non-powder gun-related ocular injuries between 1990 and 2012. These data serve as a good reminder to educate all of our patients about the importance of eye protection while playing sports.
I-Med Pharma Inc. announced a new distribution agreement with OcuSoft Inc. to make the I-Pen Osmolarity System available in the United States. On Dec. 22, 2017, the U.S. Food and Drug Administration (FDA) issued an Acceptance Review Notification for the I-Pen Osmolarity System 510k submission. This distribution partnership will officially commence upon final FDA approval of the 510k, which is anticipated in the first quarter of 2018.
I-Med Pharma, Inc. also signed an exclusive agreement with Imex for distribution of its I-Pen Tear Osmolarity System, I-Drop viscoadaptive dry eye drops, I-Plug punctum plugs, and other dry eye products for Spain and Portugal.
Ampleye Now Offered in Reduced Diameter Options
Art Optical announced that its Ampleye scleral lens design is now available in 15.0mm and 15.5mm diameter options; the standard design has a 16.5mm diameter. The new smaller-diameter availability, combined with Ampleye’s recent 510(k) U.S Food and Drug Administration clearance for therapeutic management of ocular surface disease and dry eye, expands the range of potential Ampleye patients exponentially, according to the company.
Ampleye is available in diameters from 15.0mm to 17.0mm. Additional design options include anterior-surface toric and multifocal optics, quadrant-specific control technology, and Tangible Hydra-Peg (Tangible Science) surface coating on lenses made in Optimum (Contamac) materials.
Fitting the reduced-diameter Ampleye does not require additional diagnostic lenses as a sagittal depth conversion calculation from the 16.5mm diagnostic lens will produce the same successful initial fitting results, according to the company. Or, for practitioners preferring to work with smaller scleral lenses, nine-lens diagnostic sets are available in the 15.0mm/15.5mm diameter for immediate shipment.
Latest Innovega Patent Allowance Awarded
The U.S. Patent and Trademark Office issued two notices of allowance to complement the 11 U.S. patents already issued to Innovega Inc.
Innovega’s latest allowances relate to two patents. The first, “Method and Apparatus for Constructing a Contact Lens with Optics,” relates to a contact lens that has regular vision correction optics and a central lenslet that enables focusing a display in the spectacle plane as well as a light polarizing filter that blocks display light from the surrounding region. The second allowance, “Contact Lens,” claims methods of regulating water vapor transmissibility while maintaining oxygen transmissibility in ultra-high-oxygen-permeable lens materials. Both patents were filed by Jerome Legerton, William Meyers, and Jay Marsh. Innovega also received notices of allowance in 2017 from Korea and the European Union for the foundational patent for its technology.
Atlantis Scleral Now Offers Unlimited Exchanges Warranty Policy
X-Cel Specialty Contacts announced a simplified pricing and warranty structure for its Atlantis Scleral lenses, featuring unlimited exchanges for 90 days and true paperless returns. Additionally, X-Cel has announced a new single price structure for all standard, toric, and large-diameter Atlantis Scleral designs.
Novaliq Establishes U.S. Subsidiary in Massachusetts
Novaliq GmbH announced the formation of its new subsidiary, Novaliq Inc., which will be located in Cambridge, MA. The new Cambridge-based office will be headed by Novaliq’s founder and current chief innovation officer (CIO) Bernhard Günther. Mr. Günther will build the new U.S. organization to leverage the advantages and the potential of the water-free EyeSol drug delivery technology and innovative products in the United States. Novaliq Inc. is a 100% subsidiary of Novaliq GmbH.
WCO and American Academy of Optometry Announce Joint Education Meeting
The World Council of Optometry (WCO) and the American Academy of Optometry (Academy) will be co-hosting the 3rd World Congress of Optometry in conjunction with the Academy meeting tentatively to be held in Orlando, FL on Oct. 23 to 28, 2019. The meeting will feature joint CE tracks. Information on all aspects of the meeting will be available in the future at www.worldcongressofoptometry.org and www.aaopt.org.
Two Weeks till GSLS 2018
Hear the latest contact lens insights, clinical advancements, and technology improvements from world-renowned speakers. Register today and earn up to 20 CE hours. COPE, NCLE, JCAHPO, and Florida Board of Optometry credits available. www.GSLSymposium.com
Mirko Chinellato, Treviso, Italy
This image shows dimple veiling due to incorrect application of an orthokeratology lens for myopia. It is important to fill the lens with unpreserved saline solution and to apply the lens in the center of the cornea to avoid bubbles under the lens and irregular epithelial molding.
We thank Dr. Chinellato 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
Do We Need the Fancy Toys … or Just More Experience?
The introduction of advanced diagnostic technologies is intended to improve our diagnostic performance. As it relates to scleral contact lens fitting, appropriate corneal clearance is critical to lens performance and to physiological response. More and more contact lens practitioners have added optical coherence tomography (OCT) technologies in their offices. The use of anterior segment OCT (AS-OCT) allows for a precise measurement of scleral lens corneal clearance or vaulting. However, the majority of practitioners today still do not have access to AS-OCT and utilize biomicroscopic evaluation of scleral lens vaulting to assess the fitting. Comparing the retro-lens tear thickness to a reference such as the known central thickness of the lens or the known central thickness of the cornea allows for this vault assessment.
A study was recently published that compared the accuracy of observers' ability to estimate scleral contact lens central corneal clearance (CCC) with biomicroscopy to measurements using slit lamp imaging and AS-OCT.1 In a Web-based survey with images of four scleral lens fits obtained through a slit lamp video imaging system, participants were asked to estimate the CCC. Responses were compared with known values of CCC of these images determined with an image-processing program (digital CCC) and using the AS-OCT (AS-OCT CCC). Sixty-six participants were categorized for analysis based on the amount of experience with scleral lens fitting into novice, intermediate, or advanced practitioners.
Comparing the estimated CCC to the digital CCC, all three groups overestimated by an average of +27.3μm ± 67.3μm. The estimated CCC was highly correlated to the digital CCC (0.79, 0.92, and 0.94 for each group, respectively). Compared with the CCC measurements using AS-OCT, the three groups of participants overestimated by +103.3μm and had high correlations (0.79, 0.93, and 0.94 for each group, respectively).
The investigators concluded that the results from the study validate the ability of contact lens practitioners to observe and estimate the CCC in scleral lens fittings through the use of biomicroscopic viewing. Increasing experience with scleral lens fitting did not improve the correlation with measured CCC from the digital or the AS-OCT. However, the intermediate and advanced groups displayed significantly less inter-observer variability compared with the novice group.
Therefore, this study suggests that the estimation of CCC in scleral lens fitting can be achieved quite well with the relatively “low tech” use of biomicroscopic evaluation and without the use of expensive advanced technology such as AS-OCT. However, this study failed to evaluate other elements of the scleral lens fitting assessment, such as scleral lens landing peripherally and limbal corneal clearance. These are two other critically important elements that must be evaluated to achieve proper scleral lens fitting. The use of AS-OCT is highly valuable in these areas, especially in evaluation of peripheral landing and the potential need for toric peripheral geometries, which we know are often required.
I believe that the use of AS-OCT, although not mandatory, surely allows practitioners to make a more detailed and ultimately more successful comprehensive evaluation of scleral lens fitting. This is true for initial diagnostic lens evaluations as well as for evaluation of lens performance conducted at after-care visits following lens dispensing.
1. Yeung D, Sorbara L. Scleral Lens Clearance Assessment with Biomicroscopy and Anterior Segment Optical Coherence Tomography. Optom Vis Sci. 2018 Jan;95:13-20.
OCULAR SURFACE UPDATE
Katherine M. Mastrota, MS, OD
A Hidden Problem
Demodex mites and their relationship to ocular health have been a topic of interest of late.
Just this week, I received a message from a colleague, who wrote: “About 5% to 10% of my elderly female patients have the sleeves said to be pathognomonic for Demodex. The patients are universally asymptomatic and unaware of the infestation…I've tried removing the signs of the Demodex with [an ophthalmic] spatula and continuing scrubs…When patients return, the sleeves are back as they were. I then epilated the lashes and searched for Demodex mites with a microscope, but never found any. The patients were asymptomatic before and after treatment. All they've done is spend a lot of time and money and become unnecessarily alarmed...What am I missing here and why am I doing this?”
I answered this query as best as I could given my current knowledge of the mites. However, this exchange begs the question of how Demodex mite infestation (demodicosis) should be defined. I suspect that we should attempt to develop guidelines and parameters for diagnosis and treatment just as we do for other pathologies. After all, it is still not clear whether Demodex are protective or necessary commensals for ocular health. I do believe that lid hygiene is core to supporting ocular surface health; however, I suggest we take a proactive rather than a reactive approach to it.
Please send along your experiences with Demodex to add to our collective knowledge of this mysterious mite.
An Imaging-Based Analysis of Lipid Deposits on Contact Lens Surfaces
The purpose of this study was to evaluate whether LipidTox could stain lipid deposits on contact lens (CL) surfaces and compare lipid deposition patterns on various CL surfaces using an imaging method.
Ten CLs—each of six silicone hydrogel materials and one hydrogel material—were incubated in cholesteryl oleate solution (5.60mg/ml) for 12 hours. The CLs were then separately stained with Oil Red O and LipidTox and imaged under a fluorescence microscope. Twenty worn senofilcon A CLs from both eyes of 10 participants were stained similarly. The area of deposition was calculated using Fiji software. Median deposition areas were compared between various materials using the Kruskal-Wallis test. The Mann-Whitney U test was used to compare the median deposition areas in the same material using the two dyes. It was also used to compare the median deposition areas on worn and doped senofilcon A CLs.
The researchers determined that LipidTox staining needed fewer steps compared to Oil Red O for staining the deposits. There was no statistically significant difference between the median areas of lipid deposition among the CL materials using either Oil Red O (p = 0.42) or LipidTox (p = 0.21). However, significantly different median deposition areas were found between in vitro and ex vivo stained senofilcon A CLs using both Oil Red O (p = 0.002) and LipidTox (p = 0.029).
The study results indicated that LipidTox can stain lipid deposits on contact lens surfaces and is simpler to use compared to Oil Red O. Lipid deposition in the central 2mm diameter zone did not significantly differ between various commercial CL materials.
Panthi S, Nichols JJ. An imaging-based analysis of lipid deposits on contact lens surfaces. Cont Lens Anterior Eye. 2017 Dec 11. [Epub ahead of print]