We've all heard the stories before. The long-time patient whose child was fitted in contact lenses and already purchased a year's supply who later "decides" they don't want to wear contact lenses—sound familiar? How about the irregular cornea patient who you've spent hours fitting in a very specialty contact lens, who then wants to purchase the contact lens over the internet. Then there is the patient who complains about a contact lens fitting fee, when their prescription "did not change." And who can forget the patient who had an eye exam "elsewhere" who simply wants to you to give them a contact lens prescription? We all know how frustrating these scenarios are, but how you and your staff deal with them is key to maintaining your professional reputation. If you have any sticky situation like these that you would like to share, please email us at cltoday@pentavisionmedia.com.

The U.S. Food and Drug Administration approved the Argus II Retinal Prosthesis System, the first implanted device to treat adult patients with advanced retinitis pigmentosa (RP). The device, which includes a small video camera, transmitter mounted on a pair of eyeglasses, video processing unit (VPU) and an implanted retinal prosthesis, replaces the function of degenerated cells in the retina. The VPU transforms images from the video camera into electronic data that is wirelessly transmitted to the retinal prosthesis (an array of electrodes that are implanted onto the patient's retina).

While the Argus II Retinal Prosthesis System will not restore vision to patients, it may allow them to detect light and dark in the environment, aiding them in identifying the location or movement of objects or people.

The Argus II system is intended for use in adults, age 25 years or older, with severe to profound RP who have bare light perception (can perceive light, but not the direction from which it is coming) or no light perception in both eyes, evidence of intact inner layer retina function, and a previous history of the ability to see forms. Patients must also be willing and able to receive the recommended post-implant clinical follow-up, device fitting, and visual rehabilitation.

The FDA approved the Argus II Retinal Prosthesis System as a humanitarian use device, an approval pathway limited to those devices that treat or diagnose fewer than 4,000 people in the United States each year. To obtain approval for humanitarian use, a company must demonstrate a reasonable assurance that the device is safe and that its probable benefit outweighs the risk of illness or injury. The company also must show that there is no comparable device available to treat or diagnose the disease or condition.

The FDA reviewed data included a clinical study of 30 study participants with RP who received the Argus II Retinal Prosthesis System. Results from the clinical study show that most participants were able to perform basic activities better with the Argus II Retinal Prosthesis System than without it. Following the implant surgery, 19 of the 30 study patients experienced no adverse events related to the device or the surgery. Eleven study subjects experienced a total of 23 serious adverse events, which included erosion of the conjunctiva, dehiscence, retinal detachment, inflammation, and hypotony.

Three government organizations provided support for the development of the Argus II. The Department of Energy, National Eye Institute at the National Institutes of Health and the National Science Foundation collaborated to provide grant funding totaling more than $100 million, support for material design and other basic research for the project.

Allergan, Inc. announced the launch of Refresh Optive Advanced Preservative-Free Lubricant Eye Drops, the latest innovation in Allergan's extensive dry eye management portfolio. Refresh Optive Advanced Preservative-Free features the same scientifically-advanced formula that works on all three layers of the tear film to relieve dry eye symptoms as Refresh Optive Advanced, but without the use of a preservative.

The triple-action formula of Refresh Optive Advanced Preservative-Free stabilizes the lipid layer to help reduce tear evaporation, hydrates the aqueous layer, and provides an advanced lubricating and protective shield to the mucin layer, while further protecting epithelial cells from hypertonic stress, according to the company. Some lipid-enhanced tears contain up to 2.0 uL of lipid per drop, which is up to 33 times more lipid than that found in a normal tear film. Refresh Optive Advanced Preservative-Free delivers <0.1uL of lipid per drop to stabilize the lipid layer and restore the lipid that has been lost while delivering an optimized amount for increased tolerability.

Refresh Optive Advanced Preservative-Free is available in 30 count single-use vials, as well as a preserved multi-dose formula. Both may be used in combination with dry eye prescription therapies and do not require shaking prior to use. Allergan's Refresh Brand products can be found at retail locations where over-the-counter eye care products are sold. For more information about Refresh Optive Advanced Preservative-Free, please visit www.refreshbrand.com.

Just in time for the 2013 prom season, Acuvue Brand Contact Lenses offers helpful grooming advice for teens with the Girl's and Guy's Grooming Guides for Prom. The guides are available at www.acuvue.com/prom_girlsguide and www.acuvue.com/prom_guysguide.

Tips include an idea to switch-up that special look with contact lenses. Those interested in switching from glasses to contact lenses, either full-time or part-time for special events like Prom, are encouraged to talk to an eye care professional about a daily disposable contact lens, such as 1-Day Acuvue Moist Brand Contact Lenses.

To receive a free* trial pair certificate for 1-DAY Acuvue Moist Brand Contact Lenses, teens can visit www.acuvue.com. (*Professional exam and fitting fees not included)

Bausch + Lomb (B+L) announced "The Ultimate Movie Experience Sweepstakes", designed to promote a conversation between eyecare professionals and patients about the opportunity to achieve clear, crisp vision — even in low light settings like movie theaters — with PureVision2 or SofLens daily disposable contact lenses.

The Ultimate Movie Experience Sweepstakes will run through April 28, 2013, and offers the physician educational materials and samples of lenses to help them introduce their patients to the potential of PureVision2 or SofLens daily disposable lenses. In-office materials will include posters, tear pads, counter cards and a trivia game that will also be available for the patient in the waiting area. Patients who participate have a chance to win one of 10,000 free movie rentals or a weekly drawing for a 46" Samsung HDTV. The patient can learn instantly if they are a winner, so the doctor will be able to share in the excitement during the office visit.

B+L has a strong movie heritage. In earlier days, the company's main business focus was on photo-optical products. Their Super Cinephor projection lens introduced in 1922, which helped shoot wide screen movies, won B+L an Oscar in 1954 from the Motion Picture Academy of Arts & Sciences.

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Microbial Contamination in Bandage Contact Lens Therapy

Fortunately, bandage soft contact lens (BSCL) therapy is typically successful and not associated with more complications to an already compromised ocular surface. There have been a few recent studies published surrounding microbial contamination of soft bandage lenses that are helpful to review and consider to prevent lens associated infection.

In China, Liu et al assessed bacterial contaminants of BSCLs after laser subepithelial keratectomy (LASEK) and photorefractive keratectomy (PRK).¹ They found a culture positive rate of 16.7% after LASEK and 6.67% after PRK. Methicillin-sensitive coagulase-negative staphylococci (MSSCoN) were the most common isolates and Corynebacterium and Micrococcus were also isolated. No clinical infection was noted and all microorganisms were sensitive to tobramycin.

In Chicago, Rai et al surveyed the culture results of BCLs in patients after Boston type 1 keratoprosthesis (KPro) surgery.² Of thirty-four cultures performed, 12 were positive and the most common organism cultured was coagulase-negative staphylococcus. Higher levels of contamination with coagulase-negative staphylococcus occurred only in patients not on vancomycin.

Coagulase-negative staphylococci are considered normal skin and peri-ocular flora and are frequently found on worn soft lenses. Although often considered non-virulent, coagulase negative staphylococci are associated with contact lens induced inflammation and in the setting of compromised ocular surfaces, remain a major potentially infectious agent. In BSCL therapy, simultaneous use of an antibiotic sensitive against coagulase negative staphylococci is therefore encouraged.

1. Liu X, Wang P, Kao AA, Jiang Y, Li Y, Long Q. Bacterial contaminants of bandage contact lenses used after laser subepithelial or photorefractive keratectomy. Eye Contact Lens. 2012 Jul;38(4):227-30.
2. Rai R, Shorter E, Cortina MS, McMahon T, Cruz JD. Contact Lens Surveillance Cultures in Boston Type 1 Keratoprosthesis Patients. Eye Contact Lens. 2013 Feb 6. [Epub ahead of print]

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MATERIALS & DESIGNS
Ronald K. Watanabe, OD, FAAO

A Decade of Silicone Hydrogels

The January 2013 issue of Eye & Contact Lens commemorates silicone hydrogel (SiHy) lenses with a series of excellent articles that comprehensively review the evolution of SiHy lenses to their current state. Although SiHys have virtually eliminated contact lens induced hypoxia, there are some key points to learn from these articles.

Because of the mobile nature of the silicon-oxygen bond in SiHy polymers, these hydrophobic chains tend to migrate to the lens surface, causing it to lose its hydrophilicity,¹ and though many patients enjoy excellent comfort throughout the day, comfort with SiHy lenses has not been shown to be significantly different to that of HEMA lenses.² Also, SiHy materials seem to be associated with increases in corneal staining and infiltrates,^3-5 with infiltrative events having increased two-fold.^6,7 And, the incidence of microbial keratitis has not changed.⁸ I think SiHys are excellent materials, and I use them extensively. But I also think that there is still a ways to go before we will have the "perfect" material.

1. Tighe B. A Decade of Silicone Hydrogel Development: Surface Properties, Mechanical Properties, and Ocular Compatibility. Eye Contact Lens. 2013; 39(1): 3-11.
2. Guillon M. Are Silicone Hydrogel Contact Lenses More Comfortable Than Hydrogel Contact Lenses? Eye Contact Lens. 2013; 39(1): 85-91.
3. Willcox M. Solutions for Care of Silicone Hydrogel Lenses. Eye Contact Lens. 2013; 39(1): 23-27.
4. Jones L, Powell C. Uptake and Release Phenomena in Contact Lens Care by Silicone Hydrogel Lenses. Eye Contact Lens. 2013; 39(1): 28-35.
5. Carnt N, Stapleton F. Silicone Hydrogel Lens-Solution Interaction and Inflammation. Eye Contact Lens. 2013; 39(1): 36-40.
6. Szczotka-Flynn L. Incidence and Epidemiologic Associations of Corneal Infiltrates With Silicone Hydrogel Contact Lenses. Eye Contact Lens. 2013; 39(1): 47-51.
7. Chalmers RL, Gleason W. Overview of Contact Lens Postmarket Surveillance in the United States: System and Recent Study Results. Eye Contact Lens. 2013; 39(1): 108-113.
8. Stapleton F, Keay L, Edwards K, Holden B. The Epidemiology of Microbial Keratitis With Silicone Hydrogel Contact Lenses. Eye Contact Lens. 2013; 39(1): 78-84

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This group of researchers wanted to determine the clinical sensitivity, specificity, negative predictive value, and positive predictive value of a rapid point-of-care diagnostic test to detect elevated matrix metalloproteinase 9 levels (InflammaDry).

In a prospective, sequential, masked, multicenter clinical trial, InflammaDry was performed on 206 patients: 143 patients with clinical signs and symptoms of dysfunctional tear syndrome (dry eyes) and 63 healthy individuals serving as controls. Participants were assessed as healthy controls or for a clinical diagnosis of dry eye using the Ocular Surface Disease Index, Schirmer tear test, tear breakup time, and keratoconjunctival staining. The sensitivity and specificity of InflammaDry were compared with clinical assessment.

InflammaDry showed sensitivity of 85% (in 121 of 143 patients), specificity of 94% (59 of 63), negative predictive value of 73% (59 of 81), and positive predictive value of 97% (121 of 125).

The researchers conalcuded that, compared with clinical assessment, InflammaDry is sensitive and specific in diagnosing dry eye. They also noted the following as it may apply to clinical practice. Dry eye is often underdiagnosed resulting from poor communication between the clinical assessment of dry eye severity between clinicians and patients. This often leads to a lack of effective treatment. Matrix metalloproteinase 9 is an inflammatory biomarker that has been shown to be elevated in the tears of patients with dry eyes. The ability to accurately detect elevated matrix metalloproteinase 9 levels may lead to earlier diagnosis, more appropriate treatment, and better management of ocular surface disease. Preoperative and perioperative management of inflammation related to dry eyes may reduce dry eyes that develop after laser in situ keratomileusis, improve wound healing, and reduce flap complications. Recognition of inflammation may allow for targeted perioperative therapeutic management of care for patients who undergo cataract and refractive surgery and improve outcomes. Trial Registration clinicaltrials.gov Identifier: NCT01313351.

Sambursky R, Davitt WF, Latkany R, et al. Sensitivity and Specificity of a Point-of-Care Matrix Metalloproteinase 9 Immunoassay for Diagnosing Inflammation Related to Dry Eye. JAMA Ophthalmol. 2013;131:24-8.

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To report adverse contact lens reactions visit: http://www.accessdata.fda.gov/scripts/medwatch/ or call (800) FDA-1088.
To report possible grievances related to the Fairness to Contact Lens Consumers Act or associated Contact Lens Rule visit: https://www.ftccomplaintassistant.gov/.

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