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Editor's Commentary - Jason J. Nichols, OD, MPH, PhD, FAAO
I am starting to see more and more interest in limbal stem cell (LSC) deficiency, and this condition is certainly an important one for us to consider given its potential sight-threatening outcomes. It is important to remember that the corneal epithelium is regenerated by the LSCs and the loss of these important cells can lead to corneal compromise, vascularization, and vision loss. The condition can be congenital or acquired and it has been associated with contact lens wear. Watch for this condition clinically, but laboratory tests are needed to confirm the diagnosis (e.g., impression cytology, confocal microscopy).

Judiciary Committee Discusses New Lens Pricing Strategies
Representatives from contact lens manufacturers, online retailers, optometrists and a national consumer group testified at a U.S. Senate subcommitee on Wednesday, July 30 in Washington, D.C., that focused on manufacturers’ contact lens pricing policies. Sen. Amy Klobuchar (D-MN), chairwoman of the Judiciary Antitrust Subcommittee, said that she and her colleagues were not there to decide an antitrust case, but rather to try to determine what effect the corporate policies would have on consumers.

The testimony focused on unilateral pricing policies (UPPs) or resale price maintenance (RPM) which requires practitioners or retailers to sell certain contact lenses at or above a set price or the manufacturer will no longer sell them the product. George Slover, senior policy counsel, Consumers Union, said that even if the policies are not antitrust violations from a legal standpoint, from a practical standpoint they are anticompetitive to refuse to allow discounting. Slover said with UPPs consumers will still have the right to shop around, but will not be able to save money in doing so.

R. Joe Zeidner, general counsel, 1-800 Contacts, said that he was troubled by the speed that manufacturers have implemented similar policies, and that these pricing policies apply to both new and old products. He said that his company projects that by the end of 2015, 80 percent of the market could be subject to UPPs.

A manufacturer representative, Millicent L. Knight, OD, CHC, FAARM Head of Professional Affairs, Johnson & Johnson Vision Care, said that the company has not established an RPM program but has unilaterally established a minimum price in the market. The new policy, she said, gives consumers improved visibility to the price they can expect to pay when they select one of the brands covered by the policy. She said that as a result of the UPP, consumers would have access to lower prices without having to send in rebates to get discounts, therefore making the process simpler for consumers.

Also offering testimony was American Optometric Association President David A. Cockrell, OD, who said that contact lenses are not a typical retail product but a medical device and medical supervision is needed for safe use. He described in detail the harmful effects of improper lens care.

The entire testimony is available online at http://www.judiciary.senate.gov/meetings/pricing-polices-and-competition-in-the-contact-lens-industry-is-what-you-see-what-you-get.

Alden Optical Names Exclusive Distributor
Alden Optical has named ABB Optical Group as the company’s exclusive distributor partner effective Sept. 1. As of that date, all new orders for Alden Optical lenses should be placed either directly with Alden or via ABB Optical. Alden’s current distribution network will continue to service all customer orders initiated before Sept. 1 for all transactions relating to Alden’s policies and warranties.

Alden Optical expects that this significant change in distribution strategy will result in tangible benefits for eye care practitioners. Tom Shone, president of Alden Optical, said that by partnering with the largest U.S. optical distributor the company has the opportunity to better service practitioners who want to build their specialty lens practice. Alden Optical manufactures soft and GP lenses.
Register Now for 10th Annual OMS – CE in December in Orlando
Learn from the best. Experience the motivation. Move your practice forward. Plan now to attend the Optometric Management Symposium on Contemporary Eye Care, December 5-7, 2014 at Disney's Yacht & Beach Club Resort in Lake Buena Vista, FL.

This popular annual symposium provides the perfect balance of timely, disease management courses and practice-building courses with plentiful networking and leisure time to enjoy all that Disney resorts and theme parks have to offer.

OMS offers a comprehensive program, flexible schedule, ABO, COPE and Florida Board approved credits included 12 CEE's (TQ credits)! The education is also sponsored by a school of optometry meeting the requirements of several states. Rejuvenate yourself and expand your education while visiting exhibitors to learn about their products and services during our refreshment breaks.

For agenda, more information and to register visit www.OMConference.com.
--ADVERTISING
Scleral Lens Fit Scale Now Available
Michigan College of Optometry’s Vision Research Institute (VRI) recently announced the availability of the Scleral Lens Fit Scales. This downloadable item was created by the VRI for educational purposes and is designed to assist clinicians in practice.

The Scleral Lens Fit Scales demonstrate how to correctly estimate the clearance (amount of tears underneath portions of a lens, measured in microns) by comparing the tear layer thickness to the center thickness of the lens. Optic sections clearly demonstrate the tear thickness underneath the lens both centrally and at the limbal area along with images of various edge clearances.

Link to www.ferris.edu/ScleralLensFitScales to download and print. If you prefer to have a hard copy (8.5" x 11") card sent to you, email CraigNorman@ferris.edu with the request and it will be sent immediately.

AAO, AOA, AAOph, CLAO AND FDA Join for Workshop
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health, the American Academy of Optometry (the Academy), the American Academy of Ophthalmology (AAOph), the American Optometric Association (AOA), and the Contact Lens Association of Ophthalmologists (CLAO) will co-sponsor a one-day workshop entitled, “Revamping Microbiological Test Methods for Contact Lenses, Products, and Accessories to Protect Health and Ensure Safety.” The workshop is scheduled for Friday, Sept. 12, 2014 at the FDA White Oak Campus in Silver Spring, MD. Loretta Szczotka-Flynn, OD, PhD, FAAO, will represent the Academy and Academy Board member Joseph P. Shovlin, OD, FAAO, will represent AOA.

This workshop will cover the continuing rise in keratitis associated with Acanthamoeba and also present information on other emerging pathogens in infectious keratitis. The goal of the workshop is to establish uniform testing methods for Acanthamoeba disinfection efficacy, to consider emerging pathogens in the premarket testing of lens care products, and to discuss methods for conducting real-world simulated testing of contact lens care products. The meeting will bring together scientists, clinicians, and industry experts to discuss critical aspects of disinfection efficacy testing.

For more information, including registration and complete program information, visit the workshop website at http://www.clwkshop.org/.

SynergEyes Announces New Financing
Lens manufacturer SynergEyes, Inc., has raised $12 million to accelerate expansion of its contact lenses for patients with astigmatism, presbyopia and irregular corneas. The funding also will facilitate SynergEyes’ strategic acquisitions in the field of specialty contact lenses.

Old Penetrating Keratoplasty
Maria K. Walker, OD, Forest Grove, OR

A 46 year-old female who underwent a penetrating keratoplasty in 1991 presented to our therapeutic contact lens clinic for a new fit. She had not worn a contact lens on that eye in over 5 years due to corneal GP intolerance. She was fit in a scleral contact lens with a total sagittal depth of 5900um, achieving excellent comfort and 20/20 vision.

We thank Dr. Walker for this image and we 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 an explanation of the photo and your full name, degree or title and city/state/country.


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MATERIALS & DESIGNS
David Kading, OD, FAAO
A Little Soft Contact Lens History

The introduction of soft contact lenses into the worldwide market was certainly a major win for spectacle wearers, but the process and concepts that it took to pull it off were substantial.

Most people consider Otto Wichterle the father of soft contact lenses. In the 1960s he began soft material development and manufacture by spinning HEMA in an open rotating mold. The progress of the lenses advanced steadily from there and one of the world’s first soft contact lens congresses was held in Prague later that decade to discuss the progress of the materials, designs, and issues encountering the lenses.

Fast-forward to 1971, Bausch + Lomb became the first company to have approval of soft lenses in the United States. Although there have been numerous great lenses over the past 40 years, one that stands apart is the CSI lens. In the 1970s, Dr. Don Korb and colleagues patented the first ultrathin non-HEMA soft lens, which was often referred to as a revolutionary new membrane lens. Sola/Barnes Hind launched the lens in early 1980s. Also of significance in 1981 was the approval by the FDA for a 30-day cosmetic extended wear lens.

Of incredible significance in the advancement of our contact lens field was the capability to make soft lenses through mass production. Denmark’s Dr. Michael Bay intrigued executives from several companies with his manufacturing process in which lenses could be molded in a hydrated state. Johnson and Johnson bought the rights in the 1980s and paired it with etafilcon A. In the late 1980s, Vistakon had a major challenge to win over practitioners when they launched the world’s first disposable soft lens, but did so successfully as time has shown the market today to be nearly completely a frequent replacement one.

Fast-forward a decade; Bausch + Lomb and CIBA Vision launch disposable silicone hydrogel lenses into the market. Along the way forward to the present, other advancements of significance were soft bifocal, toric, and single use lenses.

Although we could go into our history in much greater detail, understanding our foundation is a great way to better understand our present. We stand on the shoulders of giants that have paved our way with amazing technology and incredible patient care advancement. Recommend and prescribe contact lenses with confidence. We have come a long way.


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CARE SOLUTION CORNER
Susan J. Gromacki, OD, MS, FAAO

Tap Water and GP Contact Lenses: The FDA’s perspective

As I wrote in my three previous columns1-3, the use of tap water with GP lenses was one of the primary topics on which the United States Food and Drug Administration (FDA) sought input from an Ophthalmic Devices Panel meeting in May 13, 2014. Although FDA contraindicates this practice on its website, 15 out of 18 GP lens solutions still allow a tap water rinse as part of their labelled instructions. I sought to clarify FDA’s perspective, and received a response from Jennifer Rodriguez, Press Officer, Office of Media Affairs, Office of External Affairs, FDA.

Ms. Rodriguez wrote, “As noted at the 2014 Panel meeting, there has historically been underreporting of adverse events of keratitis in RGP CLs after rinsing with or storing in tap water. When this issue was again raised at the 2014 meeting, it was determined that overwhelming data does not exist at this time to mandate changes. However, while relatively rare, we believe consumers should be made aware of the possibility of infection associated with water; hence, the reason we recommend not exposing CLs to water. In the interim, we continue to work with lens manufacturers with respect to developing an alternative to water.

“The website on lens care conveys the most current scientific information and FDA’s thinking on contact lens care, but they are not formal recommendations to contact lens or contact lens care manufacturers. The input received from stakeholders (defined as anyone affected by the issue or FDA’s actions) at the meeting will inform what, if any labeling changes, we may propose in updated guidance documents.

“The FDA's advisory panels provide independent, expert advice to the agency on a range of complex scientific, technical, and policy issues. This includes questions related to the development and evaluation of products regulated by the FDA. They are a valuable resource and make an important contribution to the agency’s decision-making processes. Although advisory panels provide recommendations to the agency, the FDA is not bound by the advisory panel’s recommendations. We plan to receive public comment/input to update our daily wear soft contact lens and accessory guidance documents with respect to all issues covered.”4

1. http://www.cltoday.com/new/issue_060814.asp
2. http://www.cltoday.com/new/issue_062014.asp
3. http://www.cltoday.com/new/issue_071814.asp
4. Rodriguez J. Personal communication, July 11 and 15, 2014.

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Measurement of Anterior Scleral Curvature Using Anterior Segment OCT

The purpose of this study was to investigate and validate methods for measuring the radius of anterior scleral curvature using anterior segment optical coherence tomography images.

Twenty-four volunteers were enrolled in this study. Anterior segment optical coherence tomography images, centered on horizontal/vertical limbus, including adjacent anterior sclera, were obtained in addition to conventional images centered on the optical axis. Central horizontal, nasal, and temporal optical coherence tomography images were consolidated to a new image for subsequent analyses. The reference points of limbal surface and three scleral points were marked nasally and temporally. The radius of a best-fit circle to the six scleral points was derived (the BFC [best-fit circle] method) and the radii of two circles, the centers of which are on the optical axis and pass through the points of the scleral surface at 2 mm from the limbus nasally and temporally, were calculated (the axial method). To assess the reliability and accuracy of each method, intraobserver and interobserver agreements were analyzed and the radii of contact lenses with known curvatures were measured.

The mean (±SD) radius of a BFC was 13.12 (±0.80) mm. The mean (±SD) radius of nasal anterior scleral curvature (13.33 ± 1.12 mm) was significantly greater than that of temporal anterior scleral curvature (12.32 ± 0.77 mm) (paired samples t test, p < 0.001). The BFC and axial methods showed excellent intraobserver and interobserver agreements for measurements (intraclass correlation coefficient > 0.75, p < 0.001), whereas both methods showed a tendency to slightly underestimate the actual curvature of a rigid contact lens of known dimensions (-0.07 ± 0.13 mm [the BFC method] and -0.19 ± 0.07 mm [the axial method], Wilcoxon signed rank test, p = 0.173 and p = 0.028, respectively).

Researchers concluded that anterior segment optical coherence tomography is a valuable tool for measuring the radii of anterior scleral curvatures by image processing and mathematical calculation and can provide useful information in specific clinical situations such as designing scleral lenses.

Choi HJ, Lee SM, Lee JY, Lee SY, Kim MK, Wee WR. Measurement of Anterior Scleral Curvature Using Anterior Segment OCT. Optom Vis Sci. 2014 Jul;91(7):793-802.


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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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