CONTACT LENSES TODAY
May 21, 2006
Contact Lenses Today® is edited by Dr. Joseph T. Barr and the staff of Contact Lens Spectrum. This
week CLToday® reaches more than 12,000 readers in 74 countries.
B&L Recalls Solution
Bausch & Lomb (B&L) initiated a permanent, global recall of ReNu with MoistureLoc on Monday after an internal
investigation. B&L conducted a "topping off" test and found that over time numerous solutions including MoistureLoc worked poorly
against Fusarium strains isolated from infections. Brian Levy, O.D., M.Sc., Chief Medical Officer for B&L says if the solution
is concentrated by simulating evaporation (i.e. take water out of the formula), MoistureLoc tends to lose efficacy against Fusarium.
If a patient discards the used solution, but leaves a film of MoistureLoc on the bottom of the lens case, the concentrated polymer film
could protect Fusarium from the product’s disinfectant. The company also found this film could form on the bottle tip, which
could lead to continuous inoculation of the cornea with Fusarium.
Dr. Levy says that testing has shown the product is
sterile and effective against Fusarium in normal laboratory testing and that MultiPlus maintains full biocidal efficacy when
put through the same tests as MoistureLoc.
A statement released Friday by the CDC confirms that
use of ReNu MultiPlus was not significantly associated with the infections. According to the report, as of May 18th, the agency has
confirmed Fusarium keratitis in 130 patients, 125 of whom reported wearing contact lenses. Of those, 118 were able
to identify the type of contact lens solution used; 64% reported using ReNu with MoistureLoc alone, 12% reported using MoistureLoc
in combination with another product, 8% reported using only products other than MoistureLoc. In April, the CDC conducted a matched
case-control investigation to evaluate risk factors for infection. Results indicate an increased risk of Fusarium keratitis
associated with use of ReNu with MoistureLoc during the month before symptom onset. Though the cause of the association was unclear,
further study is ongoing.
B&L says the CDC report affirms the company’s decision to recall the
product. “The CDC’s conclusion that the MoistureLoc formulation was the only product with a statistically significant association
with reports of Fusarium keratitis in the cases they have evaluated should put to rest any further speculation that other
products may also be implicated,” says Ronald L. Zarella, CEO and Chairman of B&L.
The company
also responded to an FDA statement on its preliminary inspection findings that fault the manufacturer for failing to disclose 35
serious injury reports of Fusarium keratitis from Singapore’s Minister of Health in Feb. In a statement released to the media,
B&L says the initial cases were discussed with the FDA’s Office of Compliance in the Center for Devices and Radiological Health within
days of receiving the reports in Feb. The company also says it provided updates to the FDA as details of the Singapore cases were
gathered.
The FDA’s preliminary observations also noted that unspecified keratitis complaints
reported to the company in July 2005, were not reported to the agency. B&L says those six reports were of noninfectious keratitis
or among contact lens wearers were not related to Fusarium and did not require medical treatment. Under contact lens and
lens-care product guidelines adopted by the Contact Lens Institute in 1997, it is not necessary to report this type of infection.
B&L will work with the FDA to determine whether it should continue to reference these guidelines in future reporting decisions.
Health Insurance Marketplace Modernization and Affordability Act Defeated
In a vote taken May 11th, The U.S. Senate rejected Senate Bill 1955, the Health Insurance Modernization
and Affordability act, designed to establish small business health plans that would be exempt from many state coverage requirements.
Republican leaders backing the measure fell five votes short of the 60 necessary to move forward with consideration. The American
Optometric Association (AOA) launched a nationwide advocacy campaign against the bill in April (See CLToday, April 23rd). The legislation
would have allowed health plans to discriminate against O.D.s, according to a statement released by the AOA.
The AOA secured a seat at the table with Senate leaders to ensure that if the bill was approved, it would contain safeguards to protect
O.D.s and patients from access and fee discrimination. The AOA feels that it is now well positioned to continue to voice the concerns
of optometry should further attempts to consider small business health legislation be made.
Foundation for Keratoconus Care Begins Operations
The IRS has authorized the Foundation for Keratoconus to begin operations. The Foundation’s purpose is to
financially assist keratoconic patients who are candidates for Intacs implantation, but don’t have the means to afford the procedure.
Any private patient of a U.S. licensed doctor who cannot afford the procedure, has no insurance coverage and does not qualify for or has
been denied by Medicaid, is eligible to receive aid. The Foundation will also provide support to various projects and organizations that
directly benefit the keratoconus community. The non-profit organization is currently seeking donations. Learn more at
www.keratocouscare.org.
Real-world feedback from eye care professionals now supports pre-launch claims of ACUVUE® ADVANCE™
Brand Contact Lenses for ASTIGMATISM.
When compared to Soflens66® Toric, ACUVUE® ADVANCE™ for ASTIGMATISM clearly provides
more predictable orientation and crisper, more stable vision; the advantage comes from the Accelerated Stabilization Design. Less lid
interaction leads to superior performance versus the traditional prism-ballast design such as found in Soflens66® Toric. Also,
because of HYDRACLEAR™ Technology, the lens delivers significantly better comfort both upon insertion and at the end of the
day.
--ADVERTISING
Global Keratoconus Congress 2007
Mark your calendars for the first-ever Global Keratoconus Congress to be held January 26-28, 2007 in
Las Vegas. The Global Keratoconus Congress is an assembly of experts in the field of patient care, teaching and research. They will
share the latest information on this chronic sight-threatening condition that affects one in 2,000 people. Attendees will learn about
the latest approaches to contact lens fitting, surgical techniques, clinical research and appropriate third-party reimbursement for
medically necessary contact lens care. Manufacturers and laboratories that support the care of these patients will assist in
demonstrating the usefulness of their latest products and treatments. More information will be coming soon.
Abstract:
Daily Disposable Lenses Using Sustained Release Technology
Researchers at Aston University’s Life and Health Sciences Department in Birmingham, U.K., recently
examined the clinical performance of a new, nelfilcon A lens. Nelfilcon A lenses with AquaRelease contain Polyvinyl alcohol (PVA)
and are modified to include additional, non-functional PVA. They conducted two contralateral, masked evaluations. The first examined the
effect of adding increased molecular weight PVA to nelfilcon A. The second compared the AquaRelease lens to ocufilcon B. They
measured non-invasive break-up time (NIBUT) and subjective comfort at the beginning and end of one-week of daily wear, as well as
three times a day after 8,12 and 16 hours of wear.
All subjects completed the daily wear schedule
of 16 hours. Subjective comfort and NIBUT improved with the AquaRelease lens upon insertion. Initial comfort was better for the
AuquaRelease lens when compared with ocufilcon B lenses, but NIBUT was not significantly different. Subjective comfort
decreased with time, but there was no significant difference between AquaRelease and ocufilcon B lenses. NIBUT was not significantly
impact by wearing time or between lenses. At the end of one week of wear, participants rated subjective initial end-of-day overall
comfort and vision better with AquaRelease than ocufilcon B. The researchers concluded that the release of additional, non-functional
PVS from the nelfilcon A lenses appear to enhance comfort in contact lens wear.
Peterson RC, Wolffson JS, Nick J, et al.
Clinical performance of daily disposable soft contact lenses using sustained release technology. Cont Lens Anterior Eye. 2006
May 8;
Editor's Commentary:
Don't top off
One of the studies that Bausch & Lomb has conducted, though we haven't seen the data yet, indicates that
for a number of commonly-used solutions, adding a little more solution to what has already been used is a bad idea. It may cause an
otherwise very good product to allow microbial growth. Think about it, the lens contaminates the solution. Even if patients rub and
rinse the lens, if they don’t clean the case, they are allowing organisms to grow on its surface and evaporation is taking place. Not
only may this be compromising from an infection point of view, but any cleaning and surface enhancing the solution may provide is now
compromised, which will lead to less comfort and poorer vision. Make sure you tell your patients not to top off.
Fitting Tip:
Fitting Tip for Larger Diameter GP lenses
As we see an increase in the availability of larger GP lens designs for the fitting of irregular corneas,
as well as increased general use of GPs, we’ve found that removing these larger lenses can sometimes be a challenge. Larger lenses are
usually a little snug. The edge designs of GP lenses are computer generated to assure minimal awareness of edge and lid interaction,
resulting in occasional partial adhesion or binding, especially at the end of the day.
A fitting tip
or in this case, a removal tip, is to use a lubrication or rewetting drop before attempting to remove them by blinking or using a remover.
This ensures the lens is free of any binding to the cornea and lessens the risk of epithelial damage, which can occur if lenses are stuck
to the eye when the patient tries to remove them.
Keith Parker, President
Advanced Vision Technologies
The Global Orthokeratology Symposium presents "Fundamentals of Corneal Reshaping"
— a newly formatted educational experience for 2006. Held in conjunction with the Southern California College
of Optometry, this 2-day
course designed for the novice or new orthokeratology practitioner will focus on patient selection, corneal topography, choosing a design —
plus "live" fitting and
next-day follow-up with actual patients. Go to www.GOS2006.com for more information.
--ADVERTISING
This month at http://www.siliconehydrogels.org, consider
prescribing silicone hydrogels
for pediatric patients, evaluate the effectiveness of “no rub” multipurpose solutions, and read part two of our Academy 2005
synopsis.
Report adverse contact lens reactions here:
http://www.accessdata.fda.gov/scripts/medwatch/ or call (800)
FDA-1088.
Access a reporting form for complications you've seen that were a result of contact lenses dispensed
without a valid prescription at the Association of Regulatory Boards of Optometry's (ARBO's) Web site:
http://www.arbo.org/arbo.asp?dt=R&doc=Complications. Complete and send
the form online or print it out and fax it to (866) 886-6164.
Send your favorite tips to
tips@cltoday.com -- if your tip is selected as 'Best of the Month,' you'll receive a free golf shirt
(see http://www.CLToday.com for details). Please include your full name, degree or title and
city/state/country.
Visit Contact Lens Spectrum ( http://www.clspectrum.com ) for interactive clinical
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