FDA Announces Plans for LASIK Quality of Life Project
Funded by the government agencies, the project is composed of three phases. The objective of Phase 1, which began in July 2009, is to design and implement a Web based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK, some of which may relate to the safety of the lasers used in the LASIK procedure. Phase 2 will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy Refractive Surgery Center. Phase 3 will be a national, multi-center clinical trial and will study the impact of the procedure on quality of life following LASIK in the general population. Patient enrollment in Phases 2 and 3 have yet to begin but plans are underway. Phase 3 is expected to end in 2012.
The results of the project will help identify factors that can affect quality of life following LASIK and potentially reduce the risk of adverse effects that can impact the surgical outcome, per the agency. If any of these factors related to the safety or effectiveness of the lasers used in LASIK surgery, the FDA will evaluate whether any action is necessary. The project is part of the FDA's ongoing effort to better monitor and improve the safety and effectiveness of the lasers used in LASIK surgery.
"This study will enhance our understanding of the risks of LASIK and could lead to a reduction in patients who experience adverse effects from the procedure," said Dr. Jeffrey Shuren, Acting Director of the FDA's Center for Devices and Radiological Health.
The FDA also announced that it issued warning letters to 17 LASIK ambulatory surgical centers after inspections revealed inadequate adverse event reporting systems at all the centers. The inspections did not identify problems with the use of the LASIK devices at these facilities. Under legislation passed in 1990, user facilities, which include nursing homes, outpatient clinics and ambulatory surgical centers, must report device-related deaths to the FDA and to the device manufacturer. They also must report device-related serious injuries to the manufacturer or to the FDA if the manufacturer is not known. Requirements include having a written protocol for adverse event reporting.
For more information visit:
The FDA's Web site on LASIK:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/default.htm
FDA Guidance: Medical Device Reporting for User Facilities:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095266.pdf
Center for Patient Insights Web Site Goes Live
"The new Center for Patient Insights Web site will make it faster and easier for eye care professionals to learn about insights that can help them grow their practice and increase patient loyalty," said Steven Robins, President, North America, Vision Care. "The site provides balanced information that can help eye care professionals make informed decisions about their practice."
The Web site provides eye care professionals with brief PatientPoints, which provide summaries of industry trends; market research on patient attitudes and beliefs; and insights on how these data can be used to improve their practices. Information can be downloaded from the Web site and printed for future reference. The Web site also includes a search function that allows users to easily locate specific information via keywords and categories, including vision conditions, patient outcomes and patient preferences.
According to B&L, in addition to its Web site, the Center for Patient Insights will use a variety of channels, including publications and e-mails, to distribute timely, relevant and comprehensive data gathered from patient and consumer research.
CooperVision Launches LensLocator
To help kick off the new site, CooperVision will be donating a dollar to New Eyes for the Needy for each unique visitor to LensLocator.com, up to $5,000. Endorsed by the American Academy of Optometry, New Eyes for the Needy is a non-profit volunteer organization that helps improve vision by providing new and recycled eyeglasses to children and adults worldwide.
Doctors simply enter a patient's specific prescription or any component of a prescription, such as sphere power, cylinder power, axis, ADD, modality, and wear schedule into the LensLocator fields and then click on the search button. The tool automatically scans the entire CooperVision portfolio, ranging from spheres to multifocal toric lenses, and identifies options that contain all of the necessary information practitioners need to fit the patient. The site also provides a direct link to MyCooperVision, the company's secure e-commerce site, so that doctors can immediately place an order for the lenses.
The site will work on Web-capable smart phones and devices, allowing eye care professionals to access a comprehensive list of CooperVision products while moving through a busy office, after hours, or off-site. The LensLocator is also accessible through CooperVision's practitioner website, http://www.coopervision.com. There, eye care professionals will also find an extensive range of resources for building their practices, including inventory and profitability calculators.
Offer your patients all-day comfort that won't blink away
Additional Information
1. Data on file. Johnson & Johnson, 2008.
ACUVUE® Brand Contact Lenses are indicated for vision correction. As with any contact lens, eye problems, including corneal ulcers, can develop. Some wearers may experience mild irritation, itching or discomfort. Lenses should not be prescribed if patients have any eye infection, or experience eye discomfort, excessive tearing, vision changes, redness or other eye problems. Consult the package insert for complete information. Complete information is also available from VISTAKON®, Division of Johnson & Johnson Vision Care, Inc., by calling 1-800-843-2020 or by visiting jnjvisioncare.com.
ACUVUE®, 1·DAY ACUVUE® MOIST®, LACREON™, and VISTAKON® are trademarks of Johnson & Johnson Vision Care, Inc.
Other brand names/product names are trademarks of their respective owners.
© Johnson & Johnson Vision Care, Inc. 2009
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BCLA Calls for Papers, Posters and "Hot Topics"
The BCLA is also trying out a new submission category in 2010, Hot Topics, to make sure the latest issues are aired at the conference and to encourage discussion. Subject matter should be highly topical and could be a new fitting strategy, way of grading, proposed risk factor or revolutionary instrument/technique. Presenters will have 10 minutes each to outline the issue and an open discussion will be held at the end of each session. The final submission date for Hot Topics is April 15, 2010.
Also invited are images for the BCLA photographic competition which takes place at the conference. The winning entries will be published in the Association's journal, Contact Lens & Anterior Eye. The closing date for entries is April 23, 2010.
For each conference submission accepted by the Academic Committee, whether for scientific paper, poster, hot topic or photograph, the first author will receive a voucher towards the cost of registering for the conference.
Visit www.bcla.org.uk, email to events@bcla.org.uk or call +44 (0)20 7580 6661 for more information on how to make your submission. Full details of the conference program and registration will be available in December.
Adventure In Colors Acquires the X-Chrom Lens
The lens is a monocular soft contact lens, that when fitted to the non-dominant eye, significantly enhances color perception for those with a red-green color deficiency, according to the company, and improves many tasks by introducing additional shades to the retina, thus imparting perceptual clues to the brain. The lens is available in prescription as well as plano, the color covering only the pupil area without compromising the color of the eye or visual acuity.
The X-Chrom is now manufactured in hydroxyethylmethacrylate (HEMA) soft lens material by Adventure In Colors. The X-Chrom lens continues to be available in rigid (PMMA) material from Art Optical Contact Lens.
For sample information and literature on the Zeltzer X-Chrom soft lens and other products, please visit www.techcolors.com or call 1-800-537-2845.
Global Specialty Lens Symposium, January 28-31, 2010, Bally's Hotel & Casino, Las Vegas
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EyeScience Announces Scientific Advisory Board
The professional members of the Board include Greg Evans, OD, Patrick Dollenmayer, OD, Jerald Bovino, MD, Michael A. Samuel, MD, Stephen Breaud, MD, Tom Chang, MD and Robert Josephberg, MD.
"The establishment of the SAB to EyeScience marks a significant contribution to not only our product development and research, but also to patients in need of improved eye care," says Jeff Northup, CEO and President of EyeScience. "I am honored to have these experts on board."
For more information, visit www.eyescience.com.
Abstract: The Effect of Surface Treatment of Silicone Hydrogel Contact Lenses on the Attachment of Acanthamoeba Castellanii Trophozoites
No significant difference in attachment was established between the untreated lotrafilcon A and the conventional hydrogel lenses (P<0.001); however, surface treatment of the native Focus Night & Day material produced a significant increase in attachment (P<0.001).
The researchers concluded that commercially available Focus Night & Day lenses are subjected to a plasma surface treatment to reduce lens hydrophobicity; however, this procedure results in an enhanced acanthamoebal attachment. It is possible that the silicone hydrogel lens could be at a greater risk of promoting Acanthamoeba infection if exposed to the organism because of the enhanced attachment characteristic of this material. Eye care professionals should be aware of the enhanced affinity that Acanthamoeba show for this lens and accordingly emphasize to patients the significance of appropriate lens hygiene. This is particularly important where lenses are worn in a regime that could increase the chance of exposure to the organism, i.e., 6 nights/7 days extended wear or daily wear, where lenses will be stored in a lens case, or where lenses are worn when in contact with potentially contaminated water sources, i.e., swimming or showering.
Beattie TK, Tomlinson A. The Effect of Surface Treatment of Silicone Hydrogel Contact Lenses on the Attachment of Acanthamoeba castellanii Trophozoites. Eye Contact Lens 2009.
Editor's Commentary: We've Come a Long Way
Jason J. Nichols, OD, MPH, PhD, FAAO
This month at www.siliconehydrogels.org: adverse events with daily wear of silicone hydrogels, SEALs with extended wear, controlling case contamination, contact lens complications, and part two of our AAO 2008 synopsis.
Report possible grievances related to the Fairness to Contact Lens Consumers Act or associated Contact Lens Rule at: https://www.ftccomplaintassistant.gov/.