TearLab Osmolarity System Receives FDA Clearance
"This 510(k) clearance is a significant milestone for our company and validates the performance of our TearLab Osmolarity System for use as an aid in the diagnosis of Dry Eye Disease. Given that DED is a continuum, it is critical to diagnose and treat patients early in disease progression. We hope the TearLab will change the practice paradigm for eye care physicians in how they diagnose the DED patient population. The market for DED products is growing rapidly and there are over 20 novel therapeutic compounds being developed for the treatment of DED. We are excited to participate in the expanding commercial opportunities in eye care," commented Eric Donsky, CEO of TearLab Corporation.
The Company also intends to begin studies for CLIA Waiver categorization, with expected data submission to the FDA in the third quarter of 2009.
The TearLab Osmolarity System uses a lab-on-a-chip approach that requires less than 50 nL (nanoliters) of tear fluid in order to measure tear osmolarity. By using such a small amount of tears, the system eliminates the challenges that previously prevented point-of-care osmolarity testing, according to the company.
New Survey Provides Insight into Contact Lens Wearers with Ocular Allergies
One-third of survey respondents (33%) say they currently wear contacts, while one in ten (12%) admits to having dropped out of contacts because of allergies. Current wearers report that symptoms such as itchy, dry, red, and watery eyes, have led many of them to either use rewetting drops more frequently (50%), wear their glasses instead (50%), or wear their contacts less often (45%).
The majority of contact lens wearing respondents report that they replace their lenses monthly (45%) or every one to two weeks (38%). The survey also found that three in four respondents (74%) said that their doctor has never suggested single use contacts as an option for them to continue comfortably wearing contact lenses during allergy season.
To help allergy sufferers better understand and manage the condition, the AAFA offers a free educational brochure titled Eye Health & Allergies. The brochure, supported by 1-Day Acuvue Moist, can be viewed or downloaded at www.aafa.org/eyeallergies. Eye care professionals can order a free set (50 brochures) for their practice via e-mail at eyeallergybrochure@rprny.com. Requests should include name and complete address, including zip code.
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Alcon Sponsors Free Webinar on Building a Medical Practice
"Optometrists have a huge responsibility and opportunity to provide the majority of primary eye care to the U.S. population," said Rumpakis. "The most important thing is to provide the best care to these patients, then accurately translate this care into the proper codes that medical insurance carriers can reimburse."
Dr. Rumpakis will cover topics like How to Incorporate Medical Eye Care into Your Practice, How to Become a Medicare Provider and How to Apply Medical Coding to Typical Case Presentations. Using clinical case studies involving routine patients, he will take the attendees step-by-step through the patient care steps, discussing proper coding and how doctors and their staff can be both compliant and profitable.
There are several free webinars scheduled throughout the rest of the year. For more information and to register, visit http://events.SignUp4.com/medpractice.
ABB CONCISE Receives Award
"This award recognizes the can-do attitude of the great people in our organization, who have enabled us to succeed even in a very difficult economic climate," said Angel Alvarez, ABB CONCISE CEO.
Taiwan Macro Vision Corporation Partners with Dakota Sciences
Russell Franques, CEO of Dakota Sciences said of the partnership "We are extremely pleased to have the highly skilled group at TMVC to be the exclusive So2Clear technology provider in Taiwan. Dakota Sciences is very excited that the introduction of So2Clear technology to Asia will be driven by TMVC. We are highly confident that TMVC will generate the exceptional patient results, high practitioner satisfaction, and broad brand awareness that So2Clear has generated in both North America and Europe."
Abstract: Fluorophotometry to Evaluate the Corneal Epithelium in Eyes Undergoing Contact Lens Corneal Reshaping
Eight patients with healthy eyes, whose refractive error was between -0.50 and -4.00 diopters (D) sphere and up to -1.75 D of astigmatism, were enrolled. On the day of the fitting, two baseline fluorometric scans of the right eye were taken using the Ocumetrics Fluorotron Master. After 15 minutes, another two scans were taken of the right eye. The same fluorophotometry technique was repeated on day 1, 1 week, 1 month, and 3 months after the patient began overnight wear of the lenses. Patients' baseline corneal fluorescein levels and peak corneal fluorescence values after rinsing were compared to initial pre-fitting values to determine changes in corneal epithelial permeability.
After patients used orthokeratology, uncorrected visual acuity was 20/20 or better in 9/16 eyes and 100% had achieved 20/40 or better by day 7. No adverse events were seen in patients utilizing orthokeratology, and eye examinations for these patients continued to be within normal limits. After nightly use of orthokeratology for 1 month, baseline fluorescence of the cornea (15.64 +/- 2.29 ng/mL vs. 17.31 +/-5.43 ng/mL, P = 0.80) remained stable, and the post-15 minute scan peak corneal fluorescence values did not show significant changes from the pre-fitting (51.46 +/- 17.28 ng/mL) after use of orthokeratology (63.80 +/- 41.25 ng/mL) (P = 0.78).
The researchers concluded that reshaping of the cornea through the use of orthokeratology does not have adverse effects on corneal epithelium as evaluated by changes in corneal epithelial permeability.
Savitsky DZ, Fan VC, Yildiz EH, Du TT, Asbell PA. Fluorophotometry to evaluate the corneal epithelium in eyes undergoing contact lens corneal reshaping to correct myopia. J Refract Surg 2009;25:366-70.
Editor's Commentary: BCLA
As always, the meeting should prove to be quite a success, and I look forward to updating you on it in the near future.
Jason J. Nichols, OD, MPH, PhD, FAAO
Report possible grievances related to the Fairness to Contact Lens Consumers Act or associated Contact Lens Rule at: https://www.ftccomplaintassistant.gov/.