|By Marketwired .||
|March 25, 2014 11:05 AM EDT||
WEST LAKE VILLAGE, CA and CAMARILLO, CA -- (Marketwired) -- 03/25/14 -- Ophthalmic surgeon and researcher Dr. Paul Dougherty presented evidence and opinion at the U.S. Food and Drug Administration (FDA) Medical Devices Advisory Committee hearing May 14th that helped persuade the committee to vote in favor of STAAR Surgical's Visian® Toric Implantable Collamer® Lens (TICL) -- the first-of-its-kind in the U.S. lens implant designed to treat both nearsightedness and astigmatism in a single procedure.
Dr. Dougherty explained to the Committee how the Implantable Collamer Lens (ICL) is safe and effective for patients who meet the treatment criteria. He also discussed how the Toric version of the ICL is an excellent treatment option for those with nearsightedness and astigmatism. Without the Toric ICL, such patients must undergo two separate procedures (typically the ICL and LASIK or PRK) to correct their vision, which can double the risk of surgery.
Upon review of testimony from Dr. Dougherty and other leading ICL surgeons, the FDA's Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices, and STAAR Surgical, the Advisory Panel recommended to the Commissioner of Food and Drugs that the Toric ICL be made available to surgeons and patients in the U.S.
"The recommendation for the Toric ICL is good news for the many nearsighted people in the U.S. who can benefit from this long-awaited technology," said Dr. Dougherty. "In my experience, the ICL provides better quality vision and fewer night vision problems compared to other available treatment options."
Dr. Dougherty went on to explain how the ICL does not require the surgeon to remove corneal tissue (as is the case with LASIK), and therefore preserves the eye's corneal structure. While it is intended to provide permanent vision correction, the lens can also be removed if necessary. Finally, he pointed to ancillary benefits such as the ICL's built-in UV protection, which may help patients delay the onset of cataracts.
"Superior vision, fewer adverse side effects, reversibility and even UV protection are among the ICL's benefits, and they're the reason why surgeons across the U.S. look forward to making the Toric ICL available to their patients with nearsightedness and astigmatism," he added.
The Toric ICL is already approved for use in more than 60 countries. Its long-awaited approval by the FDA has prompted a significant number of U.S. patients with astigmatism to travel to Mexico, Canada or other nations where the lens is already available to consumers.
Dr. Dougherty's presentation during the open public hearing included data from his nearly 15 years of experience implanting the ICL on both an investigational and routine basis. He was an original clinical trial investigator for the lens, and has performed more than 1,000 ICL procedures.
The Visian Toric ICL (TICL) is a refractive phakic implant placed in the posterior chamber of the eye between the iris and the natural crystalline lens. It shares the same unique, foldable design as STAAR Surgical's Visian ICL, which was approved in the U.S. in 2005. The difference between the two is the toric optical feature of the TICL designed to permit the surgeon to correct both myopia (nearsightedness) and astigmatism (blurriness due to an irregularly shaped cornea) in a single procedure.
About Dougherty Laser Vision and Dr. Paul Dougherty
For nearly 20 years, Dougherty Laser Vision has brought the benefits of LASIK, lens implants, cataract surgery and other advanced vision correction procedures to patients who demand the highest quality care. Medical Director Dr. Paul Dougherty is an internationally renowned eye surgeon who has helped pioneer many of today's most advanced techniques. He also serves as assistant clinical instructor of ophthalmology at UCLA's Jules Stein Eye Institute and as a principal investigator for numerous FDA trials. Dr. Dougherty was one of the first surgeons in the US to perform laser vision correction on an investigational basis, and had the procedure on his own eyes in 1997. His book -- "See for Yourself - A Patient's Guide to Permanent Vision Correction," is a popular guide for consumers. Dougherty Laser Vision has locations throughout Los Angeles and Ventura Counties. More information is available at www.DoughertyLaserVision.com.
Dougherty Laser Vision
Red Hat is investing in Tesora, the number one contributor to OpenStack Trove Database as a Service (DBaaS) also ranked among the top 20 companies contributing to OpenStack overall. Tesora, the company bringing OpenStack Trove Database as a Service (DBaaS) to the enterprise, has announced that Red Hat and others have invested in the company as a part of Tesora's latest funding round. The funding agreement expands on the ongoing collaboration between Tesora and Red Hat, which dates back to Febr...
Sep. 1, 2015 04:30 PM EDT Reads: 387
SYS-CON Events announced today that DataClear Inc. will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. The DataClear ‘BlackBox’ is the only solution that moves your PC, browsing and data out of the United States and away from prying (and spying) eyes. Its solution automatically builds you a clean, on-demand, virus free, new virtual cloud based PC outside of the United States, and wipes it clean...
Sep. 1, 2015 04:15 PM EDT Reads: 433
WSM International, the pioneer and leader in server migration services, has announced an agreement with WHOA.com, a leader in providing secure public, private and hybrid cloud computing services. Under terms of the agreement, WSM will provide migration services to WHOA.com customers to relocate some or all of their applications, digital assets, and other computing workloads to WHOA.com enterprise-class, secure cloud infrastructure. The migration services include detailed evaluation and planning...
Sep. 1, 2015 04:00 PM EDT Reads: 196
Cloud and datacenter migration innovator AppZero has joined the Microsoft Enterprise Cloud Alliance Program. AppZero is a fast, flexible way to move Windows Server applications from any source machine – physical or virtual – to any destination server, in any cloud or datacenter, using its patented container technology. AppZero’s container is also called a Virtual Application Appliance (VAA). To facilitate Microsoft Azure onboarding, AppZero has two purpose-built offerings: AppZero SP for Azure,...
Sep. 1, 2015 04:00 PM EDT Reads: 207
SYS-CON Events announced today that G2G3 will exhibit at SYS-CON's @DevOpsSummit Silicon Valley, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Based on a collective appreciation for user experience, design, and technology, G2G3 is uniquely qualified and motivated to redefine how organizations and people engage in an increasingly digital world.
Sep. 1, 2015 03:00 PM EDT Reads: 509
SYS-CON Events announced today that IceWarp will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. IceWarp, the leader of cloud and on-premise messaging, delivers secured email, chat, documents, conferencing and collaboration to today's mobile workforce, all in one unified interface
Sep. 1, 2015 03:00 PM EDT Reads: 439
In 2014, the market witnessed a massive migration to the cloud as enterprises finally overcame their fears of the cloud’s viability, security, etc. Over the past 18 months, AWS, Google and Microsoft have waged an ongoing battle through a wave of price cuts and new features. For IT executives, sorting through all the noise to make the best cloud investment decisions has become daunting. Enterprises can and are moving away from a "one size fits all" cloud approach. The new competitive field has ...
Sep. 1, 2015 02:45 PM EDT
In his session at @ThingsExpo, Lee Williams, a producer of the first smartphones and tablets, will talk about how he is now applying his experience in mobile technology to the design and development of the next generation of Environmental and Sustainability Services at ETwater. He will explain how M2M controllers work through wirelessly connected remote controls; and specifically delve into a retrofit option that reverse-engineers control codes of existing conventional controller systems so the...
Sep. 1, 2015 02:45 PM EDT Reads: 136
Everyone talks about continuous integration and continuous delivery but those are just two ends of the pipeline. In the middle of DevOps is continuous testing (CT), and many organizations are struggling to implement continuous testing effectively. After all, without continuous testing there is no delivery. And Lab-As-A-Service (LaaS) enhances the CT with dynamic on-demand self-serve test topologies. CT together with LAAS make a powerful combination that perfectly serves complex software developm...
Sep. 1, 2015 02:30 PM EDT Reads: 212
The Internet of Things is in the early stages of mainstream deployment but it promises to unlock value and rapidly transform how organizations manage, operationalize, and monetize their assets. IoT is a complex structure of hardware, sensors, applications, analytics and devices that need to be able to communicate geographically and across all functions. Once the data is collected from numerous endpoints, the challenge then becomes converting it into actionable insight.
Sep. 1, 2015 01:00 PM EDT
With the proliferation of connected devices underpinning new Internet of Things systems, Brandon Schulz, Director of Luxoft IoT – Retail, will be looking at the transformation of the retail customer experience in brick and mortar stores in his session at @ThingsExpo. Questions he will address include: Will beacons drop to the wayside like QR codes, or be a proximity-based profit driver? How will the customer experience change in stores of all types when everything can be instrumented and a...
Sep. 1, 2015 12:45 PM EDT Reads: 476
SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
Sep. 1, 2015 12:30 PM EDT Reads: 912
This Enterprise Strategy Group lab validation report of the NEC Express5800/R320 server with Intel® Xeon® processor presents the benefits of 99.999% uptime NEC fault-tolerant servers that lower overall virtualized server total cost of ownership. This report also includes survey data on the significant costs associated with system outages impacting enterprise and web applications. Click Here to Download Report Now!
Sep. 1, 2015 12:30 PM EDT Reads: 258
Enterprises can achieve rigorous IT security as well as improved DevOps practices and Cloud economics by taking a new, cloud-native approach to application delivery. Because the attack surface for cloud applications is dramatically different than for highly controlled data centers, a disciplined and multi-layered approach that spans all of your processes, staff, vendors and technologies is required. This may sound expensive and time consuming to achieve as you plan how to move selected applicati...
Sep. 1, 2015 12:30 PM EDT
Consumer IoT applications provide data about the user that just doesn’t exist in traditional PC or mobile web applications. This rich data, or “context,” enables the highly personalized consumer experiences that characterize many consumer IoT apps. This same data is also providing brands with unprecedented insight into how their connected products are being used, while, at the same time, powering highly targeted engagement and marketing opportunities. In his session at @ThingsExpo, Nathan Trel...
Sep. 1, 2015 12:15 PM EDT Reads: 249