SYS-CON MEDIA Authors: Pat Romanski, Liz McMillan, Elizabeth White, Yeshim Deniz, Glenn Rossman

News Feed Item

Ventura County Eye Surgeon Helps Persuade FDA Panel to Support Approval of Long-Awaited Lens Implant

First-of-Its-Kind in the U.S. Toric Implant for Treating Nearsightedness and Astigmatism Already Cleared for Use in 60-Plus Countries; Data Reported by Dr. Paul Dougherty Helps Prompt FDA Advisory Panel Recommendation

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.

Add to Digg Bookmark with del.icio.us Add to Newsvine

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

@CloudExpo Stories
SYS-CON Events announced today that SOA Software, an API management leader, will exhibit at SYS-CON's 15th International Cloud Expo®, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. SOA Software is a leading provider of API Management and SOA Governance products that equip business to deliver APIs and SOA together to drive their company to meet its business strategy quickly and effectively. SOA Software’s technology helps businesses to accel...
Compute virtualization has been transformational, yet security policy implementation and enforcement has lagged behind in agility and automation. There are a number of key considerations when implementing policy in private and hybrid clouds. In his session at 15th Cloud Expo, Holland Barry, VP of Technology at Catbird, will discuss the impact of this new paradigm and what organizations can do today to safely move to software-defined network and compute architectures, including: How normal ope...
Samsung VP Jacopo Lenzi, who headed the company's recent SmartThings acquisition under the auspices of Samsung's Open Innovaction Center (OIC), answered a few questions we had about the deal. This interview was in conjunction with our interview with SmartThings CEO Alex Hawkinson. IoT Journal: SmartThings was developed in an open, standards-agnostic platform, and will now be part of Samsung's Open Innovation Center. Can you elaborate on your commitment to keep the platform open? Jacopo Lenzi: S...
How do APIs and IoT relate? The answer is not as simple as merely adding an API on top of a dumb device, but rather about understanding the architectural patterns for implementing an IoT fabric. There are typically two or three trends: Exposing the device to a management framework Exposing that management framework to a business centric logic • Exposing that business layer and data to end users. This last trend is the IoT stack, which involves a new shift in the separation of what stuff hap...
SYS-CON Events announced today that Utimaco will exhibit at SYS-CON's 15th International Cloud Expo®, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Utimaco is a leading manufacturer of hardware based security solutions that provide the root of trust to keep cryptographic keys safe, secure critical digital infrastructures and protect high value data assets. Only Utimaco delivers a general-purpose hardware security module (HSM) as a customiz...
Almost everyone sees the potential of Internet of Things but how can businesses truly unlock that potential. The key will be in the ability to discover business insight in the midst of an ocean of Big Data generated from billions of embedded devices via Systems of Discover. Businesses will also need to ensure that they can sustain that insight by leveraging the cloud for global reach, scale and elasticity.
SYS-CON Events announced today that ElasticBox is holding a Hackathon at DevOps Summit, November 6 from 12 pm -4 pm at the Santa Clara Convention Center in Santa Clara, CA. You can enter as an individual or team of up to 10 developers. A New Star Is Born Every Month! All completed ElasticBoxes will then be sent to a judging panel - 12 winners will be featured on the ElasticBox website in 2015. All entrants will receive five full enterprise licenses for one year + ElasticBox headphones + Elasti...
Once the decision has been made to move part or all of a workload to the cloud, a methodology for selecting that workload needs to be established. How do you move to the cloud? What does the discovery, assessment and planning look like? What workloads make sense? Which cloud model makes sense for each workload? What are the considerations for how to select the right cloud model? And how does that fit in with the overall IT tranformation? In his session at 15th Cloud Expo, John Hatem, head of V...
Cloud services are the newest tool in the arsenal of IT products in the market today. These cloud services integrate process and tools. In order to use these products effectively, organizations must have a good understanding of themselves and their business requirements. In his session at 15th Cloud Expo, Brian Lewis, Principal Architect at Verizon Cloud, will outline key areas of organizational focus, and how to formalize an actionable plan when migrating applications and internal services to...
SAP is delivering break-through innovation combined with fantastic user experience powered by the market-leading in-memory technology, SAP HANA. In his General Session at 15th Cloud Expo, Thorsten Leiduck, VP ISVs & Digital Commerce, SAP, will discuss how SAP and partners provide cloud and hybrid cloud solutions as well as real-time Big Data offerings that help companies of all sizes and industries run better. SAP launched an application challenge to award the most innovative SAP HANA and SAP ...
Ixia develops amazing products so its customers can connect the world. Ixia helps its customers provide an always-on user experience through fast, secure delivery of dynamic connected technologies and services. Through actionable insights that accelerate and secure application and service delivery, Ixia's customers benefit from faster time to market, optimized application performance and higher-quality deployments.
SYS-CON Events announced today that Calm.io has been named “Bronze Sponsor” of DevOps Summit Silicon Valley, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Calm.io is a cloud orchestration platform for AWS, vCenter, OpenStack, or bare metal, that runs your CL tools puppet, Chef, shell, git, Jenkins, nagios, and will soon support New Relic and Docker. It can run hosted, or on premise and provides VM automation / expiry, self-service portals,...
In her General Session at 15th Cloud Expo, Anne Plese, Senior Consultant, Cloud Product Marketing, at Verizon Enterprise, will focus on finding the right mix of renting vs. buying Oracle capacity to scale to meet business demands, and offer validated Oracle database TCO models for Oracle development and testing environments. Anne Plese is a marketing and technology enthusiast/realist with over 19+ years in high tech. At Verizon Enterprise, she focuses on driving growth for the Verizon Cloud pla...
SYS-CON Events announced today that Aria Systems, the recurring revenue expert, has been named "Bronze Sponsor" of SYS-CON's 15th International Cloud Expo®, which will take place on November 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Aria Systems helps leading businesses connect their customers with the products and services they love. Industry leaders like Pitney Bowes, Experian, AAA NCNU, VMware, HootSuite and many others choose Aria to power their recurring revenue bu...
The Internet of Things (IoT) is going to require a new way of thinking and of developing software for speed, security and innovation. This requires IT leaders to balance business as usual while anticipating for the next market and technology trends. Cloud provides the right IT asset portfolio to help today’s IT leaders manage the old and prepare for the new. Today the cloud conversation is evolving from private and public to hybrid. This session will provide use cases and insights to reinforce t...
As Platform as a Service (PaaS) matures as a category, developers should have the ability to use the programming language of their choice to build applications and have access to a wide array of services. Bluemix is IBM's open cloud development platform that enables users to easily build cloud-based, creative mobile and web applications without having to spend large amounts of time and resources on configuring infrastructure and multiple software licenses. In this track, you will learn about the...
Blue Box has closed a $10 million Series B financing. The round was led by a strategic investor and included participation from prior investors including Voyager Capital and Founders Collective, as well as the Blue Box executive team. This round follows a $4.3 million Series A closed in December of 2012 and led by Voyager Capital. In May of this year, the company announced general availability of its private cloud as a service offering, Blue Box Cloud. Since that release, the company has dem...
SYS-CON Events announced today that Verizon has been named "Gold Sponsor" of SYS-CON's 15th International Cloud Expo®, which will take place on November 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Verizon Enterprise Solutions creates global connections that generate growth, drive business innovation and move society forward. With industry-specific solutions and a full range of global wholesale offerings provided over the company's secure mobility, cloud, strategic network...
SimpleECM is the only platform to offer a powerful combination of enterprise content management (ECM) services, capture solutions, and third-party business services providing simplified integrations and workflow development for solution providers. SimpleECM is opening the market to businesses of all sizes by reinventing the delivery of ECM services. Our APIs make the development of ECM services simple with the use of familiar technologies for a frictionless integration directly into web applicat...
The only place to be June 9-11 is Cloud Expo & @ThingsExpo 2015 East at the Javits Center in New York City. Join us there as delegates from all over the world come to listen to and engage with speakers & sponsors from the leading Cloud Computing, IoT & Big Data companies. Cloud Expo & @ThingsExpo are the leading events covering the booming market of Cloud Computing, IoT & Big Data for the enterprise. Speakers from all over the world will be hand-picked for their ability to explore the economic...