Welcome!

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.

Latest Stories
SYS-CON Events announced today that DivvyCloud will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. DivvyCloud software enables organizations to achieve their cloud computing goals by simplifying and automating security, compliance and cost optimization of public and private cloud infrastructure. Using DivvyCloud, customers can leverage programmatic Bots to identify and remediate common cloud problems in rea...
SYS-CON Events announced today that Tintri, Inc, a leading provider of enterprise cloud infrastructure, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Tintri offers an enterprise cloud platform built with public cloud-like web services and RESTful APIs. Organizations use Tintri all-flash storage with scale-out and automation as a foundation for their own clouds – to build agile development environments...
SYS-CON Events announced today that Progress, a global leader in application development, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Enterprises today are rapidly adopting the cloud, while continuing to retain business-critical/sensitive data inside the firewall. This is creating two separate data silos – one inside the firewall and the other outside the firewall. Cloud ISVs ofte...
SYS-CON Events announced today that Tappest will exhibit MooseFS at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. MooseFS is a breakthrough concept in the storage industry. It allows you to secure stored data with either duplication or erasure coding using any server. The newest – 4.0 version of the software enables users to maintain the redundancy level with even 50% less hard drive space required. The software func...
SYS-CON Events announced today that Interoute has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Interoute is the owner operator of Europe's largest network and a global cloud services platform, which encompasses over 70,000 km of lit fiber, 15 data centers, 17 virtual data centers and 33 colocation centers, with connections to 195 additional partner data centers. Our full-service Unifie...
SYS-CON Events announced today that EARP will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. "We are a software house, so we perfectly understand challenges that other software houses face in their projects. We can augment a team, that will work with the same standards and processes as our partners' internal teams. Our teams will deliver the same quality within the required time and budget just as our partn...
SYS-CON Events announced today that Carbonite will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Carbonite protects your entire IT footprint with the right level of protection for each workload, ensuring lower costs and dependable solutions with DoubleTake and Evault.
SYS-CON Events announced today that Super Micro Computer, Inc., a global leader in compute, storage and networking technologies, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Supermicro (NASDAQ: SMCI), the leading innovator in high-performance, high-efficiency server technology, is a premier provider of advanced server Building Block Solutions® for Data Center, Cloud Computing, Enterprise IT, Hadoop/...
SYS-CON Events announced today that Outscale will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Outscale's technology makes an automated and adaptable Cloud available to businesses, supporting them in the most complex IT projects while controlling their operational aspects. You boost your IT infrastructure's reactivity, with request responses that only take a few seconds.
While some vendors scramble to create and sell you a fancy solution for monitoring your spanking new Amazon Lambdas, hear how you can do it on the cheap using just built-in Java APIs yourself. By exploiting a little-known fact that Lambdas aren’t exactly single threaded, you can effectively identify hot spots in your serverless code. In his session at 20th Cloud Expo, David Martin, Principal Product Owner at CA Technologies, will give a live demonstration and code walkthrough, showing how to ov...
SYS-CON Events announced today that Technologic Systems Inc., an embedded systems solutions company, will exhibit at SYS-CON's @ThingsExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Technologic Systems is an embedded systems company with headquarters in Fountain Hills, Arizona. They have been in business for 32 years, helping more than 8,000 OEM customers and building over a hundred COTS products that have never been discontinued. Technologic Systems’ pr...
As cloud adoption continues to transform business, today's global enterprises are challenged with managing a growing amount of information living outside of the data center. The rapid adoption of IoT and increasingly mobile workforce are exacerbating the problem. Ensuring secure data sharing and efficient backup poses capacity and bandwidth considerations as well as policy and regulatory compliance issues.
SYS-CON Events announced today that Cloudistics, an on-premises cloud computing company, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Cloudistics delivers a complete public cloud experience with composable on-premises infrastructures to medium and large enterprises. Its software-defined technology natively converges network, storage, compute, virtualization, and management into a ...
New competitors, disruptive technologies, and growing expectations are pushing every business to both adopt and deliver new digital services. This ‘Digital Transformation’ demands rapid delivery and continuous iteration of new competitive services via multiple channels, which in turn demands new service delivery techniques – including DevOps. In this power panel at @DevOpsSummit 20th Cloud Expo, moderated by DevOps Conference Co-Chair Andi Mann, panelists will examine how DevOps helps to meet th...
SYS-CON Events announced today that Progress, a global leader in application development, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Enterprises today are rapidly adopting the cloud, while continuing to retain business-critical/sensitive data inside the firewall. This is creating two separate data silos – one inside the firewall and the other outside the firewall. Cloud ISVs oft...