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 CA Technologies has been named "Platinum Sponsor" of SYS-CON's 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business - from apparel to energy - is being rewritten by software. From planning to development to management to security, CA creates software that fuels transformation for companies in the applic...
Amazon started as an online bookseller 20 years ago. Since then, it has evolved into a technology juggernaut that has disrupted multiple markets and industries and touches many aspects of our lives. It is a relentless technology and business model innovator driving disruption throughout numerous ecosystems. Amazon’s AWS revenues alone are approaching $16B a year making it one of the largest IT companies in the world. With dominant offerings in Cloud, IoT, eCommerce, Big Data, AI, Digital Assista...
Multiple data types are pouring into IoT deployments. Data is coming in small packages as well as enormous files and data streams of many sizes. Widespread use of mobile devices adds to the total. In this power panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists looked at the tools and environments that are being put to use in IoT deployments, as well as the team skills a modern enterprise IT shop needs to keep things running, get a handle on all this data, and deliver...
In his session at @ThingsExpo, Eric Lachapelle, CEO of the Professional Evaluation and Certification Board (PECB), provided an overview of various initiatives to certify the security of connected devices and future trends in ensuring public trust of IoT. Eric Lachapelle is the Chief Executive Officer of the Professional Evaluation and Certification Board (PECB), an international certification body. His role is to help companies and individuals to achieve professional, accredited and worldwide re...
You know you need the cloud, but you’re hesitant to simply dump everything at Amazon since you know that not all workloads are suitable for cloud. You know that you want the kind of ease of use and scalability that you get with public cloud, but your applications are architected in a way that makes the public cloud a non-starter. You’re looking at private cloud solutions based on hyperconverged infrastructure, but you’re concerned with the limits inherent in those technologies.
Both SaaS vendors and SaaS buyers are going “all-in” to hyperscale IaaS platforms such as AWS, which is disrupting the SaaS value proposition. Why should the enterprise SaaS consumer pay for the SaaS service if their data is resident in adjacent AWS S3 buckets? If both SaaS sellers and buyers are using the same cloud tools, automation and pay-per-transaction model offered by IaaS platforms, then why not host the “shrink-wrapped” software in the customers’ cloud? Further, serverless computing, cl...
The taxi industry never saw Uber coming. Startups are a threat to incumbents like never before, and a major enabler for startups is that they are instantly “cloud ready.” If innovation moves at the pace of IT, then your company is in trouble. Why? Because your data center will not keep up with frenetic pace AWS, Microsoft and Google are rolling out new capabilities. In his session at 20th Cloud Expo, Don Browning, VP of Cloud Architecture at Turner, posited that disruption is inevitable for comp...
Wooed by the promise of faster innovation, lower TCO, and greater agility, businesses of every shape and size have embraced the cloud at every layer of the IT stack – from apps to file sharing to infrastructure. The typical organization currently uses more than a dozen sanctioned cloud apps and will shift more than half of all workloads to the cloud by 2018. Such cloud investments have delivered measurable benefits. But they’ve also resulted in some unintended side-effects: complexity and risk. ...
With the introduction of IoT and Smart Living in every aspect of our lives, one question has become relevant: What are the security implications? To answer this, first we have to look and explore the security models of the technologies that IoT is founded upon. In his session at @ThingsExpo, Nevi Kaja, a Research Engineer at Ford Motor Company, discussed some of the security challenges of the IoT infrastructure and related how these aspects impact Smart Living. The material was delivered interac...
It is ironic, but perhaps not unexpected, that many organizations who want the benefits of using an Agile approach to deliver software use a waterfall approach to adopting Agile practices: they form plans, they set milestones, and they measure progress by how many teams they have engaged. Old habits die hard, but like most waterfall software projects, most waterfall-style Agile adoption efforts fail to produce the results desired. The problem is that to get the results they want, they have to ch...
IoT solutions exploit operational data generated by Internet-connected smart “things” for the purpose of gaining operational insight and producing “better outcomes” (for example, create new business models, eliminate unscheduled maintenance, etc.). The explosive proliferation of IoT solutions will result in an exponential growth in the volume of IoT data, precipitating significant Information Governance issues: who owns the IoT data, what are the rights/duties of IoT solutions adopters towards t...
"We are a monitoring company. We work with Salesforce, BBC, and quite a few other big logos. We basically provide monitoring for them, structure for their cloud services and we fit into the DevOps world" explained David Gildeh, Co-founder and CEO of Outlyer, in this SYS-CON.tv interview at DevOps Summit at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
In 2014, Amazon announced a new form of compute called Lambda. We didn't know it at the time, but this represented a fundamental shift in what we expect from cloud computing. Now, all of the major cloud computing vendors want to take part in this disruptive technology. In his session at 20th Cloud Expo, Doug Vanderweide, an instructor at Linux Academy, discussed why major players like AWS, Microsoft Azure, IBM Bluemix, and Google Cloud Platform are all trying to sidestep VMs and containers wit...
While DevOps most critically and famously fosters collaboration, communication, and integration through cultural change, culture is more of an output than an input. In order to actively drive cultural evolution, organizations must make substantial organizational and process changes, and adopt new technologies, to encourage a DevOps culture. Moderated by Andi Mann, panelists discussed how to balance these three pillars of DevOps, where to focus attention (and resources), where organizations might...
"When we talk about cloud without compromise what we're talking about is that when people think about 'I need the flexibility of the cloud' - it's the ability to create applications and run them in a cloud environment that's far more flexible,” explained Matthew Finnie, CTO of Interoute, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.