Posted in | Medical Optics

FDA Approves ZEISS’ VisuMax Clinical Trial Expansion for All-Femto Laser Vision Correction Procedure

ZEISS announces the US release of a new glaucoma diagnostic and management software application, FORUM® Glaucoma Workplace, at the 2013 Annual Meeting of the American Academy of Ophthalmology (AAO). FORUM Glaucoma Workplace, an application available in the FORUM data management system from ZEISS, supports efficient clinical assessment at the point of care by delivering exam data in new clinically relevant ways.

“With FORUM and the new FORUM Glaucoma Workplace, ZEISS provides doctors with an integrated solution that allows them to see glaucoma in a completely different light -- by bringing together in new ways the structural and functional data and analyses from gold standard diagnostic devices,” says Dr. Ludwin Monz, President and CEO, Carl Zeiss Meditec AG.

FORUM Glaucoma Workplace provides off-instrument review of data from the Humphrey® Field Analyzer (HFA™) in the exam lane, and virtually anywhere in the practice. The application also enables interactive functional Guided Progression Analysis™ (GPA™) to help identify patients who are progressing and at risk for further visual field loss. With interactive GPA, doctors can adjust GPA parameters as needed, change baselines, reset baselines after surgery, or exclude outliers. Through FORUM, clinicians have immediate access to visual field data, OCT scans, and fundus images to support their glaucoma diagnosis and management. The HFA-CIRRUS Combined Report simplifies interpretation and provides at-a-glance assessment of structural and functional data.

“With FORUM Glaucoma Workplace, ZEISS has truly created something exceptional. FORUM enables me to view structure and function together using dynamic and malleable data. Not only does it enhance my clinical capabilities, it expands them,” says Steven D. Vold, MD, President and Medical Director, Vold Vision.

Introduction of workflow and review package for small practices: FORUM GO from ZEISS

The popular ZEISS FORUM data management system is now also offered in a preconfigured package, FORUM GO, that is ideal for small practices. FORUM GO is a simple and affordable data management system that allows eye care professionals fast and efficient review of patient exam data, diagnostic analyses and reports in the exam lane.

“The need to integrate EMR and data management systems is not only limited to larger or multi-site practices. With FORUM GO, we now offer a sound and expandable data management solution that perfectly covers the needs of a smaller practice,” says Dr. Ludwin Monz.

Clinicians can access examination data and images from up to three ZEISS diagnostic instruments and review from up to three viewing stations simultaneously. FORUM GO can be expanded and upgraded should additional connectivity be needed. FORUM GO comes preinstalled on a computer with a 23-inch HD display. Also available is a FORUM GO glaucoma version which comes with FORUM Glaucoma Workplace preinstalled.

Designed to work together: ZEISS Cataract Suite presented with new CALLISTO eye OR management system

The ZEISS Cataract Suite designed to work together for enhanced surgical precision and greater efficiency will be presented at the ZEISS booth #1919 during the 2013 AAO. The ZEISS Cataract Suite integrates the fastest, most accurate optical biometer1, the IOLMaster® 500, with the gold standard OPMI LUMERA® 700 surgical microscope and the new computer-assisted surgery system, CALLISTO eye®, enabling cataract surgeons to precisely and efficiently align toric intraocular lenses (IOLs) for optimal patient outcomes.

“The ZEISS Cataract Suite is ahead of the game in optics, precision measurements, and alignment of IOLs. CALLISTO eye increases our efficiency without compromising patient safety. For me it’s the perfect combination,” says Richard Davidson, MD, Vice Chair for Quality and Clinical Affairs, Department of Ophthalmology at the University of Colorado Eye Center.

The individual components of the ZEISS Cataract Suite are optimally matched and integrated to meet the highest standards and to support the most efficient workflow. The surgical workflow begins with the IOLMaster 500 which delivers a measurement success ratio of up to 20% higher than that of other optical biometers2,3,4. The OPMI LUMERA 700, voted #1 surgical microscope by ophthalmic surgeons5, offers unprecedented visualization of the eye with brilliant red reflex from its patented stereo coaxial illumination (SCI™) technology and exceptional clarity through ZEISS apochromatic optics. The CALLISTO eye computer-assisted cataract surgery system works seamlessly with the OPMI LUMERA projecting visual guides into the eyepieces of the surgical microscope based on the biometric data from the IOLMaster. These visual aids enable surgeons to see the placement of incisions and LRIs (limbal relaxing incisions), the exact size, shape and placement of capsulorhexis and, for the first time, take into account the patient’s true visual axis when placing and aligning the IOL -- within ~3 degrees of intended target6. CALLISTO eye also provides easy access to patient information in the OR, can be an auxiliary interface for controlling the microscope, and documents surgeries in high definition.

ZEISS receives FDA approval for expansion of US clinical trial for new minimally invasive, all-femto laser vision correction procedure, ReLEx smile

In the field of Laser Vision Correction, ZEISS announces receiving FDA approval for the expansion for the US Clinical Trial for the VisuMax® ReLEx® smile procedure for the correction of spherical myopia. “Based on the excellent safety and effectiveness data submitted to the FDA on the first 79 subjects treated with the ReLEx smile procedure and followed for at least three months, the FDA granted approval to expand the study to the full cohort of 360 subjects. This is an important milestone for the study,” says Jon Dishler, MD, US Medical Monitor for the VisuMax IDE study.

The ReLEx smile procedure combines advanced femtosecond laser technology with highly precise lenticule extraction for minimally invasive vision correction. The US Clinical Trial commenced in June 2012 and first results were presented by Dr. Dishler in April 2013. The study is being conducted at five sites in the US and 238 patients have been treated. Outside the USA, there are more than 150 sites in 38 countries, and over 300 surgeons are trained in the ReLEx smile procedure and have performed over 50,000 procedures.

ZEISS expands its portfolio of basic diagnostic instruments with the introduction of VISULENS 500 and an SL Imaging Module

ZEISS introduces the VISULENS 500 and slit lamp Imaging Module SL Cam 5.0 (510(k) pending, not available for sale in US). The VISULENS 500, an automated lensmeter, speeds up the refraction and prescription process with its fast and easy measurement of different lens materials and indices. The SL Cam 5.0 is compatible with all ZEISS slit lamps and provides excellent image and video quality. The portfolio of basic diagnostic instruments is rounded out with the VISUREF 100, a combination autorefractor and keratometer, and the i.ProfilerPlus, a 4-in-1 aberrometer, autorefractor, keratometer and corneal topographer system.

ZEISS Sponsored Symposium on Glaucoma with Harry A. Quigley, MD and Faculty

Harry A. Quigley, MD and the Faculty of the Glaucoma Center of Excellence, Wilmer Eye Institute at Johns Hopkins presented “Integration of Structural and Functional Glaucoma Diagnostics” at a ZEISS sponsored Glaucoma Symposium, Saturday November 16, 2013 at the Hilton Riverside, New Orleans. “Now that newer methods of measuring and following glaucoma damage are available, those of us who see many such patients have developed approaches that we find useful and that may be of value to other ophthalmologists,” says Dr. Quigley. “The faculty of the Wilmer Glaucoma Center of Excellence is pleased to give a symposium outlining practical approaches to glaucoma management.”

ZEISS Booth #1919 at 2013 AAO in New Orleans

Attendees of the 2013 AAO can experience state-of-the-art innovations and practice solutions at the ZEISS booth #1919 at the Ernest N. Morial Convention Center in New Orleans, November 16 to 19, 2013.

The ZEISS FORUM data management system will also be exhibited at the AAO sponsored IHE showcase: The Electronic Office: Integrating the Healthcare Enterprise (IHE) Eye Care in Hall G, Booth # 3851

Carl Zeiss Meditec AG

Carl Zeiss Meditec AG (ISIN: DE0005313704) is one of the world’s leading medical technology companies. The company supplies innovative technologies and application-oriented solutions designed to help doctors improve the quality of life of their patients. It provides complete packages of solutions for the diagnosis and treatment of eye diseases, including implants and consumables. The company creates innovative visualization solutions in the field of microsurgery. Carl Zeiss Meditec's medical technology portfolio is rounded off by promising, future-oriented technologies such as intraoperative radiotherapy. In fiscal year 2011/12 (ended 30 September) the company's around 2,400 employees generated revenue of just under EUR 862 million. Carl Zeiss Meditec headquarters are located in Jena, Germany.

The company has subsidiaries in Germany and abroad; more than 50 percent of its employees are based in the USA, Japan, Spain and France. The Center for Application and Research in India (CARIn) in Bangalore, India, and the Carl Zeiss Innovation Center for Research and Development in Shanghai, China, strengthen the company's presence in these fast-growing countries. Around 35 percent of Carl Zeiss Meditec shares are in free float. The remaining 65% are held by Carl Zeiss AG, one of the world’s leading groups in the optical and optoelectronic industries.

In the markets for Industrial Solutions, Research Solutions, Medical Technology and Consumer Optics, Carl Zeiss has contributed to technological progress for more than 160 years and enhances the quality of life of many people around the globe. Carl Zeiss AG, Oberkochen, is fully owned by the Carl Zeiss Foundation.

For more information, please go to: www.meditec.zeiss.com

1 Chen YA, Hirnschall N, Findl O. Evaluation of 2 new optical biometry devices and comparison with the current gold standard biometer. J Cataract Refract Surg. Mar. 2011, 37(3):513-517.
2 Hill W, Angeles R, Otani T, Evaluation of a new IOLMaster algorithm to measure axial length. J Cataract Refract Surg. 2008 Jun;34(6):920-4
3 Haigis W, Clinical Experience with the IOLMaster Advanced Technology software, presented at the ESCRS meeting in Stockholm, 2007
4 Olsen T, Improved clinical results with the IOLMaster Advanced Technology, presented at the ESCRS meeting in Stockholm, 2007
5 Packer, M. Do you have a preferred surgical microscope? Premier Surgeon 250 Survey. http://www.premiersurgeon.com/index.php/may-june-2011-ps250-survey/. Published May/June 2011. Accessed November 13, 2012.
6 Lackerbauer, C Modern Solutions for Refractive Cataract Surgery: CALLISTO eye. Cataract & Refractive Surgery Today; March, 2013.

Source: http://meditec.zeiss.com/

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