April 18, 2015

Meeting the Needs of Ophthalmologists: ZEISS Showcases Integrated Solutions that Deliver Faster Practice and Surgical Workflow and Address Critical Diagnostic Challenges

At the 2015 American Society of Cataract and Refractive Surgery (ASCRS) Annual Symposium in San Diego, ZEISS Medical Technology highlights its new Humphrey® Field Analyzer 3 as part of the Glaucoma Suite, a connected solution for accurate diagnosis and confident disease management. The company also presents integrated systems that improve and streamline ophthalmic surgery with the ZEISS Cataract Suite markerless and the RESCAN™700 intraoperative OCT.

The minimally invasive, flapless SMILE procedure – 3rd generation of laser vision correction beyond PRK and LASIK – expands into its second U.S. clinical trial following FDA approval of the study

SAN DIEGO, CA USA / DUBLIN, CA USA / JENA, Germany

The new ZEISS Humphrey Field Analyzer 3 (HFA3) enables ophthalmology practices to set up perimetry exams more quickly and improves confidence in test results. The new platform offers not only multiple technological advances to streamline workflow, but also visual field test data equal to and interchangeable with results from prior generations of the HFA, providing continuity and certainty in the ongoing care of patients.

The ZEISS Glaucoma Suite, featuring the HFA3, the CIRRUS™ HD-OCT and Glaucoma Workplace software, delivers an integrated solution to help eye care professionals accurately diagnose and precisely monitor glaucoma -- all at the point of care. With the Glaucoma Suite integration, practices can reduce data entry time and errors, save printing costs and improve clinic flow. Patient encounters are improved with the full diagnostic panel on a single screen, to provide quick and clear explanations of diagnosis and treatment recommendations.

The innovative RESCAN 700 intraoperative OCT is another example of true integration from ZEISS. This breakthrough technology puts real-time high-definition OCT images right into the eyepiece of the OPMI LUMERA® 700 surgical microscope, which provides surgeons with unprecedented views below the surface of the surgical field – right down to the transparent structures in the anterior and posterior segment of the eye.

ZEISS RESCAN 700 helps surgeons to concentrate more on the surgical procedure, as the necessary structural information known from pre-operative OCTs is available all the time intraoperatively. Additionally, the continuous OCT scanning can help surgeons achieve better patient outcomes, because they can monitor progress and verify results during the procedure.

Seamless integration is a hallmark as well of the ZEISS Cataract Suite markerless, which encompasses the IOLMaster® 500 optical biometer, OPMI LUMERA® surgical microscopes, CALLISTO eye® computer-assisted cataract surgery system and FORUM® data management system. The system allows surgeons to skip the traditional time-consuming manual pre-operative and intraoperative marking of the corneal surface, thereby simplifying the toric IOL implantation and alignment workflow.

Jonathan Solomon, MD, surgical/refractive director of Solomon Eye Associates, will present data at ASCRS indicating that the intraoperative assistance tools available in the ZEISS Cataract Suite provide refractive outcomes superior to what is believed to be achievable using more traditional ink marks for toric alignment.

“By adding in the markerless component from ZEISS, I anticipate we can further optimize refractive outcomes by significantly reducing axis marking errors,” Dr. Solomon said.

Daniel Black, MD, of Sunshine Eye Clinic in Australia, has extensive surgical experience with the ZEISS Cataract Suite markerless, and in San Diego he will present compelling data showing that markerless toric IOL alignment provides more predictable refractive outcomes than the ink markered procedure. “I can better predict the refractive outcome of my patients with markerless toric alignment from ZEISS. With the markerless system, more than 99 percent of my patients have a postoperative refractive cylinder within +/- 0.50 D,” Dr. Black said.

“The Cataract Suite markerless, RESCAN intraoperative OCT and Glaucoma Suite illustrate how ZEISS provides complete, integrated solutions for the workflow challenges of today’s busy ophthalmology practice,” said Dr. Ludwin Monz, president and CEO of Carl ZEISS Meditec AG.
 

Significant Progress: Second U.S. Clinical Trial for SMILE
The minimally invasive, flapless SMILE procedure is based on a lenticule extraction technique. As the 3rd generation of laser vision correction beyond PRK and LASIK, it is the next step in refractive surgery for surgeons outside the United States.
Globally, the number of laser treatments (including LASIK) is stagnating, and lower patient attractiveness has been observed. In contrast, physicians providing SMILE report an increasing volume of patients since they started offering the new minimally invasive procedure. This confirms that SMILE is gaining high patient acceptance worldwide as a new treatment option.

The U.S. clinical investigation of SMILE continues to expand: the FDA has granted a second IDE to study the safety and effectiveness of the SMILE procedure in patients with astigmatic myopia (range: spherical myopia from ≥ -1.00 D to ≤ -10.00 D, astigmatism ≥ -0.75 D to ≤ -3.00 D and MRSE ≤ -11.50 D). Five study sites are participating, and 39 subjects have been treated to date


Since June 2012, 336 patients have been treated in the first U.S. clinical trial on ReLEx SMILE, which is studying the reduction or elimination of spherical myopia from ≥ -1.00 D to ≤ -10.00 D with MRSE ≤ -10.25 D. Study enrollment is now closed, and 310 patients have completed their 12-month follow-up visits.
ZEISS has filed three of four modules of the pre-market approval application for spherical myopia treatment utilizing for the SMILE lenticule removal procedure performed with the VisuMax femtosecond laser system. The last module will be filed later this year.

Outside the U.S., the unique minimally invasive SMILE procedure has been successfully performed on more than 200,000 eyes. More than 600 trained doctors offer the treatment in more than 300 facilities in over 50 countries, and some of the “early adopter” surgeons have completed more than 10,000 cases individually.
 

ZEISS Booth #1629 at ASCRS 2015 in San Diego
Learn more about ZEISS innovations and practice solutions by visiting booth #1629 at the San Diego Convention Center, April 18 to 20, 2015. More information is also available at www.zeiss.com/ascrs2015.

Press contact
Bill Taggart, Group Communications, Carl Zeiss Meditec, Inc.
Dublin, California
Mobile +1 925-493-9251;
Email: william .taggart @zeiss .com

Jann Gerrit Ohlendorf, Group Communications, Carl Zeiss Meditec AG
Phone +49 (0) 3641 220-331,
Email: press .meditec @zeiss .com


For investors
Sebastian Frericks, Investor Relations, Carl Zeiss Meditec AG
Phone +49 (0) 3641 220-116,
Email: investors .meditec @zeiss .com


www.meditec.zeiss.com/press

Sebastian Frericks, Investor Relations, Carl Zeiss Meditec AG
Phone +49 (0) 3641 220-116,
Email: investors .meditec @zeiss .com


www.meditec.zeiss.com/press

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