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LADARVision approval leads business news at AAO
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ORLANDO, Fla. — Alcon’s LADARVision platform for wavefront-guided customized refractive surgery received approval from U.S. regulators, the company announced at the American Academy of Ophthalmology meeting here.
The LADARVision 4000 excimer laser and the LADARWave wavefront measuring device comprise the first system to receive Food and Drug Administration approval for wavefront-guided customized LASIK surgery, according to the company.
The FDA approved the system Oct. 18 for the correction of myopia between 0 D and -7 D with up to 0.50 D of cylinder, according to Steven Bott, Alcon’s vice president of laser refractive research and development. He explained the practical application of the approval range.
“The agreement between the phoropter and the wavefront measurement has to be within a diopter of sphere and within a diopter of cylinder. These are the conditions that the FDA has approved for the device.” Mr. Bott said. “In practice, you can type into the system the phoropter measurement and then the cylinder, which is the main constraint, as you can only go up to 0.5 D of cylinder on the manifest refraction per the approval. However, if, for example, the wavefront measurement is less than 1.5 D (up to 1.49 D as read on the wavefront device), 1.49 D of cylinder would still be acceptable and would still be treated.”
“The treatment is based on the wavefront reading,” said Laurent Attias, Alcon’s director of surgical marketing, refractive.
In the multicenter clinical trial for LADARVision CustomCornea, 139 of 426 eyes were treated for myopia. Of those patients treated, 98.6% achieved 20/40 or better and 79.9% achieved 20/20 or better, according to an Alcon press release.
Clinical trials are ongoing for the treatment of myopic astigmatism, hyperopia with and without astigmatism and other ocular irregularities, according to Alcon.
Medennium SmartPlug approval
Medennium Inc. received 510(k) clearance from the FDA during the meeting to market its SmartPlug, the first Medennium product approved for sale in the United States.
The device is made of a thermodynamic hydrophobic acrylic polymer that is transformed from a solid rod 9 mm long and 0.4 mm wide to a gel-like material 2 mm long and 1 mm wide within 20 seconds of being introduced into the punctum and exposed to body temperature. SmartPlug is designed to eliminate the need for multiple plug sizes and minimize patient discomfort due to an exposed plug head.
Nidek introduces NAVEX
A new refractive laser system from Nidek recognizes existing conditions and controls spherical aberrations, according to the company. The new Nidek Advanced Vision Excimer Laser System (NAVEX) for the Nidek EC-5000 offers comprehensive solutions for the refractive surgeon, according to Philip M. Buscemi, OD, who discussed the new system at the meeting.
Supplement company launched
Biosyntrx, a new “nutraceutical” company, made its debut at the meeting. Founded by Spencer Thornton, MD, and other ophthalmologic, science and nutrition leaders, the company will provide research-based formulations that focus on eye and body health, including dry eye and macular degeneration. Dr. Thornton is a clinical professor of ophthalmology at the University of Tennessee in Memphis.
Carl Zeiss Meditec laser
Carl Zeiss Meditec AG unveiled its first new product since completion of its merger. The MEL 80 is an excimer laser that allows a refractive error of 5 D to be corrected in 15 seconds, facilitating faster restoration of vision, according to the company. The laser includes a high-speed eye tracker that adjusts the laser beam to compensate for small eye movements.
Compact HRA2
Heidelberg announced the release of the Heidelberg Retina Angiograph 2 (HRA2), a scanning laser ophthalmoscope that offers increased resolution, infrared and blue reflectance, a compact solid-state laser and a user-friendly touch screen. Bert Glaser, MD, founder of the National Retina Institute in Baltimore, said in a press release: “The new HRA2 adds significantly higher resolution in a novel compact and more portable design, creating the best system with which to detect and monitor retinal and choroidal diseases including choroidal neovascularization, retinal angiomatous proliferation and feeder vessels, while at the same time providing superior fluorescein angiography.
Heidelberg also plans to introduce the Rostock Cornea Module in 2003, an enhancement to its HRT II, pending clearance from the U.S. Food and Drug Administration. The RCM is a special lens attachment and software application for the HRT II, allowing for anterior segment analysis.