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FDA-approved excimer lasers |
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Modifications include improvements in ablation speed and accuracy.
Having received Food and Drug Administration (FDA) clearance for their excimer lasers to custom treat with wavefront technology, the big three laser manufacturers — Advanced Medical Optics, (Santa Ana, Calif.), Alcon (Fort Worth, Texas), and Bausch & Lomb (Rochester, N.Y.) — seem focused on fine tuning and improving their results, said Stephen G. Slade, M.D., Houston.
A quicker Technolas
Refractive results were good in the clinical trials that led up to the initial approvals of excimer lasers.
And they became outstanding in clinical trials of wavefront-guided excimer laser procedures, Dr. Slade said.
Still, since wavefront-guided procedures were FDA-approved for AMO, Alcon, and Bausch & Lomb, the companies have been working to make other significant changes, said Dr. Slade, who also said the improvements should lead to, “second-generation software.”
For one, Bausch & Lomb has upgraded the company’s Zylink treatment software to version 2.38, which essentially makes the excimer laser more time-efficient, Dr. Slade said.
“They have been able to cut ablation time up to 40% and the depth up to 30% in some of these refractive surgery patients,” Dr. Slade said. “So it’s a quicker treatment and it removes less tissue.”
The improvements that yield faster ablations and less tissue removal apply to both high and low myopes, Dr. Slade said. Therefore, these improvements are evident with most patients, Dr. Slade said.
Dr. Slade said he and his staff had one of the first opportunities to use the software upgrade.
“I think it’s great, but as great as I think it is, the staff is just in love with it,” Dr. Slade said. “It’s extremely practical and user friendly.”
Meanwhile, Bausch & Lomb’s Technolas 217z laser has come a long way since the Technolas laser was initially approved, Dr. Slade said.
“With Bausch & Lomb’s early version of the Technolas, some reported the occasional overcorrection,” Dr. Slade said.
Now the laser’s standard deviation from refractive correction targets is significantly improved so that rarely happens, he said.
Expanded LADARVision
and Star S4 approvals
Meanwhile, Alcon also has made several improvements to the LADARVision excimer laser system, Dr. Slade said.
CustomCornea recently has been FDA-approved to treat myopia up to -8 D, and astigmatism up to -4 D.
Formerly, CustomCornea was approved to treat up to -7 D of myopia and -0.5 D of astigmatism.
CustomCornea is Alcon’s wavefront-guided laser procedure using LADARVision.
Alcon touts these new approvals as giving LADARVision the broadest myopic treatment range for customized refractive surgery.
Stephen S. Lane, M.D., clinical professor, University of Minnesota, St. Paul, said recently that auto-registration for the LADARWave aberrometer is also now available, which allows surgeons to save time and further increase consistency in the registration process.
Registration ensures that the proper alignment of the wavefront pattern is placed onto the cornea in such a way that there is greater accuracy in ablating the areas that are necessary to fully correct the patient’s refractive error, and correct for higher-order aberrations, Dr. Lane said.
Meanwhile, auto-registration is all done internally by the machine rather than manually by a technician, leading to a faster, more consistent wavefront-capture process, he said.
In addition, Alcon unveiled its new LADAR 6000 at the most recent ASCRS•ASOA Symposium & Congress. While it holds a CE mark, it is not yet FDA-approved.
The new LADAR 6000 will automate many of the features and steps involved in customized ablations, which is expected to add surgeon control to an already accurate customized ablation system, while speeding the entire process, the company said.
Meanwhile, AMO recently launched a wavefront upgrade on its VISX system based on the Fourier method rather than Zernike polynomials to represent the wavefront of the visual system, Dr. Slade said.
According to the company, the upgrade will provide “the highest resolution available to aid in creating the most extensive individualized CustomVue treatments.”
CustomVue is AMO’s wavefront-guided laser procedure using the VISX STAR S4 IR excimer laser.
In addition, the FDA recently approved the use of CustomVue to treat for hyperopia and mixed astigmatism.
This approval is specifically for wavefront-guided LASIK for correction of hyperopia from +3 D of sphere and +2 D of cylinder, and mixed astigmatism from 1 D to 5 D of cylinder.
Editors’ note: Dr. Slade is a consultant for Bausch & Lomb and Alcon. Dr. Lane is an Alcon consultant. He is also chief medical editor of EyeWorld.
Contact Information
Lane: 651-275-3000, sslane@associatedeyecare.com
Slade: 713-626-5544, sgs@visiontexas.com |
