FDA Oks CustomVue for mixed astigmatism

May 1, 2005

Albuquerque, NM—The FDA approved a wavefront-guided LASIK procedure (CustomVue, VISX/AMO) for treating mixed astigmatism on March 22.

This approval allows for WaveScan diagnosis and CustomVue treatment of this patient population. CustomVue is presently the only procedure approved in the United States for the treatment of myopia, hyperopia, and mixed astigmatism, according to the company.

Stephen Coleman, MD, was a principal investigator in the mixed astigmatism trial as well as the previous trials for myopia and hyperopia.

"These patients have a less common ocular problem when you look across a broad range of prescriptions and because of that it can be difficult for them to achieve good correctable vision with contacts or glasses," Dr. Coleman continued. "Most importantly, these patients talk about quality of vision issues preoperatively to a greater extent than patients with myopia."

He added that patients with mixed astigmatism comment frequently that their quality of vision improves after having undergone a CustomVue procedure.

Because the results of the trial of CustomVue for mixed astigmatism proved to be so good, up until this commercial FDA approval Dr. Coleman has advised that many of his patients wait to be treated with the CustomVue software.

All patients in the mixed astigmatism trial underwent the procedure using the VISX STAR S4 IR excimer laser system and the WaveScan WaveFront System. According to the manufacturer, the procedure is approved to reduce or eliminate naturally occurring mixed astigmatism when the magnitude of cylinder (from 1 to 5 D) is greater than the magnitude of sphere and the cylinder and sphere have opposite signs.