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Doheny Laser Vision Center
Doheny Eye Institute
1450 San Pablo Street, Suite 4500
Los Angeles, CA 90033
(323) 442-6377
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VISX CustomVue™ High Myopia Approved by the FDA

October 5, 2005

 

First U.S. Wavefront Guided Procedure Approved for up to -11D of myopia.

Advanced Medical Optics, Inc. (AMO) has received

approval from the U.S. Food and Drug Administration

(FDA) to treat high myopia with myopic astigmatism

with the VISX CustomVue Wavefront platform.

The CustomVueprocedure is now the only U.S.

approved wavefront-guided laser treatment for myopia,

hyperopia and mixed astigmatism. AMO currently has

the broadest refractive range of wavefront approvals for

laser vision correction.

This FDA approval allows for WaveScan® wavefrontguided

CustomVue treatment of highly nearsighted

patients. The approval is for wavefront-guided LASIK

for correction of high myopia from -6D to -11D, with

astigmatism up to 3D.

Sandy T. Feldman, M.D., who was an investigator in the

FDA clinical trial commented “In this group of

individuals, the improved quality of vision is particularly

significant. Almost all individuals who are eligible for

LASIK surgery can now be treated with the CustomVue

procedure.”

Six-month data from the clinical trial showed that 84%

of patients achieved uncorrected visual acuity of 20/20

or better. In addition after surgery, 78% of patients were

able to see without any correction as well as they could

before with their best correction.

 

CustomVue high myopia correction is available now at the

Doheny Laser Vision Center.