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Visxpress

For Immediate Release
Contact: Amanda Peralta
Christenbury Eye Center
1 (877) 702-2020

Issue #156

VISX CustomVue™ Hyperopia Procedure Approved by the FDA

First U.S. Custom Wavefront LASIK Approval for Farsightedness and Astigmatism

VISX announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to treat hyperopia and hyperopic astigmatism with the VISX CustomVue Hyperopic LASIK procedure.

The FDA approval allows for WaveScan® diagnosis and CustomVue™ treatment of patients with farsightedness and astigmatism. This approval is specifically for wavefront-guided LASIK for correction of hyperopia with or without astigmatism up to +3.00D MRSE, with cylinder up to +2.00D.

The CustomVue procedure is the first U.S. approved wavefront-guided laser treatment for hyperopia.

Colman Kraff, M.D., principal investigator with the VISX® multi-center clinical study, stated, “VISX’s new CustomVue Hyperopia procedure is a significant step forward in the treatment of farsightedness. The overall quality of vision with this new procedure is so superior that I plan to treat all of my qualified patients with CustomVue Hyperopia.”

A six-month evaluation of clinical study participants showed that more than four times as many people were very satisfied with their night vision after the VISX CustomVue hyperopia procedure, compared to their night vision before with glasses or contacts. TheVISX clinical study results also exceeded all of the FDA required parameters for safe and effective laser vision correction.

In order to perform VISX CustomVue hyperopic LASIK procedures, physicians must complete the CustomVue Hyperopic Certification Course.

Prerequisite: U.S. Physician CustomVue Certification Course for Myopia

Here are the steps:

1. Complete the CustomVue Hyperopia Certification Course which is being emailed to all CustomVue certified physicians.

2. Log onto the VISX website, www.visx.com and click on the CustomVue Certification button. Using your password from the U.S. CustomVue Physicians Certification Course for Myopia, you will be able to verify your course completion and print your Certificate. After completing this certification, CustomVue hyperopia treatment cards can be ordered.