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雷射近視手術介紹

VISX CustomVue™雷射矯正系統已獲FDA

VISX CustomVueTM Laser Vision Correction Procedure Approved by the FDA 

First Custom Ablation Approval for Nearsightedness and Astigmatism

VISX announced on May 23, 2003 that it received approval from the U.S. Food and Drug Administration (FDA) for CustomVueTM laser vision correction. This wavefront ablation procedure sets a new standard for vision correction, with the potential to enable better vision than with contacts or glasses.

The FDA approval allows for WaveScan® diagnosis and CustomVue treatment of patients with nearsightedness and astigmatism. This approval is specifically for wavefront-guided LASIK for correction of myopic astigmatism up to -6.00D MRSE, with cylinder between 0.00 and -3.00D.

The CustomVue procedure tailors a unique correction for each individual. It employs the VISX WaveScan® System, a new diagnostic system that captures a “fingerprint” of the eye which is 25 times more precise than what was previously measurable by standard methods for glasses and contact lenses. WaveScan evaluates more than nearsightedness, farsightedness, and astigmatism; it captures other, more specific imperfections in each individual’s vision. This data is then used to generate an individualized treatment for a CustomVue procedure.

FDA clinical study data presented at the 2003 ASCRS Symposium showed that at one year following the procedure, 98% of the clinical study participants could see 20/20 or better UCVA, while nearly 70% had either the same or better post-op UCVA compared to their pre-op BSCVA. A six-month evaluation of the clinical study participants showed that four times as many participants were very satisfied with their night vision after the VISX CustomVue procedure, compared to their night vision before with glasses or contacts

 “Our goal is to continue to introduce new technologies that advance laser vision correction. We are very pleased to be the first on the U.S. market with approval of laser vision correction for both nearsightedness and astigmatism. We are now moving ahead with an FDA approved human clinical study for CustomVue procedures for the treatment of farsightedness,” stated Liz Dávila, chairman and chief executive officer of VISX.


For additional information on CustomVue certification, education, treatment card ordering, and other questions, call the VISX® Customer Response Center at 1-800-246-VISX or 1-800-246-8479.
 

* 最後修改時間:2016-09-10 11:21:37