On December 15, 2004, VISX Inc. announced that it received approval from the U.S. Food and Drug Administration (FDA) to treat farsightedness (hyperopia) and farsighted astigmatism with the VISX CustomVue (TM) Hyperopic LASIK procedure.

 

The FDA approval is specifically for the company’s wavefront-guided LASIK procedure.  The enhanced CustomVue (TM) procedure involves detailed WaveScan (R) measurements of the patient’s vision problems.  These wavefront-guided measurements help provide a more precise and customized vision correction treatment than a standard LASIK procedure. 

 

The FDA approval covers treatments of up to 3.00 diopters (D) of hyperopia without astigmatism and up to 2.00 D of farsighted astigmatism. (The spherical equivalent of a hyperopic prescription with astigmatism must not exceed +3.00 D.)

 

With this approval, VISX’s CustomVue (TM) procedure becomes the first wavefront-guided laser treatment for hyperopia in the United States.

 

Colman Kraff, M.D., principal investigator with the VISX (R) multi-center clinical study, states, “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 (TM) procedure for hyperopia when asked to compare it to their night vision with eyeglasses or contacts prior to the surgery. The VISX clinical study results also exceeded all of the FDA required parameters for safety and effectiveness.

 

 

More About VISX CustomVue (TM) Wavefront-Guided LASIK for the Correction of Nearsightedness, Farsightedness and Astigmatism

  • Nearsightedness (myopia) up to -6.00 diopters (D), with up to 3.00 D of astigmatism. (The spherical equivalent of a myopic prescription with astigmatism cannot exceed -6.00 D.)
  • Farsightedness (hyperopia) up to +3.00 diopters (D), with up to 2.00 D of astigmatism.  (The spherical equivalent of a hyperopic prescription with astigmatism cannot exceed +3.00 D.)
  • 100 percent of the 71 eyes that had nearsightedness without astigmatism before surgery could see 20/40 or better (unaided) after LASIK, and 95.8% could see 20/20 or better.
  • 99.5 percent of the 206 eyes that had both nearsightedness and astigmatism before surgery could see 20/40 or better (unaided) after LASIK, and 93.2% could see 20/20 or better.
  • Inflammation of the cornea under the flap (1.4%)
  • Double or ghost images (1.4%)
  • Scratch(es) on the surface of the eye (1.4%)
  • Dryness (9% vs. 6%)
  • Fluctuation of vision (3% vs. 2%)
  • Glare (4% vs. 2%)
  • Halos (7% vs. 5%)
  • 97.3 percent of the 74 eyes that had farsightedness without astigmatism before surgery could see 20/40 or better (unaided) after LASIK, and 66.2% could see 20/20 or better.
  • 93.0 percent of the 57 eyes that had both farsightedness and astigmatism before surgery could see 20/40 or better (unaided) after LASIK, and 56.1% could see 20/20 or better.
  • Double or ghost images (11.3%)
  • Cells growing under the flap (2.1%)
  • Scratch(es) on the surface of the eye (2.1%)
  • Feeling of something in the eye (1.4%)
  • Dryness (17% vs. 6%)
  • Fluctuation of vision (14% vs. 6%)
  • Blurry vision (10% vs. 7%)
  • Halos (10% vs. 5%)
  • Double or ghost images (7% vs. 3%)
  • People with collagen vascular or autoimmune disease (e.g. rheumatoid arthritis)
  • People with immunodeficiency disease
  • People with signs of keratoconus or abnormal corneal topography
  • People under the age of 21
  • People with unstable eyeglasses prescriptions
  • People taking Accutane (R) medication for acne
  • People taking Cordarone (R) medication for cardiac arrhythmia
  • Women who are pregnant or nursing

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