Statements regarding the potential benefits of wavefront-guided LASIK (CustomVue) are based upon the results of clinical trials. These results are indicative of not only the CustomVue treatment but also the care of the clinical physicians, the control of the surgical environment by those physicians, the clinical trials’ treatment parameters and the clinical trials’ patient inclusion and exclusion criteria. Although many clinical trial patients after the CustomVue procedure saw 20/20 or better and/or had or reported having better vision during the day and at night, compared to their vision with glasses or contact lenses before the procedure, individual results may vary. You can find information about the clinical trials below in the CustomVue Patient Information Booklet..

Only an eye professional trained in laser vision correction can determine whether you are a suitable candidate for the CustomVue procedure.

WaveFront-Guided LASIK Indications and Intended Uses

The VISX STAR S4™ Excimer Laser System and WaveScan WaveFront System is approved to perform wavefront-guided laser assisted in-situ keratomileusis (LASIK) treatments for the reduction or elimination of myopic astigmatism, with cylinder between certain limits in patients.

Wavefront-guided LASIK for correction of myopic astigmatism is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), conventional LASIK, and other refractive surgeries.

Contraindications

Wavefront-guided LASIK is contraindicated in patients with collagen vascular, autoimmune or immunodeficiency disease, signs of keratoconus or abnormal corneal topography, patients taking isotretinoin or amiodarone hydrochloride or are pregnant or nursing.

Precautions

The safety and effectiveness of wavefront-guided LASIK surgery has ONLY been established with an optical zone of 6 mm and an ablation zone of 8 mm for myopic astigmatism, and an optical zone of 6 mm and an ablation zone of 9 mm for hyperopic astigmatism.

Although the WaveScan WaveFront System measures the refractive error and wavefront aberrations of the human eye, including myopia, hyperopia, astigmatism, coma, spherical aberration, trefoil, and other higher order aberrations through sixth order, in the clinical studies, the average higher order aberration did not decrease after CustomVue treatment.