Evaluation of Outcomes Using the Amo Advanced CustomVue Ilasik Procedure (iLASIK)
The purpose of this study is to assess the efficacy, predictability and safety of the Advanced CustomVue™ iLASIK procedure (WaveScan WaveFront® System, STAR S4 IR™ Excimer Laser System and IntraLase™ FS System).
|Study Design:||Time Perspective: Retrospective|
|Official Title:||Evaluation of Outcomes Using the Amo Advanced CustomVue Ilasik Procedure|
- Comparisons and statistical analysis will be done to determine if any statistical differences exist between preoperative and postoperative visits, and assess the efficacy, predictability and safety of the Advanced CustomVue™ iLASIK procedure. [ Time Frame: End of Study ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2008|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Laser in situ keratomileusis (LASIK) surgery has been performed worldwide since 1990. More recently, customized corneal ablation utilizing wavefront-sensing technology to determine the optical aberration of a patient's cornea has optimized LASIK surgery results. Prior to the introduction of wavefront-guided laser vision correction, the variables used for correcting refractive errors were limited to sphere and cylinder. With the introduction of wavefront laser vision correction surgeons are now able to provide individualized laser-induced corneal tissue resection based not only on sphere and cylinder measurements, but also on an attempt to treat 3rd through 6th higher-order aberrations (HOAs) utilizing Zernike polynomial wavefront reconstructions and Fourier transformation.
Advanced Medical Optics, Inc. (AMO) has recently introduced the Advanced CustomVue™ iLASIK procedure which utilizes the WaveScan WaveFront® System, a STAR S4 IR™ Excimer Laser System and IntraLase™ FS System technology to provide the broadest range of wavefront-guided FDA approved usages and an unprecedented level of precision and accuracy for patients undergoing LASIK surgery. The procedure leverages Iris Registration, Fourier algorithms, VSS™ and VRR™ technologies and 3D ActiveTrak™ to ensure precise corneal ablation.1, 2
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765960
|United States, South Carolina|
|Magill Laser Center, Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Kerry D Solomon, MD||Professor of Ophthalmology|