Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT00765960

Evaluation of Outcomes Using the Amo Advanced CustomVue Ilasik Procedure

Status
Withdrawn
Phase
Study type
Observational
Enrollment
0 (actual)
Sponsor
Medical University of South Carolina · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Accepted

Summary

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).

Detailed description

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

Conditions

Timeline

Start date
2008-09-01
Primary completion
2008-10-01
Completion
2009-10-01
First posted
2008-10-03
Last updated
2018-06-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00765960. Inclusion in this directory is not an endorsement.