Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT00765960
Status:
WITHDRAWN
Last Update Posted:
2018-06-06
First Post:
2008-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Outcomes Using the Amo Advanced CustomVue Ilasik Procedure
Sponsor:
Medical University of South Carolina
Organization:
Study Overview
Official Title:
Evaluation of Outcomes Using the Amo Advanced CustomVue Ilasik Procedure
Status:
WITHDRAWN
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Prinicipal Investigator separating employment from University.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iLASIK
Brief 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 18294 | OTHER | Medical University of SC | View |