Ignite Creation Date:
2024-05-06 @ 8:43 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02806726
Status:
TERMINATED
Last Update Posted:
2019-02-08
First Post:
2016-06-08
Brief Title:
Clinical Investigation iDesign System With 13-PRESBY Treatment and STAR S4 IR Excimer Laser System
Sponsor:
Abbott Medical Optics
Organization:
Abbott Medical Optics
Study Overview
Official Title:
A Prospective Study to Evaluate the Feasibility of a New Treatment Algorithm to Increase Depth of Focus After Wavefront-guided LASIK Correction of Myopic Refractive Errors With the iDesign System and Star S4 IR Excimer Laser System
Status:
TERMINATED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Decision to discontinue product development at this time
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective study to evaluate the feasibility of a new treatment algorithm to increase depth of focus after wavefront-guided LASIK correction of myopic refractive errors with the iDesign Advanced Wavescan Studio System and Star S4 IR Excimer Laser System The purpose of this study is to determine whether wavefront-guided LASIK correction of myopic refractive errors with CustomVue combined with iDesign 13-PRESBY presbyT-LASIK treatments mitigate the effects of presbyopia by increasing the depth of focus compared to iDesign CustomVue treatments
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None