Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT00770094
Status:
UNKNOWN
Last Update Posted:
2009-08-06
First Post:
2008-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi Laser Platform Comparison Study for LASIK
Sponsor:
Durrie Vision
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Multi Center Clinical Comparison Of Fellow Eyes Undergoing Lasik Using The Amo/Visx Customvue™ , The Bausch And Lomb Zyoptix And Planoscan And The Wavelight Allegretto Wave™ Wavefront Guided And Wavefront Optimized Excimer Laser Systems
Status:
UNKNOWN
Status Verified Date:
2009-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VBLWL-001
Brief Summary:
Comparison of LASIK outcomes using 3 different lasers and a total of 5 different treatment platforms.
Detailed Description:
This will be a prospective, randomized, multicenter clinical trial in which up to 180 consecutive eyes scheduled to undergo excimer laser in situ keratomileusis (LASIK) for the correction of myopia with or without astigmatism will be enrolled. Enrolled subjects will have a different Excimer laser system performed in each eye. There will be 30 subjects (60 eyes) in each group.
Group 1: WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment in one eye of the subject and the AMO/VISX CustomVue™ wavefront guided Excimer Laser System performed on the contralateral eye Group 2: WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment in one eye of the subject and the Bausch and Lomb Zyoptix™ wavefront guided Excimer Laser System performed on the contralateral eye Group 3: WaveLight ALLEGRETTO WAVE™ wavefront optimized excimer laser treatment in one eye of the subject and the Bausch and Lomb Planoscan™ Excimer Laser System performed on the contralateral eye The choice of treatment will first be randomized into one of the three groups and then will also be randomized to the dominant eye prior to LASIK procedure according to the randomization schedule
Group 1: WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment in one eye of the subject and the AMO/VISX CustomVue™ wavefront guided Excimer Laser System performed on the contralateral eye Group 2: WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment in one eye of the subject and the Bausch and Lomb Zyoptix™ wavefront guided Excimer Laser System performed on the contralateral eye Group 3: WaveLight ALLEGRETTO WAVE™ wavefront optimized excimer laser treatment in one eye of the subject and the Bausch and Lomb Planoscan™ Excimer Laser System performed on the contralateral eye The choice of treatment will first be randomized into one of the three groups and then will also be randomized to the dominant eye prior to LASIK procedure according to the randomization schedule
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?: