NCT00770094

Multi Laser Platform Comparison Study for LASIK

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Durrie Vision · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Myopia
• Astigmatism

Interventions

Type	Name	Description
DEVICE	Excimer Lasers	WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment AMO/VISX CustomVue™ wavefront guided Excimer Laser System
DEVICE	Excimer Laser for the LASIK procedure	WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment Bausch and Lomb Zyoptix™ wavefront guided Excimer Laser System
DEVICE	Excimer Laser for LASIK	WaveLight ALLEGRETTO WAVE™ wavefront optimized excimer laser treatment Bausch and Lomb Planoscan™ Excimer Laser System

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-10-09
• Last updated: 2009-08-06

Locations

3 sites across 1 country: United States