Astigmatism, Myopia
Conditions
Keywords
LASIK, Laser Vision correction, Myopia, Myopia with astigmatism, Nearsighted
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
Interventions
DEVICEExcimer Lasers
WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment AMO/VISX CustomVue™ wavefront guided Excimer Laser System
DEVICEExcimer Laser for the LASIK procedure
WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment Bausch and Lomb Zyoptix™ wavefront guided Excimer Laser System
DEVICEExcimer Laser for LASIK
WaveLight ALLEGRETTO WAVE™ wavefront optimized excimer laser treatment Bausch and Lomb Planoscan™ Excimer Laser System
Sponsors
Alcon Research
Durrie Vision
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who have up to -7.00D of spherical equivalent myopia or myopia with astigmatism, with up to -7.00D of spherical component and up to 3.00 D of astigmatic component at the spectacle plane in both eyes. * Subjects must have a stable refraction as documented by previous clinical records or clinical history. Spherical equivalent has not progressed at a rate of more than 0.50D per year prior to the baseline examination in both eyes or as documented by clinical judgment by the investigator. * Subjects who wear contact lenses must discontinue wear at least 3 days for soft and at least 3 weeks for RGP prior to the preoperative evaluation or surgery, in either eye. * Subjects must have visual acuity correctable to at least 20/20 in both eyes. * Subjects must be at least 18 years of age. * Subjects must be willing and able to return for scheduled follow up examinations for three months after LASIK surgery. * Subjects must sign and be given a copy of the written Informed Consent form.
Exclusion criteria
* Subjects for whom both eyes do not meet all inclusion criteria and either eye meets any
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uncorrected visual acuity | 1 month post operative |
Countries
United States
Outcome results
None listed