Refractive Errors
Conditions
Brief summary
The purpose of this study is to assess the WaveLight Ultraviolet Femtosecond Laser System, Model 1026 (UV fs-Laser) corneal flap creation accuracy as compared to the already marketed WaveLight FS200 Infrared Femtosecond Laser, Model 1025 (IR fs-Laser).
Detailed description
Subjects who qualify to participate will have both eyes treated in the study (one eye with the UV fs-Laser and the other eye with the IR fs-Laser) and will attend a total of 5 study visits over a period of approximately 2 months. This study will be conducted outside the United States.
Interventions
DEVICEUV fs-Laser
Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery
DEVICEIR fs-Laser
Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery
PROCEDURELASIK
Laser-assisted in situ keratomileusis (LASIK) surgery
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Good ocular health; * Natural lens with no evidence of cataract; * Eligible for LASIK; * Stable refraction; * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Presence of dry eye; * Contraindicated systemic disease or ocular conditions; * Treatment with a contraindicated medication; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum deviation of corneal flap thickness at the margins from achieved central flap thickness at 1 month | Month 1 | Corneal flap thickness will be measured using optical coherence tomography (OCT) |
Countries
Australia
Outcome results
None listed