Contralateral Study of the WaveLight® Ultraviolet Femtosecond Laser, Model 1026 Versus the WaveLight® FS200 Infrared Femtosecond Laser, Model 1025 for Corneal Flap Creation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 47
- Locations
- 2
- Primary Endpoint
- Maximum deviation of corneal flap thickness at the margins from achieved central flap thickness at 1 month
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Good ocular health;
- •Natural lens with no evidence of cataract;
- •Eligible for LASIK;
- •Stable refraction;
- •Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- •Presence of dry eye;
- •Contraindicated systemic disease or ocular conditions;
- •Treatment with a contraindicated medication;
- •Other protocol-defined exclusion criteria may apply.
Outcomes
Primary Outcomes
Maximum deviation of corneal flap thickness at the margins from achieved central flap thickness at 1 month
Time Frame: Month 1
Corneal flap thickness will be measured using optical coherence tomography (OCT)
Secondary Outcomes
No secondary outcomes reported