Contralateral Study of WaveLight® Femtosecond Laser Devices for Corneal Flap Creation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Contralateral Study of the WaveLight® Ultraviolet Femtosecond Laser, Model 1026 Versus the WaveLight® FS200 Infrared Femtosecond Laser, Model 1025 for Corneal Flap Creation

Conditions
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Refractive Errors

Intervention / Treatment
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* Device: UV fs-Laser
* Device: IR fs-Laser
* Procedure: LASIK


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UV fs-Laser<br>First surgical eye randomly assigned to the UV fs-Laser with the second surgical eye (fellow eye) assigned to the IR fs-Laser for the purpose of corneal flap creation during LASIK surgery | Device: UV fs-Laser<br>* Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery<br>* Other names: WaveLight Ultraviolet Femtosecond Laser Model 1026 with Patient Interface Model 1507;Procedure: LASIK<br>* Laser-assisted in situ keratomileusis (LASIK) surgery<br>|
| Active Comparator: IR fs-Laser<br>First surgical eye randomly assigned to the IR fs-Laser with the second surgical eye (fellow eye) assigned to the UV fs-Laser for the purpose of corneal flap creation during LASIK surgery | Device: IR fs-Laser<br>* Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery<br>* Other names: WaveLight FS200 Infrared Femtosecond Laser Model 1025 with Patient Interface Model 1515;Procedure: LASIK<br>* Laser-assisted in situ keratomileusis (LASIK) surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum deviation of corneal flap thickness at the margins from achieved central flap thickness at 1 month | Corneal flap thickness will be measured using optical coherence tomography (OCT) | Month 1 |