LASIK Flap Thickness and Visual Outcomes Using the WaveLight FS200 Femtosecond Laser

Study Overview
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Brief Summary
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The objective of this study is to evaluate the visual outcome, accuracy, predictability and complications of LASIK flap creation using the Alcon Wavelight FS200 Femtosecond laser and compare these results to those obtained using current IntraLase FS60 Femtosecond laser. The primary outcome to be evaluated is the flap thickness accuracy.

Detailed Description
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Laser in situ keratomileusis (LASIK) is a method for treating myopia, hyperopia and astigmatism. In LASIK, the cornea is reshaped to focus images more clearly on the retina without the aid of glasses or contact lenses. LASIK involves two steps: creation of a corneal flap, which can be performed by a mechanical microkeratome or a femtosecond laser, and reshaping of the cornea by another laser, an excimer laser. The accuracy of the LASIK flap thickness is a key safety consideration to reduce the likelihood of complications following LASIK. Femtosecond laser technology has significantly improved the predictability of LASIK flap dimensions while supporting similar visual acuity results. The Alcon FS200 femtosecond laser is approved for human use by the United States Food and Drug Administration and was recently released in the US market. This study will directly compare outcomes of LASIK performed with this newer laser to those performed with the AMO IntraLase femtosecond laser.

Official Title
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LASIK Flap Thickness and Visual Outcomes Using the WaveLight FS200 Femtosecond Laser: 3 Months Follow-up of Initial US Clinical Series

Conditions
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Myopia

Intervention / Treatment
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* Device: FS200 femtosecond laser LASIK
* Device: IntraLase femtosecond laser LASIK


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with ametropia (Spherical, spherocylindrical, presbyopic) suitable for treatment by LASIK, including different target refractions (Plano or Monovision). Exclusion Criteria: Patients unsuitable for LASIK procedure because of an estimated residual stromal bed < 300 microns after calculation of the ablation (Corneal thickness - flap thickness - simulated stromal ablation for the desired correction). Patients unsuitable for LASIK due suspicious topography for ectasia, form frust keratoconus or unstable ( more than 0.50 diopter change in sphere or cylinder in the last year) refraction. Patients with amblyopia or any eye disease that might limit the visual recovery. Patients younger than 18 years old.

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: Single Group Assignment
Interventional Model Description: Contralateral eye study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FS200 femtosecond laser LASIK<br>LASIK flap created with an FS200 femtosecond laser system | Device: FS200 femtosecond laser LASIK<br> <br> * Other names: Alcon FS200 femtosecond laser;|
| Experimental: IntraLase femtosecond laser LASIK<br>LASIK flap created with an IntraLase femtosecond laser system | Device: IntraLase femtosecond laser LASIK<br> <br> * Other names: AMO IntraLase femtosecond laser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of LASIK Flap Thickness | Central LASIK flap thickness for each femtosecond laser. Each treatment was set for a 110 micrometer thick flap. | 3 months |