WaveLight® Refractive Flap Accuracy Study

A Prospective, Global, Multi-Center Study to Evaluate Longitudinal Flap Accuracy on Subjects Undergoing Myopic Refractive Surgery Using the WaveLight® Refractive Suite

The purpose of this study is to evaluate the accuracy of the WaveLight FS200 femtosecond laser, as assessed by 1 day and 1 month post-operative optical coherence tomography (OCT) anterior segment corneal measurements compared to pre-operative flap thickness target.

Inclusion Criteria:

• Willing and able to understand and sign an informed consent form.
• Have refractive error (in both eyes) that requires refractive surgery.
• Willing to undergo LASIK surgery using the Wavelight® Refractive Suite.
• Myopia between 0.00 to -12.0 Diopters pre-operatively.
• Astigmatism between 0.00 to +6.00 Diopters pre-operatively.
• Willing and able to attend post-operative examinations per protocol schedule.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Participation in a clinical study within the last 30 days.
• History of previous corneal surgery in either eye.
• Multifocal ablations in either eye.
• PRK or PTK surgery in either eye.
• Suffering from acute or recurring eye diseases in either eye, such as corneal ulcers, cataract, etc.
• Any ocular disease and/or condition that, in the Investigator's clinical judgment, may put subject at significant risk, compromise study results, or interfere significantly with subject's participation in the study.
• Unable to discontinue contact lens wear as specified in protocol.
• History of Herpes simplex or Herpes zoster keratitis.
• Active ocular rosacea.
• Lyme disease.
• Severe ocular allergies.
• Other medical conditions and use of medications as specified in protocol.
• Pregnant or planning to become pregnant during the study.
• Other protocol-specified exclusion criteria may apply.