Clinical Investigation of a Femtosecond Laser for Corneal Flap Creation

Clinical Investigation of the WaveLight® Ultraviolet Femtosecond Laser for Corneal Flap Creation

The purpose of this study is to see how safe the WaveLight Ultraviolet Femtosecond Laser, Model 1026 (UV fs-Laser), is for creating corneal flaps during laser-assisted in situ keratomileusis (LASIK) surgery. This study will be conducted in Australia.

Subjects who qualify to participate will have both eyes treated. Each subject will be randomly assigned to 1 of 2 topical anesthetics (numbing eye drops) and each eye will be randomly assigned to either the UV fs-Laser or the WaveLight FS200 Infrared Femtosecond Laser, Model 1025 (IR fs-Laser).

Subjects will attend a total of 6 scheduled study visits, including a preoperative Screening Visit (Day -45 to -1), a Surgery Visit (Day 0), and 4 postoperative visits at Day 1, Week 1, Month 1, and Month 3/exit, for a total individual duration of participation of approximately 4 months.

Key Inclusion Criteria:

• Eligible for LASIK treatment;
• Myopia as specified in the protocol;
• Uncorrected distance visual acuity of greater than or equal to 0.30 logMAR;
• Best corrected distance visual acuity of less than or equal to 0.10 logMAR;
• Presence of clear natural lens (non-cataractous eye);
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• An active implanted device for which laser use may be a contraindication;
• Previous ocular surgery;
• Ocular conditions that may affect subject safety or impact study outcomes;
• Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study;
• Current use of medications with known ocular side effects and photosensitivity;
• Other protocol-defined exclusion criteria may apply.