Overview
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.
Description
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.
Eligibility
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.