Clinical Investigation of a Femtosecond Laser for Corneal Flap Creation

Launched by ALCON RESEARCH · Jun 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new laser device called the WaveLight Ultraviolet Femtosecond Laser, which is used during LASIK eye surgery to create a thin flap on the cornea (the clear front part of the eye). This flap is an important step in the surgery that helps correct vision problems like nearsightedness (myopia). The main goal of the study is to find out how safe this laser device is when used for this purpose. The study will take place in Australia and is not yet open for participants.

People who might be eligible to join this study are adults aged 65 to 74 who are good candidates for LASIK surgery to correct myopia. To qualify, participants need to have a certain level of vision without glasses and good vision with glasses or contact lenses, as well as a clear natural lens in their eye (meaning they don’t have cataracts). People with previous eye surgeries, certain eye conditions, or medical issues that could make surgery risky will not be eligible. If you join the study, you can expect to have your eye treated with this specific laser during LASIK, and the researchers will closely monitor your safety and vision after the procedure. This study is focused on making sure this newer laser technology works safely before it becomes more widely used.

Gender

ALL

Eligibility criteria

• 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.