Early Feasibility Study of UV-Femtosecond Laser Assisted Lenticular Extraction

Early Feasibility Study of UV-Femtosecond Laser Assisted Lenticular Extraction

The purpose of this study is to evaluate the initial safety of the UV-FS laser in humans.

Inclusion Criteria:

• Photopic distance visual acuity worse than best corrected visual acuity (BCVA) 20/400 in the study eye;
• Myopia with manifest refraction spherical equivalent (MRSE) of - 1.50 diopter (D) or higher in the study eye;
• Able to comprehend and provide documented informed consent;
• Willing and able to comply with schedule for follow-up visits;
• Minimum required endothelial cell density (ECD) in study eye as outlined in the protocol;
• Presence of natural lens in study eye;
• A treatment simulation with spectacles or contact lenses on the study eye does not negatively impact participant's daily activities;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Pregnant or nursing;
• Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study as clinically assessed by the Investigator;
• Active implanted device, including but not limited to, heart pacemaker or defibrillator, for which laser use may be a contraindication;
• Current use of medications with known ocular side effects;
• Predicted residual stromal bed thickness <300 micrometers (μm) in study eye
• Ocular conditions in the study eye;
• Previous ocular surgery in the study eye that resulted in corneal distortions within the treatment zone;
• Residual, recurrent or active ocular disease that may impact study outcomes;
• Previous or current diagnosis of dry eye;
• Known allergic reaction to medications expected to be used preoperatively, during laser refractive surgery, and for postoperative care;
• Pre-existing corneal opacities in study eye;
• Contact lens worn in study eye and not removed prior to study testing affected by wear per timeframe specified in the protocol;
• Other protocol-specified exclusion criteria may apply.