Use of the VisuMax™ Femtosecond Laser

Exclusion Criteria

• •Mesopic pupil diameter \> 8.0 mm;
• •Cylinder \> -0.50 D;
• •Treatment depth is less than 250 microns from the corneal endothelium;
• •Eye to be treated is targeted for monovision;
• •Fellow eye has BSCVA worse than 20/40;
• •Abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration in either eye;
• •History of or current anterior segment pathology, including cataracts in the eye to be treated;
• •Clinically significant dry eye syndrome unresolved by treatment in either eye;
• •Residual, recurrent, active ocular or uncontrolled eyelid disease, corneal scars or other corneal abnormality such as recurrent corneal erosion or severe basement membrane disease in the eye to be treated;
• •Ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect) in either eye;
• •Irregular or unstable (distorted/not clear) corneal mires on central keratometry images in either eye;
• •History of ocular herpes zoster or herpes simplex keratitis;
• •Deep orbits, strong blink, anxiety, pterygium, or any other finding suggesting difficulty in achieving or maintaining suction;
• •Difficulty following directions or unable to fixate;
• •Previous intraocular or corneal surgery of any kind in the eye to be treated, including any type of surgery for either refractive or therapeutic purposes;
• •History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP \> 21 mmHg in either eye;
• •History of diabetes, diagnosed autoimmune disease, connective tissue disease or clinically significant atopic syndrome;
• •Immunocompromised or requires chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing;
• •History of known sensitivity to planned study medications;
• •Participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation;
• •Pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.