Study of the MEL 80 Excimer Laser Using LASIK in the Treatment of Moderate to High Myopia

Inclusion Criteria: * Myopia \> -7.00 D to -12.00 D, and astigmatism less than or equal to -6.00 D at the spectacle plane, with a maximum MRSE ≤-12.00 D. * Stable refraction for at least the last twelve months, as demonstrated by a change of less than 1.00 D of the spherical equivalent during the twelve months prior to the baseline examination of the eye to be treated, documented by previous clinical records. * Discontinue use of contact lenses at least 2 weeks for hard contacts and 3 days for soft lenses prior to the preoperative examination. * Hard contact lens wearers must have two central keratometry readings and two manifest refractions taken at least one week apart that do not differ by more than 0.50 D. * Visual acuity correctable to at least 20/40 in both eyes. * UCVA of 20/40 or worse in the operative eye. * At least 18 years of age. * Operative eye must be targeted for emmetropia. * Have a normal corneal topography. * Willing and able to return for scheduled follow up examinations for twelve months after surgery. * Sign and be given a copy of the written Informed Consent form. Exclusion Criteria: * History of anterior segment pathology, including cataracts (in the operative eye). * Clinically significant dry eye syndrome unresolved by treatment. * Residual, recurrent, active ocular or uncontrolled eyelid disease, corneal scars within the ablation zone or other corneal abnormality such as recurrent corneal erosion or severe basement membrane disease. * Ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect). * An ablation deeper than 250 microns from the corneal endothelium. * Irregular or unstable (distorted/not clear) corneal mires on central keratometry readings. * Blind in the fellow eye. * Undergone previous intraocular or corneal surgery of any kind in the operative eye(s), including any type of surgery for either refractive or therapeutic purposes. * History of ocular Herpes zoster or Herpes simplex keratitis. * History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP \>21 mm Hg. * Must not have diabetes, diagnosed autoimmune disease, connective tissue disease, or clinically significant atopic syndrome. * Must not be immunocompromised or use chronic systemic corticosteroid or other immunosuppressive therapy. * Patients must not be pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control. * Patients must not have a known sensitivity to planned study medications. * Patients must not be participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation. * For Fellow (Second) Eyes in Simultaneous Bilateral Treatment Procedures * 1\. Flap complications during the first eye's surgery such as a free cap, partial flap, thin flap, or irregular flap. * 2\. Epithelial defect exceeding 2 mm x 2 mm in dimension, or clinically significant debris in the interface between the flap and underlying stroma for the first eye. * 3\. Severe blepharospasm in the first eye that may have prevented or impeded the completion of the keratectomy and/or the laser ablation procedure. * 4\. Poor subject cooperation with instructions for the first eye's surgery and/or poor subject fixation on the laser fixation target. * 5\. Aborted LASIK procedure in the first eye or PRK was performed in the first eye because LASIK was not possible.