Contralateral Comparison of Three Excimer Laser Systems in Performing LASIK
Condition: Myopia; Astigmatism
MeSH terms: Myopia; Astigmatism
Intervention: Excimer Laser; AMO/VISX CustomVue™; LADARVision 4000 excimer laser
Intervention description: WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment; Excimer Laser; Excimer Laser
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Myopia; LASIK; Astigmatism; Laser Vision Correction; Excimer Laser

Summary:

      The purpose of this study is to compare LASIK outcomes using the WaveLight ALLEGRETTO WAVE™
      wavefront guided or optimized excimer laser treatment with the AMO/VISX CustomVue™ and the
      LADARVision 4000 excimer laser treatment.

      Standard refractive outcomes such as uncorrected and best corrected visual acuity, and
      intended vs. achieved postoperative refractions will be evaluated; in addition, high order
      optical aberrations, contrast sensitivity, and topography will be measured.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have up to -7.00D of spherical equivalent myopia or myopia with
             astigmatism, with up to -7.00D of spherical component and up to 3.00 D of astigmatic
             component at the spectacle plane in both eyes.

          -  Subjects must have a stable refraction as documented by previous clinical records.
             Spherical equivalent has not progressed at a rate of more than 0.50D per year prior to
             the baseline examination in both eyes or as documented by clinical judgment by the
             investigator.

          -  Subjects who wear contact lenses must discontinue wear at least 3 days for soft and at
             least 3 weeks for RGP prior to the preoperative evaluation or surgery, in either eye.

          -  Subjects must have visual acuity correctable to at least 20/20 in both eyes.

          -  Subjects must be at least 18 years of age.

          -  Subjects must be willing and able to return for scheduled follow up examinations for
             twelve months after LASIK surgery.

          -  Subjects must sign and be given a copy of the written Informed Consent form.

        Exclusion Criteria:

          -  Subjects for whom both eyes do not meet all inclusion criteria and either eye meets
             any exclusion criteria.

          -  Subjects for whom the combination of their baseline corneal thickness and the planned
             operative parameters for the LASIK procedure would result in less than 250 microns of
             remaining posterior corneal thickness below the flap postoperatively in either eye.

          -  Eyes for which the baseline standard manifest refraction exhibits greater than 1.00D
             more minus in sphere power, or a difference of greater than 0.75 D in cylinder power.

          -  Subjects desiring spherical under correction in one eye (i.e. no monovision correction
             is permitted).

          -  Subjects for whom the preoperative assessment of the ocular topography and /or
             aberrations indicates that either eye is not a suitable candidate for LASIK vision
             correction procedure. Examples include frank or forme frust keratoconus, corneal
             warpage, pellucid marginal degeneration, etc.

          -  Subjects with clinically significant dry eye syndrome or clinically significant
             blepharitis in either eye.

          -  Subjects with anterior segment pathology, including clinically significant cataracts
             or corneal scarring or neovascularization in either eye.

          -  Subjects with residual, recurrent, active ocular or eyelid disease, including any
             corneal abnormality (specifically, recurrent corneal erosion, severe basement membrane
             disease) in either eye.

          -  Subjects with ophthalmoscopic signs of progressive or unstable myopia or keratoconus
             (or keratoconus suspect) in either eye.

          -  Subjects with unstable (distorted/not clear) corneal mires on central keratometry in
             either eye.

          -  Subjects who have undergone previous intraocular or corneal surgery of any kind,
             including any type of surgery for either refractive or therapeutic purposes in either
             eye.

          -  Subjects who have a history of Herpes zoster or Herpes simplex keratitis.

          -  Subjects on chronic systemic corticosteroid or other immunosuppressive therapy that
             may affect wound healing, any immunocompromised subjects, and subjects with clinically
             significant atopic disease, connective tissue disease, or diabetes.

          -  Subjects with a history of steroid-responsive rise in intraocular pressure, glaucoma,
             or preoperative Intraocular pressure>23 mm Hg in either eye.

          -  Subjects with macular pathology in either eye.

          -  Subjects who are pregnant, lactating, or planning to be pregnant during the course of
             the study.

          -  Subjects with known sensitivity to planned study concomitant medications.

          -  Subjects participating in any other ophthalmic drug or device clinical trial during
             the time of this clinical investigation.