Use of the VisuMax™ Femtosecond Laser
Condition: Myopia
MeSH terms: Myopia
Intervention: Treatment with the VisuMax™ Femtosecond Laser
Intervention description: The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 357.0
Sex: All
Minimum age: 22 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of this clinical trial is to evaluate the safety and effectiveness of the Carl
      Zeiss Meditec VisuMax™ Femtosecond Laser lenticule removal procedure for the reduction or
      elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE (Manifest
      Refractive Spherical Equivalent) ≤ -8.25 D.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects age 22 years of age and older;

          -  Spherical myopia from ≥ -1.00 D to ≤ -8.00 D, with ≤ -0.50 D cylinder and MRSE ≤ -8.25
             D in the eye to be treated;

          -  A stable refraction for the past year, as demonstrated by a change in MRSE of ≤ 0.50 D
             in the eye to be treated;

          -  A difference between cycloplegic and manifest refractions of < 0.75 D spherical
             equivalent in the eye to be treated;

          -  UCVA worse than 20/40 in the eye to be treated;

          -  BSCVA at least 20/20 in the eye to be treated;

          -  Discontinue use of contact lenses for at least 2 weeks (for hard lenses) or 3 days
             (for soft lenses) prior to the preoperative examination, and through the day of
             surgery;

          -  All contact lens wearers must demonstrate a stable refraction (within ±0.5 D), as
             determined by MRSE, on two consecutive examinations at least 1 week apart, in the eye
             to be treated;

          -  Central corneal thickness of at least 500 microns in the eye to be treated;

          -  Willing and able to return for scheduled follow-up examinations;

          -  Able to provide written informed consent and follow study instructions in English.

        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.