Safety and Efficacy Study of Topography-Guided LASIK to Treat Myopia and Hyperopia
Condition: Myopia; Hyperopia
MeSH terms: Myopia; Hyperopia
Intervention: T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 212.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This purpose of this study is to evaluate the safety and effectiveness of a topography-based
      custom ablation treatment using the ALLEGRETTO WAVE® Eye-Q 400 Hz laser system for treating
      myopia and hyperopia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older;

          -  Signed Informed Consent;

          -  Willingness and ability to comply with schedule for follow-up visits;

          -  be a candidate for topography guided LASIK treatment of myopia or hyperopia in both
             eyes based on your doctors examination of your eyes;

          -  Intended treatment is targeted for emmetropia;

          -  Stable refraction (0.5 D or less change in manifest refraction spherical equivalent
             (MRSE) per year) for 12 months or longer, based on previous clinical records or
             prescription history (e.g., old glasses/contact lens prescriptions).

          -  Able to obtain a reliable corneal topography that can be used to determine the T-CAT
             treatment plan;

          -  Best spectacle-corrected visual acuity (BSCVA) 20/25 or better in each eye;

          -  Less than 0.75 D spherical equivalent (SE) difference between cycloplegic and manifest
             refractions.

          -  Is not a contact lens wearer or, if wearing contact lenses, has discontinued wearing
             contact lenses for the required period of time and completed the contact lens
             stability check;

          -  be able to maintain your eye position steady during the course of the treatment.

        Exclusion Criteria:

          -  History of prior refractive treatment;

          -  Mixed astigmatism refractive error;

          -  Lenticular astigmatism that, in the investigator's opinion, is clinically significant;

          -  Corneal topography showing evidence of keratoconus, keratoconus suspect, forme fruste
             keratoconus, pellucid marginal degeneration, or other topographic abnormality that
             would place the eye at risk for developing post-refractive corneal ectasia;

          -  Treatment plan for T-CAT would predict a residual stromal bed thickness less than 250
             microns;

          -  History or current evidence of corneal or other anterior segment disease that might
             reasonably be expected to affect the outcome of treatment (e.g., herpes simplex
             keratitis, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal
             dystrophy, etc.);

          -  Evidence of retinal vascular disease;

          -  Female patients who are pregnant or lactating or plan to become pregnant during the
             course of the study;

          -  A known sensitivity to study medications;

          -  Nystagmus or any other condition that would prevent a steady gaze during the LASIK
             treatment or other diagnostic tests;

          -  Corneal dystrophy or corneal guttae;

          -  Pathology involving the iris (e.g., coloboma, tears, cuts, significant pigment loss,
             etc.);

          -  Residual, recurrent or active ocular pathology;

          -  Previous intraocular or corneal surgery that might confound the outcome or increase
             the risk of the study;

          -  Acute or chronic illness that might increase the risk or confound the outcome of the
             study (e.g., diagnosed autoimmune disease, systemic connective tissue disease,
             clinically significant atopic disease, diabetes mellitus, etc.)

          -  The use of systemic medications that may confound the outcome or increase the risk of
             the study, including, but not limited to: corticosteroids and antimetabolites;

          -  Intraocular pressure > 23 mm Hg, a history of glaucoma, or a glaucoma suspect;

          -  An increased risk for developing strabismus after treatment (applicable only to
             treatment of hyperopic refractive errors);

          -  Presence or history of any other condition or finding that, in the investigator's
             opinion, makes the patient unsuitable as a candidate for LASIK or study participation
             or may confound the outcome of the study.