Overview

To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.

Eligibility

Inclusion Criteria:

        Subjects who have one or both eyes that meet criteria 1 and 1 or more of the following
        criteria will be considered candidates for this study:
          1. 12 years of age or older
          2. Presence of central or inferior steepening.
          3. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid
             marginal degeneration
          4. Presence of one or more findings associated with keratoconus or pellucid marginal
             degeneration, such as:
               1. Fleischer ring
               2. Vogt's striae
               3. Decentered corneal apex
               4. Munson's sign
               5. Rizzutti's sign
               6. Apical Corneal scarring consistent with Bowman's breaks
               7. Scissoring of the retinoscopic reflex
               8. Crab-claw appearance on topography
          5. Steepest keratometry (Kmax) value ≥ 47.20 D
          6. I-S keratometry difference > 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or
             topography map
          7. Posterior corneal elevation >16 microns
          8. Thinnest corneal point <485 microns
          9. Predicted Post LASIK/PRK stromal ablation depth <350 microns or expected keratometry
             >47.2 D, or patients undergoing PRK/SMILE in keratoconus suspect eyes
         10. AvaGen (Avellino Labs) genetic testing keratoconus risk score of 67 or higher (high
             risk).
         11. Bacterial or fungal corneal keratitis persistent and not responding despite > 2 weeks
             of standard antimicrobial therapy or with rapid progression of corneal thinning, with
             loss of >25% corneal thickness
         12. Contact Lens Wearers Only:
             a. Removal of contact lenses for the required period of time prior to the screening
             refraction:
             Contact Lens Type Minimum Discontinuation Time Soft 1 Week Soft Extended Wear 2 Weeks
             Soft Toric 3 Weeks Rigid gas permeable Scleral Lenses 2 Weeks per decade of wear
             Investigator Discretion
             Discontinuation of scleral lenses not required unless there is clinical evidence of
             corneal hypoxia (e.g. corneal neovascularization) at time of screening.
         13. Signed written informed consent
         14. Willingness and ability to comply with schedule for follow-up visits
        Exclusion Criteria (any of the following are reasons for exclusion):
        1. All subjects meeting any of the following criteria will be excluded from this study:
          1. Eyes classified as either normal or atypical normal on the severity grading scheme.
          2. Corneal pachymetry at the screening exam that is <300 microns at the thinnest point in
             the eye(s) to be treated.
          3. Previous ocular condition (other than refractive error) in the eye(s) to be treated
             that may predispose the eye for future complications, for example:
               1. History of or active corneal disease (e.g., herpes simplex, herpes zoster
                  keratitis, recurrent erosion syndrome, acanthomeoeba, etc.)
               2. Clinically significant corneal scarring in the CXL treatment zone that is not
                  related to keratoconus or, in the investigator's opinion, will interfere with the
                  cross-linking procedure.
          4. Pregnancy (including plan to become pregnant) or lactation during the course of the
             study
          5. A known sensitivity to study medications
          6. Patients with nystagmus or any other condition that would prevent a steady gaze during
             the CXL treatment or other diagnostic tests.
          7. Patients with a current condition that, in the physician's opinion, would interfere
             with or prolong epithelial healing.