Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking

Eligibility Criteria

• * 12 years of age or older
• * Evidence of progressive keratoconus (based on the discretion of the physician as evidenced by an increase in astigmatism, asymmetry, or worsening vision in the last 3 or more months)
• * Presence of central or inferior steepening.
• * Axial topography consistent with keratoconus
• * Presence of one or more findings associated with keratoconus such as:
• * Fleischer ring
• * Vogt's striae
• * Decentered corneal apex
• * Munson's sign
• * Rizzutti's sign
• * Apical Corneal scarring consistent with Bowman's breaks
• * Scissoring of the retinoscopic reflex
• * Crab-claw appearance on topography
• * Steepest keratometry (Kmax) value ≥ 47.20 D
• * I-S keratometry difference \> 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or topography map
• * Posterior corneal elevation \>16 microns
• * Thinnest corneal point \<485 microns
• * AvaGen (Avellino Labs) genetic testing keratoconus risk score of 67 or higher (high risk).
• * Signed written informed consent
• * Willingness and ability to comply with schedule for follow-up visits
• * For Contact Lens Wearers Only: 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: 2 Weeks per decade of wear
• * Scleral Lenses
• * Investigator Discretion \[Discontinuation of scleral lenses not required unless there is clinical evidence of corneal hypoxia (e.g. corneal neovascularization) at time of screening\]
• * Signed written informed consent
• * Willingness and ability to comply with schedule for follow-up visits
• * Eyes classified as either normal or atypical normal on the severity grading scheme.
• * Corneal pachymetry at the screening exam that is \<330 microns at the thinnest point in the eye(s) to be treated.
• * Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
• * History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthomeoeba, etc.)
• * 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.
• * Pregnancy (including plan to become pregnant) or lactation during the course of the study
• * A known sensitivity to study medications
• * Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
• * Patients with active medical implants (e.g. cardiac pacemakers)'
• * Patients who are aphakic/ pseudophakic