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

Inclusion Criteria31

• Subjects who have one or both eyes that meet criteria 1 \& 2 and 1 or more of the following criteria will be considered candidates for this study.
• 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