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

Inclusion Criteria

• •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.
• •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