Safety and Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

Patients with progressive keratoconus, pellucid marginal degeneration, or at risk for post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery. Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, pachymetry, and visual function.

Inclusion criteria

Subjects who have one or both eyes that meet criteria 1-4 and also meet at least 1 or more of criteria 5-11 will be considered candidates for this study:

• 8 years of age or older
• Signed written informed consent
• Willingness and ability to comply with schedule for follow-up visits
• 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 3 days Soft Extended Wear 3 days Soft Toric 3 days Rigid gas permeable 2 Weeks

• Subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses.
• Presence of central or inferior steepening.
• Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
• Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, 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/Orbscan map or topography map
• Posterior corneal elevation >16 microns
• Thinnest corneal point >300 microns