Safety and Effectiveness of the PXL Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Position

Inclusion Criteria

• •1. 12 years of age or older
• •2. Signed written informed consent
• •3. Willingness and ability to comply with schedule for follow-up visits
• •4. Presence of central or inferior steepening
• •5. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
• •6. Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as
• •1. Fleisher 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
• •7. Steepest keratometry (Kmax) value greater than or equal to 47.2
• •8. I-S keratometry difference \< 1.5 D on the Pentacam map or topography map
• •9. Posterior corneal elevation \> 16 microns
• •10. Thinnest corneal point \<485 microns
• •11. Predicted Post LASIK/PRK stromal ablation depth \<350 microns or expected keratometry \>47.2, or patients undergoing PRK/SMILE in keratoconus suspect eyes
• •12. Bacterial or fungal 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
• •13. Contact lens wearers only:
• •1. Removal of contact lenses for the require period of time prior to the screening refraction:
• •Contact Lens Type Discontinuations Time: Soft, 1 week; Soft Extended Wear, 2 weeks; Soft Toric, 3 weeks; Rigid Gas Permeable, 2 weeks per decade of wear -