Safety and Effectiveness of the PXL -Platinum 330 System for Cornea Collagen Crosslinking in Eyes With Corneal Thinning Conditions
This study study is to determine the effectiveness of cornea cross linking in patients with Keratoconus or other cornea thinning conditions.
• healthy subjects with no other medical or ocular conditions
∙ Subjects who have one or both eyes that meet criteria 1 and 1 or more of the following criteria will be considered candidates for this study:
• 18 years of age or older
• Presence of central or inferior steepening (on Pentacam topograph)
• Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration (See keratoconus grading section 7.0 for details)
• Presence of one or more findings associated with keratoconus or pellucid marginal degeneration on slit lamp exam 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 on simK or Pentacam
• I-S keratometry difference \> 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or topography map
• Posterior corneal elevation \>16 microns (µm on Pentacam tomography)
• Thinnest corneal point \<485 microns (ultrasound pachymetry or Pentacam tomography)
• Predicted Post LASIK/PRK stromal ablation depth \<350 microns or expected keratometry \>47.2 D, or patients undergoing PRK/SMILE in keratoconus suspect eyes
• Bacterial or fungal corneal 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
• 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
• Signed written informed consent
• Willingness and ability to comply with schedule for follow-up visits