Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
249
Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea
Cornea Associates of Texas
Dallas, Texas, United States
K-Max
Change in K-Max measured by corneal topography, compared to baseline
Time frame: 12 Months
K-Mean
Change in K-Mean measured by corneal topography, compared to baseline
Time frame: 12 Months
Uncorrected Visual Acuity
Change in uncorrected corrected visual acuity using snellen measurements, compared to baseline
Time frame: 12 Months
Best Corrected Visual Acuity
Change in best corrected visual acuity using snellen measurements, compared to baseline
Time frame: 12 Months
Central Pachymetry
Change in central pachymetry, measured by Pentacam compared to baseline
Time frame: 12 Months
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