This study is being conducted to evaluate the safety and effectiveness of using the PXL Platinum 330 system for performing corneal collagen cross-linking (CXL) for the treatment of corneal thinning disorders. The PXL Platinum 330 system is a combination product consisting of a UVA 365 nm wavelength light source (PXL Platinum 330 Illumination System) and riboflavin (Peschke-TE 0.25% ophthalmic solution or Peschke-L 0.23% ophthalmic solution) administered in conjunction with the UVA light as a photosensitizer.
The primary objective of this study is to evaluate the safety and effectiveness of corneal collagen cross-linking (performed using the PXL-Platinum 330 system) for treating corneal curvature and biomechanical anomalies associated with corneal thinning conditions, e.g., progressive or non-progressive keratoconus, pellucid marginal degeneration, and treatment of patients with bacterial or fungal keratitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
The cross-linking procedures will be performed on an outpatient basis using the PXL Platinum 330 System (UVA light source and riboflavin solution).
UPMC Eye Center
Pittsburgh, Pennsylvania, United States
PXL-Platinum 330 system
Keratometry
Time frame: 12 months
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