To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.
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, intraocular pressure, and pachymetry.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea
Colorado Eye Consultants/Corneal Consultants of Colorado
Littleton, Colorado, United States
RECRUITINGChicago Cornea Consultants, Ltd.
Highland Park, Illinois, United States
ACTIVE_NOT_RECRUITINGCleveland Eye Clinic
Brecksville, Ohio, United States
RECRUITINGCorrected distance visual acuity
Change in corrected distance visual acuity (CDVA) at the last required study visit (6 months post-op), compared to baseline.
Time frame: 6 months
Uncorrected visual acuity
Change in UCVA at 6 months, compared to baseline.
Time frame: 6 months
Keratometry
Change in Kmax, compared to baseline.
Time frame: 12 months
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