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, pachymetry, and visual function questionnaire.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
500
Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea
Goodman Eye Center
San Francisco, California, United States
RECRUITINGBest-contact corrected visual acuity (BSCVA)
Change in BSCVA compared to baseline.
Time frame: 3, 6, and 12 months
Uncorrected visual acuity
Change in UCVA compared to baseline.
Time frame: 3, 6, and 12 months
Keratometry
Change in Kmax, compared to baseline.
Time frame: 1 year
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