Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Conditions
Pacific Clear Vision Institute
Summary
To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.
Description
Patients with progressive keratoconus, pellucid marginal degeneration, infectious keratitis, 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 visual function questionnaire.
Eligibility
- Age range
- 12–45 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Subjects who have one or both eyes that meet criteria 1 \& 2 and 1 or more of the following criteria will be considered candidates for this study. * 12 years of age or older * Evidence of progressive keratoconus (based on the discretion of the physician as evidenced by an increase in astigmatism, asymmetry, or worsening vision in the last 3 or more months) * Presence of central or inferior steepening. * Axial topography consistent with keratoconus * Presence of one or more findings associated with keratoconus such as: * Fleischer ring * Vogt's striae * Decentered corneal…
Interventions
- Combination ProductPXL-330 Platinum device for crosslinking with Peschke ribofflavin solution
Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea
Location
- Pacific Clear Vision InstituteEugene, Oregon