Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12-45
SponsorPacific Clear Vision Institute
About this trial
To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.
Eligibility criteria
Qualifiers
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
Disqualifiers
Eyes classified as either normal or atypical normal on the severity grading scheme.
Corneal pachymetry at the screening exam that is <330 microns at the thinnest point in the eye(s) to be treated.
History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthomeoeba, etc.)
Clinically significant corneal scarring in the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross-linking procedure.
Trial design
Treatments tested in this trial
- PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov