About this trial

To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.

Eligibility criteria

Qualifiers

Fleischer ring

Vogt's striae

Decentered corneal apex

Munson's sign

Disqualifiers

Eyes classified as either normal or atypical normal on the severity grading scheme.

Corneal pachymetry at the screening exam that is <300 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 riboflavin solution

Treatment groups

500 Participants
are divided into 2 treatment groups

Locations

1
Goodman Eye Center94115, San FranciscoCalifornia, United States

Sponsors and collaborators

Goodman Eye Center

Lead sponsor