Safety and Efficacy of Corneal Crosslinking Using the PXL-Platinum 330 for Eyes With Corneal Ecta… (NCT04240457) | Clinical Trial Compass
TerminatedPhase 2
Safety and Efficacy of Corneal Crosslinking Using the PXL-Platinum 330 for Eyes With Corneal Ectatic Conditions
Stopped: Study was terminated due to enrollment and other challenges attributable to the Covid-19 public health emergency.
United States11 participantsStarted 2020-07-08
Plain-language summary
To evaluate the safety and effectiveness of the PXL Platinum 330 device for performing Corneal Crosslinking in patients with corneal thinning conditions.
Who can participate
Age range12 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 12 years of age or older
✓. Presence of central or inferior steepening.
✓. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
✓. Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as:
✓. Fleischer ring
✓. Vogt's striae
✓. Decentered corneal apex
✓. Munson's sign
Exclusion criteria
✕. 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.
✕. Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
✕. History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthamoeba, 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.