CompletedPhase 2

Safety and Effectiveness of the PXL Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Position

United States12 participantsStarted 2020-05-04

Plain-language summary

To determine whether the Peschke PXL-330 is safe and effective in the treatment of corneal thinning conditions.

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 12 years of age or older
✓. Signed written informed consent
✓. Willingness and ability to comply with schedule for follow-up visits
✓. 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
✓. Fleisher ring
✓. Vogt's striae

✕. Eyes classified as normal or atypical normal on the severity grading scheme
✕. Corneal pachymetry at the screening exam that is \<300 microns at the 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 the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross-linking procedure.
✕. Pregnancy (including plan to become pregnant) or lactation during the course of the study
✕. A known sensitivity to the study medications
✕. Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment of diagnostic tests.

Mean keratometry in diopters

Timeframe: 1 year

NCT IDNCT04213885

SponsorEye Specialists of Indiana

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-05

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 12 years of age or older
✓. Signed written informed consent
✓. Willingness and ability to comply with schedule for follow-up visits
✓. 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
✓. Fleisher ring
✓. Vogt's striae

✕. Eyes classified as normal or atypical normal on the severity grading scheme
✕. Corneal pachymetry at the screening exam that is \<300 microns at the 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 the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross-linking procedure.
✕. Pregnancy (including plan to become pregnant) or lactation during the course of the study
✕. A known sensitivity to the study medications
✕. Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment of diagnostic tests.