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

Completed · Phase 2

Conditions studied: Keratoconus, Unstable, Ectasia Corneal, Bacterial Keratitis

In brief

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

Key facts

Study ID

NCT04213885

Run by

Eye Specialists of Indiana

People needed

12

Starts

2020-05-04

Expected to finish

2024-08-05

Last updated by the study team

2024-08-29

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.
• Patients with a current condition that, in the physician's opinion, wold interfere with or prolong epithelial healing.

Where it is running

• Eye Specialists of Indiana — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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