Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking

ConditionsKeratoconus, Unstable Bacterial Keratitis Ectasia of Cornea

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution
Combination product
Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea

Treatment groups

300 Participants

are divided into 2 treatment groups

Group A: Pulsed, acceleratedExperimental treatment 1 intervention

Group B: ConventionalActive comparator 1 intervention

Trial outcomes

Primary outcomes

Mean keratometry in diopters

Average keratometry across the anterior topography of the cornea computed by a validated Scheimpflug topographer

Time frame

12 months

Secondary outcomes

Best corrected visual acuity

Measurement of best corrected visual acuity on the validated early-treatment diabetic retinopathy study scale

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pacific Clear Vision Institute

Lead sponsor

Source ClinicalTrials.gov

Apply now