Trial | NCT04401865  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    300
To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.
Patients with progressive keratoconus, pellucid marginal degeneration, or at risk for post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery. Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, intraocular pressure, and pachymetry.
Study Started
Jun 01
2020
Primary Completion
Jun 30
2022
Anticipated
Study Completion
Jun 30
2023
Anticipated
Last Update
Jan 25
2022

Combination Product PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea

  • Other names: Corneal cross-linking

Pulsed, Accelerated Experimental

5 mW, 10 sec on, 10 sec off, 24 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Conventional Active Comparator

4 mW, 10 sec on, 10 sec off, 30 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Criteria 

Inclusion Criteria:

Diagnosis of keratoconus, forme fruste keratoconus, post-LASIK ectasia, pellucid marginal degeneration, forme fruste pellucid marginal degeneration, history of radial keratotomy with fluctuating vision, Terrien's marginal degeneration.
Must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form.
Must be willing and able to return for scheduled treatment and follow-up examinations for the duration of the study.
Must be at least 8 years of age.
Non-consenting/impaired individuals with a LAR's signature

Exclusion Criteria:

Corneal thickness < 300 microns measured by ultrasound or Pentacam.
Contraindications or sensitivities to any study medications or their components.
Pregnancy or breastfeeding.
Any history of Herpes simplex corneal disease in an eye to be treated.
Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment.
Inability to cooperate with diagnostic tests.
Current enrollment in another ophthalmic clinical trial.
No Results Posted