Safety and Effectiveness of the PXL-Platinum 330 System

  • STATUS
    Recruiting
  • participants needed
    300
  • sponsor
    Colorado Eye Consultants/Cornea Consultants of Colorado
Updated on 19 February 2024
keratoconus
riboflavin
radial keratotomy
terrien's marginal degeneration

Summary

To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.

Description

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.

Details
Condition Keratoconus, Corneal Ectasia, Pellucid Marginal Corneal Degeneration
Age 8-100 years
Treatment PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
Clinical Study IdentifierNCT04401865
SponsorColorado Eye Consultants/Cornea Consultants of Colorado
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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