Safety and Effectiveness of the PXL-Platinum 330 System

STATUS

Recruiting
participants needed

300
sponsor

Colorado Eye Consultants/Cornea Consultants of Colorado

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Updated on 19 February 2024

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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	8years - 100years
Treatment	PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
Clinical Study Identifier	NCT04401865
Sponsor	Colorado Eye Consultants/Cornea Consultants of Colorado
Last Modified on	19 February 2024

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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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Safety and Effectiveness of the PXL-Platinum 330 System