NCT04177082

Safety and Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

Evaluation of the Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions Using Peschke Riboflavin Solution

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Cornea Associates of Texas · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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, pachymetry, and visual function.

Conditions

• Keratoconus
• Pellucid Marginal Corneal Degeneration
• Corneal Degeneration
• Corneal Ectasia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-01-10
• Primary completion: 2022-05-05
• Completion: 2022-05-05
• First posted: 2019-11-26
• Last updated: 2022-10-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study