NCT04094090

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Goodman Eye Center · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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.

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, intraocular pressure, pachymetry, and visual function questionnaire.

Conditions

• Keratoconus
• Pellucid Marginal 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: 2019-10-19
• Primary completion: 2029-10-19
• Completion: 2029-10-19
• First posted: 2019-09-18
• Last updated: 2025-10-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study