NCT03918408

Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Pacific Clear Vision Institute · Academic / Other
• Sex: All
• Age: 12 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.

Detailed description

Patients with progressive keratoconus, pellucid marginal degeneration, infectious keratitis, 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 visual function questionnaire.

Conditions

• Keratoconus, Unstable
• Bacterial Keratitis
• Ectasia of Cornea

Interventions

Type	Name	Description
COMBINATION_PRODUCT	PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution	Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea

Timeline

• Start date: 2019-09-01
• Primary completion: 2029-12-01
• Completion: 2030-12-01
• First posted: 2019-04-17
• Last updated: 2024-11-12

Locations

1 site across 1 country: United States

Regulatory

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