NCT04213885

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Eye Specialists of Indiana · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

To determine whether the Peschke PXL-330 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
• Ectasia Corneal
• Bacterial Keratitis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	PXL 330 Platinum device/Riboflavin	30mW, 5 sec, 5 sec off, 10 minutes of illumination

Timeline

• Start date: 2020-05-04
• Primary completion: 2024-08-05
• Completion: 2024-08-05
• First posted: 2019-12-30
• Last updated: 2024-08-29

Locations

1 site across 1 country: United States

Regulatory

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