NCT04240457

Safety and Efficacy of Corneal Crosslinking Using the PXL-Platinum 330 for Eyes With Corneal Ectatic Conditions

Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Crosslinking in Eyes With Corneal Ectatic Conditions

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Arbor Center for Eye Care · Academic / Other
• Sex: All
• Age: 12 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and effectiveness of the PXL Platinum 330 device for performing Corneal Crosslinking in patients 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, intraocular pressure and visual function questionnaire assessments.

Conditions

• Keratoconus
• Cornea Ectasia

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.	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: 2020-07-08
• Primary completion: 2023-02-18
• Completion: 2023-02-18
• First posted: 2020-01-27
• Last updated: 2024-12-12
• Results posted: 2024-09-23

Locations

1 site across 1 country: United States

Regulatory

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