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

Phase 1

Completed

• Conditions: Corneal Ectasia; Corneal Degeneration; Pellucid Marginal Corneal Degeneration; Keratoconus
• Interventions: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

• Registration Number: NCT04177082
• Lead Sponsor: Cornea Associates of Texas

Brief 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.

Study Timeline

• Study First Submitted: 2019-11-22
• Study First Submitted QC: 2019-11-22
• Study First Posted: 2019-11-26
• Study Start: 2020-01-10
• Primary Completion: 2022-05-05
• Study Completion: 2022-05-05
• Status Verified: 2022-09
• Last Update Submitted: 2022-10-17
• Last Update Posted: 2022-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulsed 6mW/cm2	PXL-330 Platinum device for crosslinking with Peschke riboflavin solution	6mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 30 minute total treatment time
Pulsed 4mW/cm2	PXL-330 Platinum device for crosslinking with Peschke riboflavin solution	4mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 45 minute total treatment time

Primary Outcome Measures

Name	Time	Method
K-Max	12 Months	Change in K-Max, compared to baseline
K-Mean	12 Months	Change in K-Mean, compared to baseline

Secondary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity	12 Months	Change in best corrected visual acuity, compared to baseline
Central Pachymetry	12 Months	Change in central pachymetry, compared to baseline
Uncorrected Visual Acuity	12 Months	Change in uncorrected visual acuity, compared to baseline

Trial Locations

Locations (1)

Cornea Associates of Texas; 🇺🇸 Dallas, Texas, United States